CN110161266B

CN110161266B - Method for collecting liquid sample

Info

Publication number: CN110161266B
Application number: CN201810715825.XA
Authority: CN
Inventors: 吴志强; 洪亮; 朱杨煜; 科恩·罗玲; 吴淑江
Original assignee: Hangzhou Biotest Biotech Co Ltd
Current assignee: Hangzhou Biotest Biotech Co Ltd
Priority date: 2018-02-13
Filing date: 2018-06-29
Publication date: 2020-07-31
Anticipated expiration: 2038-06-29
Also published as: CN209014585U; CN110161266A; CN209559910U; CN209014587U; CN208953548U; CN209014584U; CN209014586U; CN209656722U; CN209148707U; CN110161268A; CN209559909U; CN208721694U; CN209656723U; CN110161265A; CN110161264A; CN110161267A

Abstract

The present invention provides a method of collecting and detecting a liquid sample, the method comprising: there is provided an apparatus for collecting a liquid sample, wherein the apparatus comprises: a first chamber for collecting a liquid sample, wherein the first chamber has an opening for receiving the liquid sample; a second chamber for collecting a liquid sample for confirmation of detection, the second chamber having an opening for receiving the liquid sample from the first chamber; a tray structure comprising a second cavity, wherein the tray structure is detachably combined, coupled or combined with the first cavity. A first chamber is used to collect a liquid sample, and the liquid sample is allowed to enter a chamber through an opening of the first chamber. Wherein the first chamber has an aperture in fluid communication with the second chamber. The method can avoid the pollution to the sample when the detection reagent strip of the traditional device is contacted with the liquid sample; the space required for storing the liquid sample is effectively reduced, and the risk of leakage of the liquid sample in the transportation process is greatly reduced.

Description

Method for collecting liquid sample

The application claims priority of the prior application of China, application No. 201810150485.0, application date 2018-02-13.

Technical Field

The present invention relates to a method for collecting a liquid sample, and more particularly to a device and method for collecting and detecting an analyte in a liquid sample in the field of rapid diagnosis, such as a urine collection and detection device.

Background

Currently, a large number of test devices for detecting whether a sample contains an analyte are used in hospitals or homes, and these test devices for rapid diagnosis include one or more test reagent strips, such as an early pregnancy test, a drug abuse test, and the like. The rapid diagnosis test device is convenient, and can obtain the test result on the test reagent strip within one minute or at most ten minutes.

Drug detection is widely applied and is commonly used in drug-resistant departments, public security bureaus, drug rehabilitation centers, physical examination centers, national soldier physical examination places and other institutions. The drug detection urine cup has various drug detection types and frequent times, and has a huge market demand, and after the drug detection urine cup on the market finishes detection, the sample in the urine cup is polluted by the detection reagent and cannot be continuously used for secondary confirmation detection, for example, as described in U.S. patent 7300633.

Although, in the conventional technique, the sample to be tested can be isolated from the collected sample, it is costly and not easy to handle. For example, U.S. patent No. 7,300,633 describes a piston urine cup that allows a liquid sample, such as urine, in a collection chamber to be transferred from the collection chamber to a detection chamber during advancement of a piston, where a test element is located to detect an analyte in the sample, and the liquid sample in the collection chamber is separated by the piston so that the two samples do not mix, and can be used for subsequent confirmatory testing. Although the sample that can keep apart the detection like this and the sample of collecting, the urine cup of this kind of piston is with high costs, and the operation is difficult moreover, and it needs great strength to promote the piston after all, this because the piston needs to reach and shifts the sample, must need to play liquid seal's effect with the wall of piston, reaches sealed effect and needs to let piston and piston chamber inseparable combination, in addition, when carrying out the secondary detection, must transport whole device to inspection mechanism and go on.

For another example, U.S. patent 8,992,855 describes a device for collecting a liquid sample that includes a piston structure integral with and movable with a cap, and that, while allowing separation of the test sample from the collected sample, requires a large amount of pressure to be overcome to access the test sample after it has entered the test chamber, and requires the cap and cup to be precisely dimensioned so that the piston integral with the cap can be accurately inserted into the separation chamber.

In addition, after the initial tests of these conventional collecting and detecting devices are completed, if the subsequent confirmation tests are required, the whole collecting and detecting device needs to be transported to a confirmation and detection mechanism for further confirmation tests, which brings about many problems, at least such problems: first, most current liquid collection and testing devices are provided with only a preliminary testing chamber. If subsequent confirmation detection is required, the whole device containing the urine and the detection reagent strip can only be sent to a confirmation detection mechanism for detection. Thus, the sample in the urine cup may be contaminated with the detection reagent. Secondly, when the whole device is sent to the confirmation detection mechanism, the risk of liquid leakage exists in the transportation process due to the fact that the cup opening is large, and therefore more cost is needed to enable the device to have a better sealing effect, and the risk of leakage is reduced as much as possible; third, the confirmation and testing mechanism requires a large low-temperature warehouse to store the entire testing device, preventing the liquid sample from deteriorating, and preparing for possible further confirmation and testing later, which causes a significant increase in the cost of the confirmation and testing mechanism (which may be referred to as a secondary testing mechanism).

In view of the above technical problems, it is desirable to improve the above and provide an alternative way to overcome the shortcomings of the conventional technologies.

Disclosure of Invention

In view of the above, to overcome the defects of the prior art, the present invention provides a detection device capable of separating an initial detection sample and a confirmation detection sample (secondary detection), which can allow the initial detection sample and the confirmation detection sample to enter two cavities, such as a first cavity and a second cavity, after a liquid sample is collected and before or after detection, and then separate the second cavity from the initial collection cavity (first cavity) after or before the initial detection is completed, thereby realizing detachable separation of the second cavity and the cavity for initially collecting the sample. A second chamber separate from the initial collection chamber may be used for a subsequent second test or a subsequent confirmation test. So as to achieve the effective separation of the initial detection sample and the subsequent possible confirmation detection sample (second detection), and finally the first collection is performed at least two detections.

It is also contemplated that when the collection device includes two chambers that receive the same liquid sample, e.g., urine, simultaneously or sequentially, one of the chambers, e.g., the first chamber, is used to collect a portion of the liquid sample and the other chamber, e.g., the second chamber, is used to collect another portion of the liquid sample. When collected or while collected, the liquid in the first chamber may be used to contact the test element to perform a first test, and the second chamber may be separated from the first chamber for a second test.

In a first aspect of the invention, there is provided a device for collecting a liquid sample, the device comprising: a first chamber for collecting a liquid sample; and a second chamber for collecting a sample of the test fluid for confirmation; wherein, the first cavity and the second cavity are detachably combined, combined or connected.

In some preferred forms, the first chamber and the second chamber are in fluid communication before the second chamber is separated from the first chamber; alternatively, when the first chamber and the second chamber are combined together, the first chamber and the second chamber are in a liquid communication state. Thus, whether the first chamber or the second chamber collects or receives a liquid sample, the liquid can be allowed to flow within both chambers, such that the flow is either an active flow or a passive flow.

In some preferred modes, the active flow is that the liquid can naturally flow from the first cavity to the second cavity or from the second cavity to the first cavity without external force. In some preferred forms, the passive flow is by external force to allow liquid to flow from the first chamber to the second chamber or from the second chamber to the first chamber. The external force may be negative pressure, or liquid pressing, so as to make the liquid flow.

In some preferred forms, the first and second chambers are not in fluid communication after or just prior to separation of the second chamber from the first chamber, thus allowing fluid not to flow between the two chambers. In some preferred forms, the first and second chambers are not in liquid communication prior to or just prior to separation of the second chamber from the first chamber. Alternatively, in some preferred forms the second chamber is separate from the first chamber while the first and second chambers are not in fluid communication. In some preferred embodiments, the second chamber is separated from the first chamber, and the second chamber stores the liquid sample from the first chamber. In some preferred embodiments, the second chamber also collects the liquid sample from the first chamber during or after collection of the liquid sample from the first chamber. In some preferred embodiments, the second chamber collects the liquid sample from the first chamber at the same time that the first chamber collects the liquid sample.

In some further embodiments, the first and second chambers are removably combined together by a combination location through which the chambers are separated. The combination is that the two cavities are separated before use, assembled together when in use, and separated after use. Alternatively, the first chamber and the second chamber may be directly combined together, or may be indirectly combined together through a structure. The combined position may be where the first and second chambers are in physical contact. Thus, in another aspect of the invention, the first chamber and the second chamber are initially assembled and the second chamber is separated from the first chamber after the liquid sample is collected. The first chamber may be used for a first test and the second chamber for a second test or confirmation test. In an alternative mode, the first cavity and the second cavity are separated and not assembled together, after the liquid sample is collected, the second cavity is combined with the first cavity, so that part of liquid is communicated or flows between the first cavity and the second cavity, and when secondary detection is needed, the two cavities are separated. The first chamber may be used for a first test and the second chamber for a second test or confirmation test.

In a second aspect, the present invention provides a device for collecting a liquid sample, the device comprising: a first chamber for collecting a liquid sample; and a second chamber for collecting a sample of the test fluid for confirmation; wherein the first cavity and the second cavity are indirectly or directly detachably combined, combined or connected together through a combination position.

In some preferred forms, the second chamber and the first chamber are in fluid communication via a connecting channel. In some preferred forms, the first and second chambers are in fluid communication via the connecting channel before the second chamber is separated from the first chamber. In some preferred forms, after or while the second chamber is separated from the first chamber, the first and second chambers are not in fluid communication, and the channel is sealed. In some preferred embodiments, the second chamber is separated from the first chamber, and the second chamber stores the liquid sample from the first chamber. In some preferred embodiments, the second chamber also collects the liquid sample from the first chamber through the connecting channel during or after the collection of the liquid sample from the first chamber. In some preferred embodiments, the second chamber collects the liquid sample from the first chamber through the connecting channel at the same time as the first chamber collects the liquid sample.

In one embodiment of all of the foregoing aspects, the first chamber includes an opening for collecting the liquid sample, and the liquid sample enters the first chamber through the opening. In some preferred embodiments, the connecting channel is in fluid communication with the first chamber and the second chamber, and the liquid sample can be exchanged between the first chamber and the second chamber through the connecting channel. In some preferred forms, the liquid sample is able to flow from the first chamber to the second chamber through the connecting channel. In some preferred forms, the connecting channel has a first opening in fluid communication with the first chamber and a second opening in fluid communication with the second chamber. In some preferred forms, the connecting channel is located on or in the first chamber. The second cavity is detachably connected, combined or combined with the first cavity through the connecting channel. Thus, the connecting channel may allow the first and second chambers to be in an indirect removable combination, joined or connected together.

In some preferred forms, the connecting channel includes a structure connecting the first chamber and the second chamber and a structure separating the first chamber and the second chamber, wherein the structure connecting the first and second chambers is a space or a duct constituting the channel. In some other preferred modes, the connecting channel has two states of sealing or non-sealing, and when in the non-sealing state, the liquid can flow from the first cavity to the second cavity. Preferably, when the connecting passage is in a sealed state, the liquid of the first chamber cannot flow from the connecting passage into the second chamber. Therefore, the connection passage is sealed or not sealed to define a state of fluid communication between the first chamber and the second chamber, and if the connection passage is not sealed, fluid communication between the two chambers is possible, and when the connection passage is sealed, there is no fluid communication between the two chambers.

In a third aspect of the invention, a sealing element is provided that can seal a connection channel, leaving the connection channel in a sealed state. In a preferred mode, the connecting channel connects the first chamber and the second chamber, so that the second chamber is in a liquid-tight state with the first chamber by sealing with the sealing element. In some preferred forms, the device further includes a sealing member that seals the connecting passage. In some preferred embodiments, the sealing element excludes the liquid sample from the interior of the second chamber while sealing the channel, simultaneously with sealing, or after sealing. Preferably, the liquid sample is expelled into the first chamber. Alternatively, the sealing member seals the connecting channel while a portion of the liquid sample (if any) within the connecting channel is excluded from the connecting channel, e.g., in the first chamber or elsewhere. In some preferred forms, the sealing element may further include an elastic sealing ring, which allows the sealing element to contact the inner wall of the connecting passage, thereby allowing the sealing element to be more sealed. In other preferred forms, the sealing element is more flexible relative to the connecting channel, so that upon contact between the two, either one is deformed or squeezed, thereby bringing the sealing element into intimate contact with the inner wall of the connecting channel, thereby providing a sealing effect. For example, the sealing member is elastic and the connecting passage is rigid, so that when an external force forces the sealing member into the connecting passage, the elastic member is compressed and deformed, thereby sealing the connecting passage.

In other forms, the sealing element and the connection are sealed by means of a thread. For example, the sealing element has an external thread and the connecting channel has an internal thread, the sealing element sealing the connecting channel by means of relative rotation. In other preferred forms, the sealing element is a cap-like structure having internal threads and the outer edge of the first opening of the connecting channel has external threads, so that the sealing element and the connecting channel can act as a seal.

In a fourth aspect of the invention, the device of the invention may further comprise a drainage member, part of which enters the second chamber before the sealing member seals the first opening of the connecting channel. In some preferred forms, part of the drainage member enters the second chamber after the sealing member seals the opening of the connecting passage. Alternatively, part of the drainage element may pass through the connection channel into the second chamber before the sealing element seals the first opening of the connection channel.

In a fourth aspect of the invention, therefore, the device of the invention provides a drainage member for draining a portion of the liquid in the second chamber out of the second chamber. Preferably, part of the drainage element enters the second chamber before the sealing element seals the first opening of the connecting channel. In some preferred forms, part of the drainage member enters the second chamber after the sealing member seals the opening of the connecting passage. Optionally, the drainage element enters the second chamber through the connecting channel, thereby draining a portion of the liquid out of the second chamber. In some preferred forms, the drainage member and the sealing member are integrally formed. In some forms the drainage member enters the fluid connection passage before the sealing member. Preferably, the second chamber is detachably combined with, combined with or connected to the first chamber through the second opening of the liquid connection channel. Or alternatively, the liquid discharge member is adjacent the first opening of the connecting channel prior to the sealing member, wherein the first opening is in fluid communication with the first chamber. In some preferred forms, the sealing element is integrally or removably associated with the drainage element, or in some forms, the sealing element serves two functions, sealing and drainage, and optionally the drainage element serves two functions, sealing the link channel while drainage occurs. The difference in names here is merely a difference in function, and of course both functions can be realized by one element.

In a fifth aspect of the invention, the device of the invention may further comprise a lyophobic passage through which the liquid removed by the liquid removing member or the sealing member is removed to the outside of the connection passage and/or the second chamber. So-called out-of-band includes in the first cavity or elsewhere, e.g. in the receiving cavity. In some preferred forms, a liquid receiving chamber is included in the sealing member, and the liquid sample discharged from the second chamber enters the receiving chamber of the sealing member through the lyophobic passage. The term "receiving chamber" is used herein to refer to a chamber that collects excess liquid displaced by the drainage member or sealing member, and thus the receiving chamber may be the first chamber, or may be elsewhere, such as a space in the sealing member or drainage member. Thus, the drained liquid enters the receiving cavity through the lyophobic passage. In some preferred modes, the lyophobic passage is provided with one or more liquid inlets, and liquid is enabled to enter the holding cavity through the liquid inlets. In some preferred forms, the liquid inlet is located downstream of the first opening of the connecting channel. Or the lyophobic channel is provided with one or more liquid inlets which are positioned on the sealing element, wherein the liquid inlets are led into the connecting channel before the sealing element. In some preferred modes, after the sealing element seals the connecting channel, the liquid inlet opening of the lyophobic channel is positioned in the second cavity. In some preferred forms, the housing cavity is located within the sealing member. In some preferred modes, the liquid inlet of the lyophobic channel is positioned on the wall of the sealing element. In some preferred modes, the liquid inlet of the lyophobic channel is positioned at the tail end of the sealing element.

In some preferred modes, the sealing element and the liquid discharging element are connected into a whole structure, wherein the liquid discharging element enters the connecting channel before the sealing element. In some preferred forms, part of the drainage element enters the second chamber and a sealing element seals the connecting channel, preferably the sealing element is located in the connecting channel. In some forms, the liquid inlet of the lyophobic passage is located between the sealing element and the liquid discharge element, or below the sealing element, or above the liquid discharge element. In some embodiments, the liquid inlet of the lyophobic passage is arranged at the tail end of the liquid discharge element, and the liquid discharge element enters the connecting passage before entering the second cavity before entering the liquid discharge element.

In a sixth aspect of the present invention, there is provided an open first cover for covering the first chamber for collecting the liquid sample, wherein a sealing member for sealing the connection passage is connected to the cover, or the sealing member and the cover are integrated into a single structure. Thus, when the first cover body covers the opening of the first cavity, the sealing element also enters the connecting channel to seal the connecting channel. In some preferred forms, the first cover includes a sealing member. In some preferred forms, a sealing member coupled to the first cover seals the first opening of the connection passage while the first cover closes the first cavity opening. The process of closing the opening of the first cavity by the first cover body is almost performed substantially simultaneously with the process of sealing the first opening of the connecting channel by the sealing element. Or when the sealing element and the liquid discharging element are connected into a whole, or the sealing element and the liquid discharging element are arranged on the first cover body, the three parts can be connected into a whole or can be detachably combined. Thus, the cover body covers the opening of the first cavity, the process from the cover body to the cover body is also the process that the sealing element seals the opening of the connecting channel, the liquid drainage element drains part of liquid (if any) in the second cavity, and the redundant drained liquid enters the holding cavity through the liquid drainage channel.

In some preferred forms, the central axis of the sealing element on the cover and the central axis of the connecting channel are substantially collinear, so that when the first cover covers the first cavity opening, the sealing element also seals the connecting channel. In some preferred forms, the sealing element is removably connected to the cover. In some forms, the sealing member is threadably coupled to the cap. In some embodiments, the sealing element is connected to the cover body through the connecting rod, so that the first cavity has a certain depth, when the cover body covers the opening of the first cavity, the sealing element is located at or close to the opening of the connecting channel, and when the cover body covers the first cavity, the sealing element connected to the connecting rod enters the connecting channel from the first opening close to the connecting channel, so as to seal the connecting channel.

It will be appreciated that the sealing element is attached at one end to a connecting rod, and the other end of the connecting rod is attached to the cover, and movement of the cover causes the sealing element to move synchronously, e.g. rotation of the cover causes rotation of the sealing element, or top-to-bottom movement of the cover also causes top-to-bottom movement of the sealing element. It will be further appreciated that the synchronous movement is such as to seal the connecting passage when the sealing element seals the connecting passage by means of a piston. Of course, if the sealing element and the connecting channel are threaded, the simultaneous rotation may also cause the sealing element to seal the connecting channel.

In some embodiments, the present invention provides an open first cover for covering the first chamber for collecting the liquid sample, wherein the first cover comprises a sealing element and a drainage element, or the sealing element and the drainage element are connected to the cover, or are connected to the cover as an integral structure. In some preferred modes, when the first cover body covers the opening of the first cavity, the sealing element connected with the first cover body seals the first opening of the connecting channel, and the drainage element enters the second cavity. It will be appreciated that movement of the first cover member moves the sealing member and the drainage member together.

In a seventh aspect of the present invention, in some preferred forms, the apparatus of the present invention may further include a second cover for sealing the opening of the second chamber. In some embodiments, the second cover is disposed on the second cover, and when the opening of the second cavity needs to be sealed, the second cover is removed from the first cover to seal the opening of the second cavity. Therefore, in some embodiments, the second cover is located on the first cover and is disposed on the first cover by means of a screw, a piston, a plug, or the like. In other preferred forms, the second cover is removably located on the first cover so that the second cover can be easily removed from the first cover.

In some preferred forms of all of the foregoing, the second chamber has an opening for collecting a liquid sample. In some preferred forms, the opening of the second chamber is in fluid communication with the second opening of the connecting channel. In some preferred forms, the second chamber is removably connected to the connection passage by a screw thread. In some preferred modes, the opening of the second cavity is provided with an internal thread and an external thread, wherein the internal thread is matched and connected with the external thread of the connecting channel. The external thread of the opening of the second cavity is matched and connected with a second cover body covering the opening of the second cavity. Alternatively, the second cavity and the second opening of the connecting channel may be detachably connected together without a thread, and may be in a snap-fit manner.

In some preferred forms, the device further comprises a test element, the test element being in fluid communication with the first chamber. In some preferred forms, the device further comprises a detection chamber, and the test element is located in the detection chamber.

In an eighth aspect, the present invention provides a method of collecting a liquid sample, providing a device for collecting a liquid sample as described above, the device comprising a first chamber for collecting a liquid sample; and a second chamber for collecting a liquid sample for confirmation testing; wherein, the first cavity and the second cavity are detachably combined, combined or connected; and allowing the liquid sample to enter the first cavity through the opening of the first cavity, and allowing the liquid sample to enter the second cavity from the first cavity.

In some preferred forms, the device includes a connecting channel that places the first chamber in fluid communication with the second chamber.

In some preferred forms, the method provides a sealing member for sealing the connecting passage after the liquid enters the second chamber.

In some preferred forms, the sealing member seals the connecting passage and separates the second chamber from the first chamber.

In some preferred modes, after the second cavity is separated from the first cavity, the opening of the second cavity is covered by the cover body.

In some preferred forms, the method includes, after separating the second chamber from the first chamber, leaving the first chamber and the second chamber out of fluid communication. In some preferred embodiments, the second chamber is used to store the liquid sample from the first chamber after the second chamber is separated from the first chamber. In some preferred embodiments, the second chamber is also allowed to collect the liquid sample from the first chamber either during or after collection of the liquid sample from the first chamber. In some preferred embodiments, the second chamber collects the liquid sample from the first chamber at the same time that the first chamber collects the liquid sample.

In some preferred forms, the method includes placing the first chamber and the second chamber in fluid communication via a connecting channel. In some preferred forms, the first and second chambers are placed in fluid communication through the passageway before the second chamber is separated from the first chamber. In some preferred forms, after or while separating the second chamber from the first chamber, the first chamber and the second chamber are not in fluid communication, and the connecting channel is sealed. In some preferred embodiments, the second chamber is separated from the first chamber, and the second chamber stores the liquid sample from the first chamber. In some preferred embodiments, the second chamber also collects the liquid sample from the first chamber through the connecting channel during or after the collection of the liquid sample from the first chamber. In some preferred embodiments, the second chamber collects the liquid sample from the first chamber through the connecting channel at the same time as the first chamber collects the liquid sample.

In some preferred forms, the first chamber includes an opening for collecting the liquid sample, and the liquid sample is allowed to enter the first chamber through the opening. In some preferred embodiments, the connection channel connects the first chamber and the second chamber, so that the liquid sample can be exchanged between the first chamber and the second chamber through the connection channel. In some preferred forms, the liquid sample is able to flow from the first chamber to the second chamber through the liquid channel. In some preferred forms, the connecting channel has a first opening and a second opening, wherein the first opening is in fluid communication with the first chamber and the second opening is in fluid communication with the second chamber. In some preferred forms, the connecting channel is located on or in the first chamber. The second chamber is detachably connected, combined or combined with the first chamber through the liquid channel.

In some preferred forms, the connecting passage has a structure for connecting the first chamber and the second chamber and a structure for separating the first chamber and the second chamber, wherein the structure for connecting the first chamber and the second chamber is a space constituting the passage. Or the connecting channel has two states of sealing or non-sealing, and when in the non-sealing state, the liquid can flow from the first cavity to the second cavity; when the connecting channel is in a sealed state, the liquid in the first cavity cannot flow from the connecting channel to the second cavity.

In some preferred forms, the method comprises: the apparatus includes an open first cover for covering the first chamber for collecting the liquid sample, wherein a sealing member is coupled to and engages the cover. In some preferred forms, the first cover includes a sealing member. In some preferred forms, the sealing element to which the first cover is attached seals the second cavity opening of the connecting channel while or during or after the first cover closes the first cavity opening. In some preferred modes, the cover body comprises a second cover body used for sealing the opening of the second cavity. In some preferred forms, the sealing element is removably connected to the cover. In some forms, the sealing member is threadably coupled to the cap.

In some preferred forms, the second chamber has an opening for collecting a liquid sample. In some preferred forms, the opening of the second chamber is in fluid communication with the second chamber opening of the connecting channel. In some preferred forms, the second chamber is removably connected to the connection passage by a screw thread. In some preferred modes, the opening of the second cavity is provided with an internal thread and an external thread, wherein the internal thread is matched and connected with the external thread of the connecting channel. The external thread of the opening of the second cavity is matched and connected with a second cover body covering the opening of the second cavity.

The above detachable connection mode of the first cavity and the second cavity is detachable connection through the structural design of the connecting channel and the second cavity, and the detachable connection is direct connection. In some preferred forms, the second chamber may be removably connected, combined or joined to the first chamber by a threaded connection, and the first and second chambers are in fluid communication when directly removably combined together between the second and chambers. Preferably, the first and second chambers are in fluid communication via a connecting channel. In some preferred forms, the opening of the second chamber is in fluid communication with the second opening of the connecting channel. In some preferred forms, the second chamber is provided on a base which forms a removable combination with the first chamber. Optionally, the second chamber and the base also form a removable combination. Thus, when the base is directly combined with the first chamber, the connection channel of the opening of the second chamber is brought into fluid communication. When the base is separated from the first chamber, the second chamber located on the base is separated from the second chamber along with the base. Preferably, when the base is separated from the first chamber, the second chamber located on the base is separated from the connection passage along with the base. In some preferred modes, after the base and the second cavity on the base are separated from the first cavity, the second cavity is separated from the base. In some preferred modes, after the second cavity is separated from the base, the opening of the second cavity is covered by the second cover body.

In a sixth aspect of the present invention, there is also provided a method for collecting a liquid sample, the method comprising providing the aforementioned apparatus for collecting a liquid sample, the apparatus comprising a first chamber and a second chamber, wherein the second chamber and the first chamber are detachably connected, and collecting a liquid sample with the first chamber, and allowing the liquid sample to flow into the second chamber.

In some preferred embodiments, the second chamber is separated from the first chamber when the second chamber contains the liquid sample, and the opening of the second chamber is covered by the second cover.

In some preferred forms, the first chamber and the second chamber are connected together by a connecting channel, wherein the first opening of the connecting channel is in fluid communication with the first chamber and the second opening of the connecting channel is in fluid communication with the second chamber.

In some preferred forms, the device further comprises a sealing element for sealing the connecting passage before the second chamber is separated from the first chamber.

In some preferred modes, the device further comprises a cover body, and the cover body and the sealing element are connected into a whole structure, so that when the cover body covers the opening of the first cavity, the cover body drives the sealing element to seal the second opening of the connecting channel.

In some preferred embodiments, the cover body carries the sealing element into the connecting channel. In some preferred forms, the second chamber is separated from the first chamber after the sealing member seals the connecting passage.

In some preferred modes, a liquid drainage element for draining part of liquid in the second cavity is further arranged on the cover body, so that the cover body drives the liquid drainage element to enter the second cavity. In some preferred forms, the cover has a sealing member and a drainage member, the drainage member being advanced into the second chamber before the sealing member.

In some preferred forms, the device further comprises a lyophobic passage, through which the liquid sample discharged from the liquid discharge element is discharged to the outside of the second cavity. In some preferred modes, the sealing element enters the connecting channel, and liquid discharged by the sealing element is discharged out of the connecting channel through the lyophobic channel.

In some preferred modes, the liquid removed by the sealing element or the liquid discharging element is discharged into the first cavity through the lyophobic passage. In some preferred modes, a containing cavity is arranged on the cover body, the containing cavity is in liquid communication with the lyophobic channel, and liquid discharged by the sealing element or the liquid discharging element is discharged into the containing cavity through the lyophobic channel.

In a ninth aspect, the present invention provides a method of detecting the presence of an analyte in a liquid sample, the method comprising the liquid collection device of any of the above aspects, and detecting the liquid sample from the first chamber with the test element after the liquid sample has been collected in the first chamber. And after the detection result is obtained, separating the second cavity from the first cavity according to any mode.

In some embodiments, the device further comprises a detection chamber for receiving the test element, the detection chamber being in fluid communication with the first chamber, and the fluid flowing into the detection chamber when the first chamber has collected the fluid sample. When the detection cavity comprises the test element, the second cavity is separated from the first cavity after the test element completes detection. In some preferred embodiments, the liquid sample is allowed to pass from the first chamber into the detection chamber and then into the second chamber. Such a configuration is designed as described above, so as to avoid that liquid entering the detection chamber also enters the second chamber, thereby contaminating the liquid sample in the second chamber.

In a tenth aspect of the present invention, there is provided a cover provided with a sealing member for sealing the connecting passage. In some preferred modes, a sealing ring is arranged on the sealing element. In some preferred forms, the sealing element and the connecting channel are of the same or different materials. In some preferred forms, the sealing element is of a flexible material and the connecting channel is of a rigid material. In some preferred modes, the sealing element is connected with the first cover body into an integral structure through a connecting rod. In some preferred modes, the sealing element further comprises an opening of the lyophobic passage. In some preferred forms, the opening of the lyophobic passage is located below the sealing member, or the opening of the lyophobic passage is advanced into the connecting passage prior to the sealing member. In some preferred modes, the cover body further comprises a containing cavity, and the containing cavity is in liquid communication with the lyophobic channel. The containing cavity is communicated with the opening of the lyophobic passage. In some preferred forms, the housing cavity is located in the sealing member.

In other preferred forms, a drainage member is further provided on the first cover, the drainage member being further from the first cover than the sealing member. Alternatively, the drainage element is arranged below the sealing element, or the sealing element and the drainage element are arranged such that the drainage element enters the second chamber before the sealing element, or the drainage element enters the connection channel before the sealing element. Or, when the cover body is provided with the connecting rod to connect the first cover body and the sealing element, and the sealing element is connected with the liquid drainage element. Alternatively, the connecting rod and the sealing element and the drainage element are of an integral structure.

Advantageous effects

By adopting the structure, the device has the characteristics of simple and reasonable structure, low cost of used materials and excellent performance; the secondary detection is convenient. Particularly, when subsequent confirmation detection is required, the whole detection device is not required to be sent to the testing mechanism for detection, but only the second cavity is taken out of the device and then sent to the detection structure, so that the detection device is safe, saves space and cost, and is more environment-friendly.

Drawings

Fig. 1 is a schematic exploded view of a collection device according to an embodiment of the present invention.

Fig. 2 is a schematic perspective view of a cover according to an embodiment of the present invention.

Fig. 3 is a schematic longitudinal sectional view of the cover shown in fig. 2 according to an embodiment of the present invention.

FIG. 4 is a schematic longitudinal sectional view of the first chamber (without the detection chamber) in an embodiment of the present invention.

Fig. 5 is a schematic longitudinal sectional view of a second chamber according to an embodiment of the present invention.

Fig. 6 is a perspective view of an embodiment of the present invention without a first cover.

Fig. 7 is a schematic longitudinal sectional view of the device of fig. 6 according to the present invention, in which the first chamber and the second chamber are combined.

Fig. 8 is a partially enlarged schematic view of a combination of a first chamber and a second chamber according to an embodiment of the present invention.

Fig. 9 is a perspective view of a combination of a first chamber and a second chamber in an embodiment of the present invention.

Fig. 10 is a perspective view illustrating an operation process of the first cover body covering the opening of the first cavity according to an embodiment of the present invention.

Fig. 11 is a schematic perspective view of a first cover covering an opening of a first cavity according to an embodiment of the present invention.

FIG. 12 is a schematic cross-sectional view of the device shown in FIG. 11, according to an embodiment of the present invention.

Fig. 13 is a schematic perspective view illustrating a structure in which the second cavity is separated from the first cavity and the second cover is separated from the first cover according to an embodiment of the present invention.

Fig. 14 is a schematic perspective view illustrating a second cover covering a second cavity according to an embodiment of the present invention.

Fig. 15 is a schematic perspective view of an apparatus according to another embodiment of the present invention.

Fig. 16 is a perspective view of a first chamber according to an embodiment of the present invention.

FIG. 17 is a perspective view of a test element carrier according to one embodiment of the present invention.

Fig. 18 is a perspective view of a first cover with a sealing member according to an embodiment of the present invention.

FIG. 19 is a schematic perspective view of a first chamber (without a second chamber) in accordance with an embodiment of the present invention.

Fig. 20 is a schematic sectional view showing a structure of a second chamber combined with the first chamber according to an embodiment of the present invention (a partially-enlarged view of the first chamber and the second chamber being detachably combined).

Fig. 21 is a schematic perspective view of the first cover after the first cover starts to cover the opening of the first cavity (operation process) according to another embodiment of the present invention.

FIG. 22 is a schematic cross-sectional view of the device of FIG. 21 in accordance with an embodiment of the present invention (the sealing member does not seal the connecting channel and begins to approach the opening).

FIG. 23 is a schematic cross-sectional view of the device shown in accordance with one embodiment of the present invention (sealing element into the connecting channel).

Fig. 24 is a schematic perspective view illustrating a structure in which the second cavity is separated from the first cavity and the second cover is separated from the first cover according to an embodiment of the present invention.

Fig. 25 is a schematic perspective view of a combination process of a second chamber and a first chamber in a detecting or collecting device according to another embodiment of the present invention (the second chamber is located in a tray structure).

Fig. 26 is a schematic structural view of the detecting or collecting device of the present invention after the first chamber and the tray are combined.

Fig. 27 is a schematic cross-sectional structure view of the structure shown in fig. 26 in the detecting or collecting device of the present invention.

Fig. 28 is a schematic structural view of a second cavity sealed by a second cover according to another embodiment of the present invention.

Fig. 29 is a schematic view of the second chamber leaving the tray.

Fig. 30 is a perspective view of a tray without a second chamber coupled to a first chamber.

Fig. 31 is a perspective view of a first cover with a sealing member according to another embodiment of the present invention.

Fig. 32 is a cross-sectional view of the first cover with a sealing member according to another embodiment of the present invention shown in fig. 31.

Fig. 33 is a perspective view of another embodiment of the present invention with a sealing element.

Fig. 34 is a schematic cross-sectional structure view of the structure shown in fig. 33.

Fig. 35A and 35B are schematic views showing the structure of one of the sealing member, the drainage member, or the sealing member shown in fig. 33, which is interchanged or absent.

FIG. 36 is a schematic diagram of the separation and combination of a first chamber and a second chamber in accordance with further embodiments of the present invention.

Fig. 37 is a schematic view of a combination of a first chamber and a second chamber according to another embodiment of the present invention.

Fig. 38A and 38B are schematic views showing the structure of fig. 37 in which the first chamber is separated from the second chamber and the first chamber is used for secondary confirmation detection.

FIG. 39 is a schematic perspective view of a first chamber and a second chamber according to further embodiments of the present invention.

FIG. 40 is a schematic diagram of a schematic three-dimensional structure of a first chamber and a second chamber separated and combined according to further embodiments of the present invention.

Detailed Description

The structures referred to in the present invention or these terms of art used therein are further described below, and if not otherwise indicated, they are understood and interpreted in accordance with the common general terminology used in the art.

Detection of

Detection refers to assaying or testing for the presence of a substance or material, such as, but not limited to, a chemical, organic compound, inorganic compound, metabolic product, drug or drug metabolite, organic tissue or a metabolite of organic tissue, nucleic acid, protein, or polymer. In addition, detection indicates the amount of the test substance or material. Further, the assay means immunodetection, chemical detection, enzyme detection, and the like.

Sample(s)

The test device or collected sample of the present invention comprises a biological fluid (e.g., a case fluid or a clinical sample). The liquid sample or liquid sample may be derived from solid or semi-solid samples, including fecal matter, biological tissue, and food samples. The solid or semi-solid sample may be converted to a liquid sample by any suitable method, such as mixing, triturating, macerating, incubating, dissolving, or enzymatically digesting a solid sample in a suitable solution (e.g., water, phosphate solution, or other buffered solution). "biological samples" include samples derived from animals, plants and food, including, for example, urine, saliva, blood and components thereof, spinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures, cell cultures and media of tissues and organs derived from humans or animals. Preferably the biological sample is urine. Food samples include food processing materials, end products, meat, cheese, wine, milk and drinking water. Plant samples include those derived from any plant, plant tissue, plant cell culture and medium. An "environmental sample" is derived from the environment (e.g., a liquid sample from a lake or other body of water, a sewage sample, a soil sample, groundwater, seawater, and a waste liquid sample). Environmental samples may also include sewage or other wastewater.

Any analyte can be detected using a suitable detection element of the invention. The invention is preferably used for detecting drug small molecules in saliva and urine. Of course, the collecting device of the present invention can collect any form of the above samples, whether initially solid or liquid, as long as the liquid or liquid sample flows into the first chamber, the liquid sample can flow into the second chamber at the same time or later, and since the second chamber can be detachably combined, combined or connected with the first chamber, when the subsequent confirmation detection is required, the second chamber is separated from the first chamber, so that the second chamber can perform the secondary detection, and the liquid in the first chamber can perform the primary detection. Alternatively, the liquid in the second chamber may be tested for a first time and the liquid in the first chamber may be tested for a second time.

Alternatively, after the liquid sample or processed sample is collected in the first chamber in a liquid state, it is necessary to use the second chamber to extract a portion of the liquid sample in the first chamber for subsequent confirmation tests before or after the initial test is performed. The first chamber may be initially combined with the second chamber, or may be combined at the time of use and then separated.

Downstream and upstream

Downstream or upstream is divided with respect to the direction of liquid flow, typically liquid flows from upstream to downstream regions. The downstream region receives liquid from the upstream region, and liquid may also flow along the upstream region to the downstream region. It is also generally divided in the direction of liquid flow, for example, on materials that use capillary forces to urge liquid flow, the liquid may flow by gravity in the opposite direction to gravity, and in this case, the upstream and downstream are also divided in the direction of liquid flow. For example, in some preferred forms of the collection device of the present invention, the first chamber serves as a chamber for collecting the liquid sample, and the second chamber is in fluid communication with the first chamber, with liquid entering the first chamber flowing into the second chamber, which may be referred to as upstream and downstream. Of course, this flow is a natural flow under the gravity of the liquid. Alternatively, the natural flow is a flow of liquid from the first chamber into the second chamber. Of course, the liquid may flow passively from upstream to downstream, for example, the liquid is forced to flow from upstream to downstream or from a low position to a high position by a reaction force, which may be a capillary action or a force of an external pressure, so that the liquid flows from a low position to a high position.

Gas or liquid communication

By gas or liquid communication is meant that liquid or gas can flow from one place to another, possibly guided by some physical structure during the flow. By physical structures is generally meant that the liquid flows passively or actively to another place through the surface of the physical structures or the space inside the physical structures, and passively is generally a flow caused by external force, such as a flow under capillary action. The flow here can also be a liquid or a gas, because of its own effect (gravity or pressure), or a passive flow. Communication herein does not necessarily mean that a liquid or gas is required to be present, but merely that in some cases a connection or condition between two objects, if any, may flow from one object to the other. This refers to a state in which two objects are connected, and conversely, if there is no liquid communication or gas communication between the two objects, if there is liquid in or on one object, the liquid cannot flow into or on the other object, and such a state is a state of non-communication, non-liquid or gas communication.

Detachable combination

A removable combination, as used herein, means that two elements are physically connected in a number of different positions or locations, e.g., when two elements are physically separated, when connected or combined together in a first instance where appropriate, and when two elements are separated in a second instance where appropriate, the separation being physically separate and not touching. Alternatively, the two components may initially be combined, and where appropriate, may be physically separated. Alternatively, the two objects may be initially separate and combined together to perform a function when desired, and then separated, or later combined again for a purpose. In general, the combination of the two components or the separation of the two components can be easily performed, and the combination or the separation can be repeated for a plurality of cycles, and of course, the combination and the separation can be performed in a disposable manner. In addition, the two components can be detachably combined, and also three or more components can be detachably combined in pairs. For example, there are first, second and third members, the first member and the second member can be detachably combined, the second member and the third member can be detachably combined, and the first member and the third member can be detachably combined or separated. In addition, the combination mode can be that the two objects are detachable, and the two objects can be indirectly combined through other objects.

Test element

The term "test element" as used herein refers to an element that can detect whether a sample or specimen contains an analyte of interest, and the detection can be based on any technical principles, such as immunology, chemistry, electricity, optics, molecular, nucleic acid, physics, etc. The test element may be a lateral flow test strip which detects a plurality of analytes. Of course, other suitable test elements may be used with the present invention,

various test elements may be combined for use in the present invention. One form is a test strip. Test strips for the analysis of analytes, such as drugs or metabolites indicative of a physical condition, in a sample may be in various forms, such as immunoassay or chemical assay forms. The test strip may be used in a non-competitive or competitive assay format. The test strip includes a bibulous material having a sample application area, a reagent area, and a test area. The sample is added to the sample application zone and flows by capillary action to the reagent zone. In the reagent zone, the sample binds to the reagent if the analyte is present. The sample then continues to flow to the detection zone. Other reagents, such as molecules that specifically bind to the analyte, are immobilized at the detection zone. These reagents react with the analyte (if present) in the sample and bind the analyte to the zone, or to one of the reagents of the reagent zone. The label for indicating the detection signal is present in the reagent zone or in a separate label zone.

A typical non-competitive assay format is one in which a signal is generated if the sample contains the analyte and no signal is generated if the analyte is not present. In a competition method, a signal is generated if the analyte is not present in the sample and no signal is generated if the analyte is present.

The test element can be a test paper, and can be made of water-absorbing or non-water-absorbing materials. The test strip may include a variety of materials for liquid sample delivery. One of the test strips may be coated with another material, such as a nitrocellulose membrane coated with filter paper. One region of the test strip may be selected from one or more materials and another region may be selected from a different one or more materials. The test strip may be adhered to some support or hard surface for improved strength when the test strip is held in place.

The analyte is detected by a signal producing system, such as one or more enzymes that specifically react with the analyte, and one or more compositions of the signal producing system are immobilized on the analyte detection zone of the test strip by a method such as that described above for the immobilization of a specific binding substance on the test strip. The signal-producing substance can be on the sample addition zone, reagent zone, or detection zone, or the entire test strip, and the substance can be impregnated on one or more materials of the test strip. A solution containing the signal is applied to the surface of the strip or one or more materials of the strip are immersed in the solution containing the signal. The strip to which the solution containing the signal substance was added was dried.

The various regions of the test strip may be arranged as follows: the device comprises a sample adding area, a reagent area, a detection area, a control area, a sample adulteration area and a liquid sample absorption area. The control zone is located behind the detection zone. All zones may be arranged on a strip of test paper using only one material. It is also possible to use different materials for the different zones. The zones may be in direct contact with the liquid sample, or different zones may be arranged according to the direction of flow of the liquid sample, with the ends of each zone being contiguous with and overlapping the ends of the other zone. The material used can be a material with good water absorption such as filter paper, glass fiber or nitrocellulose membrane. The test strip may take other forms.

A commonly used reagent strip is a nitrocellulose membrane reagent strip, i.e., a detection area comprises a nitrocellulose membrane, and a specific binding molecule is fixed on the nitrocellulose membrane to display the detection result; and may be a cellulose acetate film, a nylon film, or the like. Such as the reagent strips or devices containing the reagent strips described in some of the following patents: US 4857453; US 5073484; US 5119831; US 5185127; US 5275785; US 5416000; US 5504013; US 5602040; US 5622871; US 5654162; US 5656503; US 5686315; US 5766961; US 5770460; US 5916815; US 5976895; US 6248598; US 6140136; US 6187269; US 6187598; US 6228660; US 6235241; US 6306642; US 6352862; US 6372515; US 6379620; and US 6403383. The test strips disclosed in the above patent documents and similar devices with test strips can be applied to the test element or the test device of the present invention for detecting an analyte, such as an analyte in a sample.

The test strips of the present invention may be of the so-called lateral flow test strips (L inorganic flow test strips), the specific structure and detection principles of which are well known to those of ordinary skill in the art, a conventional test strip comprising a sample collection area comprising a sample receiving pad, a labeling area comprising a labeling pad, a wicking area comprising a bibulous pad, wherein the detection area comprises the necessary chemical substance to detect the presence of an analyte, such as an immunological or enzymatic chemical reagent, a conventional test strip is a nitrocellulose strip, i.e., the detection area comprises a nitrocellulose membrane on which specific binding molecules are immobilized to show the results of the test, a cellulose acetate or nylon membrane, or the like, a test result control area downstream of the detection area, wherein the control area and the detection area are of course present in the form of a transverse line, are provided as a test strip or a control line, such test strip is a reagent strip, other test strip using capillary action, or other types of reagent strips, such as described herein, a reagent strip is provided with a liquid reagent, or a reagent strip for detecting the presence of a detectable substance, such as a reagent, a reagent strip for detecting the presence of a capillary action, a reagent strip for detecting the presence of a liquid, a reagent strip for detecting the presence of a reagent strip being provided as described below, a reagent strip, a reagent for detecting the present in a reagent, a reagent strip, or a reagent strip for detecting a reagent strip, a reagent strip for detecting the detection reagent strip, and a reagent for detecting the presence of the present in a reagent strip, a reagent strip for detecting a reagent for detecting a capillary action, or a reagent for detecting a reagent for.

In addition to the test strip described above or the lateral flow test strip itself being used to test for the presence of an analyte in a liquid sample by contacting the liquid in the first chamber. In some preferred embodiments, the test element may also be disposed on some carrier, such as some card 106, which has a plurality of recesses therein, and the test element is disposed in the recess, and the entire test card is disposed in the detection chamber 105, with the sample application area of the test element at the bottom 1051 of the detection chamber to contact the liquid sample. Such a liquid sample may be from the first chamber 103, for example, the liquid sample may be in fluid communication through a through-hole 1038 between the detection chamber 105 and the first chamber (e.g., as shown in fig. 9 and 1). The sample application region of the test element can be positioned in the sample collection region of the detection chamber to contact the liquid sample, thereby completing detection of the analyte.

In another aspect, such as that shown in fig. 16 and 17, a carrier 206 is provided having a plurality of channels sealed 2062 at one end and open 2063 at the other end, one or more test strips are disposed in the channels, with a sample application area at one end of the opening 2063, and one or more test strip-receiving channels in the carrier 206, with a test element disposed in each channel, and when there are a plurality of channels, different analyte test elements can be disposed in each channel, such that multiple analytes can be detected from the same sample. The carrier 206 is placed in the first cavity 203 with two retaining

strips

2032 and 2033 on the walls of the cavity 203, and the carrier 206 is inserted or snapped into the two retaining grooves with the open channel end 2065 near the bottom of the first cavity and the sealed channel end 2064 near the opening 2031 of the first cavity (fig. 16). When the liquid sample flows into the first chamber through the opening 2031 of the first chamber, the liquid sample contacts the sample application area of the test strip, thereby completing the test. Such vectors are described in detail in the applicant's U.S. patent application Ser. No. 15/644,148, and Chinese patent application Nos. 2016106132817, 2016106079834. Of course, in addition to the carriers disclosed in the above patents, additional carriers may be employed in the present invention as carriers for carrying test strips.

For example, in some embodiments, the first chamber may collect a liquid sample and then use the test element alone to perform the analyte detection in the liquid sample in the first chamber. The test is performed with a test strip or a card or carrier with a test strip inserted into the first chamber. It will be appreciated by those skilled in the art that the test strips may not be disposed on a carrier, but rather may be present independently, and that the detection chamber 105 of the present invention may be absent in some cases, or the test strips may be absent in some cases, as described herein. As will be explained in more detail later.

Analyte substance

Examples of analytes that can be used in the present invention include small molecules including drugs (e.g., drugs of abuse). "drugs of abuse" (DOA) refers to drugs used at non-medical destinations (usually acting as paralytic), abuse of which may lead to physical and mental damage, dependence, addiction and/or death, examples of drug abuse include cocaine, amphetamine AMP (e.g., black americans, white amphetamine tablets, dextroamphetamines, dextroamphetamine tablets, Beans), methamphetamine MET (crank, mefenamipramine, crystal, speed), barbiturate BAR (e.g., Valium □, rolfine, Nutley, nejersey), sedative (i.e., hypnotic drugs), lysergic acid diacetylamide (L SD), inhibitors (e.g., dowers, barnacles, meyerba, hypnotics, mejayejay), anti-anxiety or anti-anxiety, or anti-anxiety drug-anxiety, such as amphetamine, or amphetamine-containing compounds, which are readily absorbed by benzodiazepine, amphetamine, or.

For example, analytes to be detected using the present invention include, but are not limited to, creatinine, bilirubin, nitrite, protein (non-specific), hormones (e.g., human chorionic gonadotropin, progesterone hormone, follicle stimulating hormone, etc.), blood, leukocytes, sugars, heavy metals or toxins, bacterial material (e.g., proteins or carbohydrate materials directed against specific bacteria, such as Escherichia coli 0157: H7, staphylococci, Salmonella, Clostridium, Campylobacter, L. monocytogenes, Vibrio, or Cactus) and substances associated with physiological characteristics in urine samples, such as pH and specific gravity.

Flow of liquid

The flow of liquid usually refers to a flow from one place to another, and in general, the natural liquid flow mostly depends on gravity from high to low, and the flow here also depends on external force, i.e. the flow under the external gravity condition, and can be the natural gravity flow. In addition to gravity, the flow of liquid may also overcome gravity and move from low to high. For example, the liquid is pumped, or the liquid is compressed, or the liquid is pressurized and flows from the bottom to the top, or the pressure is concerned and flows by the gravity of the liquid itself. For example, in fig. 9,19, 22 and 27, the first chamber is located above the second chamber, and the second chamber is located below the first chamber, so that when liquid enters the second chamber, the liquid can naturally flow into the second chamber from the first chamber by gravity and can naturally flow into a downstream position from an upstream position.

Detection or collection device

The detection device is a device for detecting whether or not an analyte is contained in a sample. The collection device is used for collecting and storing the liquid sample. The detection means may comprise collecting means which may also comprise detection means, or the collecting means may be separate from the detection means, and the collecting means and the detection means may be combined at the time of detection, thereby completing the detection. The collection device and the detection device may be an integrated device, once the liquid sample is collected, the detection can be performed immediately to obtain the test result, and the separation of the detection sample and the collection sample is performed simultaneously, so that the secondary detection can be performed (if necessary). The meanings of the detection device or the detection cavity can be interchanged, and the collecting device and the collecting cavity can be interchanged, so that the functions are interchanged only by playing different roles. For example, when the present invention refers to a collecting device, it may not comprise a detection chamber or a test element, but the collecting device may comprise a test element or a carrier containing a test element, and the collecting device containing a test element may also be referred to as a detection device. Of course, the collecting device may comprise a space for arranging the test elements, but does not necessarily have to comprise test elements, which may subsequently be combined with the collecting device at any suitable time to form the detecting device. For example, the collection device may include a space for receiving a test element, such as a test chamber 105 (FIG. 7), or a suitable location in the fluid collection chamber of the collection device for positioning a test element or a carrier containing a test element (FIG. 16), so that the present invention may be designed for collecting a fluid sample only, or may be a test device that performs a test simultaneously with the collection.

The first chamber and the second chamber being detachably combined, coupled, or co-operating

The first chamber and the second chamber of the invention can form a combination of detachable pairs, and when the first chamber and the second chamber are combined before liquid collection is needed, the second chamber can be separated from the first chamber after the liquid sample collection is finished. Or the first cavity and the second cavity are separated, when the liquid sample needs to be collected, the first cavity and the second cavity are combined together, and after the collection is finished, the first cavity and the second cavity are separated. In some embodiments of the present invention, as shown in fig. 1-14, the present invention provides a testing device for testing whether a liquid sample contains an analyte or not, or a collecting device for collecting a liquid sample, which comprises a first chamber 103 and a second chamber 104, wherein the first chamber 103 can be used as a collecting chamber, i.e. for collecting a liquid sample, and wherein the first chamber and the second chamber are detachably combined, connected or assembled.

The word "combine, connect, or assemble" as used herein means substantially the same thing, and the words used herein differ only and may mean combined, and such combination corresponds to "separate". The binding and separation can be carried out under any conditions and can be freely selected. In some embodiments, the first and second chambers are in fluid communication when the first and second chambers are combined. In other embodiments, the first and second chambers are not in fluid communication prior to or during or after separation of the first and second chambers.

In some preferred forms, the device further comprises a connecting channel, the first lumen being removably engaged, bonded or otherwise assembled with the connecting channel. Thereby, a detachable attachment, coupling or assembly with the second chamber is achieved. As shown in FIG. 9, the first chamber 103 is used as a collection chamber having an opening 1031 for collecting or receiving a liquid sample, which flows into the first chamber 103, and a connection passage 109 having a first opening 1091 at the bottom thereof and a second opening 1092 at the other end thereof. The first opening 1091 of the connecting channel 109 is in fluid communication with the first chamber 103, and the liquid sample in the first chamber can flow into the connecting channel 109 through the first opening 1091 and then flow out through the second opening 1092 at the other end. Therefore, the present invention provides a chamber for collecting a fluid sample, said chamber comprising an opening 1031 for allowing the fluid sample to enter the chamber 103, and a channel in the bottom of the collection chamber, said channel having a first opening and a second opening, wherein a portion of the fluid sample can enter the connecting channel through the first opening 1091 of the connecting channel and flow out through the second opening 1090 of the connecting channel. Outflow means outflow outside the first chamber 103. Preferably, the liquid flowing out of the connecting channel enters the second chamber 104. The collecting device may therefore also comprise a second chamber, typically a first chamber having an opening and side walls and a bottom enclosing a single chamber. The connecting channel is generally located on the bottom of the first chamber. In this particular embodiment, the connecting channel is located on the region of the base. However, the connecting channel is not limited to the position, and may be located on the sidewall or at the junction of the bottom and the sidewall. Any position that allows the liquid sample entering the collection chamber 103 to enter the connecting channel.

"connecting channel" as used herein generally means a structure that connects a first chamber and a second chamber, when desired, to allow the first chamber and the second chamber to be connected or joined together, and when in some cases, to allow the second chamber and the first chamber to be separated. In fact, the connecting channel serves two functions, one is to connect the first and second chambers together in a detachable manner, and the other is to serve as a fluid connection between the first and second chambers, through which fluid can flow between the two chambers, such as a tube, a channel, or other means, so that the use of the "connecting channel" is a preferred embodiment of the invention. It will be appreciated that in the preferred embodiment herein, the connection and the channel having the fluid communication between the first and second chambers are the same structure providing two different functions, such as the tubular structure of the present invention, and that the connection channel shown in fig. 9 or 9 and 4 also has a structure connecting the second chamber to the first chamber and also providing fluid communication. It is to be understood that the mechanism for connecting the channels may be defective, as will be described in further detail below. Of course, the term "connecting channel" is understood to be a connecting channel that serves only as a connecting channel, allowing the second chamber and the first chamber to be detachably connected or combined, and does not have a function of allowing the second chamber and the first chamber to be in fluid communication; alternatively, the term "connecting channel" is also to be understood as merely functioning to bring the second chamber into fluid communication with the first chamber, and not as a connecting channel between the first chamber and the second chamber. Alternatively, the term "connecting channel" is also understood to mean a connecting channel as described above, i.e. a connecting channel which has the same function as the connecting channel and also has the function of allowing fluid communication.

In some preferred forms, the connecting channel has an external thread on the outside of the second opening. The second cavity 104 is provided, the second cavity 104 has an opening 1042, the outer diameters of the second opening 1042 and the connecting channel are equal to or slightly larger than the outer diameter of the connecting channel, and an inner thread is provided inside the opening of the second cavity 104, so that the second cavity and the first cavity can be detachably matched, combined or connected through the matching of the outer thread of the connecting channel and the outer thread of the second cavity. Namely, when the combination is carried out, the second cavity is directly connected with the connecting channel in a threaded mode; when disassembly is required, the form of the counter-rotating thread allows the second chamber 104 to be separated from the connecting channel and thus from the collecting chamber 103. Alternatively, internal threads may be provided in the second opening 1092 of the connecting channel, external threads may be provided outside the opening 1042 of the second chamber 104, and the internal threads of the channel opening may mate with the external threads of the second chamber to allow the first and second chambers to be assembled or connected in a removable manner. When the second chamber is separated from the first chamber, the opening 1042 of the second chamber is covered by the second cover, thereby sealing the second chamber.

Of course, alternatively, as shown in fig. 9, the outer wall of the second opening 1092 of the connecting channel is not threaded, but rather, an elongated space 1098 is provided on the outer wall of the second opening 1092 of the connecting channel 109, which is just matched with the opening of the second cavity 104, i.e. the thickness of the opening of the second cavity. For example, the elongated space is formed by the outer wall 1905 of the second opening 1092 of the connecting channel and the corresponding wall 110 (for example, as shown in fig. 8), and the wall 110 is provided with a thread structure which is matched with the external thread at the opening 1042 of the second cavity 104, so that the external thread of the second cavity is matched with the thread on the wall 110, thereby realizing the combination of the first cavity and the second cavity, and the combination is also completed by matching the inner wall of the opening of the second cavity with the outer wall of the end 1092 of the connecting channel. The second chamber 104 and the first chamber 103 are in a removable fit, combination or connection. In order to allow a better sealing fit between the first chamber and the second chamber, a second sealing ring 107 may be provided inside the opening of the second chamber, which allows the inner wall of the opening of the second chamber to be more closely fitted with the outer wall of the connecting channel, thereby preventing the liquid sample entering the second chamber 104 from leaking (see fig. 8 and 9). It will be understood by those skilled in the art that "detachable" as used herein means that two objects can be combined together to form a unitary structure when desired and can be easily separated when desired, such separation being primarily in a physical sense without physical contact in the spatial structure.

The detachable means can be any other means besides screw-type connection, such as snap-type connection, plunger type connection, plug-in type connection, snap-lock type connection, etc., as long as the first chamber and the second chamber can be combined together when necessary, so as to obtain a part of liquid sample from the first chamber, and when the two are required to be separated, the first chamber and the second chamber are separated. For example, in the form of a screw thread, that is, a screw thread that is rotated in the opposite direction to disengage from the first chamber; or may be unlocked in some other manner, such as by being withdrawn, and then easily separated from the second chamber 104 after the second chamber has been emptied of the liquid sample from the first chamber. This way of obtaining a liquid may allow the first chamber 103 and the second chamber 104 to be in liquid communication when connected.

Of course, in a specific embodiment, it is also preferred that the connection channel 109 and the first cavity 103 are injection molded once, while the second cavity 104 is injection molded separately, by detachable bonding, engagement or combination with the connection channel. It will be appreciated that the connecting channel 109 and the second cavity 104 are injection molded in one piece, and that it is also possible that the connecting channel 109 and the second cavity 104 are detachably joined, joined or combined with the first cavity 103.

Therefore, it is also possible that the function of so-called "connecting" is performed by a separate structure itself, with the first and second chambers being in fluid communication by another structure. It is also easy to understand that the first and second chambers are connected together in a detachable manner, for example by means of a connecting mechanism, while the liquid cannot flow between the second and first chambers by means of the connecting mechanism itself, but instead by means of another structure, for example a channel, the liquid flows from the first chamber to the second chamber. It will therefore be appreciated that in some preferred forms the device further comprises a connecting structure by which the first and second chambers are releasably engaged, joined or assembled, when connected by the connecting structure, to place the first and second chambers in fluid communication. The fluid communication may here be through further structures, such as tubes, channels, grooves, to put the two chambers in fluid communication.

It will be appreciated by those skilled in the art that the connecting channel 109 may be omitted. It is sufficient to have the first chamber collect the liquid sample in a second chamber connected to the first chamber, for example, and to have the second chamber easily separated from the first chamber when separation of the second chamber from the first chamber is desired, in other suitable ways as will occur to those of skill in the art upon viewing the present disclosure. For example, as shown in fig. 36, a hole 903 is formed in the side wall of the first cavity 903, and the hole is initially sealed by a easily-punctured film or a self-sealing silicone, rubber or soft plastic seal, when a sample needs to be collected, the sample is collected by the first cavity 903, and after the liquid sample is collected, a second cavity 904 (not initially connected with the first cavity) is provided, and the opening portion of the second cavity is punctured by a sealing film (not shown) on the first cavity, so that the liquid in the first cavity flows into the second cavity, and is separated from the first cavity again, and secondary detection is performed by the liquid in the second cavity. For another example, as illustrated in fig. 37-38, the first and second chambers are not removably combined via the connecting passage, but rather are removably combined via cooperating thread structures. As further illustrated in fig. 25-27, the removable assembly is provided by a tray structure, as will be described in detail below.

Alternatively, referring to fig. 8, the present invention designs the connecting channel 109 to connect with the opening 1042 of the second chamber 104, but the connecting channel 109 is not required, and the opening 1042 of the second chamber 104 is used as the connecting channel, and the opening 1042 of the second chamber is directly connected with the inside of the first chamber, and the connecting channel can be in the form of a snap, a piston, or a lock, and at this time, the bottom of the first chamber has a hole, so long as the opening 1042 of the second chamber corresponds to the hole, so that the liquid can flow from the first chamber to the second chamber. Preferably, the first chamber and the second chamber are connected together before the first chamber collects the sample, and when the second chamber is separated from the first chamber, the separation is convenient.

In other preferred forms, the detachable connection, combination or combination of the first and second chambers is not a direct detachable connection of the first and second chambers as shown in fig. 33 without additional structure, nor is the first and second chambers indirectly detachably connected by a connecting channel as shown in fig. 8-9,1, 22-23, but is a detachable connection or combination as shown in fig. 25-30. As set forth in detail below.

Accordingly, in another aspect of the invention, there is provided a collection or testing device comprising a first chamber for collecting a liquid sample; and a second chamber for performing a confirmation secondary test, wherein the device further comprises a tray structure that is detachably combined, coupled or assembled with the first chamber. In some modes, the second cavity is located on the tray, namely the detachable mode combination or combination between the second cavity and the first cavity is indirectly realized through the detachable mode combination or combination of the tray and the first cavity, namely the tray structure and the second cavity are carried out through linkage, the linkage generally refers to that the movement of the tray drives the movement of the second cavity, so that the separation from the first cavity is realized, and then the separation from the tray structure or the non-separation can be realized after the linkage.

At this time, the connecting passage may or may not be provided, and therefore, a communicating structure is not necessary. For example, as shown in fig. 25-30, the second cavity is located on a base structure or tray structure 1004, and the opening of the second cavity is still in fluid communication with the connecting channel (with the connecting channel), but there is no need to rely on direct connection of the second cavity with the connecting channel by means of its own structure for fluid communication as described above, but in this embodiment, only the opening of the second cavity is needed to be coupled with the second outlet of the connecting channel, and the base structure 1004 is coupled with the bottom of the first cavity 103 by means of a mating structure (fig. 27), such as in the form of threads. Like this, the base structure has the screw thread, and for example the external screw thread, and the bottom in first chamber has the internal thread, and both combine together through the mode of screw thread, lets the second chamber and the inseparable cooperation of interface channel through the cohesion of screw thread. Specifically, the following modes are adopted: for example, as shown in FIGS. 25-28, the second chamber 304 is located on a base tray 1004, and the base tray 1004 is removably connected to the first chamber, and the second chamber 304 is also removably combined with the base tray 1004. In particular, the tray structure 1004 has internal threads that mate with external threads 3031 extending from the bottom of the first chamber 303 to provide a removable combination of the tray structure 1004 with the first chamber 303. Thus, if a connecting channel is also present, as shown in fig. 27, the connecting channel 309 may still have a first opening 3091 in fluid flow with the first chamber and a second opening 3092 in fluid flow with the second chamber, while the connecting channel has an extension 3098 which extends into the opening 3052 of the second chamber, in contact with the inner wall of the opening 3041, and may snap together, i.e.: the outer diameter of the extended area matches the inner diameter of the opening 3041. Although the second chamber and the first chamber may also be snap-connected via the connecting channel 109 as shown in fig. 27, this connection does not require a very secure connection and does not require as tight a connection as in fig. 8-9 (by means of threads etc.) because the tray structure 1004 is engaged by the threads 10041 with the external threads 3031 of the extension of the first chamber 103, so that no matter how small the amount of liquid sample the second chamber 304 collects, no leakage problem between the connecting channel 109 and the second chamber opening 1042 is caused. Therefore, the inner diameter of the connecting channel 109 may be smaller than the inner diameter of the opening 1042 of the second cavity, so that the connecting channel can be inserted into the opening 3042 of the second cavity in a manner that the connecting channel can be easily inserted (shown in FIG. 27). And threads are provided only on the outer edge of the opening 3042 for the covering of the second cover (see fig. 27). In this case, the connection between the connection channel and the opening of the second chamber is sufficient to ensure that no leakage occurs during collection of the liquid sample, i.e. that the liquid can enter the second chamber without further structural restrictions. The connection can be in the forms of clamping, piston and locking. In practice, the detachable combination, coupling or engagement of the first chamber with the second chamber is accomplished in an indirect manner.

After the collection is completed, the sealing of the connecting channel and/or the draining of the second chamber is performed according to the method described later, and if a second confirmation test is required, the lower tray structure 1004 is separated from the first chamber 103, for example, by rotating the tray in reverse to match the threaded structure at the bottom of the first chamber, at this time, the second chamber 104 on the tray is also separated from the first chamber 103 along with the tray structure, as shown in fig. 27, at this time, the second cover 101 is removed to cover the opening 3042 of the second chamber, and then the second chamber is separated 1004 from the tray (as shown in fig. 29), because the bottom of the second chamber and the bottom of the tray have the structure 10042 for clamping, so that the tray and the second chamber are separated from the first chamber 103 together. The tray 1004 is then detached from the second chamber 304, and the tray 1004 is then separately connected to and assembled with the first chamber 103. At this time, the integrity of the first chamber is still maintained, and the second chamber may be sent to a validating assay mechanism for a second validation assay. In order to allow the second cavity 304 to be separated from the first cavity along with the movement of the tray, the tray has a snap ring 10042, which has a shape adapted to the shape of the cavity of the second cavity 304, for example, the cavity of the second cavity is U-shaped, and the snap ring 10042 is also U-shaped, so that the tray structure 1004 rotates to drive the second cavity 304 to rotate together, and since the second cavity and the snap ring can be slightly tightly fitted, the second cavity 304 is naturally separated from the first cavity 303 together with the tray structure 1004. Certainly in some modes, the second chamber is the structure of similar square, sets up 4 buckle structures at the tray, lets second chamber and buckle structure joint together to the motion that realizes the tray drives the motion of second chamber, and then realizes the separation of second chamber and first chamber.

At this time, in order to ensure the safety property of the second cavity covered by the second cover, a seal may be attached to the second cavity, and the seal covers the second cover and a part of the second cavity. The sample in the second cavity is guaranteed not to be replaced maliciously, and the liquid in the second cavity is kept consistent with the original sample in the first cavity. Alternatively, the tray 1004 and the second cavity may be packaged and transported together, and the seal may cover the second cavity and the tray and the cover sealing the second cavity, thereby forming an integral structure for transportation. It will also be appreciated that the base structure 1004 and the second cavity 104 are integrally formed and are one-time injection molded, such that when the base 1004 is coupled to the first cavity 104, the second cavity 104 is also coupled to the connecting channel 109.

Alternatively, the connecting channel and the extension 3098 may be omitted because the connecting channel only needs to have a hole at the bottom of the first cavity 103, and the hole is equal to or larger than the opening 3042 of the second cavity 304, and the connecting channel does not need to have an extension (as shown in fig. 27), and the first opening 3091 of the connecting channel can function as the bottom hole, so that when the second cavity is combined with the first cavity via the tray, the opening 1042 of the second cavity corresponds to the bottom opening (similar to the position of the illustration 3091) of the first cavity 103, and depending on the cooperation of the tray 1004 and the first cavity 303, the opening of the second cavity 304 and the area around the hole form a tight fit, or form a tight contact, so that the second cavity and the first cavity form a liquid communication state, and when the first cavity collects liquid, the liquid will flow into the second cavity. If it is desired to separate the first chamber 103 from the second chamber, the aperture in the bottom of the second chamber (similar to the position shown in FIG. 27 at 3091) is sealed, thereby allowing the tray 1004 to be separated from the first chamber 103, and the second chamber 103 to be separated from the first chamber together. The same function is also realized. Alternatively, the aperture may be initially sealed by a readily pierceable sealing material, and after collection of the liquid, or after initiation of the test, the sealing material may be pierced to allow the liquid to flow into the second chamber, the manner of sealing the element being described in more detail below.

After first chamber liquid gathers to collect and ends, can let second chamber and first chamber separation, thereby the second chamber can be stored or transport and carry out the secondary for detection mechanism and confirm and detect, liquid in the first chamber can regard as first or first detection, or, after first chamber liquid gathers to end, can let second chamber and first chamber separation, after the separation, carry out the primary detection to the liquid in first chamber, after waiting to obtain the testing result, can store or directly send to the detection structure to the second chamber of separation and carry out the secondary and confirm and detect, or again, after liquid sample gathers to end, detect the liquid sample of first chamber, after waiting to obtain the primary testing result, after letting second chamber and first chamber separation, the second chamber of separation is used for storing or subsequent second time to confirm and detect.

Of course, the liquid in the first chamber may be stored, or the like, for the appropriate time for the initial test. In some preferred embodiments, it is desirable that the first chamber is simultaneously subjected to a first or second test after the liquid has been collected, and that a second confirmation test is performed, if necessary, on the results of the first test after the test is completed. Once the primary test is only a preliminary test for the presence of analyte in the sample, the sensitivity of the test generally need not be high, and sometimes, when the analyte in the sample is at a critical threshold, the primary test does not give a positive or negative result, and it is desirable to perform a secondary confirmation test on the same portion of the sample.

Whether the second chamber or the first chamber is used to confirm the secondary detection after the first chamber and the second chamber are separated can be realized, for example, the first chamber can be used to perform the secondary detection, and the liquid sample in the second chamber can be used to perform the primary detection. Therefore, the first and second chambers are not limited to the second chamber only for confirmation testing. In some aspects, such as shown in fig. 37 and 38, the present invention provides a first chamber 603 for collecting a liquid sample and a second chamber 604 for performing a primary assay, the second chamber having a detection chamber 605, the detection chamber and the second chamber having a fluid communication port 6038. The first chamber has an opening 6031, a connecting channel 609 at the bottom of the first chamber, which has a first opening 6091 in fluid communication with the first chamber, and a second opening 6092, wherein the first opening is sealed by a sealing element, which is a shell-piercing sealing element, such as a film, double-sided tape, aluminum foil, or the like. Thus, when the first chamber is used for collecting a liquid sample, the liquid does not initially flow out through the first opening of the connecting channel. After the first chamber has collected the liquid sample, it is combined with the second chamber, for example, by using the external thread 6031 of the first chamber and the internal thread of the second chamber, or the first chamber and the second chamber are already combined together by means of the thread at the beginning, and the first chamber 603 is used to directly collect the liquid sample. When the collection is completed, the seal member with the seal 6028 and the piercing member 6029 is used to pierce the first opening of the seal connecting passage, release the liquid into the second chamber 604 for the primary test, and the liquid enters the test chamber 605 for the primary test, and when the secondary confirmation test is required, the first chamber is detached from the second chamber, and the opening of the first chamber is sealed with the cover, so that the liquid sample in the first chamber is subjected to the secondary confirmation test. Optionally, the cap for sealing the first chamber includes the sealing member 6028 and the piercing member 6029, the first chamber has an extended channel 610 corresponding to the first opening 6091 of the connecting channel 609, the channel extends into the first chamber, such that when the cap covers the first chamber, the cap and the sealing member 6028 are in a linked relationship with the piercing member 6029, such that the sealing member and the piercing member move together, and when the piercing member pierces the first opening 6091 of the sealing connecting chamber, the sealing member pushes the fluid in the channel 610 into the second chamber for the initial assay, such that the cap seals the opening of the first chamber. As shown in the upper diagram of fig. 38A. When it is desired to perform a confirmation second assay, the first chamber 603 is detached from the second chamber 604, the second opening of the connecting channel is then sealed, e.g., by threading, with a second cap, and the first chamber 603 is then sent to the detection mechanism for a second confirmation test, as shown in the diagram of FIG. 38B.

Of course, the piercing element may also have a function of draining the liquid in the second cavity, and in this case, the piercing element may also have a liquid-repellent passage, a liquid inlet, and an accommodation cavity. Thus, after piercing the first opening 7091 of the sealing connection channel, the piercing element is partially inserted directly into the second chamber, in order to allow liquid to drain away, and liquid can be allowed to flow through the liquid inlet of the lyophobic channel into a receiving chamber, for example, the receiving chamber is located in the piercing element, as will be clearly understood and appreciated in conjunction with the detailed description that follows.

In some alternatives, when used as a test device, the collection device further comprises a test element that allows the collected sample to be tested. For example, the collection device comprises a detection chamber, wherein the detection chamber is in fluid communication with the first collection chamber, i.e. a liquid sample located in the first chamber may flow into the detection chamber. Of course, the inclusion of a detection chamber in the detection device is only a preferred embodiment, and the detection chamber may be absent when used as a collection device, or the detection device may include a detection chamber but not with a test element, or the like, into which a detection element is inserted when detection is desired. In some embodiments, a detection chamber 105 is disposed outside the sidewall of the first chamber, the first chamber 103 is in fluid communication with the detection chamber 105 (see FIG. 9), and if there is a liquid sample in the first chamber 103, the liquid can be in fluid communication through the through holes 1038 disposed in the detection chamber 105 and the collection chamber 103, and then enter the detection chamber for performing the necessary primary assay or detection.

In general, the sensitivity of detection of the liquid sample in the first chamber 103 (first or primary detection) is not as high as the sensitivity of the secondary confirmation detection, or the specificity of the first or primary detection is not as accurate as the specificity of the secondary confirmation detection. Thus, the secondary detection can basically confirm whether the primary detection is accurate or not. For example, primary detection is performed by immunological or chemical methods, while secondary confirmation detection is generally performed by mass spectrometry (GS), gas or liquid chromatography. Such a second test is typically performed using a liquid sample in a second chamber separate from the first chamber because the first and second chambers are for the same sample, are identical in nature, and are separated into different portions, and the second test can be validated for the first test.

In some preferred embodiments, the fluid in the first chamber 103 is detected at the same time as the fluid sample is collected or shortly after the collection. Therefore, in a preferred form of the invention, the first chamber 103 is in fluid communication with a detection chamber 105, which contains a test element. In some preferred forms, the test elements are arranged on a carrier. In a preferred form, the test chamber includes a test carrier 106 having a plurality of card slots 1061, each of which has a test element disposed therein. For example, as shown in FIG. 9, when the liquid sample is collected in the first chamber 103, a portion of the liquid sample flows into the detection chamber 105 through the through hole 1038, and the liquid sample flowing into the detection chamber contacts with the test element, thereby completing the detection of the analyte; another portion of the liquid sample flows into the second chamber 104 through the opening 1091 of the connecting channel 109. After the test element in the test chamber finishes the test, the first test result is read, and after the reading, when it is determined that the second test is necessary to be confirmed, the second chamber 104 is separated from the first chamber 103, and then the second cover 101 is used to seal the opening 1042 of the second chamber 104, and the second chamber 104 is stored or directly sent to the test structure for confirmation test to perform further confirmation test. And the fluid in the first chamber 103 and the detection chamber 105 for the first detection may be discarded or disposed of.

The mode of separating the first detection and the second confirmation detection is adopted, so that some defects of the traditional detection equipment are overcome. In the conventional detection device, after the test is completed, if a secondary test is required, the whole detection device (with the first cavity as a cavity for collecting liquid and/or with a detection cavity, or a test element in the detection cavity) needs to be stored, or the whole detection device needs to be packaged and transported (on the land of a vehicle, by sea or by air) to a secondary test mechanism for confirmation test, so that any structure of the whole detection device needs to be ensured or guaranteed, no liquid sample can be leaked anywhere, external pollution can be caused once the sample is leaked, samples can be polluted mutually, and uncertain results are brought to confirmation or secondary test. This necessitates the hermetic encapsulation of every structure that may cause leakage, which adds considerable cost and design difficulties to the manufacture of such test devices, since these primary test devices are typically plastic and disposable, and it is difficult to achieve a device that will not cause leakage of liquid in any way, even if it is guaranteed that no leakage occurs, but the manufacturing costs are high. Ideally, on one hand, the cost is reduced as much as possible, and at the same time, it is necessary to ensure that the liquid sample does not leak, which brings great challenges to manufacturers. For example, this requires a complicated design of the first cover 102 sealing the opening 1031 of the first chamber to ensure that liquid cannot leak out through the opening 1031. If the device also includes a test element, this requires more precise machining or design of the chamber (if any) that houses the test element to ensure that the liquid sample cannot leak out through the test chamber, and in particular, these devices typically require air transport and do not leak under negative or high pressure, presenting significant manufacturing and design challenges. In the tradition, avoid revealing always adopts the sealing washer or trades the silica gel pad as sealed part, but in case the device storage time is longer, these silica gel or plastics can oxidize or age, cause the leakage of liquid when using. Secondly, if the sample of the primary detection result needs to be stored, more storage space is needed to accommodate the detection device with large volume; this necessarily adds more space, and particularly for professional assay facilities, the number of samples tested is very large, which requires sufficient space to store the first tested samples, which are contained in relatively large test devices, requiring a larger area or volume of storage space. Thirdly, the transportation cost of the devices finished by the primary detection is obviously increased due to the large size, the transportation packaging cost is increased, and after all, the traditional detection devices are large in size and are packaged and transported independently. Fourth, if the test device initially has a test element, the collected fluid is always in contact with the test element during transport, and the test element contains chemicals that are not present in the fluid sample itself, which can cause contamination of the fluid sample by contact with the test element over time, potentially adversely affecting subsequent secondary tests. In summary, the conventional detection device or collection device has, for whatever reason, one or several of the drawbacks described above.

With the device of the present invention, the volume of the second chamber is typically smaller than the volume of the first chamber, even by a factor of ten or a fraction of the conventional detection chamber. Typically only 1-50 ml of sample is required for the second chamber sufficient for a second assay, e.g. only 1.1 ml, 0.2 ml, 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml, 1 ml, or only 1.2 ml, 1.4 ml, 1.6 ml, 1.8 ml, 2 ml, or only 3 ml, 4 ml, 5 ml, 6 ml is sufficient, 7 ml, 8 ml, 9 ml, 10 ml, 11 ml, 12 ml, 15 ml, 25 ml, 30 ml. The volume of the first chamber is typically a volume of 5-500 ml, e.g., 8 ml, 10 ml, 12 ml, 14 ml, 16 ml, 18 ml, 20 ml, 22 ml, 24 ml, 26 ml, 28 ml, 30 ml, 32 ml, 34 ml, 36 ml, 38 ml, 40 ml, 42 ml, 44 ml, 46 ml, 48 ml, 50 ml, 60 ml, 70 ml, 80 ml, 100 ml, 150 ml, 200 ml, 250 ml, 500 ml. Also, generally, the second chamber has only one opening 1042, and it can be confirmed that the sample is not leaked as long as the second opening 1042 is sealed. On the one hand, the second chamber is small and light, so that the cost of transportation and packaging is remarkably reduced, and the storage space is small. On the other hand, it is not necessary to have as high a sealing requirement as conventional devices for the first chamber and/or the component containing the detection chamber, e.g. the sealing requirement for the first cover to seal the opening 1031 of the first chamber is much lower, and the sealing requirement for the detection chamber provided for the test element is much lower than conventional, even if the sealing effect of the first cover on the opening of the first chamber 103 is not taken into account, and also the sealing effect of the detection chamber itself is not taken into account, because the first chamber 103 and/or the first chamber with the test chamber 105, even the first cover 102, can be disposed of once the initial test has been completed. Compared with the traditional disposable detection device, the disposable detection device saves a large amount of cost and is safer and more reliable. In addition, the property of the liquid in the second cavity is consistent with that of the first cavity, so that the effectiveness property of secondary detection is ensured. Thirdly, because the volume of second cavity is little, need not consider storage space specially, very little place just can save a large amount of second cavities, has reduced the pressure of affirming the laboratory, has also reduced the cost of transportation, can guarantee the security of transportation simultaneously. Since there is no need to worry about the risk of liquid leakage too much.

In some preferred embodiments, when it is desired to perform the testing of the liquid sample collected in the first chamber 103 and to collect the secondary confirmation sample in the second chamber 104 at the same time, it is desirable that the sample flowing into the testing chamber (if having the testing chamber) does not potentially contaminate the liquid sample entering the second chamber 104, and the opening 1091 of the connecting channel 109 is located at a position higher than the height of the through-hole 1038 (e.g., as shown in fig. 7 and 6, and as shown in fig. 9), so that the liquid flowing into the testing chamber will not or hardly enter the second chamber, thereby ensuring that the liquid in the second chamber 104 is substantially the same as the liquid sample that is not in contact with the test element. After all, the liquid sample in contact with the test element may contain some chemical reagent or other component that has been processed on the test element and, if such reagent or component enters the second cavity, may adversely affect the results of the second test. It will be appreciated that having the opening 1091 of the connection channel higher than the through-hole 1038, or, in accordance with the method described above, having the opening through which the liquid flows into the second chamber higher than the through-hole of the detection chamber (e.g., the bottom hole of the previous embodiment, which does not have an incoming connection channel), it is possible to avoid that a liquid sample coming into contact with the test strip enters the second chamber when the test element is included in the device and comes into contact with the liquid sample.

In some preferred forms, the first chamber body contains a

collection area

1035 or 1036 for collecting liquid, which is located at the bottom of the first chamber 103, around the periphery of the connecting channel 109 or the connecting channel first opening 1091. In some preferred embodiments, these pooling regions are located below the connection channel openings 1091 such that, when fluid enters the first chamber, it first pools in the pooling regions and then contacts the test element by passing through the through-holes 1038 into the detection chamber. Thus, in the order of arrival of the liquids, the collection region is reached with the liquid first, then flows into the through-hole 1038 into the detection chamber (if present), and then reaches the location of the first opening 1091 of the connecting channel.

In some preferred forms, for example, as shown in fig. 12, 4 and 5, the first chamber has a raised area at a central location at the bottom thereof, the raised area defining a space for receiving a portion of the body structure of the second chamber 104. The raised area is provided with a connecting channel or hole, and the raised area also forms a collection area u (shown in fig. 4 and 5) when viewed from the bottom of the first cavity (for example, fig. 4), the bottom is recessed into the first cavity 103, and the recessed area is used to accommodate a portion of the area inside the opening 1042 of the second cavity 104, so that, when viewed as a whole, the material of the detecting device is not additionally added, and the detecting device is not obtrusive, as shown in fig. 7-11, the opening part of the second cavity is arranged below the bottom of the first cavity 103, and the detecting device is still inferior to the conventional detecting device when viewed as a whole. In some preferred embodiments, the

collection areas

1036 and 1035 are positioned below the through-holes 1038, such that the collected liquid sample can first enter the detection chamber (if present) 105 through the through-holes 1038, and the excess liquid can enter the second chamber 104 through the first opening 1091 of the connecting channel 109 once the detection chamber is filled or the through-holes 1038 are closed by the liquid. This prevents as much as possible liquid that flows into the detection chamber from exiting the detection chamber into the second chamber. Or, according to the flowing sequence of the liquid, the liquid generally reaches the collection region to be collected, and after the liquid is collected to a certain height, the liquid flows into the detection chamber through the through hole 1038 to be tested and tested, and after the liquid sample is collected in the detection chamber, the through hole 1038 is sealed by the liquid, and as the liquid increases, the liquid level reaches the position of the connecting channel opening 1091, so as to enter the second chamber, and the second chamber is filled with the liquid or a part of the liquid sample enters the second chamber to be used for subsequent secondary confirmation detection.

In other embodiments, the test device does not separately include a test chamber (as shown in FIG. 1), such as in FIGS. 15-17, and includes an area on the side wall of the first chamber 203, such as in FIG. 16. the first chamber 203 includes two

vertical strips

2032 and 2033 that bound the area into which the carrier shown in FIG. 17 is inserted to form a test-enabled structure. For example, as shown in FIG. 17, a carrier structure is provided having a plurality of test element-containing channels 2063, closed at one end 2062 and open at the other end 2061, each channel being oriented in such a compatible orientation on the carrier that the detection and water-absorbing regions on the test element are located in the channels and the sample application region on the test element is located at one end of the channel opening 2063, and the test elements in each channel are positioned such that the sample application region of the test element in each channel is located at the end 2065 of the carrier and correspondingly, the detection region of the test element is located at the end near the channel seal at the top end 2064 of the carrier. In assembling the carrier into the first cavity 103, the end 2065 of the carrier is adjacent the bottom 2034 of the first cavity and the tip 2064 of the carrier is adjacent the opening 2031 of the first cavity. Thus, a portion of the sample of the liquid sample entering through the opening of first chamber 203 contacts the sample application area of the test element near 2034 near the bottom of first chamber 203, thereby completing the test assay for the analyte in the liquid sample. In other preferred forms, such as shown in fig. 25-30, the removable combination of the second chamber 304 and the first chamber 303 may be implemented in the same manner as described above, e.g., in fig. 1, 6-13, or any of the foregoing, including any subsequent manner to seal or separate.

In some preferred embodiments, the bottom 2034 of the first chamber has a groove 2035 configuration, the groove 2035 configuration allowing the liquid sample plate to pool within the first chamber, as shown in fig. 22 and 23. In some preferred embodiments, the height of the first opening 2091 of the connecting channel 209 is higher than the height of the groove, i.e., the opening 2091 of the connecting channel 2091 is located upstream of the groove 2035, so as to prevent the liquid sample in contact with the test element in the vicinity of the groove from flowing into the second chamber 204 through the first opening 2091 of the connecting channel 209. Similarly, when the test element in the carrier in the first chamber is tested for the first time or after the first time, and a subsequent second confirmation test is deemed necessary, the second chamber may be separated from the first chamber directly, and after separation, the second cover 201 may be used to seal the opening 2041 of the second chamber 204 for separate storage, or may be packaged separately for transportation to a second confirmation test structure for confirmation test. Correspondingly, the carrier 206 with the completed primary test and the first cover 202 with the carrier first cavity 203 and the opening 2031 with the sealed first cavity 203 are discarded or disposed of. The volume of the first cavity is generally larger than that of the second cavity, and they may be designed by the difference of the volumes as described above, of course, the volume of the first cavity may be equal to that of the second cavity, and optionally, the volume of the first cavity may be smaller than that of the second cavity.

In some aspects, there is no particular limitation on the shape of the first cavity and the shape of the second cavity, for example, generally, the first cavity is cylindrical in shape and the second cavity is cylindrical in shape, and of course, the first cavity may be rectangular parallelepiped, square, ellipsoid or cone in shape, and correspondingly, the second cavity may be rectangular parallelepiped, square, ellipsoid or cone in shape.

The foregoing teaches the removable of the first and second chambers, typically with the second chamber located within or at the bottom of the first chamber, or, initially, the first and first chambers are combined, typically after collection of the liquid, to separate the first and second chambers. Of course, the specific location of the second cavity is not limited and the second cavity may be otherwise.

Sealing element

In some preferred embodiments, the first chamber and the second chamber, which are originally in fluid communication, are not in fluid communication after or just before or during the separation of the first chamber from the second chamber, thereby preventing fluid communication between the first chamber and the second chamber. Or, whether the first cavity and the second cavity are communicated with each other for liquid has the following states: the first state is liquid non-communication and the second state is liquid communication; alternatively, the first state is liquid communication and the second state is liquid non-communication. The second chamber and the second chamber may be designed and selected arbitrarily as to whether they are in liquid communication or not in different states for different purposes or during operation. For example, when the first chamber collects a fluid or liquid sample, the first chamber and the second chamber are in fluid communication; before or when separation is required, the second chamber is not in liquid communication with the first chamber. Alternatively, the first chamber and the second chamber are not in fluid communication when the first chamber collects a fluid or liquid sample; before or when the separation is needed, the second cavity is not in a liquid circulation state with the first cavity, so that the second cavity collects liquid from the first cavity, and then the first cavity and the second cavity are not in a liquid circulation state, so that the second cavity is separated from the first cavity.

Therefore, in some embodiments, a sealing member is provided, which seals the connection channel if the first chamber 103 is detachably combined with the second chamber 104 through the connection channel 109, so that the liquid in the first chamber cannot enter the second chamber again, or the liquid in the first chamber cannot flow out through the channel of the liquid entering the second chamber. In any case, in these embodiments, after or while the second chamber is separated from the first chamber, or before the separation, the place where the first chamber and the second chamber are connected is in a liquid-tight state, so that the liquid is not allowed to enter the second chamber, or after the separation of the second chamber, the liquid sample is not leaked to the environment outside the first chamber through the connection. In some preferred forms, the liquid cannot leak through the junction to the environment of the first chamber containing the test chamber, or the liquid cannot leak through the junction to the environment of the first chamber containing the test element. It can be easily understood that when the connection and the fluid communication are not realized by the "connection channel" in the preferred mode of the present invention, but are connected by two separate structures of the connection structure and the communication channel, the fluid flow is realized by sealing the communication channel only with the sealing member once the first chamber and the second chamber are separated by the connection structure. Therefore, the sealing member functions to change the state from the liquid flowing state to the liquid non-flowing state by preventing the first chamber and the second chamber from being in the liquid flowing state.

In some preferred forms, when the second chamber is detachably connected to the first chamber through the connecting channel, the connecting channel is sealed by the sealing member before, after or simultaneously with the separation of the second chamber from the first chamber. The sealing member may seal the first opening 1091 of the connection passage, as shown in fig. 12. Here, the sealing member blocks the opening 1091 of the connection passage like a plug, thereby preventing the liquid from entering into the second chamber or not allowing the liquid to flow out of the first chamber from the first opening 1091 of the connection passage. The sealing element here may be adapted or adapted to the shape of the opening of the connecting channel, thereby sealing the connecting channel. By conforming is meant that the sealing element and the connecting channel cooperate to provide a fluid tight seal by means of one or a combination of suitable dimensions, materials and shapes. For example, the first opening of the connecting channel is circular and the sealing element is circular, or the connecting channel is plastic and the sealing element is plastic and is sealed by the mechanical elasticity of the material itself, or the sealing element is rigid and the connecting channel is elastic, or the sealing element is rigid and the connecting channel is rigid, which can achieve the sealing effect, thereby achieving the above-described function. For example, the sealing element is elastically deformable while the connecting channel is rigid, the sealing element being plugged into the connecting channel, thereby sealing the opening of the connecting channel. This sealing means can be arbitrarily selected. The sealing element may be used alone to seal the connecting channel or to seal the place where the first and second chambers are in fluid communication, allowing the first and second chambers to be in fluid communication.

In some preferred forms, the first cover 102 includes a sealing element for sealing the connecting channel, and the sealing element seals the opening of the connecting channel while the first cover covers the opening of the first cavity. In effect, the sealing element and the cover form a linkage mechanism, the movement of the cover driving the movement of the sealing element. The movement of the first cover body is used for sealing the opening of the first cavity, and if the first cover body moves, the sealing element can be used for simultaneously sealing the connecting channel, so that the operation is more convenient. Of course, it is understood that the first cover covering the first cavity and the sealing element sealing connection channel are not linked, and can be completed in two steps, which also falls within the scope of the present invention. Preferably, the sealing element seals the first opening of the connecting channel. It is also possible that the movement of the first cover and the change of the state of liquid communication between the first chamber and the second chamber are performed in a linked manner. For example, movement of the first cover changes the first and second chambers in fluid communication to a state in which the first and second chambers are not in fluid communication during the movement. Or, the state that the first cavity and the second cavity are not in liquid communication is changed into the state that the first cavity and the second cavity are in liquid communication by the movement of the first cover body, and the first cavity and the second cavity are not in liquid communication along with the movement.

The covering means that the first cover body is matched with the first cavity body to cover the opening 1031 of the first cavity, or the cover body can seal the opening 1031 of the first cavity 103, and the sealing can be only a general sealing or an unsealed state, so that the liquid sample is only prevented from spilling out of the first cavity, for example, the liquid is prevented from spilling out of the opening 1031 of the first cavity body when the first cavity is moved. As described above, the first cover and the opening of the first chamber do not need to be sealed as in the conventional detection device, because the entire detection device is not required to be transported or transported in some extreme conditions. When the first cavity collects enough amount of liquid, the sealing element on the cover body generally needs to cover the opening of the first cavity, and when the cover body covers the opening 1031 of the first cavity, the sealing element connected to the cover body simultaneously seals the opening of the connecting channel or the connecting channel, so that the liquid is prevented from entering the second cavity, and after the second cavity is separated from the first cavity, the liquid cannot be leaked to the outside through the connecting channel. Therefore, the operation is more convenient, simple and quick, and two functions are completed while the operation is performed in one step. The sealing effect of the sealing element here to seal the connection channel can only be temporarily to prevent leakage of liquid through the connection channel to the outside, without the need for a sealing effect as in conventional detection devices, ensuring that leakage cannot occur under extreme transport conditions (e.g. high pressure or vacuum). This is also because the sample in the second chamber serves as a transport carrier for the second confirmation test, and the liquid in the first chamber does not have to be transported or stored for subsequent disposal. Therefore, the sealing of the opening 1031 of the first chamber and the connection passage or the connection passage opening 1091 is only a general sealing here, and does not require a sealing state under a negative pressure, vacuum state as in the conventional device. Mainly because there is no need to transport the liquid in the first chamber to a professional laboratory or testing facility for a second test.

For convenience and low production cost, the first cavity and the second cavity are made of plastic materials, the first cavity and the second cavity are formed in a one-time injection molding mode, the sealing element and the first cover body are also formed in an injection molding mode, the joint of the first cavity and the second cavity which are sealed by the sealing element can be reached by means of physical properties between the plastic materials, and preferably, the connecting channel which is used for hermetically connecting the first cavity and the second cavity is formed. For better sealing, an elastic sealing ring 108, such as an "O" ring, e.g., a silicone sealing ring, may be disposed on the sealing element, and the sealing ring may have flexibility relative to the material of the sealing element, so as to increase the sealing effect when the sealing element seals the first opening 1091 of the connecting passage. It will be appreciated that when it is desired to have the cover and sealing element co-operate, typically the openings of the first cover and the first chamber are co-joined by a screw thread, first this being the opening of the first chamber of the cover in a rotational manner, and the sealing element also being in a rotational manner to enter the connecting channel or to seal the opening of the connecting channel or to seal the aperture of the first chamber and the second chamber in fluid communication (if the connecting channel is omitted).

It can be understood that the "O" ring and the sealing element are used together, and the "O" ring can be produced separately and then assembled to the sealing element, so that the sealing function is achieved. Of course, in other cases, the "O" ring seal may be absent, and sealing may be achieved simply by virtue of the material of the connecting passage and the sealing element being different.

In some preferred forms, the sealing element may be injection molded in one piece when coupled to the first cover, or may be removably coupled to the cover. For example, as shown in fig. 2 and 3, a sealing member 1028 is attached to the first cover, and a sealing ring 108 is disposed on the sealing member, and the sealing member is integral with the cover 102. In order to better fix the sealing ring, a groove structure is arranged on the sealing element, so that the sealing element is elastically fixed on the groove. Generally, the first chamber needs to contain a certain volume of the liquid sample, so that the opening 1031 of the first chamber is at a certain distance from the first opening 1091 of the connection channel at the bottom of the first chamber, so that the sealing member is connected with the cover 102 by the connection structure 1023 to form a unitary structure. As shown in fig. 12, when the cover is covered on the opening 1031 of the first chamber by a covering manner, for example, a rotating manner, the sealing member 1028 integrated with the cover also rotates into the connecting channel 109, and then the sealing member enters into the connecting channel during the covering process of the cover, so that the sealing member 1028 seals an opening 1091 of the connecting channel, thereby preventing the liquid sample from entering into the first chamber, and when the second chamber is separated from the first chamber, the liquid sample in the first chamber does not leak to the outside through the connecting channel.

For example, as shown in fig. 22, a connection structure 2023 is connected to the first cover 202, and the connection structure 2023 extends to be a section as a sealing element 2028 to seal the connection channel; in the condition shown in fig. 22, the first and second chambers are in fluid flow condition when the sealing element 2028 (i.e., where 208 the seal is located) is not yet adjacent to the opening 2091. As the position of the cover changes, the sealing element is moved to close the opening 2091, and as the sealing element moves, the sealing element seals the opening 2091, so that the liquid in the first chamber does not flow into the second chamber.

Preferably, the cap and sealing member are coupled such that the first and second chambers are not in fluid communication. The cover body and the sealing element can be finished by one-time injection molding or assembled together by multiple injection molding. For example, the cover is formed by one-time injection molding, and the connecting rod 2023 and the sealing element 2028 are formed by one-time injection molding; and then the sealing elements are driven to move together by the movement of the cover body through any optional splicing, threads or other modes, so that the sealing elements are called to be linked. In another form, it is also possible that the sealing element, the connecting rod and the cover are injection moulded separately and then assembled together.

Therefore, in some preferred forms, the sealing element is also removably connected to the cover. For example, as shown in fig. 31-35, the cover 402 includes a sealing element 4028 that has a shape that matches the shape of the connection passage or that matches the shape of the

first opening

1091,3091, such as the shape of the piston. In this manner, a portion of the attachment structure 4023 is used as the sealing element 4028, and there is no sealing ring at this time. However, the material may be different, and the material of the common sealing element is generally more elastic, so that the elastic sealing element is easier to seal the connection channel, or the first opening of the connection channel, even without the sealing ring. For example, the sealing element may be latex, silicone, or other elastic material, or the sealing element may be formed of two parts, the interior of the sealing element is made of a relatively hard material, and a layer of elastic silicone, rubber, latex, or other material is coated on the surface of the hard material to enhance the sealing effect between the sealing element and the opening of the connection channel or opening 1091. At the same time, when the first cover 402 covers the opening of the first cavity 103,203, less force is required to seal the connection channel or opening by the sealing member 4028, for example, by the sealing member entering the connection channel. Alternatively, the seal 5029 (when 5029 is used as the seal) and the connecting rod 5023 are threaded together, as shown in fig. 33-34. in this embodiment, one end 5030 of the seal 5029 is provided with external threads, and one end 5023 of the connecting structure is provided with internal threads, and the seal is connected with the cover by threads, so that the seal can be made of different materials from the cover and the connecting structure, and the seal has more design forms and ways to meet different sealing requirements.

The seal may be a separate component or may be located where the second chamber is connected to the first chamber to block fluid flow between the second chamber and the first chamber. The flow here is generally an active flow. In fact, the sealing element is not necessary when the liquid passively flows from the second chamber to the first chamber.

Also, as previously discussed in connection with fig. 27, when the first and second chambers are not provided with a connecting channel structure, which actually has only one hole, e.g., a hole similar to 3091, but lacks a connecting channel extension portion 3098, the sealing member only needs to seal the opening 3091 and does not need to enter the connecting channel. For example, a sealing element such as a rubber plug is disposed on the connecting rod 3023 of the cover, and the cooperation of the cover causes the plug to plug the opening 3091, thereby changing the liquid communication state between the first chamber and the second chamber.

Also, the sealing member may initially seal the first opening of the connecting channel, after the first chamber 103 has collected the liquid sample, or before or after the first chamber liquid sample is subjected to the first test, the sealing member may be punctured with a puncturing member or removed to allow the liquid sample to flow into the connecting channel and enter the second chamber 104 through the second opening, and the second chamber may be removably combined with the first chamber to allow the second chamber to be separated from the first chamber for a subsequent possible confirmation test. Thus, the sealing member herein may be of a pierceable construction when the sealing member is pierced, e.g., the sealing member may be a non-stick adhesive, a double-sided tape, a plastic sheet, etc. Typically, the pierceable member does not initially allow fluid to enter the connecting passageway, but rather is pierced before it enters. The manner in which the puncture is made is very diverse, e.g., a sharp object. In some embodiments, a piercing element may be disposed on the first cover 102 and operatively associated with the piercing structure, the piercing element sealing the first cover when the first cover closes the opening of the first chamber 103, thereby allowing fluid to flow from the first chamber to the second chamber. If the first cavity and the second cavity are required to be separated, another sealing element is allowed to seal the puncture part before separation, so that the change of the liquid communication state between the first cavity and the second cavity is realized.

For example, as illustrated in FIGS. 39-40, first chamber 702 includes an opening 7031 for receiving a liquid sample, and a hole in the first chamber, which is a first opening 7091 for connection to a channel, sealed by a pierceable seal 70281, and a detection chamber 705 in fluid communication with the first chamber, is in fluid communication through channel 7038. In contrast to the embodiments shown in fig. 37-38, the first chamber serves as a chamber for collecting a liquid sample for a primary test, and a second chamber 704 is detachably connected to the second opening 7092 of the connecting channel. When a liquid sample is collected, the liquid portion of the first chamber flows into the detection chamber for initial assay detection, and then the opening of the first chamber is closed by a first cover having a second cover provided with a sealing element 7028 and a piercing element 7029. Thus, the cover and sealing element 7028 and puncturing element 7029 form a linkage mechanism, such that when the first cover closes the first chamber, the sealing element and the puncturing element are driven to perform linkage, the puncturing element now punctures the seal sealing the first opening of the connecting passage, then releases the liquid into the second chamber, and then seals the opening of the second chamber with the seal. Of course, the piercing element may also have a function of draining the liquid in the second cavity, and in this case, the piercing element may also have a liquid-repellent passage, a liquid inlet, and an accommodation cavity. Thus, after piercing the first opening 7091 of the sealing connection channel, the piercing element is partially inserted directly into the second chamber, in order to allow liquid to drain away, and liquid can be allowed to flow through the liquid inlet of the lyophobic channel into a receiving chamber, for example, the receiving chamber is located in the piercing element, as will be clearly understood and appreciated in conjunction with the detailed description that follows. Such as shown in the upper diagram of fig. 40. When a second confirmation test is required, the second chamber is removed from the first chamber, e.g., by rotating the screw, and the opening 7041 of the second chamber 704 is sealed with a second cap for a subsequent second confirmation test.

In summary, it appears that the liquid may flow from the first chamber to the second chamber when the liquid enters the first chamber and may flow to the second chamber at the same time, or the liquid may flow into the second chamber after the liquid sample has flowed into the second chamber, and this is because the second chamber is not in liquid communication with the first chamber, but rather is in liquid communication with the first chamber at any subsequent time. Either in fluid communication or in fluid communication is a timing issue for the sealing element, for example, puncturing the sealing element at the first or

second openings

1091 and 1092 of the sealing connecting channel is a way to allow the two chambers to communicate. Of course, the second chamber is separated so that the liquid in the first chamber does not continue to the second chamber, and the puncture is sealed.

Thus, in some embodiments, the second chamber is in fluid communication with the first chamber when the first chamber 104 is not being used to collect the liquid sample, and the second chamber is not in fluid communication with the first chamber when the liquid sample is collected or after collection of the liquid sample is complete. Of course, optionally, when the first chamber 104 is not used for collecting the liquid sample, the second chamber is not in fluid communication with the first chamber, when the liquid sample is collected or after the collection of the liquid sample is finished, the second chamber is in fluid communication with the first chamber, when or after the liquid sample enters the second chamber, and before the first chamber and the second chamber are separated, the second chamber and the first chamber are not in fluid communication again. In these ways, the sealing element performs different functions at different times. When the sealing is carried out and when the sealing is not carried out, the sealing can be selected according to proper time.

In the above example where the sealing member is required, the liquid sample can always freely flow from the first chamber 103 to the second chamber (for example, the liquid always flows from the high position to the low position under the action of gravity), and the sealing member is used after the two chambers are separated from each other and the liquid sample is prevented from flowing continuously; in practice, however, the sealing element is not necessarily required when the liquid sample is passively flowing against gravity from a lower position to an upper position. Such as the example in design 3, a separate sealing element is not required.

Lyophobic channel

A "lyophobic passage" as used herein is a passage like a liquid discharge through which a liquid is dredged or discharged, and may be considered as a passage through which a liquid flows from one place to another. In addition, the lyophobic channel can also remove redundant gas, so that the effect of pressure is relieved; the passage through which the gas is to be dredged or discharged may also be considered as a passage through which the gas flows from one place to another. Therefore, the lyophobic passage can remove the redundant liquid state, the redundant gas state or the mixed state of the gas and the liquid state. By "channel" is meant, for example, a tube shaped, for example, closed all around, and comprising two openings, one opening being a liquid inlet and the other opening being a liquid outlet; alternatively, one opening may serve as an air inlet and the other opening may serve as an air outlet; alternatively, one opening may be a mixed state port for entering a liquid state and a gaseous state, and the other opening may be a port for excluding a mixed state of the liquid state and the gaseous state. The one inlet and one outlet are only one embodiment and may of course comprise one or more inlets and may also comprise one or more outlets. The length of the channel itself is not limited, and may be longer or shorter, which can be easily implemented by those skilled in the art according to the actual situation.

In some more preferred forms, the seal is achieved by simply sealing the aperture between the first and second chambers, but if a better seal is desired, such as when connecting the first and second chambers with a connecting channel, the connecting channel typically has an extension 3094 which in fig. 27 extends into the opening of the second chamber, although it may extend a distance or length into the first chamber at the connecting channel 3091. To achieve a better sealing effect, a sealing element like a plug is generally inserted partially into the connecting channel to seal the connecting channel, which normally contains the liquid sample before sealing the connecting channel, and the second chamber is also filled with the liquid sample. This is because the collected liquid sample still needs a sufficient volume to satisfy the secondary confirmation test and the primary test for the test element. Therefore, in some preferred embodiments, the level of the liquid sample in the first chamber is higher than the first opening of the connecting channel, i.e. the first opening of the connecting channel is located below the liquid level, so that both the connecting channel and the second chamber are filled with liquid. In such a case, the sealing element is partially inserted into the connecting channel to achieve a better sealing effect, and the liquid sealing is such that the liquid sample is not leaked from the first chamber to the outside after the second chamber is separated from the first chamber. In such a case, the entry of the sealing element into the connecting channel presents a certain difficulty, since the sealing element, although of comparable size to the connecting channel, necessarily needs to overcome a certain liquid reaction force acting on the sealing element when sealing the connecting channel 109. This is because, in order to achieve a better sealing effect, it is necessary to let the sealing element enter into a part of the connecting channel, so that a better sealing is obtained. In order to obtain a better sealing, the sealing process, in the presence of the connecting channel, is a dynamic process starting from the first condition, in which the sealing element is close to the connecting channel, to a second condition, in which the sealing element totally blocks the connecting channel from the first opening, and then the sealing member enters the connecting channel (the third state, which is to achieve the third state to obtain a better sealing effect), in the process, when the second state is required to be changed into the third state, the reaction force of the liquid sample in the connecting channel, which is in contact with the sealing member, is actually required to be overcome, particularly, the sealing member enters the connecting channel, the liquid in the connecting channel is required to be pressed, if the liquid cannot be removed, it is difficult to bring the sealing element from the second state to the third state. The distance from the first opening of the sealing connecting channel to the entrance of the connecting channel may be 0.1-10 mm, or a further distance, so as to ensure a good sealing effect, e.g. the distance of the sealing element to the entrance of the connecting channel is 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm or 7-10 mm. In order to reduce the reaction force of the liquid, which is the pressure applied by the liquid to the sealing element, the volume of liquid removed by the sealing element needs to be removed to another place smoothly, so that the reaction pressure to which the sealing element is subjected can be reduced, and the sealing element can enter the connecting channel more easily. Therefore, it is necessary to remove a part of the liquid volume in the connection passage when the sealing member enters the connection passage, so that the sealing member can smoothly enter the connection passage, thereby smoothly sealing the connection passage or the opening of the connection passage. This is similar to the way a bottle stopper is used to plug into the opening of a bottle, and if the bottle is filled with water, the stopper is difficult to plug into the bottle, and a portion of the water or liquid in the bottle needs to be poured off, so that the stopper can be plugged into the bottle opening to close the opening of the bottle. However, when the second chamber is filled with liquid and the connecting channel is filled with liquid, sometimes the first opening of the connecting channel is located below the liquid level of the first chamber, and the sealing element is required to enter or the sealing element is in the form of a piston to seal the opening of the connecting channel, which requires that part of the liquid in the connecting channel is removed to another place to facilitate the entering of the sealing element into the connecting channel, preferably in such a way that the part of the liquid is removed at the time of entering, and the entering of the sealing element is forced into the connecting channel by an external force.

Therefore, in some preferred forms, the device further includes a lyophobic passage through which a liquid squeezed by the connection passage into which the sealing member enters can be discharged to the outside of the connection passage, thereby allowing the sealing member to smoothly enter the connection passage. For example, in some preferred modes, the liquid inlet of the lyophobic channel is positioned on the sealing element, and as the sealing element enters the connecting channel, the redundant liquid enters the lyophobic channel through the liquid inlet and is discharged out of the connecting channel. The liquid repellent passage may be a place other than the liquid repellent passage, such as a receiving chamber, e.g., a first chamber, or a detection chamber, or other places, which does not include the connection passage and a second chamber detachably connected to the connection passage. Therefore, the device further comprises a receiving chamber for receiving liquid or gas from the lyophobic passage. Typically, the sealing element seals or otherwise blocks the flow of fluid between the first chamber and the second chamber, typically in two states, and first, the sealing element seals the channel prior to the first chamber and the second chamber being in communication, at which time fluid can be exchanged between the two chambers, typically to allow fluid to naturally flow from the first chamber to the second chamber. Secondly, when the sealing element starts to seal the connecting channel, for example, the opening of the connecting channel, the first cavity and the second cavity are not communicated, the pressure of the connecting channel and the second cavity will increase due to the continuous entering of the sealing element into the connecting channel, and the liquid of the connecting channel and the second cavity will enter the containing cavity through the liquid inlet of the lyophobic channel to reduce the pressure of the connecting channel due to the action of the pressure, so that the sealing element can smoothly seal the connecting channel. Of course, the lyophobic passage can be arranged at will, and the lyophobic passage is generally in liquid communication with the containing cavity. Thus, if the sealing element continues to enter the connecting channel, the drained liquid enters the receiving cavity through the lyophobic channel.

In some aspects, such as shown in fig. 3 and 2, the sealing member 1028 is configured to seal the opening 1091 of the connecting channel 109, and the receiving cavity can be located within the sealing member, such as the sealing member having a hollow structure, such that the removed liquid can enter the receiving cavity, and the hollow structure 1029 can be used as the receiving cavity. For example, as shown in FIG. 3, the sealing member 1028 further includes a receiving cavity 1029, when the sealing member enters the connecting passage, the excess liquid enters the receiving cavity 1029 through the lyophobic passage 1025, so as to relieve the pressure, but the lyophobic passage 1025 is short because the sealing member is thin-walled or hollow. Of course, it will be readily understood that the receiving cavity need not be located on the sealing member, and that when coupling bar structure 1023 is hollow structure 1030, hollow structure 1030 and receiving cavity 1029 communicate to form a large receiving cavity for receiving the volume of liquid displaced by the sealing member, or hollow structure 1030 may be used as a receiving cavity with equal effect. In some preferred forms, such as shown in fig. 2-3,12, the sealing member 1028 seals the opening of the connecting channel 1091 and into the connecting channel 109, while excess liquid passes through the lyophobic channel 1025 into the holding chamber 1029. In such an embodiment, the liquid-repellent passage has one end opening (liquid inlet) in fluid communication with the liquid in the connecting passage and the other end opening (liquid outlet) in fluid communication with the receiving chamber, so that the liquid can only enter the receiving chamber, where the liquid-repellent passage is short, and there is always a liquid inlet and a liquid outlet, no matter how short, because the liquid-repellent passage is provided on the hollow sealing element. In fact, when the containing cavity is located in the sealing element or in the subsequent liquid discharging element, the liquid inlet and the liquid outlet are not strictly divided, and only when the lyophobic passage is longer, the liquid inlet and the liquid outlet are divided, because the sealing element or the liquid discharging element is of a hollow structure and the wall is very thin, in fact, a hole is formed in the wall and plays a role of allowing liquid to enter the containing cavity, and when the liquid inlet or the liquid outlet is not necessarily divided, the hole can also be called as a liquid inlet or a liquid outlet, and in short, the division of the position is not very obvious.

In some preferred forms, as shown in fig. 12, the liquid inlet of the lyophobic passage is located below the sealing member. In some preferred forms, the liquid inlet of the lyophobic passage is located on the sealing element and enters the connecting passage earlier than the sealing element, so that the redundant liquid can be discharged out of the connecting passage, thereby reducing the reaction resistance of the liquid level to which the sealing element is subjected. The lyophobic passages can be through holes on the receiving cavity 1029. Such lyophobic passages may be one or more.

In a preferred embodiment, the liquid inlet of the lyophobic channel is arranged before the sealing element into the connecting channel. Therefore, in some modes, if the lyophobic passage is relatively long, and the first cavity is used as the accommodating cavity, the liquid inlet of the lyophobic passage is located on the sealing element, but enters the connecting channel earlier than the sealing element, so that in the process that the sealing element enters the connecting channel, the discharged liquid enters the lyophobic passage through the liquid inlet of the lyophobic passage and then enters the first cavity through the liquid outlet of the lyophobic passage or enters the accommodating cavity. Here, the first chamber is a specific embodiment of the housing chamber, and the first chamber may be a chamber having a common housing chamber. The housing chamber is therefore not necessarily located on the sealing element, but preferably on the sealing element or in a connecting rod connecting the sealing element to the cover. In this way, as the sealing element enters the connecting channel, the excess liquid is discharged out of the connecting channel through the liquid inlet of the lyophobic channel. This removal is the liquid that is forced to be removed due to the pressure on the liquid surface created by the entry of the sealing element into the connecting channel. Of course, the size of the receiving cavity is related to the liquid to be removed. It is sufficient to set a suitable volume capacity to accommodate the liquid to be removed.

The "liquid inlet of the lyophobic passage" is located in such a way that the sealing element is forced into the connection passage, in which case the liquid inlet is located below the sealing element, and the "lower" is merely a relative position and is not necessarily located on the sealing element. For example, the liquid inlet may be located on a wall of the connecting channel, and when the sealing element enters the connecting channel, the liquid inlet on the wall of the connecting channel is located at a position below the sealing element, and as the sealing element continues to enter the connecting channel, a part of the liquid is forced to enter the liquid inlet and is removed, so as to smoothly enter the sealing element. In one case, the sealing element may continue to enter the connecting channel until the sealing element overlaps the liquid inlet in the wall of the connecting channel, and liquid cannot enter the lyophobic channel through the liquid inlet, thereby being excluded from the connecting channel. Therefore, in some preferred embodiments, the inlet is located below the sealing member, for example, as shown in fig. 2-3, and an inlet 1032 is provided below the position of the sealing member 1028, and is lyophobic to the inlet of the liquid channel 1025.

As another example, as shown in fig. 15,18,22,23, 27. For example, as shown in fig. 15-24, the sealing element 2024 and the connecting structure 2023 are a unitary structure, the extending portion of the connecting structure serves as the sealing element, and the whole connecting structure and the extending structure are

hollow structures

2030,2029, the hollow structures serve as a large accommodating cavity, and the liquid inlet 2025 of the lyophobic passage is an opening located on the side wall of the extending structure, the opening is a liquid inlet of the lyophobic passage and is also located below the sealing element. For another example, as shown in fig. 23, during the process of the sealing element 2028 entering the connecting channel, the inlet 2025 of the lyophobic channel under the sealing element discharges the redundant liquid, thereby reducing the resistance of the sealing element entering. In some preferred forms, the difference from the arrangement shown in figure 31 is that the sealing element 3028, which lacks the sealing ring 208, is part of the connecting structure 3024 as a sealing element, and the connecting structure extension has an opening 3025 at the top end thereof, the opening 3025 communicating with a hollow receiving cavity 2039 in the sealing element, and when the sealing element enters the connecting channel, the excess liquid sample enters the receiving cavity through the lyophobic channel inlet 3025, as shown in figures 33-35B, for example, although the sealing element 4029 is detachably combined with the connecting rod 4024, and the top end of the sealing element is provided with a liquid inlet 4038 to remove the excess liquid. It will be appreciated that the sealing member is preferably shaped or sized to match the connecting passage for better sealing of the connecting passage, for example the connecting passage is of circular hollow configuration and the sealing member is also of circular configuration to facilitate sealing engagement therebetween.

With continued reference to fig. 33-35, a coupling stem 5023 is provided on the first cap 502, which has a sealing member 5028 thereon, which may be used to seal the connecting channel, if the connecting channel is sealed with a sealing member 4028 as described above, a liquid inlet 4038 for the liquid-repellent channel is provided at a top end 4029 thereof, and a receiving cavity 5030 is included in the sealing member 5028 to collect liquid expelled by the sealing member into the connecting channel. Of course, a liquid inlet 5025 can also be provided below the sealing element 5028, and when the sealing element 5028 enters the connecting channel to seal the connecting channel, the excessive liquid enters the receiving cavity through the liquid inlet 5025, i.e., the hollow structure serves as the receiving cavity 5030. At this point, member 4029 does not act as a seal, but rather as a drain, where the extended tip 4028 of the connecting rod 4024 acts as a seal.

Of course, if instead of using a portion of the structure 5028 of the connecting rod 5022 as a sealing element, a sealing element 5029 is provided on the structure shown at 5035, as shown in fig. 33-35, the sealing element 5029 can be removably connected to the connecting rod, such as by a plug, screw, or snap connection. For example, member 5035 includes an end 5030 having external threads that mate with internal threads 5027 of the connecting rod. And the sealing element 5029 engages the inner wall of the connecting channel to seal the connecting channel. The liquid inlet of the lyophobic passage is disposed at the top end 5038 of the member 5035, and when the sealing member 5029 enters the connection passage, the excess liquid enters the housing cavity 4029 in the sealing member through the liquid inlet 4038, and the liquid inlet 5025 may be omitted or omitted.

In some preferred modes, in order to facilitate the removal of the liquid and also facilitate and effectively allow the liquid to enter the liquid inlet, the vertical plane position of the liquid inlet of the lyophobic channel is lower than the vertical position of the outermost surface of the sealing element, in other words, the horizontal projection area of the position of the liquid inlet of the lyophobic channel is not completely consistent with the horizontal projection area of the sealing element, and preferably, the horizontal projection area of the position of the liquid inlet of the lyophobic channel is located within the horizontal projection area of the sealing element. It is understood from the other meaning that the sealing element needs to be in contact with the inner wall of the connecting channel, and the liquid inlet of the lyophobic channel is preferably not in contact with the inner wall of the connecting channel, since the contact seals the liquid inlet; thus, the liquid can enter the liquid inlet of the lyophobic passage and be discharged. As can be seen in fig. 2 and 3, for example, the diameter of the position of the sealing element with the sealing ring 108 is larger than the diameter of the position of the liquid inlet 1025, so that the liquid inlet 1025 is prevented from contacting the inner wall of the connecting channel to influence the smooth liquid entering the lyophobic channel and then reaching the receiving cavity. In FIG. 2, the dashed area 1055 is the projected area A-A 'of the sealing member, and the projected area point or area of the loading port 1025, which is located between A-A', is divided by B. Therefore, according to such a principle, in some embodiments, the sealing element may have an inverted cone structure (the function of which will be described later, namely, the function of draining liquid), and the liquid inlet 1025 of the lyophobic passage is located on the surface of the cone, so that the liquid inlet of the lyophobic passage does not contact with the inner surface of the connecting passage, and the drained liquid can be conveniently drained into the liquid inlet of the lyophobic passage. It can also be understood from fig. 18 that the position of the sealing element 2028 is such that, due to the presence of the sealing ring 208, the projection of the liquid inlet 2025 at the sealing element 2028 is located within the projection of the sealing ring. It can be easily understood that the liquid inlet is provided with an inverted conical shape, and the liquid inlet of the lyophobic channel is arranged on the surface of the cone, so that liquid can easily enter the lyophobic channel, and the redundant liquid sample can be discharged. In fig. 31-32, for example, the liquid inlet of the lyophobic passage is arranged at the top end, and the condition that the liquid inlet of the lyophobic passage is sealed by the side wall of the connecting passage is not considered, but the principle that the projection of the liquid inlet is located in the horizontal projection area of the sealing element is satisfied. Referring again to FIGS. 33-34, while it is preferable to use either the extended end 5028 of the connecting rod 5023 as the sealing member or the portion 5029 as the sealing member, the projection of the

inlet

5025 or 5027 of the lyophobic passage is still within the horizontal projection of the sealing member, because the

inlet

5025 or 5027 is provided in the recess, the inlet is not sealed by the side wall of the connecting passage, and the inner wall of the connecting passage is generally flat and smooth, thus being easily sealed, which facilitates the removal of the liquid.

In summary, when the sealing member seals the connecting passage, it is preferable that the sealing member enters the connecting passage, and to relieve the pressure of the entering of the sealing member, a lyophobic passage is provided to discharge the liquid discharged from the entering of the sealing member into the connecting passage to another place. As described above, the liquid inlet of the lyophobic passage is arranged below the sealing element, and the inlet at one end of the lyophobic passage is advanced into the connecting passage compared with the sealing element, so that the redundant liquid can enter the lyophobic passage. Also as described above, when the receiving chamber is in the sealing member or located elsewhere, the other outlet (liquid outlet) of the lyophobic passage communicates with the receiving chamber to receive the excess liquid in the connecting passage.

In some other alternatives, the first chamber may also be used as a receiving chamber, so that the liquid sample discharged from the sealing member at the connecting channel is discharged to the first chamber through the lyophobic channel. In the above embodiment, the inlet of the lyophobic passage is located on the sealing member or on the connecting structure integrally connected with the cover body or below the sealing member. Alternatively, the lyophobic channel is not located on the sealing element, and may be located on the connecting channel, for example, the lyophobic channel is located on a side wall of the connecting channel, an inlet (liquid inlet) of the lyophobic channel is located on the side wall of the connecting channel, and the liquid outlet is communicated with the first cavity. It is conceivable for a person skilled in the art to read the embodiment of the present invention that no matter how the lyophobic passage is arranged, for example, the positions of the liquid inlet and the liquid outlet, it is sufficient that the excluded liquid sample entering the connecting passage due to the sealing element can be excluded, so as to reduce the resistance of the liquid of the sealing element to the sealing element, for example, the liquid inlet of the lyophobic passage is located above the sealing element or at other positions.

In other embodiments, the loading port may be sized arbitrarily, e.g., so that liquid may enter it, but liquid is not allowed to flow freely out of it. Because the liquid enters the lyophobic channel through the liquid inlet, the liquid often enters the lyophobic channel due to the pressure of the liquid, and after the liquid enters the lyophobic channel, the liquid cannot flow out of the liquid inlet due to the surface tension of the liquid inlet. This has the advantage that, since the loading port is generally located below the sealing element, when the second chamber and the connecting channel are open, the loading port is exposed to the outside, which may also lead to the risk of contamination of the environment with the liquid sample if the liquid in the receiving chamber is allowed to flow out through the loading port, and therefore, it is desirable that the loading port only allows the liquid to enter but not the liquid to flow out. Generally, the size of the loading port is set, for example, 0.1 to 1 to 2 mm, so that the liquid in the receiving chamber does not flow out of the loading port due to surface tension.

In some embodiments, the sealing element may be detachable from the first cover after sealing the connecting channel, if the sealing element is provided on the cover. In one embodiment, the sealing element is integrally connected or combined with the cover body, and the sealing element is used for sealing the connecting channel along with the first cover body covering the opening of the first cavity. After the sealing is completed, if the first cover body needs to be opened, the first cover body is rotated reversely to expose the opening of the first cavity, and at this time, the sealing element still stays in the connecting channel to seal the connecting channel, and the first cover body is removed, so that part of the liquid sample can be taken out from the first cavity to perform other detection or assay. For example, as shown in FIGS. 33-35, the seal 5029 and the cap are removably coupled together via the coupling rod 5023, at which time the seal 5029 is positioned on the 5035. The member 5035 is detachably combined with the connecting rod 5023 of the cap body in a manner that the member 5035 is inserted into one end of the connecting rod, instead of the threaded structure as shown in fig. 33-35. After the first cap 502 drives the sealing element 5029 to seal the connecting channel, the second cavity can be separated from the first cavity, so as to seal the opening of the second cavity, for example, the second cap seals the opening of the second cavity, and the sample in the second cavity is used for a second test. At this point, the first cover 502 has closed the first chamber, such as the opening 1031 of the first chamber 103 shown in fig. 9; if it is desired to remove the liquid sample from the first chamber, the first cap is inverted, the sealing member is fitted into the connection channel, the member 5035 is merely plugged into the connection rod, and the first cap is separated from the first chamber 103 again to allow the member 5035 to stay in the connection channel. The advantage of this design is that if the first chamber is only used for collecting the sample, after having collected the sample, sealed the connecting channel, the partition processing of liquid sample has been carried out, can open first lid in this time, takes out some samples as the assay from the first chamber, if the assay result needs further confirmation to detect, can take off the second chamber from the first chamber, carries out the secondary assay. In practice, the sample may be removed from the first chamber a plurality of times for a plurality of tests or assays without indicators.

The liquid to be removed is generally when both the connecting channel and the second chamber are filled with the liquid sample. It can be understood that when the second chamber is not filled with the liquid sample, the connecting channel will not generally contain the liquid sample, and if the sealing member enters the connecting channel to seal the connecting channel, the lyophobic channel can serve to discharge a portion of the compressed gas to the outside of the second chamber, and the resistance of the sealing member entering the connecting channel can be reduced, and the resistance at this time is the reaction force generated by the gas compression to block the entrance of the sealing member.

Therefore, in some preferred modes, in both cases, when the connecting channel is filled with liquid, the lyophobic channel plays a role in draining the liquid; in order to better seal the connecting channel by the sealing element when the second chamber is not filled with liquid, the lyophobic channel plays a role in exhausting air. Therefore, the lyophobic passage can simultaneously play two roles or one role in function, so that the lyophobic passage can be called a passage for discharging fluid, wherein the fluid refers to liquid or gas or a mixture of the liquid and the gas, correspondingly, a liquid inlet of the lyophobic passage can be called an air inlet, a liquid outlet can be called an air outlet, or the liquid inlet and the fluid outlet can be called a fluid inlet and a fluid outlet. It can be understood that if the compressed gas is to be exhausted, the exhaust channel does not need to be specially arranged, the exhaust can be realized by the lyophobic channel, and the channel also does not need to be specially designed, because the sealing element only needs to achieve the liquid sealing degree when liquid exists, and if the gas exists, the sealing element only needs to achieve the liquid sealing actually. Therefore, when gas removal is required, the gas removal function can be selected from small gaps between the sealing element and the connecting channel element, which can be errors between mechanical structures, or deliberately designed structures, which can allow gas to pass but not liquid, so as to achieve the gas removal function. Of course, the venting channel or the venting structure is not essential here either, since a liquid-tight effect, rather than a gas-tight effect, is required for the sealing element to seal the connecting channel. In contrast, a liquid-tight seal is not necessarily achieved when a gas-tight seal is achieved, but the liquid-tight seal is achieved when a gas-tight seal is achieved.

The "lyophobic passage" is also a preferable mode of the present invention, because the sealing element can better seal the connecting passage, and a part of the sealing element can enter the connecting passage to achieve better sealing effect. It is also possible, if otherwise, that the sealing element only seals the first opening of the connecting channel, without sealing the opening and requiring access to a distance at one end of the connecting channel, in which case the lyophobic passage may be absent. If there are other chambers that are not filled with liquid, the lyophobic passages may be absent, since the function of the sealing opening or the connecting passage is not important, since there is no leakage of liquid. .

Also, in another case, it may not be necessary to provide a structure like a lyophobic passage, for example, as shown in the drawing (design 2, when the opening of the connection passage is sealed with a cap, the lyophobic passage is not necessary)

Liquid discharge element

In some preferred forms, the device of the present invention may further comprise a drainage element for draining a portion of the liquid sample from the second chamber. The term "liquid discharge element" is used herein to refer to a liquid discharge element when an object enters a liquid sample, the object having a volume which occupies a certain space in the liquid sample, thereby discharging a certain volume of liquid, the volume of liquid entering the object being the volume of liquid discharged. It is understood here that like a ship in water, a ship will occupy the space originally occupied by water due to the weight of the ship which requires the removal of a certain volume of water. Of course, as mentioned above, if the space does not contain liquid but gas, the gas is removed instead of liquid after the liquid discharge element enters the space containing gas.

In other embodiments, for example, when the second chamber is filled with the liquid sample, even if the sealing element seals the connecting channel, but the liquid in the second chamber is completely filled with the liquid sample, when the second chamber needs to be detached from the first chamber, the liquid in the filled second chamber overflows due to mechanical operation, which causes the unfriendly operation and the pollution to the outside or the operator. In addition, even if the second chamber filled with the liquid sample is carefully removed or detached from the first chamber, it is not easy to seal the opening of the second chamber with the second cover, so that the second chamber filled with the liquid may also cause some risks of leakage during transportation. Therefore, in some preferred embodiments, it is desirable to remove a portion of the liquid sample from the second chamber to the outside of the second chamber at the same time, after, or before the sealing member seals the connecting channel. Thereby let the liquid of second chamber not fill up to, the liquid sample in the second chamber that separates from first chamber can not overflow out, has increased the security and the friendship nature of operation, has also reduced the follow-up risk of revealing that detects in the transportation of carrying on the second simultaneously, has also increased the friendship nature and the security of the operation of follow-up second detection.

When the second chamber is detached from the device, as shown in fig. 13, a certain space is reserved in the second chamber, and the liquid does not fill the second chamber, so that the liquid sample does not overflow from the second chamber during detachment, and the risk of polluting the outside is reduced.

In some preferred forms, the device further comprises a drainage member for draining the liquid sample from the second chamber to the outside of the second chamber. It will be appreciated that the drainage element may be any structure or method for reducing the liquid sample in the second chamber. In some preferred forms, the drainage element is formed as an extension of the sealing element, or the drainage element is located on the sealing element. For example, in fig. 2-3, fig. 18,23,27,31, 33. For example, in fig. 2-3, the sealing member 1028 is a unitary structure with the drain member 1027, and the drain 1017 and the sealing member 1028 are generally similar in shape except that they have a longitudinal dimension slightly larger than the sealing member and a transverse dimension smaller than the sealing member. At this time, it is also possible that the horizontal projection of the liquid discharge element is located within the horizontal projection of the sealing element or that a part of the horizontal projection of the liquid discharge element is located within the horizontal projection of the sealing element. At this time, when the sealing member enters the connection channel, firstly the liquid discharge member 1027 enters the connection channel, and since the diameter of the liquid discharge member 1027 is smaller than that of the connection channel 109, all of the excess liquid sample is discharged to the first chamber 103 outside the second chamber 104 or outside the connection channel 109 through the space or gap 809 between the surface of the liquid discharge member and the surface of the connection channel 109, and as the liquid discharge member 1027 further enters the second chamber (see fig. 22 and 12), the sealing member starts to seal the opening 1091 of the connection channel 109, thereby performing the sealing of the liquid-tight connection channel as described above. Since liquid discharge element 1027 enters the second chamber, part of the liquid sample in the second chamber is removed. When the sealing member 1028 initially seals the opening 1091 of the connecting channel, the liquid sample below the opening 1091 of the connecting channel cannot be removed through the space between the surface of the liquid discharge element 1027 and the surface of the connecting channel 109, and if the sealing member needs to move downward, the liquid sample continuously removed by the liquid discharge element and the liquid sample removed by the sealing member itself enter the lyophobic channel through the inlet of the lyophobic channel, and then enter the accommodating chamber. In some preferred forms, therefore, the inlet of the lyophobic passage is located on the drainage element. More preferably, the receiving cavity is located in the drainage element. It will be readily appreciated that the sealing member and the drainage member may be injection moulded in one piece. During injection, the injection mold is in a hollow structure, so that a containing cavity is formed to contain the discharged liquid.

As mentioned above, in order to facilitate the liquid entering the inlet of the lyophobic passage and being discharged to the outside, the lateral diameter of the liquid discharge element is smaller than the inner diameter of the connecting passage. For example, the drainage element may be in the shape of an inverted cone and a conical structure as in fig. 18, i.e. where the inlet 3025 of the lyophobic passage is located. For example, the drainage element 3027 in fig. 27 is of an inverted cone-shaped configuration. A tapered structure 4027 under the sealing member 4029 shown in fig. 31 and 32, such as the tapered structure formed by the drainage structures 435 shown in fig. 33-35. In fact, the drainage does not require a separate structure, and if the sealing element is long enough, the sealing element can penetrate into the second cavity, and in this case, the sealing element can play a dual role, namely, the change of the liquid communication state between the second cavity and the first cavity is realized, and meanwhile, part of liquid in the second cavity is also discharged. The drainage element is therefore only functionally defined and does not require separate structures to achieve this. In fact, these tapered structures may also be used as drainage elements, as will be described in more detail below.

In other forms, such as shown in fig. 15,18,22-23, and 27, the

drainage element

2027,3027 is connected to the

sealing element

2028,3028 and is also formed as an extension of the sealing element. A sealing ring 208 is provided outside the sealing element 2024 such that the sealing ring 208 is disposed on the surface of the sealing element, slightly above the outer surface of the sealing element 2014. Thus, even if the diameter of the drainage element 2017 is the same as the diameter 2024 of the sealing element, when the drainage element 2027 enters the connecting channel 209 (see, for example, fig. 22), at which time the sealing element and the drainage element enter together, the drainage element first enters the connecting channel because the drainage element is at the end and the sealing element is above the drainage element, and if there is liquid in the connecting channel, the liquid drained by the drainage element entering the connecting channel enters the first chamber 103 through the gap 809 between the surface of the drainage element and the inner surface of the connecting channel. With further movement of the sealing element and the drainage element, the drainage element 2027 enters the first chamber, at which time the sealing ring may not yet seal the opening 2091 of the connecting channel 209, and with further movement of the drainage element 2027 into the second chamber 204, liquid may still be drained into the first chamber 203 through the gap 809. When the sealing ring 2023 on the sealing element 2024 seals the opening 2091 of the connecting channel 209, no liquid can be expelled into the first chamber through the slit 900. At this time, the sealing element and the sealing ring need to continue to move in the connecting channel, so that a stable sealing effect is achieved. Continued movement requires continued removal of the liquid sample, at which time excess removed liquid sample is removed through the liquid inlet 2025 of the lyophobic passage to the outside of the connecting passage and the second chamber. For example, through the inlet 2025 of the lyophobic passage into the lyophobic passage, and then through the outlet of the lyophobic passage into the receiving chamber 2029 or the first chamber. At this point, the second chamber 204 is separated from the device, for example as shown in fig. 24 and 28, from the connecting channel, and the liquid discharge element 2027 is located in the second chamber, thereby removing a portion of the liquid sample from the second chamber. When the second chamber is removed from the device, as shown in fig. 28, a certain space is reserved in the second chamber, and the liquid does not fill the second chamber, so that the liquid sample does not overflow from the second chamber during the removal, and the risk of polluting the outside is reduced.

It will be appreciated that the drainage member is of the same size as the sealing member, and that the liquid in the connecting channel may not be removed from the slit before the sealing member seals the connecting channel, but may be removed from the connecting channel or the second chamber through the inlet of the lyophobic channel.

In other embodiments, the seal and the drain are not significantly separated, such as shown in fig. 31-32, the seal 5028 is not a seal, the drain 5027 and the seal 5028 are on an extension of the coupling 5023, and the coupling 5023 is coupled to the first cap 502 at one end and to the seal 5028 or the end of the coupling. The sealing element 5028 is in turn connected to a drainage element 5027. The liquid 5025 of the lyophobic passage is located at the tail end of the liquid discharge element, and the containing cavity is located in the liquid discharge element, the sealing element or the connecting structure. When the connecting structure, the sealing element and the liquid discharging element are of hollow structures, the liquid outlet of the liquid dredging channel is communicated with the containing cavity. As described above, when such a liquid discharge element 5027 enters the connecting channel, the discharged liquid enters the lyophobic channel through the liquid inlet 5038 at the end of the liquid discharge element, and then enters the receiving cavity through the liquid outlet of the lyophobic channel. The liquid inlet can be set to be of such size, so that liquid can smoothly pass through the liquid inlet, but the liquid entering the receiving cavity cannot leak out of the liquid inlet due to the surface tension of the liquid at the position of the liquid inlet. This is because the surface of the discharge element 5027 forms a seal with the inner surface of the connecting channel 209 as soon as the discharge element has entered the connecting channel 109,209 through the

opening

2091,1091 of the connecting channel, and at this time the discharge element and the sealing structure are the same structure, the discharge element simultaneously serving the dual function of sealing the connecting channel and removing liquid. As the discharge element moves within the connecting passage there is a pressure on the liquid in the connecting passage which counteracts the discharge element thereby increasing the difficulty of the discharge element 4027 entering the connecting passage. To reduce the reaction force of the liquid, excess liquid is allowed to enter the liquid inlet 4025 of the lyophobic passage and thus into the receiving cavity 4029 in the drain cock 4027.

When the second chamber is separated from the device, the liquid sample is partially removed from the second chamber because the liquid discharge element 1027 is located in the second chamber. When the second chamber is detached from the device, as shown in fig. 13, a certain space is reserved in the second chamber, and the liquid does not fill the second chamber, so that the liquid sample does not overflow from the second chamber during detachment, and the risk of polluting the outside is reduced. In addition, the liquid sample in the housing chamber does not leak out through the liquid inlet port 3025 due to the surface tension at the liquid inlet port 3025.

In some embodiments, such as shown in fig. 33-35, the element 5035 can be used as a drain and the seal 5028 can be located on the connecting rod 5024, in which case the drain and seal are removably connected, the overall transverse dimension of the drain 5035 is smaller than the dimension of the seal 5028, such as the diameter of the drain being smaller than the dimension of the seal 5028 (as shown in fig. 33), the connection between the drain and seal is threaded, such as shown in fig. 35A and 35B, in which the seal 5028 is a hollow structure with internal threads on the inside surface, and the drain 5035 has an upwardly extending segment 5030 with an end that is externally threaded, such that the drain and seal 5028 can be connected together by the mating of the internal and external threads. When the sealing member and the drainage member are let into the connection channel 209, the drainage member is easy to enter the connection channel because the size of the drainage member is smaller than that of the connection channel, and the surplus liquid enters the first chamber through the gap between the drainage member and the connection channel. With the sealing element sealing the opening 2091 of the connecting channel 209, no liquid can enter the first chamber through the slit, and with the sealing element entering the connecting channel, excess liquid enters the receiving chamber or the first chamber through the inlet 4025 of the lyophobic channel.

In some preferred forms, referring again to fig. 33 and 35, where the size of the liquid discharge element 5035 is comparable to the diameter of the sealing element 5028, or where the size of the liquid discharge element is smaller than the diameter of the sealing element 5028, the liquid inlet 5025 of the liquid repellent channel is disposed on the extension 5030, as can be seen in fig. 34, where the liquid inlet 5025 has a smaller diameter than the diameter of the sealing element 5028 and also smaller than the diameter of the liquid discharge element 5029, forming a recessed region at the liquid inlet 5025. Thus, when the liquid discharge member 5035 enters the connecting channel 209, liquid removed by the removal structure 5029 is removed through the liquid inlet 4025 of the lyophobic channel in the recess. Similarly, as the drainage element further enters the connection passage and then subsequently enters the space of the second chamber, the sealing element seals the opening 2091 of the connection passage and then subsequently enters the connection passage, and liquid removed by one or both of them can be removed through the liquid inlet 5025 of the drainage passage, for example, into the receiving chamber or the first chamber. It will be appreciated that the drainage element is also preferred herein and is not a necessary way of accomplishing the invention.

Movement of sealing or drainage elements

As mentioned above, the sealing element seals the connection channel, and the drainage element can also enter the connection channel or the second chamber. These are all a movement process, and the movement of the sealing element and the drainage element needs to be initiated by moving the sealing element and/or the drainage element by means of a certain external force or by means of another mechanical structure. Therefore, the sealing element and the liquid discharge element can be operated in a linkage manner, for example, the movement of the sealing element drives the movement of the liquid discharge element; for example, movement of the drainage element moves the sealing element.

The term "linkage" refers to the movement of one object directly or indirectly driving the movement of another object, and usually, the movement modes of the two objects are identical, for example, one object rotates, and the driven object also rotates; for example, one object moves in an interposing manner, and the other object moves in an interposing manner. For another example, an object moves from an initial position to an end position, and during this movement, another substance is also moved from the initial position to the end position. The rotational movement may be from an initial position to an end position, although rotation and insertion may be mixed or used separately. Movement and shifting are meant to be understood interchangeably herein.

The first cover body and the sealing element or the liquid drainage element move in a linkage mode, namely the movement of the first cover body drives the sealing element to move, so that the liquid drainage element is driven to move. Or the first cover body and the liquid drainage element move in a linkage mode, namely the movement of the first cover body drives the liquid drainage element to move, so that the sealing element is driven to move. In some preferred modes, the sealing element is located on the first cover body, and when the cover body covers the opening of the first cavity, the cover body drives the sealing element to seal the connecting channel to form a sealing state. As described above, the sealing of the sealing member against the connecting passage is generally divided into three states, the first state being that the sealing member does not contact the opening of the connecting passage. For example, as shown in fig. 22, the first cover 202 has a sealing element 2028, when the cover covers the opening 2031 of the first cavity 203, the sealing element 2028 is driven into the first cavity, and at this time, the sealing element does not contact the first opening 2091 of the connecting channel (fig. 22), and at this time, the connecting channel connects the first cavity and the second cavity, and at the same time, the first cavity and the second cavity are in fluid communication through the channel. As the cover closes over the opening 2031 of the first chamber, the cover moves from top to bottom along the longitudinal axis of the first chamber, bringing the sealing element closer to the opening 2091 of the connecting channel. At this time, as the first cover is further closed, the sealing member 2028 comes into contact with the first opening 2091 of the connection passage 209, thereby sealing the opening (fig. 23). The connecting channel 209 can now be considered to be sealed. However, in order to ensure a more stable sealing of the connection channel, it is desirable that the sealing element enters the connection channel 209 a distance, thereby more stably sealing the connection channel, at which time a covering of the cover is still required, thereby pushing the sealing element 2028 into the connection channel. A similar process, such as that shown in fig. 12. Whatever the type or form of sealing element, it is a preferred way for the sealing element and the cover to move simultaneously. Of course, the movement of the cover and the movement of the sealing element may also be separate movements, for example the first cover is used to cover the opening of the first cavity, thereby completing the covering process. The sealing element instead performs the sealing of the connecting channel by a separate movement, not in cooperation with the first cover body.

In the case of a drainage member, the function is to drain some of the liquid from the second chamber, as previously mentioned, when the second chamber is filled with liquid, the drainage member is required for liquid drainage, but if the second chamber is not filled with liquid, the drainage member may not be required. Therefore, the drainage element is a preferred form of the invention and is not essential. When the liquid drainage element is needed, the liquid drainage element and the cover body can be connected into a whole structure, so that the movement of the cover body drives the liquid drainage element to move, and the liquid drainage element is inserted into the second cavity to drain liquid. Of course, as previously mentioned, the sealing element and the drainage element are two distinct elements, and the drainage element enters the second chamber before the sealing element. Preferably, the drainage element enters the connection channel and thus the second chamber before the sealing element. For such a design, the drainage element is located at the end of the sealing element, further away from the first cover body, thereby achieving such a functional design.

In some preferred forms of the invention, therefore, the invention provides a cover body provided with a sealing element for sealing the connecting channel. In some preferred modes, a sealing ring is arranged on the sealing element. In some preferred forms, the sealing element and the connecting channel are of the same or different materials. In some preferred forms, the sealing element is of a flexible material and the connecting channel is of a rigid material. In some preferred modes, the sealing element is connected with the first cover body into an integral structure through a connecting rod. In some preferred modes, the sealing element further comprises an opening of the lyophobic passage. In some preferred forms, the opening of the lyophobic passage is located below the sealing member, or the opening of the lyophobic passage is advanced into the connecting passage prior to the sealing member. In some preferred modes, the cover body further comprises a containing cavity, and the containing cavity is in liquid communication with the lyophobic channel. The containing cavity is communicated with a liquid outlet of the lyophobic passage. In some preferred forms, the housing cavity is located in the sealing member.

In another aspect, if the first and second chambers are not initially in fluid communication, but require that the first and second chambers be in fluid communication after the first chamber has collected the liquid sample, the cap may include a first element that allows the first and second chambers to be in fluid communication and a second element that allows the first and second chambers to be out of fluid communication. For example, the first and second chambers may not be initially in fluid communication with each other by having a sealing member initially sealing the first opening 1091 of the connecting channel, and if the first and second cover portions are coupled, first contacting the first member with the sealing member, e.g., when the sealing member is a structure that is easily punctured, the first member is a sharp puncturing structure, and the fluid in the first chamber enters the second chamber after puncturing. Subsequently, the second member is allowed to reseal the first opening, thereby effecting a change in the flow state of the liquid. Thereby, the second chamber can be separated from the first chamber. The skilled person will appreciate that the second member may be an alternative to any of the sealing members described above, may comprise a drainage member, may comprise a hydrophobic channel, etc. Such as the embodiment previously shown in fig. 37-40.

First cover body and second cover body

The first cover is here a cover for covering the first cavity, while the second cover is a cover for covering the opening of the second cavity. Specific examples of the cover may be in the shape of the cover shown in fig. 1-28. Of course, the cover body actually plays a role of covering the opening of the first cavity, and the first cover body does not necessarily need to seal the opening of the first cavity. However, the main function of the second cap is to seal the opening of the second chamber so that it does not cause leakage of the liquid sample. Therefore, in some embodiments, the second cover is disposed on the first cover, and the second cover is detachably combined with the first cover. For example, the second cover may be screwed or otherwise inserted together, and when it is desired to seal, typically liquid seal, the opening of the second chamber, the second cover may be removed from the first cover to seal the second chamber.

Method for detecting or collecting liquid sample

The invention also provides a method for collecting a liquid sample, which comprises the step of providing the device for collecting the liquid sample, wherein the device comprises a first cavity and a second cavity, the second cavity and the first cavity are detachably connected, the first cavity is used for collecting the liquid sample, and the liquid sample flows into the second cavity. In some preferred embodiments, the second chamber is separated from the first chamber when the second chamber contains the liquid sample, and the opening of the second chamber is covered by the second cover. In some preferred forms, the first chamber is not placed in fluid communication with the second chamber prior to separating the first chamber from the chamber. In some preferred forms, the sealing member separates the first chamber from the second chamber, thereby leaving the first chamber and the second chamber out of fluid communication.

In some preferred forms, the first chamber and the second chamber are connected together by a connecting channel, wherein the first opening of the connecting channel is in fluid communication with the first chamber and the second opening of the connecting channel is in fluid communication with the second chamber. Separating the second chamber from the first chamber by separating the second chamber from the connecting channel; or the second cavity is detachably connected with the connecting channel, and the connecting channel is not detachably connected with the first cavity; alternatively, the second chamber is detachably connected to the connecting channel, and the connecting channel is also detachably connected to the first chamber.

In some forms, the sealing element seals the connection channel when the second chamber is removably connected to the first chamber through the connection channel. Therefore, in some preferred forms, the device further comprises a sealing element for sealing the connecting passage before the second chamber is separated from the first chamber. In some preferred modes, the device further comprises a cover body, and the cover body and the sealing element are connected into a whole structure, so that when the cover body covers the opening of the first cavity, the cover body drives the sealing element to seal the first opening of the connecting channel. In some preferred embodiments, the cover body carries the sealing element into the connecting channel. In some preferred forms, the second chamber is separated from the first chamber after the sealing member seals the connecting passage. In some preferred modes, a liquid drainage element for draining part of liquid in the second cavity is further arranged on the cover body, so that the cover body drives the liquid drainage element to enter the second cavity. In some preferred forms, the cover has a sealing member and a drainage member, the drainage member being advanced into the second chamber before the sealing member. In some preferred forms, the device further comprises a lyophobic passage, through which the liquid sample discharged from the liquid discharge element is discharged to the outside of the second cavity. In some preferred modes, the sealing element enters the connecting channel, and liquid discharged by the sealing element is discharged out of the connecting channel through the lyophobic channel. In some preferred modes, the liquid removed by the sealing element or the liquid discharging element is discharged into the first cavity through the lyophobic passage. In some preferred modes, a containing cavity is arranged on the cover body and is in liquid communication with the lyophobic channel, and liquid discharged by the sealing element or/and the liquid discharging element is discharged into the containing cavity through the lyophobic channel.

In some embodiments, the lyophobic passage has a liquid inlet and a liquid outlet, and the liquid removed by the sealing element and/or the liquid discharging element enters the liquid inlet and then enters the receiving cavity through the liquid outlet of the lyophobic passage.

In some other modes, the cover body is provided with a sealing element, and when the opening of the first cavity is covered by the cover body, the sealing element is driven to seal the connecting channel. In some forms, the sealing element is left in the connecting channel if the first cover body leaves the opening of the first cavity again, the latter being separated from the cover body.

In another aspect, the present invention provides a method of detecting the presence of an analyte in a liquid sample, the method comprising the liquid collection device of any of the above aspects, and detecting the liquid sample from the first chamber with the test element after the liquid sample is collected in the first chamber. And after the detection result is obtained, separating the second cavity from the first cavity according to any mode. In some embodiments, the device further comprises a detection chamber for receiving the test element, the detection chamber being in fluid communication with the first chamber, and the fluid flowing into the detection chamber when the first chamber has collected the fluid sample. When the detection cavity comprises the test element, the second cavity is separated from the first cavity after the test element completes detection. In some preferred embodiments, the liquid sample is allowed to pass from the first chamber into the detection chamber and then into the second chamber. Such a configuration is designed as described above, so as to avoid that liquid entering the detection chamber also enters the second chamber, thereby contaminating the liquid sample in the second chamber.

Detection cavity

The detection chamber is used in the present invention to analyze a liquid sample from the first chamber for the presence of an analyte. The detection chamber may be free of detection means and typically includes a test element within the detection chamber which is brought into contact with the liquid sample to perform an assay or test on the liquid sample. In conventional products, it is common to manufacture devices with test chambers by first fabricating the test elements or placing the test elements on a carrier, then inserting the test elements into the test chambers, and then sealing the test chambers. In this case, the detection chamber typically has an opening to allow the test element to be accessed into the detection chamber. For example, as shown in fig. 1 and 9, the detection chamber 105 has an opening 1051 near the opening 1031 of the first chamber 103, and a test element (not shown) placed on the test carrier 106 is positioned in a card slot 1061 of the test carrier, and then the carrier 106 is inserted into the detection chamber through the opening of the detection chamber. Usually, after insertion into the test chamber, the opening 1051 of the test chamber needs to be sealed, which is very high in sealing effect and quality, and as explained above, the whole test device or collection device needs to be transported and packaged together, so that in order to avoid leakage of the liquid in the test chamber or the liquid in the first chamber, any place where leakage may occur needs to be strictly sealed, and each product needs to be tested for tightness, which increases the production cost. However, with the second chamber of the invention having secondary confirmation, there is no deliberate need to be made to seal those previously considered to be good, and such seals need only be temporary seals and do not require a seal that requires permanence. For example, as shown in FIG. 9, the opening 1051 for the test volume may be sealed by conventional sealing, such as heat sealing with a film that is air-tight or liquid-tight during the test, and after separating the second chamber from the first chamber after the test is completed, the first chamber and the test chamber may be disposed of as a discard without the need to store and transport the entire test device.

Examples 1

How the detecting unit of the present invention is assembled and operated will now be described with reference to specific embodiments.

Such as the device shown in fig. 1-3,6-14, which includes a first chamber 103 and a second chamber 104, the first chamber 103 having an opening 1031 for introducing a liquid sample. As shown in fig. 1, the first chamber is defined by a side wall and a bottom, and the bottom of the first chamber has a raised area, for example, as shown in fig. 9, the raised area is located at the center of the whole bottom, and an opening 1091 is provided in the raised area and has a connecting channel 109, the connecting channel 109 has a first opening 1091 communicated with the inside of the first chamber 103, and another opening 1092 communicated with an opening 1042 of the second chamber. A recess is formed around the raised area inside the first chamber that forms a liquid sample collection area 1035,1036 (fig. 7). On the opposite wall 110 on the outside of the connecting channel 109 near the second opening 1092, a thread structure 1101 is provided, and on the outside wall of the opening 1042 of the second chamber 104, a thread structure 1041 is provided, which forms a rotating fit with the thread 1101 on the wall 110, thereby allowing the second chamber 104 to form a detachable fit with the first chamber through the connecting channel 109. Also included is a detection chamber 105 which is in fluid communication with the first chamber via a through-hole 1038. A test element is included in the detection chamber. The test elements are disposed in the card slots 1061 of the test carrier 106. Typically, the sample application zone of the test element is located in the region of the test carrier near the bottom of the second chamber, or near the bottom 1051 of the detection chamber, and the bibulous region of the test element is near the other end of the detection chamber (near the end of the first chamber opening 1031).

A cover 102 is also provided, a connecting rod 1023 is connected to the center of the cover, a sealing element 1028 is provided at the end of the connecting rod, and a sealing ring 108 is provided on the sealing element. Meanwhile, a liquid discharge element 1027 is provided under the sealing element, and the liquid discharge element 1027 and the sealing element and the connection rod 1023 are integrally formed, just a division of the unused functional area. Typically, the length of the connecting bar 1023 and the sealing element 1038 and the liquid discharge element 1027 is slightly greater than the distance from the opening 1031 of the first chamber 103 to the opening 1042 of the second chamber 104, so that the liquid discharge element 1027 can enter the second chamber 104 and thus serve to drain a portion of the liquid sample in the second chamber. Meanwhile, a liquid inlet 1025 of a lyophobic channel is arranged below the sealing element 1028 (fig. 2 and 3). The liquid inlet 1025 may be located between the liquid discharge element 1027 and the sealing element 1028. Meanwhile, the sealing member, the liquid discharging member and the connecting rod are hollow structures, and the interior of the hollow structures includes a receiving cavity 1029 for collecting the excessive liquid sample. In use, the liquid sample is collected at the opening of the first chamber, and then collected at the bottom of the first chamber along with the liquid sample, and then enters the detection chamber through the through hole 1038, and the liquid sample entering the detection chamber contacts with the sample reagent region of the test element, so as to perform assay and detection. As the liquid increases, the liquid sample enters the second chamber through the opening 1091 of the connecting channel, then the liquid sample gradually fills the second chamber 104, then flows over the first opening 1091 of the connecting channel, and finally reaches a level higher than the first opening 1091 of the connecting channel 109. At this point, collection of the liquid sample is stopped. Subsequently, the first cover 102 is closed over the opening 1031 of the first chamber 103. As the cover body covers the opening 1031, the cover body is rotated to cover the opening 1028, the liquid discharge element 1027 and the liquid inlet 1025 of the lyophobic passage, which are close to the opening of the connecting passage 109 (see fig. 10,11 and 12). As the cover is rotated, the drainage element 1027 first enters the connection channel 109, while the sealing ring of the sealing element is not yet close to the first opening 1091 of the connection channel. Liquid can enter the first chamber 103 through the gap between the liquid discharge element 1027 and the connecting channel 109. As the sealing element enters the connecting channel 109, the liquid discharged at this time enters the receiving cavity 1029 through the liquid inlet 1025 of the lyophobic channel, so as to discharge the excessive liquid sample, and the pressure of the sealing element entering the connecting channel is also reduced, so that better sealing is more easily achieved. After the liquid discharge element has entered the second chamber, the sealing element also seals the connecting channel 109. At this time, the testing element of the detection chamber is detected for the first time, and after it is considered necessary to retain the remaining sample for the second confirmation assay, the second chamber is separated from the first chamber by rotating the second chamber, and the liquid sample in the first chamber does not leak out because the sealing element seals the connection channel. The opening 1042 of the second cavity 104 is then sealed with the second cover 101 disposed over the first cover 102 (as shown in fig. 14 and 13). Therefore, the second cover body can be independently stored or packaged and transported to a testing mechanism for secondary confirmation testing.

Example 2 of embodiment

For example, as shown in fig. 15-18,23-28, a device is shown that includes a first chamber 203 and a second chamber 204, the first chamber 203 having an opening 2031 for introducing a liquid sample. As shown in fig. 16, the first chamber is defined by side walls and a bottom, and the bottom of the first chamber has a raised area, for example as shown in fig. 24, located centrally of the entire bottom, and an opening 2091 is provided in the raised area, having a connecting passage 209, the connecting passage 209 having a first opening 2091 communicating with the interior of the first chamber 203 and a further opening 2092 communicating with the opening 2042 of the second chamber. A groove is formed around the raised area inside the first chamber that forms a liquid sample collection area 2035,2034 (see fig. 24). A threaded formation 2101 is provided on the opposing wall 210 of the connecting channel 209 on the outside adjacent the second opening 2092 and a threaded formation 2043 is provided on the outside wall of the opening 2042 of the second chamber 204, the threads forming a rotational fit with the threads 2101 on the wall 210, thereby allowing the second chamber 204 to be removably fitted to the first chamber via the connecting channel 209. Also, a carrier 206 is provided having a plurality of channels sealed 2062 at one end and open 2063 at the other end, one or more test strips disposed in the channels, with a sample application area at one end of the opening 2063, and one or more channels in the carrier 206 for receiving the test strips, with one test element for each channel, and where there are multiple channels, different test elements for analytes can be disposed in each channel, such that multiple analytes can be detected from the same sample. The carrier 206 is placed in the first cavity 203 with two retaining

strips

2032 and 2033 on the walls of the cavity 203, and the carrier 206 is inserted or snapped into the two retaining grooves with the open channel end 2065 near the bottom of the first cavity and the sealed channel end 2064 near the opening 2031 of the first cavity (fig. 16). When the liquid sample flows into the first chamber through the opening 2031 of the first chamber, the liquid sample contacts the sample application area of the test strip, thereby completing the test.

A cover 202 is also provided, a connecting rod 2023 is connected to the center of the cover, a sealing element 2028 is provided at the end of the connecting rod, and a sealing ring 208 is provided on the sealing element. Meanwhile, a liquid discharge element 2027 is provided under the sealing element, and the liquid discharge element 2027 and the sealing element 2028 and the connecting rod 2023 are integrally formed, and are merely a division of a functional area which is not used. Generally, the length of the connecting rod 2023, the sealing element 2028 and the drainage element 2027 is slightly larger than the distance from the opening 2031 of the first cavity 203 to the opening 2042 of the second cavity 204, so that the drainage element 2027 can enter the second cavity 204 and thus can drain part of the liquid sample in the second cavity. Meanwhile, a liquid inlet 2025 of a lyophobic passage is provided below the sealing member 2028 (fig. 18 and 26). The liquid inlet 2025 may be located between the liquid discharge element 2027 and the sealing element 2028.

Meanwhile, the sealing element, the liquid discharging element and the connecting rod are hollow structures, and the interior of the hollow structures comprises a containing cavity 2029 for collecting the redundant liquid sample. When the test element is used, the liquid sample is collected in the opening of the first cavity, is collected at the bottom of the first cavity along with the liquid sample, and is contacted with the application area of the test element on the carrier for testing and detection. As the liquid increases, the liquid sample enters the second chamber through the connecting passage opening 2091, then the liquid sample gradually fills the second chamber 204, then flows over the connecting passage first opening 2091, and finally is at a higher level than the connecting passage 209 first opening 2091. And stopping receiving the liquid sample when the liquid reaches the set position with the addition of the liquid, wherein the collection of the liquid sample is stopped. The first cover 202 is then placed over the opening 2031 of the first cavity 203. As the cover body covers the opening 2031, the cover body is rotated to cover the opening, and the sealing element 2028, the liquid discharge element 2027 and the liquid inlet 2025 of the lyophobic passage are driven to be close to the opening of the connecting passage 209 (as shown in fig. 22). As the cover rotates, the drainage element 2027 first enters the connecting channel 209, while the sealing ring of the sealing element is not yet close to the first opening 2091 of the connecting channel, but does not seal the first opening 2091 of the connecting channel. Liquid can enter the first chamber 203 through the gap 809 between the liquid discharge element 2027 and the connecting channel 209. Along with the sealing of the connecting channel in the connecting channel 209 by the sealing element, the liquid discharged by the sealing element or the liquid discharging element enters the receiving cavity 2029 through the liquid inlet 2025 of the lyophobic channel, so that the redundant liquid sample is discharged, the pressure of the sealing element entering the connecting channel is also reduced, and better sealing is more easily achieved. After the drainage element has entered the second chamber, the sealing element also seals the connection channel 209 at this time. At this time, the test element of the detection chamber is detected for the first time or the first time, and after it is considered necessary to retain the remaining sample for the second confirmation assay, the second chamber is separated from the first chamber by rotating the second chamber, and the liquid sample in the first chamber does not leak out because the sealing member seals the connection passage. The second cover 201 disposed on the first cover 202 is then used to seal the opening 2042 of the second cavity 204 (see fig. 24). This allows the second chamber to be stored or packaged separately for transport to an assay facility for a second confirmatory assay.

EXAMPLE 3

Such as the device shown in fig. 25-30, which includes a first chamber 303 and a second chamber 304, an opening 3031 in the first chamber 303 for introducing a liquid sample. As shown in fig. 27, the first chamber is defined by sidewalls and a bottom, and the bottom of the first chamber has a raised area, for example, as shown in fig. 27, the raised area is located at the center of the entire bottom, and an opening 3091 is provided in the raised area, and has a connecting channel 309, the connecting channel 309 has a first opening 3091 communicating with the inside of the first chamber 303, and another opening 3092 communicating with the opening 3042 of the second chamber. A groove is formed around the raised area inside the first chamber that forms a liquid sample collection area 3035,3036 (see fig. 27). Adjacent the second opening 3092 in the connecting channel 309 are smooth outer and inner walls. There is a tray structure 1004 having internal threads 10041 that threadably mate with the external threads of the bottom of the first chamber.

The second chamber 304 is located on a base tray 1004, and the base tray 1004 is detachably connected to the first chamber, and the second chamber 304 is also detachably combined with the base tray 1004. In particular, the tray structure 1004 has internal threads that mate with external threads 3031 extending from the bottom of the first chamber 303 to provide a removable combination of the tray structure 1004 with the first chamber 303. Thus, if a connecting channel is also present, as shown in fig. 27, the connecting channel 309 may still have a first opening 3091 in fluid flow with the first chamber and a second opening 3092 in fluid flow with the second chamber, while the connecting channel has an extension 3098 which extends into the opening 3052 of the second chamber, in contact with the inner wall of the opening 3041, and may snap together, i.e.: the outer diameter of the extended area matches the inner diameter of the opening 3041. Although the second chamber and the first chamber may also be snap-connected via the connecting channel 109 as shown in fig. 27, this connection does not require a very secure connection and does not require as tight a connection as in fig. 8-9 (by means of threads etc.) because the tray structure 1004 is engaged by the threads 10041 with the external threads 3031 of the extension of the first chamber 103, so that no matter how small the amount of liquid sample the second chamber 304 collects, no leakage problem between the connecting channel 109 and the second chamber opening 1042 is caused. Therefore, the inner diameter of the connecting channel 109 may be smaller than the inner diameter of the opening 1042 of the second cavity, so that the connecting channel can be inserted into the opening 3042 of the second cavity in a manner that the connecting channel can be easily inserted (shown in FIG. 27). And threads are provided only on the outer edge of the opening 3042 for the covering of the second cover (see fig. 27). In this case, the connection between the connection channel and the opening of the second chamber is sufficient to ensure that no leakage occurs during collection of the liquid sample, i.e. that the liquid can enter the second chamber without further structural restrictions. The connection can be in the forms of clamping, piston and locking. In practice, the detachable combination, coupling or engagement of the first chamber with the second chamber is accomplished in an indirect manner.

A cover body 302 is also provided, a connecting rod 3023 is connected to the center of the cover body, a sealing element 3028 is arranged at the end of the connecting rod, a sealing ring is arranged on the sealing element, and the sealing ring and the sealing element are made of the same material and are formed by one-step injection molding. Meanwhile, a drainage element 3027 is provided under the sealing element, and the drainage element 3027 and the sealing element and the connecting rod 3023 are integrally formed, and are merely a division of the unused functional area. Generally, the length of the connecting rod 3023 and the sealing member 3038 and the drainage element 3027 is slightly greater than the distance from the opening 3031 of the first chamber 303 to the opening 3042 of the second chamber 304, so that the drainage element 3027 can enter the second chamber 304 and drain a portion of the liquid sample in the second chamber. Meanwhile, a liquid inlet port 3025 (fig. 27) of a lyophobic passage is provided below the sealing member 3028. The liquid inlet port 3025 may be located between the drain element 3027 and the sealing element 3028 or on the drain element. Meanwhile, the sealing element, the liquid discharging element and the connecting rod are hollow structures, and the interior of the hollow structures comprises a containing cavity 3029 for collecting redundant liquid samples. When the liquid sample collecting device is used, the liquid sample is collected at the opening of the first cavity and is collected at the bottom of the first cavity along with the liquid sample. As the liquid increases, the liquid sample enters the second chamber through the opening 1091 of the connecting channel, then the liquid sample gradually fills the second chamber 304, then flows over the first opening 3091 of the connecting channel, and finally has a higher liquid level than the first opening 3091 of the connecting channel 309. At this point, collection of the liquid sample is stopped. The first cover 302 is then placed over the opening 3031 of the first chamber 303. As the cover covers the opening 3031, the cover is rotated to cover and drive the sealing element 3028, the liquid discharge element 3027 and the liquid inlet port 3025 of the lyophobic passage to approach the opening of the connecting passage 309. As the cover is rotated, the drainage element 3027 first enters the connection channel 309, while the sealing ring of the sealing element is not yet adjacent to the first opening 3091 of the connection channel. Liquid can enter the first chamber 303 through the gap between the drainage element 3027 and the connecting channel 309. As the sealing element enters the connecting channel 309, the liquid removed at this time enters the receiving chamber 3029 through the liquid inlet port 3025 of the lyophobic channel, so that the excess liquid sample is removed, the pressure of the sealing element entering the connecting channel is also relieved, and better sealing is more easily achieved. After the liquid discharge element has entered the second chamber, the sealing element also seals the connection channel 309.

In this time, the liquid in the first cavity can be used for subsequent primary detection, after the residual sample is considered to be necessary to be reserved for secondary confirmation and assay, the tray structure is separated from the first cavity by rotating the tray structure, so that the second cavity is separated from the first cavity, and the second cavity is separated from the first cavity. The opening 3042 of the second cavity 304 is then sealed with a second cover 301 disposed over the first cover 302 (see FIG. 28). At this time, the tray structure and the second cavity can be packaged together and sent to an assay mechanism for secondary assay. Alternatively, the second chamber is removed from the tray and packaged for a second confirmation assay (fig. 29). At this point, the tray is again transferred to the first chamber, forming the finished structure (fig. 30).

All patents and publications mentioned in the specification of the invention are indicative of the techniques disclosed in the art to which this invention pertains and are intended to be applicable. All patents and publications cited herein are hereby incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. The invention described herein may be practiced in the absence of any element or elements, limitation or limitations, which limitation or limitations is not specifically disclosed herein. For example, the terms "comprising", "consisting essentially of … …" and "consisting of … …" in each instance herein may be substituted for the remaining 2 terms of either. The word "a" or "an" herein means only "one", and does not exclude only one, but may mean 2 or more. The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described, but it is recognized that various modifications and changes may be made within the scope of the invention and the claims which follow. It is to be understood that the embodiments described herein are preferred embodiments and features and that modifications and variations may be made by one skilled in the art in light of the teachings of this disclosure, and are to be considered within the purview and scope of this invention and the scope of the appended claims and their equivalents.

Claims

1. A method of collecting a liquid sample: the method comprises the following steps:

there is provided a device for collecting a liquid sample, wherein the device comprises: a first chamber for collecting a liquid sample, wherein said first chamber has an opening for receiving the liquid sample; and a second chamber for collecting a liquid sample for use in performing a confirmatory test, the second chamber having an opening for receiving the liquid sample from the first chamber; the tray structure comprises a second cavity, wherein the tray structure is detachably combined with the first cavity; wherein the first chamber has an aperture in fluid communication with the second chamber;

collecting a liquid sample with a first chamber, and allowing the liquid sample to enter the first chamber through an opening of the first chamber;

subsequently allowing the liquid to automatically flow from the first chamber into the second chamber through said aperture; or, part of the liquid enters the first cavity, and the other part of the liquid enters the second cavity;

after the liquid sample is collected, a sealing element seals the hole, so that the second cavity is not in fluid communication with the first cavity;

when the second cavity is not in fluid communication with the first cavity, the tray structure is separated from the first cavity, so that the second cavity is driven to separate from the first cavity;

and when the second cavity body leaves the first cavity, the second cavity body is separated from the tray structure.

2. The method of claim 1, wherein the aperture has an extended channel, a portion of the extended channel being located in the second cavity.

3. The method of claim 1, wherein the opening of the second cavity is closed with a second cover before or after the second cavity is released from the tray structure, thereby forming a sealed second cavity.

4. The method of claim 2, wherein a first cover is provided to cover the opening of the first chamber, and the sealing element is provided on the first cover to allow for coordinated movement of the first cover and the sealing element.

5. The method of claim 4, wherein the first cover carries the sealing element to prevent fluid communication between the first chamber and the second chamber when the first cover covers the opening of the first chamber.

6. The method of claim 4, wherein the first cover carries a sealing element to seal the aperture or part of the extended channel of the first cavity.

7. The method of claim 4, wherein the first cover carries the sealing element with a portion of the sealing element into the extended channel.

8. A method according to claim 4, wherein the first cover member is further provided with a drainage member, the drainage member being spaced from the cover member relative to the sealing member.

9. The method of claim 8, wherein the drainage member further comprises a lyophobic passage, the lyophobic passage comprising a liquid inlet, the liquid inlet being positioned farther from the first cover than the sealing member; alternatively, the liquid inlet is arranged before the sealing element enters the extension channel.

10. The method of claim 9, wherein the projected area of the inlet is located within the projected area of the sealing member.

11. The method of claim 10, wherein a portion of the liquid is forced by the sealing element through the liquid inlet into the lyophobic passage and thereby excluded from the second cavity.

12. The method of claim 11, wherein the lyophobic passage includes a liquid outlet, and the liquid outlet is in fluid communication with a receiving cavity.

13. The method of claim 12, wherein the receiving cavity is in the sealing member, the drainage member, or the first cover.

14. The method of claim 13, wherein the receiving cavity is configured to receive the liquid sample removed from the sealing member when the portion of the sealing member enters the extension channel.

15. The method of claim 14, wherein the portion of the liquid sample removed by the drainage element enters the collection volume when the drainage element enters the second chamber.