CN106732835B

CN106732835B - Collection detection device of fluid sample

Info

Publication number: CN106732835B
Application number: CN201510814418.0A
Authority: CN
Inventors: 勾利剑
Original assignee: ABON Biopharm Hangzhou Co Ltd
Current assignee: ABON Biopharm Hangzhou Co Ltd
Priority date: 2015-11-21
Filing date: 2015-11-21
Publication date: 2020-09-15
Anticipated expiration: 2035-11-21
Also published as: CN106732835A

Abstract

The invention relates to a fluid sample collection and detection device, which comprises a sample collector, a sample collection and detection device and a detection device, wherein the sample collector is used for receiving and containing a fluid sample and is characterized by comprising a rigid receiving part and a flexible container body, wherein the rigid receiving part is used for receiving the fluid sample; the receiving member is located at the sample collector opening; the container body is positioned at the lower part of the sample collector; the receiving member is connected to the container body. The collecting and detecting device is convenient and quick to store samples through the combination of the rigid cup mouth and the flexible cup body, realizes the separation of the collected samples from the detected samples in time, and can detect the collected samples at any time.

Description

Collection detection device of fluid sample

Technical Field

The invention relates to a collecting and detecting device for a fluid sample, in particular to a collecting and detecting device for collecting a urine sample.

Background

The following background is provided to aid the reader in understanding the present invention and is not admitted to be prior art.

The technology of detecting whether an analyte exists in a sample by using the principle of an immunological binding reaction is widely used in various fields. It can be used to detect analytes in various biological samples (saliva, blood, urine, serum, sweat, etc.) to monitor diseases and human health (early pregnancy, tumors, infectious diseases, drugs, etc.). The underlying principle of such detection techniques is to establish the ability to specifically bind between immune molecules, such as antibodies and antigens, haptens/antibodies, biotin and avidin, and the like.

In the field of medical diagnosis, it is a common method to determine whether a liquid sample is analyzed by using a detection device or a detection cup without collecting the liquid sample. Such test devices or test cups typically require the sample to be collected in a sample container, and the associated technician includes a test strip and immerses a portion of the test strip in the sample, removes the test strip after a period of time, and reads the test results. In a more improved way, the sample collection container is handled after the closure cap is applied thereto. Currently, there are many closure devices such as those disclosed in US 4976923, US 5429804, and US 6726879. These devices are used to hold test strips on the cover of the test device. When the device is used, the container is turned or inclined to enable the sample to infiltrate the detection reagent strip for detection.

U.S. patent application publication No. US2003/0027359A1, published on 6/2/2003, discloses a urine cup for testing. The urine cup still needs to push the plunger piston to move by the push rod after the cover is covered on the opening of the cup, so that the fluid sample flows out of the cup cavity and wets the detection element. Chinese patent application 200510113911.5 discloses a device for detecting a liquid sample, in which a strip of detection reagent is located on a cup lid, a tube is provided between the cup lid and the cup body, and the liquid sample is pressed into the tube to make the liquid enter the cup lid for detection.

Along with the standardization and daily standardization of various body fluid sample detections, household detections are increasing day by day, and the various disclosed detection devices have large volumes, high transportation costs and inconvenient carrying. Chinese patent CN102338799 discloses a new collecting device using a bag body as the collecting device, which is convenient to carry. However, the device needs to support the bag opening by force to collect the fluid sample when in use, the operation is inconvenient, and the collection and detection device needs to detect immediately after collecting the sample, so that the device is not suitable for the situation that the sample is collected firstly and then transported to a detection place for detection.

Disclosure of Invention

The present invention is directed to the above-mentioned problems, and provides an improved device for collecting and testing a fluid sample, which combines a rigid cup with a flexible cup body, and provides a specific structure to make the device more convenient for collecting a sample, and to select the time for testing the sample.

The invention provides a device for collecting and detecting a fluid sample, which comprises a sample collector, a sample collecting device and a detection device, wherein the sample collector is used for receiving and accommodating the fluid sample; the receiving member is located at the sample collector opening; the container body is positioned at the lower part of the sample collector; the receiving member is connected to the container body.

The term "rigid" as used herein means that the material itself has a certain hardness and a certain fixed shape, and is not easily deformed by external force such as bending and folding. Hard metals, such as iron, steel, etc., and hard plastics, such as PVC, etc., all have the characteristic of being "rigid". The flexibility is opposite to the rigidity, namely, the object has certain flexibility and elasticity, the shape of the object can be changed under the action of external force, for example, the object can be folded and bent, and the material of the object is soft plastic, thin film, paper and the like, and has the characteristic of flexibility. In the present invention, the rigid container member and the flexible container body in the collector are not limited in material so as to satisfy the characteristics of rigidity and flexibility and to meet the standards of medical materials. In some embodiments, the rigid receiving member is made of a plastic material having a certain hardness, such as PVC. The flexible container body can be made of soft plastics and thin films.

In some preferred embodiments, the receiving part and the container body can be of an integrated structure or a detachable split structure, and only the receiving part and the container body are connected to form a complete collector and can realize the function of bearing samples without leakage; i.e. the joint between the two needs to be sealed.

In some preferred embodiments, the receiving member comprises a cup for receiving the fluid sample. In some embodiments, to facilitate the receiving of the sample, the cup opening has a cylindrical shape with a certain opening size, such as a cylindrical shape, an elliptical cylindrical shape, and the like.

In some preferred embodiments, the receiving means further comprises a hollow cup located below the rim; the cup mouth is connected with the cup body, and the cup body is connected with the container body. More specifically, the cup is connected with container body and because of container body is flexible material, can be folded or warp, and for the convenience of container body and the connection of accomodating the part, hollow cup is long and flat structure.

In some preferred embodiments, the cup includes a recess in an inner sidewall of the cup. The groove is positioned on one side of the inner side wall of the cup body.

In some preferred embodiments, the flexible container body is a foldable bag body, and the bag body is connected with the cup body. The pouch can be folded or compressed to reduce the volume of the collector, particularly when not carrying a fluid sample, to facilitate transport of the device of the invention before testing and handling after testing is complete.

In some preferred embodiments, the kit further comprises a detection plate for detection.

In some preferred embodiments, the test panel is located within the pouch body and is not in fluid communication with the pouch body.

In some preferred embodiments, the test strip is a one-piece structure with only one end open for insertion of the test strip. The detection plate is of an integrated structure, only one end of the detection plate is opened, the detection plate is not only used for placing the test strip, and meanwhile, the fluid sample can only enter the detection plate from the opened end, namely enters a sample receiving area of the test strip, so that the fluid sample is prevented from entering other areas of the test strip and influencing the detection result.

In some preferred embodiments, one end of the opening of the detection plate is snapped into the recess.

In some preferred embodiments, the recess has a front projection therein which secures the test panel and a rear projection which secures and seals the test panel. Through the matching of the groove and the protrusion in the groove and the detection plate, a fluid sample can flow through a gap between the front protrusion of the groove and the detection plate, reach the bottom of the groove and then reach the opening end of the detection plate, and finally reach the test strip to realize detection.

In some preferred embodiments, the bag body further comprises a sheet, and the sheet and the bag body form a sealed cavity; the detection plate is located in the sealed cavity. The sheet may be made of the same material as the bag body or may be made of a material slightly harder than the bag body.

In some preferred embodiments, one end of the tab is located within the recess. That is, the sheet is positioned in the groove with the open end of the cavity formed by the bag body. The sheet is located between the detection plate and the front projection. That is, the open end of the sealed hollow cavity formed by the sheet and the bag body is positioned in the groove, so that the detection plate in the cavity is communicated with the groove fluid.

In some preferred embodiments, the device further comprises a cover that covers and seals the sample collector.

In the invention, after a sample is collected in the sample collector, namely, the sample is positioned in the bag body, the cover body is covered and sealed at the cup mouth, so that the device is sealed, then the device is turned upside down, so that the liquid in the bag body enters the groove of the cup body, then enters the bottom of the groove through the gap between the bulge in the front of the groove and the detection plate or the sheet, then enters the sample receiving area of the test strip at the opening end of the detection plate, and sequentially flows through the test strip, thereby completing the detection process. After the sample is collected in the device, the device does not turn over, and the sample can not contact the test strip with the open end positioned in the groove of the cup body, so that the sample can not be detected. Therefore, the detection may be performed immediately after the sample is collected, or may be performed at another time as needed. Thus, the need for detection is facilitated.

Advantageous effects

The collecting and detecting device is convenient and quick to store samples through the combination of the rigid cup mouth and the flexible cup body, realizes the separation of the collected samples from the detected samples in time, and can detect the collected samples at any time.

Drawings

FIG. 1 is an exploded view of a sample collection and testing device according to the present invention;

FIG. 2 is a schematic view of a sample collection and testing device according to the present invention;

FIG. 3 is a schematic view of a receiving member of the sample collection and testing device of the present invention;

FIG. 4 is a schematic cross-sectional view of a sample collection and testing device according to the present invention;

FIG. 5 is an enlarged view of a portion of FIG. 4;

description of reference numerals:

a sample collection and testing device 100; a cover body 110; a sample collector 120; a housing member 121; a container body (bag body) 124; a cup rim 122; a cup body 123; a sheet 125; a detection board 130; a detection plate upper cover 132; a detection plate lower cover 131; a test strip 131; groove 1231, groove front projection 1232; a groove rear projection 1233; the outer side of the cup body is concave-convex 1235; cup rim outer threads 1221; the sheet and bag form a cavity 126

Detailed Description

The present invention will be further described with reference to the structures or terms used herein. In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. It is not excluded that the invention can also be implemented in other embodiments and that the structure of the invention can be varied without departing from the scope of use of the invention.

As shown in FIGS. 2 and 1, the sample collection and testing device 100 of the present invention generally includes a sample collector 120 and a cover 110 for sealing the sample collector. After the cover 110 is closed on the sample collector 120, the device 100 is in a sealed state, and no fluid sample leaks from the device 100 no matter the device is rotated, shaken or even turned over. In some embodiments, the cover 110 has a screw thread on the inner side wall and the sample collector 120 has a screw thread 1221 thereon, which are engaged and sealed by a threaded engagement. To increase the sealing effect, a gasket is typically provided at the apex of the inner sidewall of the cover 110 to form a further seal with the opening of the collector 120 to prevent leakage of the liquid sample.

In order to facilitate carrying and transportation of the device 100 of the present invention and to facilitate the operation of collecting a sample, the collector 120 is made of a non-deformable plastic material with a certain hardness at the opening 121 thereof for receiving the sample, and the container body 124 of the collector connected thereto for carrying the liquid sample is made of a deformable flexible film, so that the volume of the collector 120 can be changed, and the volume of the container body 124 can be reduced to 0 even by squeezing or folding, thereby greatly reducing the space occupation and facilitating carrying and transportation.

In a more specific embodiment, as shown in fig. 3, the rigid receiving member 121 is composed of two parts: a spout 122 having a larger opening and a cup 123 for facilitating attachment to the container body. More specifically, the rim 122 is cylindrical, and the cup 123 is a flat elongated cavity, which are connected by a funnel-shaped barrel. The rim 122 has a thread 1221 to be engaged with the lid on the outside thereof, and the cup 123 also has an indentation 1235 to be engaged with the flexible container body 124 on the outside thereof.

The device 100 further comprises a detection plate 130 for detecting the collected fluid sample, as shown in fig. 1, a test strip 131 for testing is contained in the detection plate 130, and the test strip 131 is clamped in the detection plate 130 by an upper cover 132 and a lower cover 131 of the detection plate. In a more specific embodiment, sensing plate 130 is located within sensing device 100 as a unitary structure. Generally, during the test, it is desirable that the sample flows from the sample receiving area of the strip sequentially through the downstream labeled zone, the test result zone, and then the zone is effectively completed. Thus, the test strip in the test plate 130 is required to receive the fluid sample at only one end (sample receiving area) thereof, and the test plate 130 with the test strip is located in the container body 124 of the collector, so that in some embodiments, the test plate 130 is of a sealed structure with only one end open for receiving the test strip and maintaining communication with the outside.

Also as shown in fig. 3, a groove 1231 is formed at one side of the inner wall of the cup body 123, and the groove 1231 is used to engage and fix the detection plate 130. The end of the detection plate 130 having the opening is located in the groove 1231, i.e., the open end of the detection plate 130 communicates with the groove 1231. In more specific embodiments, as shown in the cross-sectional views of fig. 4 and 5, the groove 1231 further includes a front protrusion 1232 and a rear protrusion 1233 therein, which engage the sensing plate 130 and secure the same, and the rear protrusion 1233 on the inner sidewall of the cup 123 forms a seal with the sensing plate 130 to inhibit fluid flow.

The container body of the device 100 may be specifically a bag body 124 made of a plastic film, and in order to facilitate observation of the sample and observation of the detection result, the bag body 124 may be transparent, where transparent means that the shape, color, and the like of the object located in the transparent object can be observed by naked eyes. For example, the amount of sample collected can be observed, and the color of the display can be detected. The opening of the bag 124 is bonded to the exterior of the cup by heat deformation 1235 and is cooled and secured to form a fixed unit, the sample collector 120. Of course, the cup 123 and the bag 124 can be detachably connected, so as to facilitate the recycling of the collection and detection device 100.

In some preferred embodiments, the pouch 124 further includes a sheet 125, the sheet 125 forms only one opening with one side of the pouch 124, and the remaining portion of the sealed cavity 126, the open end of the cavity 126 being located in the recess 1231 of the cup 123. After the sensing plate 130 is placed in the cavity 126, the sensing plate 130 communicates with the groove 1231 and the exterior of the groove 1231 only through the opening of the cavity 126 located in the groove 1231. In a more specific embodiment, the sheet 125 is located between the front protrusion 1232 of the groove 1231 and the detection board 130, so that when the sample reaches the groove 1231, the sample flows into the open end of the cavity 126 formed by the sheet 125 and the bag 124, i.e. the bottom of the groove 1231, through the gap between the front protrusion 1232 and the sheet 125, and further flows onto the test strip 131 of the detection board, thereby completing the detection. In the present invention, the sheet may be made of the same flexible plastic or film as the bag, or may be made of a relatively rigid sheet-mounted plastic.

In the present invention, the sample required for detection by the test strip 131 is small, usually less than 1ml, and the liquid sample collected by the bag 124 generally has a volume of 5-20 ml. If a large amount of liquid flows into the test strip 131 after the device 100 is inverted, it will cause a test failure, and therefore the gap between the projections 1232 of the groove that controls the flow and outflow of liquid and the test strip 130 or sheet 125 (if any) should not be too large, in some embodiments, between 0.1 mm and 0.5mm, so that the liquid can flow through the gap after reaching the gap, or be wicked to the open end of the test strip 130 and the test strip 131.

The following describes a specific collection and detection process of the sample collection and detection device 100 of the present invention.

First, the cover 110 on the cup opening 122 is unscrewed, and a urine sample is injected into the bag 124 through the opening of the cup opening 122, and usually, the sample collection amount reaches 2/3 of the volume of the bag 124.

Next, the cover 110 is closed to seal the entire apparatus 100.

Third, when testing is desired, the sample collection test device 100 is inverted, such that fluid flows into the well 1231 of the cup 123, through the gap between the front projection 1232 and the sheet 125, and into the test plate 130, thereby completing the test.

Claims

1. A device for collecting and testing a fluid sample, comprising a sample collector for receiving and containing the fluid sample, wherein the sample collector comprises a rigid receiving member for receiving the fluid sample and a flexible container body for containing the fluid sample; the receiving member is located at the sample collector opening; the container body is positioned at the lower part of the sample collector; the receiving part is connected with the container body and comprises a cup opening for receiving the fluid sample and a hollow cup body positioned below the cup opening; the cup mouth is connected with the cup body.

2. The collection testing device of claim 1, wherein the cup includes a recess therein located in an inner sidewall of the cup.

3. The collection testing device of any of claims 1-2, wherein the flexible container body is a collapsible bag; the bag body is connected with the cup body.

4. The collection detection device of claim 3, further comprising a detection plate for detection.

5. The collection test device of claim 4, wherein the test panel is positioned within the pouch in fluid communication with the pouch.

6. The collecting and testing device of claim 5, wherein said test strip is a one-piece structure with only one end open for insertion of a test strip.

7. The collection sensing device of claim 6, wherein an end of the opening of the sensing plate is snap-fit into the recess.

8. The collection testing device of claim 7, wherein said recess has a front projection therein for securing the test panel and a rear projection for securing and sealing the test panel.

9. The collection testing device of claim 8, further comprising a sheet within the pouch, the sheet and pouch forming a sealed cavity; the detection plate is located in the sealed cavity.

10. The collection testing device of claim 9, wherein an end of the sheet is positioned within the recess.

11. The collection testing device of claim 10, further comprising a cover that covers and seals the sample collector.