CN110967478A

CN110967478A - Device for detecting analyte in liquid sample

Info

Publication number: CN110967478A
Application number: CN201811139751.6A
Authority: CN
Inventors: 雷似愚; 方剑秋; 沈荔丽
Original assignee: Zhejiang Orient Gene Biotech Co Ltd
Current assignee: Zhejiang Orient Gene Biotech Co Ltd
Priority date: 2018-09-28
Filing date: 2018-09-28
Publication date: 2020-04-07

Abstract

The invention discloses a device for detecting an analyte in a liquid sample, which comprises a cup body; a first receiving area for receiving a liquid sample; a flow-through channel through which a sample can be added or collected; the flow guide channel is communicated with the first receiving area, and the bottom surface of the flow guide channel is an inclined surface; wherein, the first receiving area and the flow guide channel are arranged in the cup body; the device also comprises a secondary sampling port; the flow guide channel is a groove; a second receiving area is arranged in the groove; the second receiving area includes a corner region for collecting the subsamples. The invention also discloses a using method of the device for detecting the analyte in the liquid sample. The device can be used for detecting the existence or the quantity of the analytes in the liquid sample, and can still detect the liquid sample under the condition that the liquid sample has extremely poor fluidity and/or the sample amount is extremely small, and an operator can conveniently suck the liquid sample to perform secondary confirmation detection.

Description

Device for detecting analyte in liquid sample

Technical Field

The present invention relates to a device for detecting an analyte in a liquid sample.

Background

Currently, there are various sample collection and testing devices available on the market for clinical or home use, and some documents also describe devices for detecting analytes in samples. US patent 5,376,337 discloses a saliva sampling device in which a piece of filter paper is used to collect saliva from the mouth of a subject and transfer the saliva onto an indicator reagent. US5,576,009 and US5,352,410 each disclose a syringe-type fluid sampling device. In these devices, after an initial result is obtained, the collected fluid sample cannot be stored for later use in a confirmation test. Chinese patent CN 1828307B discloses a device for detecting an analyte in a fluid sample, which is convenient for sampling and performing a confirmation test, but when the fluid sample has poor fluidity and/or a small sample amount, the device can only perform a marginal test, and cannot perform a secondary confirmation test, and even when the fluid sample has very poor fluidity and/or a small sample amount, the device cannot be used for a direct test.

Many other sample collection and testing devices have difficulty performing secondary tests by extracting samples from the device. Many devices are very complex in their design and manufacture and require the use of rather expensive materials.

Disclosure of Invention

In view of the above, to overcome the drawbacks of the prior art, the present invention provides a device for detecting an analyte in a liquid sample. The device can be used for detecting the existence or the quantity of analytes in the liquid sample, and when the liquid sample has extremely poor fluidity and/or the sample amount is extremely small, the device can still detect the liquid sample, is convenient for an operator to suck the liquid sample, performs secondary confirmation detection, avoids the liquid sample from being detained at the bottom of the cup body in a large area, is not beneficial to collection, even cannot be collected, and cannot perform secondary confirmation detection.

In order to solve the technical problems, the invention provides the following technical scheme:

the invention provides a device for detecting the existence or quantity of an analyte in a liquid sample, which can comprise a sample collector and a sample receiving cup, wherein the sample collector is used for directly or indirectly collecting the sample from the body of a patient or a part needing to be collected or a certain scene separated from the body of the patient. The sample receiving cup can receive and hold a sample collector, in some preferred modes, the sample receiving cup can receive the sample collector or a part of the sample collector, after the sample collector collects the sample, the sample collector can be placed into the sample receiving cup, and then the sample in the sample receiving cup is transferred into the sample receiving cup; in some preferred embodiments, the sample receiving cup can directly receive the sample collected by the sample collector.

In some preferred forms, the sample receiving cup includes at least one test element for detecting the presence or quantity of an analyte residing in the sample.

In some preferred forms, the detection device may have a flat surface which enables the entire device to be in a resting state when lying across, i.e. without any rolling motion, and since the detection element may be flat, it is necessary to test it lying flat, and it is necessary to ensure that it does not roll after being placed so as to affect the detection. In some preferred forms, the detection means may have at least one of the above-mentioned planes. In some preferred forms, the outer wall of the detection device may be formed by at least three of the above-mentioned planes.

In some preferred modes, the sample collector comprises a collecting element for collecting the liquid sample and a push rod for fixing the collecting element.

In some preferred forms, the sample receiving cup includes a cup body having fixedly attached therein a sleeve for cooperating with the collection element, the sleeve being capable of receiving and retaining the sample collector.

In some preferred forms, the collection element is compressible, squeezing or absorbing the sample by compression and rebound thereof. In some preferred forms, the collection element is fixedly attached to the sample collector by a connector, and in some preferred forms, the collection element is removably attached to the sample collector. In some preferred forms, the sample collector is provided with a member for connecting the collecting element, and the member may be a rod, so that the collecting element extends into the sample collector to place the sample after the sample is collected.

In some preferred forms, the collection element is a sponge, which may be natural or synthetic. In some preferred forms, the collection element is a cylindrical sponge material adapted to be placed in the mouth of a subject to collect saliva. In certain embodiments, the collection element is treated with a chemical composition (e.g., citrate or other chemical) to promote salivation and facilitate absorption by the collection element.

In some preferred forms, the collection element is secured to the connector at one end of the push rod, and in some preferred forms, the collection element may be adhered or welded to the connector of the push rod by a sealant or a hot melt adhesive or other glue. In some preferred modes, a sealing structure, such as a sealing ring, is arranged on the connector, and the sealing structure on the connector can be attached to the inner wall of the sleeve and ensures that the collected sample cannot flow back when the connector is pressed downwards.

In some preferred modes, the one end that the connector was kept away from to the push rod is connected on the fixing base, and the cross sectional area of fixing base is greater than the cross sectional area of push rod, so the setting of fixing base is convenient for the operator to snatch the sample collector. In some preferred modes, the push rod and the fixed seat can be fixedly connected through integral molding, and in some preferred modes, other suitable connection modes are adopted, such as the push rod and the fixed seat are connected together through a snap connection, or the push rod and the fixed seat are connected through adhesion or matching of internal threads and external threads. In some preferred modes, the fixed seat cover surface is provided with a cylindrical protrusion, and the fixed seat cover surface refers to: when the fixed seat covers the sleeve, the push rod is fixedly connected to the cylindrical protrusion in an integrated forming mode through a contact surface which is in contact with the upper surface of the sleeve. In some preferred forms, the cylindrical projection is externally threaded on its periphery. In some preferred forms, the fixed seat is provided with an internal thread for detachably connecting the sleeve. In some preferred forms, the mounting base is provided with other suitable formations for releasably connecting the sleeves, such as snap formations, or other features which snugly fit and hold the two members together.

In some preferred modes, the fixing seat can completely cover the sleeve, and the completely covering mode refers to that: after the holder completely covers the sleeve, a sealed structure is formed, and the liquid sample cannot leak from the device through the covered position. The process that the sleeve pipe is completely covered by the fixing seat, and the collecting element is continuously compressed.

In some preferred modes, the covering surface of the fixed seat is provided with a positioning convex part or a positioning concave part. The positioning convex part or the positioning concave part is arranged on the covering surface, the external structure of the fixed seat or the cup body cannot be influenced, and meanwhile, the external structure of the device cannot influence the positioning of the device. In some preferred manners, the positioning protrusion may be a positioning block, and the positioning recess may be a positioning groove. In some preferred modes, be equipped with the arc locating piece on the fixing base lid closes the face, the tip of cylindrical protruding external screw thread of arc locating piece connection for after the external screw thread was screwed up, the arc locating piece smoothly by the screw in corresponding constant head tank, realize the location like this.

In some preferred modes, the fixing base inner wall is provided with a reinforcing structure for reinforcing the fixing base side wall, so that the fixing base is firmer and more stable and is not easy to damage. In some preferred modes, the reinforcing structure is a paddle-shaped structure, the paddle-shaped reinforcing structure has a good reinforcing effect, the whole fixed seat is firm, the fixed seat is not easy to damage, and the appearance is attractive. In other embodiments, the reinforcing structure may be plate-like or any other suitable structure.

In some preferred modes, one end of the sleeve is provided with a connecting part, so that the connecting part can be connected with the cup body and is convenient for the sleeve to be matched with the sample collector for use. In some preferred forms, the cannula has an inner cap at one end that covers the cup opening, the inner cap having an opening to facilitate insertion of the collection element into the cannula. In some preferred forms, the other end of the sleeve has a closing surface which closes the other end of the sleeve. In some preferred forms, the closing surface is provided with a nozzle at an off-center location to facilitate the flow of the liquid sample from the nozzle after it has been squeezed. In some preferred forms, the sleeve is tapered, the inner cap opening inner diameter is greater than the diameter of the closing face, the closing face diameter is greater than the outer nozzle diameter, the inner cap opening inner diameter is greater than the width of the largest cross-section of the collection element, and the closing face diameter is less than the width of the smallest cross-section of the collection element. After the collecting element absorbs the liquid sample, the collecting element is inserted into the sleeve from the opening of the inner cover, and in the process of continuously inserting the sleeve, the collecting element is pushed by the push rod and is extruded by the inner wall of the sleeve to the periphery of the sleeve, so that the liquid sample can be separated from the collecting element quickly and completely. In other embodiments, the cannula may have other shapes that interact with the shape of the collection element.

In some preferred embodiments, the inner lid of the sleeve is fixedly connected to the cup body by being bonded or welded to the open end of the cup body, and in other embodiments, may be fixed by other suitable methods. In some preferred modes, an inner thread matched with the outer thread on the periphery of the bulge of the fixing seat is arranged at the opening of the inner sleeve cover, and an arc-shaped positioning groove matched with the arc-shaped positioning block on the covering surface of the fixing seat is formed in the upper surface of the inner sleeve cover. Through rotating the fixing base, the external screw thread on the fixing base is continuously screwed into the internal screw thread at the opening of the inner cover until the inner cover is completely covered, and the arc-shaped positioning block is also completely screwed into the arc-shaped positioning groove. Arc locating piece and arc constant head tank mutually support and can restrict the fixing base and further to screwing up the direction motion, but can allow the fixing base to open the fixing base to the opposite direction motion under the exogenic action, the setting of locating piece and constant head tank can make the operator clearly and definitely feel that the fixing base has covered the inner cup completely, avoid covering after closing the inner cup after screwing up, because the user is uncertain whether to screw up, and screw up the fixing base with bigger power once more, this will damage the fixing base easily, simultaneously because uncertain whether to screw up, the user just can screw up the fixing base many times, the waste time, influence the operating efficiency. After the rotation is completed, the fixed seat completely covers the opening of the sleeve to form a sealing structure, a liquid sample cannot leak from the device through the covering position, and meanwhile, the positioning block is screwed into the positioning groove to give a prompt of rotating to the position, so that an operator can clearly know that the device is completely covered without screwing the fixed seat by using force. During rotation, the collection element, which has absorbed the liquid sample, is squeezed, thereby squeezing the liquid sample from the collection element out of the nozzle and into the sample receiving cup.

In some preferred forms, the holder and/or the cup may be polyhedral in shape. In some preferred modes, the fixing seat and the cup body are both polyhedral, that is, the cross sections of the fixing seat and the cup body are polygonal, can be three-deformation, quadrilateral, pentagonal or other polygons, and can also be regular polygons or non-regular polygons. In some preferred modes, one or more detection elements can be arranged in the polyhedron-shaped cup body, so that different analytes in the sample can be detected simultaneously. In some preferred modes, the detection element can be arranged on the inner wall of any side surface of the polyhedral cup body, and the inner wall of any side surface in the cup body can be provided with a placing part for placing the detection element. In some preferred modes, the cup body is an irregular pentahedron, namely the cross section of the cup body is in an irregular pentagon shape, wherein a detection element placing part is arranged on the inner wall of one side face of the pentahedron with the largest area, and is used for placing a detection element. In some preferred modes, the shape and the side length of the inner cover are the same as the cross section shape and the side length of the cup body, and are also in an irregular pentagonal shape, so that the inner cover can tightly cover the opening of the cup body, and the side lengths of the inner cover do not extend out of the side surface of the cup body, so that the cup body can be horizontally and stably laid on the side.

In some preferred modes, the fixing seat and the cup body can be polyhedrons with the same number of faces or polyhedrons with different numbers of faces. In some preferred modes, the fixing seat and the cup body are both irregular pentahedrons, and after the fixing seat completely covers the cup body, the side face with the largest area of the fixing seat is aligned in parallel with the side face with the largest area of the cup body, so that the fact that the fixing seat completely covers the cup body is convenient to confirm. In some preferred modes, the length of a side of fixing base and cup cross section pentagon is close, and when the fixing base closed the cup completely, every side of fixing base was close flush with every side of cup, was in the coplanar almost for the device that closes completely can lie flat side stably, the scanning of the testing result of being convenient for.

In some preferred modes, the cup body is made of transparent materials, so that the test result can be observed conveniently.

In some preferred modes, one side surface of the cup body is provided with a secondary sampling opening, in some preferred modes, the lower part of one side surface of the cup body is provided with an arch-shaped concave part, and the secondary sampling opening is arranged in the arch-shaped concave part. The secondary sampling mouth can be plugged up to the stopper, and after the secondary sampling mouth was plugged up to the stopper, the side that is equipped with the secondary sampling mouth still can stably lie the side and put. In some embodiments, the secondary sampling port may be capped with a plug during testing of the sample and transport device to seal. When the device is received on a clinical testing apparatus, the stopper may be removed and the user may remove a sample from the secondary sampling port for a secondary confirmation test, and the secondary sampling port may be configured to facilitate the user's addition of a solvent or other desired substance from the secondary sampling port, such as adding a solvent to increase the volume of the sample of the liquid sample, diluting the sample solution or adding a solvent to decrease the viscosity of the liquid sample. In some embodiments, when the stopper is opened, the operator may conveniently remove the sample using a pipette or other sampling device. The sample receiving cup can be conveniently held in a closed position and still allow the liquid sample to be removed.

In some preferred modes, be equipped with anti-skidding structure on the lateral surface of cup, in some preferred modes, anti-skidding structure is the sand grip, the setting of sand grip for the user snatchs easily or holds sample receiving cup, avoids the hand cunning, and the damage sample receiving cup falls down. In some preferred modes, other anti-skid structures such as pits or any other suitable structures are arranged on the outer side surface of the cup body.

In some preferred modes, a first receiving area for receiving and storing the sample is arranged in the sample receiving cup; in some preferred modes, a flow guide channel through which a sample can be added or collected is further arranged in the sample receiving cup; the first receiving area is in communication with the flow guide channel such that the sample can move therebetween. In some preferred modes, the first receiving area and the flow guide channel are arranged at the bottom of the cup body.

In some preferred embodiments, the sample receiving cup may include at least one detection element for detecting the presence or quantity of an analyte residing in the sample. In some preferred modes, the detection elements can be distributed on one side inner wall of the device of the invention or on a plurality of side inner walls of the device of the invention. In some preferred modes, a placing part for placing the detection element is further arranged on the inner wall of the side surface of the cup body, and the detection element can be placed in the placing part. The placing component is connected with the inner wall of the side surface of the cup body, and in some preferred modes, the placing component is detachably connected with the inner wall of the side surface of the cup body.

In some preferred forms, the placement member may employ a detection plate. In some preferred forms, the placement member may have a slot, and in some preferred forms, the sensing element may be a strip or the like that is placed within the slot. In some preferred modes, one slot may be provided on one detection plate, and in other preferred modes, a plurality of slots may be provided on one detection plate.

In some preferred embodiments, the test element can be any test device that provides a test result. In some preferred forms, the detection element is a test strip, which may have a specific binding molecule immobilized on the test strip and a reagent for performing an immunoassay. In some preferred embodiments, the detection element may also contain a chemical reaction-based test reagent, a biological-based test reagent (e.g., an enzyme or ELISA assay), or a fluorescence-based test reagent, among others. In addition, in other embodiments, the test element may have other reagents thereon that can be used to detect the presence or quantity of the analyte in the sample. In some embodiments, the detection element comprises a reagent for detecting the presence of the drug of abuse.

In some preferred forms, the sample in which the analyte is detected according to the present invention may be any fluid sample. Fluid samples suitable for testing using the present invention include oral fluid, saliva, whole blood, serum, plasma, urine, spinal fluid, biological extracts, mucus, and tissue. "saliva" refers to the secretions of the salivary glands. An "oral fluid" is any fluid present in the oral cavity. The analyte to be detected may be any analyte for which the detection element may be made.

In some preferred modes, the first receiving area is arranged below the detection element, and the liquid sample in the first receiving area can reach the detection element, so that the detection element can detect the sample. In some embodiments, the bibulous material absorbs the liquid sample from the first receiving area and transports it to the test element, thereby providing fluid communication between the first receiving area and the test element such that the bibulous material does not absorb and transport more liquid sample than can be loaded onto the test element, thereby causing no overflow onto the test element. A structure that is "in fluid communication" means that fluid from one structure will encounter another structure with which it is in fluid communication. Thus, when the first receiving area is in fluid communication with the detection element, the liquid sample of the first receiving area reaches the detection element through the water-absorbent material. The first receiving area, the bibulous material and the detection element may be in direct physical contact, or there may be gaps between them but fluid communication is maintained. A "water-absorbent material" is a material that absorbs liquid and can transport it by capillary action. Absorbent materials include, but are not limited to, filter paper or other types of absorbent paper, certain nylons, nitrocellulose, and other materials having the described properties. In some preferred embodiments, the absorbent material may be absent, fluid communication between the first receiving area and the test element may still be maintained, and the liquid sample in the first receiving area may still reach the test element.

In some preferred modes, the flow guide channel is connected with the first receiving area and the inner wall of the other side surface of the cup body, and the other side surface is the side surface where the secondary sampling port is located.

In some preferred modes, the diversion channel can be a groove, the groove comprises a bottom surface and a side wall, and a channel for providing circulation for the liquid sample is provided. The arrangement of the groove is convenient for guiding and collecting the liquid sample, so that the liquid sample is prevented from randomly flowing to all positions in a large area, the collection of the liquid sample is not facilitated, and secondary detection is carried out; the waste of liquid samples can be avoided, particularly for liquid samples with poor flowability and/or small sample amount, the arrangement of the grooves is very important, and the liquid samples with poor flowability and/or small sample amount are prevented from being retained at the bottom of the cup body in a large area, so that the liquid samples are not beneficial to collection and even cannot be collected, and secondary detection cannot be carried out.

In some preferred embodiments, the nozzle extends into the well but does not contact the floor of the well, so that after the liquid sample is expressed from the nozzle, it contacts the floor of the well, and the side walls of the well block some of the liquid sample from splashing out of the well. In some preferred modes, the nozzle is closer to the groove inlet, so that the nozzle is closer to the first receiving area, the flow path of the liquid sample is shortest, the liquid sample can reach the first receiving area more quickly, and waste and loss of the liquid sample with poor liquidity and/or less sample amount can be effectively avoided for the liquid sample with poor liquidity and/or less sample amount.

In some preferred modes, the bottom surface of the groove is provided with an inclined surface, and the first receiving area is positioned at the lower end of the inclined surface, so that the smooth flowing of the liquid sample into the first receiving area can be accelerated, and the liquid sample with poor liquidity and/or small sample amount can be effectively prevented from being retained on a contact surface in contact with the liquid to influence the detection of the liquid sample.

In some preferred forms, the inlet of the recess is connected to the first receiving area and the outlet of the recess is connected to a side of the cup. In some preferred modes, the outlet of the groove is connected with an opposite side of the side where the detection element is located, wherein the opposite side refers to the side of the cup body which is not adjacent to the side where the detection element is located, and the side is the side where the secondary sampling port is located.

In some preferred modes, the groove inlet is lower than the groove outlet, when the liquid sample is sprayed out from the nozzle, the liquid sample contacts the groove and flows into the first receiving area along the groove, the groove inlet is lower, the smooth flowing of the liquid sample into the first receiving area can be accelerated, when secondary confirmation detection is needed, the plug can be opened, the cup body is inclined, the liquid sample in the first receiving area can enter the groove from the groove inlet, and the liquid sample flows to the second receiving area along a channel of the groove, so that an operator can conveniently suck the liquid sample.

In some preferred forms, the second receiving area may include a corner region for collecting samples to facilitate sub-sampling. In some preferred modes, one side wall of the groove is provided with a corner, and the corner can be a right angle, a round angle, a chamfer angle, a fan-shaped angle and other suitable shapes, when the cup body is inclined, the corner is arranged to collect the liquid sample conveniently, and the liquid sample is collected and sucked conveniently in the corner area.

In some preferred modes, a corner area is arranged near the secondary sampling port, when sampling is needed, the cup body structure is slightly inclined, so that the sample flows from the first receiving area to the corner area through the groove, at the moment, a straw or the like can conveniently extend from the secondary sampling port, and the corner area is easily reached to absorb the sample. Since the corner regions have a pooling function, enough samples can be pooled for subsampling if the sample size is small.

In some preferred forms, the corner regions are not directly opposite the subsampling openings, but are offset. The deviation means that the corner area is not on the same line with the central axis of the secondary sampling port but deviates from the central axis, so that a straw is obliquely inserted through the secondary sampling port to reach the corner area for sampling during sampling.

In some preferred modes, the outlet of the groove is connected with a secondary sampling port, the secondary sampling port is arranged at the upper part of the outlet of the groove, and the outlet of the groove is overlapped with the secondary sampling port. In some preferred forms, one half of the area of the secondary sampling port overlaps the outlet of the recess, and the secondary sampling port and the corner region cooperate to facilitate insertion of the suction device into the secondary sampling port to remove the liquid sample from the corner region for secondary testing or other uses, and to add a solvent or other desired substance to the secondary sampling port, such as adding a solvent to increase the volume of the liquid sample, diluting the liquid sample, or adding a solvent to reduce the viscosity of the liquid sample.

The invention also provides a using method of the device for detecting the analyte in the liquid sample, the collecting element of the sample collector absorbs a certain amount of liquid sample, then the sample collector is inserted into the sleeve, the fixing seat is rotated until the opening of the sleeve is completely covered, the liquid sample cannot leak from the device through the covered part, and meanwhile, the positioning block is screwed into the positioning groove to give a prompt of rotating to the position; during rotation, the collecting element absorbing the liquid sample is pressed, so that the liquid sample in the collecting element can be extruded out of the nozzle, the liquid sample flows through the inlet of the groove from the bottom surface of the groove and enters the first receiving area, and the liquid sample in the first receiving area reaches the detection element to be detected on the detection element. After a period of time required to complete the detection assay, the presence and amount of analyte in the liquid sample is determined. When secondary confirmation detection is needed, the plug is opened, the cup body of the sample receiving cup is inclined, the residual liquid sample in the first receiving area enters the groove from the groove inlet, flows along the groove and is collected in the corner area, and the sampler can extend into the liquid sample in the corner area from the secondary sampling port, so that the liquid sample is sucked and reserved for secondary confirmation detection.

The invention has the beneficial effects that:

(1) according to the invention, the flow guide channel is arranged at the bottom of the device and is a groove, so that the collection and detection of samples are facilitated, and the problems that samples with poor fluidity and/or small sample amount are retained at the bottom of the cup body in a large area, the samples are wasted, the collection is not facilitated, even the collection cannot be carried out, and the secondary detection cannot be carried out are avoided.

(2) The bottom surface of the groove is an inclined plane, the inlet of the groove is lower than the outlet of the groove, so that the liquid sample can flow into the first receiving area more quickly, the collection and detection efficiency is improved, and the problem that the sample with poor fluidity and/or less sample amount is retained on the inclined plane and cannot flow into the first receiving area smoothly to influence the detection is avoided.

(3) One side wall of the groove is provided with a corner, the corner is arranged to collect a sample to a corner area, when the sample needs to be sampled, the cup body is slightly inclined, the sample flows to the corner area from the first receiving area through the groove, at the moment, a straw and the like conveniently extend from the secondary sampling port, and the corner area is easy to absorb the sample. Since the corner regions have a pooling function, enough samples can be pooled for subsampling if the sample size is small.

(4) The secondary sampling port is arranged at the upper part of the groove outlet, and the secondary sampling port is overlapped with the groove outlet, so that the secondary sampling port can conveniently extend into the groove outlet, a sample can be taken out for secondary confirmation and detection, and simultaneously, a solvent or other required substances can be conveniently added into the secondary sampling port.

(5) The cup body is made of transparent materials, so that the test result can be observed conveniently.

(6) The invention is provided with a positioning convex part or a positioning concave part on the covering surface of a fixed seat, and the inner cover of the sleeve is provided with a concave part matched with the positioning convex part on the covering surface of the fixed seat or the inner cover is provided with a convex part matched with the positioning concave part on the covering surface of the fixed seat. The convex part and the concave part are matched with each other, so that an operator can clearly feel that the inner cover is completely covered on the fixed seat, the cup body is completely covered, the situation that the fixed seat is easily damaged because a user does not determine whether to screw the fixed seat or not and screws the fixed seat with larger force again after the cup body is screwed down is avoided, and meanwhile, the user can screw the fixed seat for multiple times due to the fact that whether to screw the fixed seat or not is not determined, time is wasted, and operation efficiency is influenced. The positioning convex part or the positioning concave part is arranged on the covering surface instead of other positions, the structure outside the fixed seat or the cup body cannot be influenced, and meanwhile, the positioning of the device cannot be influenced by the structure outside the device.

(7) According to the invention, the fixed seat and the cup body are irregular pentahedrons, the sizes of the cross sections of the fixed seat and the cup body are close to each other, when the fixed seat completely covers the cup body, one side surface of the fixed seat is approximately flush with one side surface of the cup body, so that the completely covered detection device can be stably laid on the side, the scanning of a detection result is facilitated, and the phenomenon that the cup body rolls or slides to damage the detection cup and cause the leakage and pollution of a sample in the cup body is avoided.

(8) The anti-skidding structure is arranged on the outer side surface of the cup body, so that a user can easily grab or hold the sample receiving cup, and the detection device is prevented from being damaged due to slipping and falling.

(9) The inner wall of the fixed seat is provided with the reinforcing structure, the reinforcing structure enables the fixed seat to be firmer and more stable and not easy to damage, and the paddle-shaped reinforcing structure is further adopted, so that the reinforcing effect is better, the whole fixed seat is firmer, not easy to damage and attractive in appearance.

(10) The nozzle is arranged at the eccentric position of the closed surface, the nozzle extends into the groove but does not contact the bottom surface of the groove, so that a liquid sample is extruded from the nozzle and contacts the bottom surface of the groove, and the side wall of the groove can block part of the liquid sample from splashing out of the groove; and the nozzle is closer to the groove inlet, so that the nozzle is closer to the first receiving area, the flow path of the liquid sample is shortest, the liquid sample can reach the first receiving area quickly, and waste and loss of the liquid sample with poor liquidity and/or less sample amount can be effectively avoided for the liquid sample with poor liquidity and/or less sample amount.

Drawings

FIG. 1 is a schematic diagram of the structure of the apparatus of the present invention.

Fig. 2 is an exploded view of the device of the present invention.

Fig. 3 is a schematic structural view of the fixing base of the device of the present invention.

Fig. 4 is a schematic view of the structure of the sleeve of the device of the present invention.

Fig. 5 is a schematic view of the bottom structure of the device of the present invention.

Figure 6 is an exploded view of a sample receiving cup of the present invention.

Fig. 7 is a top view of the device of the present invention in an assembled state.

Fig. 8 is a cross-sectional view taken along line B-B of fig. 7 (with the collection element hidden).

Figure 9 is a schematic view of the internal structure of the sample receiving cup of the present invention (with one side of the cup hidden to clearly show the structure of the flow directing channels).

Reference numbers in the figures: the sample receiving cup 1, the cup body 5, the fixing seat 6, the positioning block 7, the positioning groove 8, the protrusion 9, the secondary sampling port 11, the plug 12, the anti-slip structure 13, the reinforcing structure 14, the collecting element 15, the sleeve 16, the push rod 17, the connector 18, the nozzle 19, the first receiving area 20, the flow guide channel 21, the placing part 22, the corner 23, the groove inlet 24, the inner cover 25, the covering surface 26, the closing surface 27, the slot 28, the corner area 29, the barrier strip 30, the bottom surface 31, the side wall 32, the head 181, the middle section 182 and the end section 183.

Detailed Description

The technical solutions of the present invention are further described in detail below with reference to the accompanying drawings, and it should be noted that the detailed description is only for describing the present invention, and should not be construed as limiting the present invention.

As shown in FIG. 1, the present invention provides a device for detecting the presence or amount of an analyte in a liquid sample, which is in an assembled state, and which may include a sample collector and a sample receiving cup 1, wherein the sample collector is used for directly or indirectly collecting a sample from a body of a patient or a part to be collected or a scene separated from the body of the patient.

The sample receiving cup 1 can receive and hold a sample collector, in some preferred modes, the sample receiving cup 1 can receive the sample collector or a part of the sample collector, after the sample collector collects the sample, the sample collector can be put into the sample receiving cup 1, and then the sample in the sample receiving cup 1 is transferred into the sample receiving cup 1; in some preferred embodiments, the sample receiving cup 1 can directly receive the sample collected by the sample collector.

In some preferred forms, the various components of the test device are conveniently made of molded plastic, but any other suitable material may be used.

In fig. 2, the sample collector and the sample receiving cup 1 are shown. In the shown embodiment, the sample collector 2 comprises a collecting element 15 for collecting the liquid sample, a push rod 17 for fixing the collecting element 15. The sample receiving cup comprises a cup body 5, a sleeve 16 matched with a collecting element 15 is fixedly connected in the cup body 5, and the sleeve 16 can receive and hold a sample collector.

In some preferred forms, the acquisition element 15 is compressible, squeezing or absorbing the sample by its compression and rebound. In some preferred forms, the collection element 15 is fixedly attached to the sample collector by a connector, and in some preferred forms, the collection element 15 is removably attached to the sample collector. In some preferred forms, the sample collector is provided with a member for connecting the collecting element 15, which may be a rod, so that the collecting element extends into the sample collector to place the sample after the sample is collected.

For example, a sample collector employs a compressible collection element 15 to absorb a liquid sample, compressible referring to the material property that the shape of a material can be deformed by mechanical pressure to squeeze liquid out of the material while the material retains the liquid. The acquisition element 15 may be made of any material that absorbs and retains liquid. In some embodiments, the acquisition element is a sponge, but in other embodiments it can be a nonwoven, absorbent paper, nylon, cotton, or any other material that can absorb and retain liquids. When the material of the acquisition element 15 is a sponge, it may be natural or synthetic. In the illustrated embodiment, as shown in fig. 2, the collection element 15 is a cylindrical sponge material adapted to be placed in the mouth of a subject to collect saliva. In other embodiments, however, the capture element 15 may be any suitable and convenient shape. In certain embodiments, the collection element 15 is treated with a chemical composition (e.g., citrate or other chemical) to promote salivation and facilitate absorption by the collection element 15.

In the embodiment shown, as shown in fig. 2, the acquisition element 15 is connected to a connecting head 18 at one end of the push rod 17, in some preferred ways the acquisition element 15 is detachably connected to the connecting head 18, in other embodiments the acquisition element 15 is fixedly connected to the connecting head 18. In some preferred forms, the acquisition element 15 may be glued or welded to the connector 18 of the push rod 17 by means of a glue or hot melt or other glue, or may be attached to the connector 18 by any suitable means. In some preferred embodiments, the connector 18 is provided with a sealing structure, such as a sealing ring, which can be engaged with the inner wall of the sleeve 16 and ensure that the collected sample does not flow back when the connector 18 is pressed downward. In the illustrated embodiment, as shown in fig. 3, the connector 18 includes a head 181, a middle section 182, and an end section 183. In some preferred forms, the acquisition element 15 is attached to the end face of the head 181. In some preferred forms, an acquisition element 15 may also be attached to the intermediate section 182. In some preferred forms, the collection element 15 may also be attached to the end segment 183. In some preferred forms, the acquisition element 15 is closer to the head 181 of the connection head 18 than the sealing structure. In some preferred forms, the sealing structure is attached to the middle section 182 of the connector and the capture element 15 is attached to the end face of the connector head 181. In some preferred forms, the sealing structure is attached to the connector end segment 183.

The one end that the connector was kept away from to push rod 17 is connected on fixing base 6, and the cross sectional area of fixing base 6 is greater than the cross sectional area of push rod, so the operator is convenient for snatch the sample collector in the setting of fixing base. The push rod 17 and the fixed seat 6 may be fixedly connected by integral molding or by any other suitable connection means, such as by snap-fit connection, or by adhesion or by matching of internal and external threads. In the embodiment shown, as shown in fig. 2-3, the fixing seat 6 has a cylindrical protrusion 9 on the covering surface, and the fixing seat covering surface 26 refers to: when the fixed seat covers the sleeve 16, the contact surface is contacted with the upper surface of the sleeve 16. The push rod is fixedly connected to the cylindrical protrusion 9 in an integrated forming mode, and external threads are arranged on the periphery of the cylindrical protrusion 9. In some embodiments, the anchor block 6 is provided with an internal thread for the detachable connection sleeve 16. In other embodiments, the anchor block 6 is provided with other structures for detachably connecting the bushings 16. Such as a snap-fit arrangement, or other feature that snugly fits and holds the two members together.

The fixing seat 6 can completely cover the sleeve 16, and the completely covering means that: after the holder 6 is fully closed over the sleeve 16, a sealed structure is formed through which the liquid sample cannot leak from the device. The holder 6 is completely covered with the sleeve and the pick-up element 15 is continuously compressed.

The fixed seat covering surface 26 is provided with a positioning convex part or a positioning concave part. The positioning convex part or the positioning concave part is arranged on the covering surface 26, the external structure of the fixed seat 6 or the cup body 5 cannot be influenced, and meanwhile, the external structure of the device cannot influence the positioning of the device. The positioning convex part can be a positioning block 7, and the positioning concave part can be a positioning groove 8. In the illustrated embodiment, as shown in fig. 2-3, the arc-shaped positioning block 7 is disposed on the fixing seat covering surface 26, and the arc-shaped positioning block 7 is connected to the end of the cylindrical protrusion external thread, so that after the external thread is screwed out, the arc-shaped positioning block 7 is smoothly screwed into the corresponding positioning groove to achieve positioning.

In the illustrated embodiment, the inner wall of the fixing base 6 is provided with a reinforcing structure 14 for reinforcing the side wall of the fixing base, so that the fixing base 6 is firmer and more stable and is not easily damaged. As shown in fig. 1, the reinforcing structure 14 is a paddle-shaped structure, which has a better reinforcing effect, and the fixing base 6 is integrally firmer, not easy to be damaged, and has an attractive appearance. In some embodiments, the reinforcing structure 14 may be plate-like or any other suitable structure.

In the embodiment shown, as shown in fig. 2, cannula 16 has an inner cap 25 at one end, inner cap 25 being capable of covering the opening of cup 5, the inner cap 25 being provided with an opening to facilitate insertion of collection element 15 into cannula 16. The other end of the sleeve 16 has a closing face 27, the closing face 27 closes the other end of the sleeve 16, and the eccentric position of the closing face 27 is provided with a nozzle 19 for facilitating the liquid sample to flow out of the nozzle 19 after being squeezed. The body of the cannula 16 is tapered, the inner cap 25 opening inner diameter is greater than the diameter of the closing face 27, the closing face 27 diameter is greater than the outer diameter of the nozzle 19, the inner cap 25 opening inner diameter is greater than the width of the largest cross-section of the collection element 15, and the closing face 27 diameter is less than the width of the smallest cross-section of the collection element 15. After the liquid sample is absorbed by the collecting element 15, the collecting element 15 is inserted into the sleeve 16 from the opening of the inner cover, and during the continuous insertion of the sleeve 16, the collecting element 15 is not only pushed by the push rod 17, but also pressed by the inner wall of the sleeve 16 to the periphery thereof, so that the liquid sample can be separated from the collecting element 15 quickly and completely. In other embodiments, the cannula 16 may have other shapes that interact with the shape of the collection element 15.

The inner lid 25 of the sleeve 16 is fixedly attached to the cup body 5 by being bonded or welded to the open end of the cup body 5, or by any other suitable means. In the illustrated embodiment, as shown in fig. 2, an opening of the inner cover 25 is provided with an internal thread matching with an external thread on the periphery of the protrusion 9 of the fixing base, and the upper surface of the inner cover 25 is provided with an arc-shaped positioning slot 8 matching with the arc-shaped positioning block 7 on the covering surface 26 of the fixing base.

Through rotating the fixing base 6, the external thread on the fixing base 6 is continuously screwed into the internal thread at the opening of the inner cover 25 until the inner cover 25 is completely covered, and the arc-shaped positioning block 7 is also completely screwed into the arc-shaped positioning groove 8. Arc locating piece 7 and arc constant head tank 8 cooperate each other and can restrict fixing base 6 and further move to screwing up the direction, but can allow fixing base 6 to move in the opposite direction under the exogenic action and open fixing base 6, the setting of locating piece 7 and constant head tank 8 can make the operator clearly and definitely feel that fixing base 6 has covered the inner cup 25 completely, avoid covering after closing inner cup 25 after screwing up, because the user is uncertain whether to screw up, and screw up fixing base 6 with bigger power once more again, this will damage fixing base 6 easily, simultaneously because uncertain whether to screw up, the user just can screw up the fixing base many times, waste time, influence operating efficiency. After the rotation is finished, the fixed seat 6 completely covers the opening of the sleeve 16 to form a sealing structure, a liquid sample cannot leak from the device through the covering position, meanwhile, the positioning block 7 is screwed into the positioning groove to give a rotation to position prompt, so that an operator can clearly know that the device is completely covered, and the fixed seat 1 does not need to be screwed down by using force. During rotation, the collection element 15, which has absorbed the liquid sample, is squeezed, thereby squeezing the liquid sample on the collection element 15 from the nozzle 19 into the sample receiving cup 1.

The sample receiving cup 1 comprises a cup body 5, as shown in fig. 1-2, a fixed seat 6 in the sample collector can cover an inner cover 25, so that the cup body 5 is covered, the fixed seat 6 can tightly cover the cup body 5, the fixed seat 6 completely covers the cup body 5 to form a whole, and the whole is transported, carried, used, stored or discarded.

The cup body 5 and/or the holder 6 may be polyhedral. The fixing seat 6 and the cup body 5 are both polyhedrons, that is, the cross sections of the fixing seat 6 and the cup body 5 are polygonal, can be three-deformation, quadrangle, pentagon or other polygons, and can also be regular polygon or non-regular polygon. One or more detection elements 10 can be arranged in the cup body 5 of the polyhedron, so that different analytes in a sample can be detected simultaneously. The detecting element 10 can be arranged on the inner wall of any side of the polyhedron cup body, and the inner wall of any side in the cup body 5 can be provided with a placing part 22 for placing the detecting element. As shown in fig. 2, in the illustrated embodiment, the cup body 5 is an irregular pentahedron, that is, the cross section of the cup body 5 is an irregular pentagon, wherein the inner wall of one side of the pentahedron with the largest cup body area is provided with a detection element placing part 22 for placing the detection element 10. The shape and the side length of the cross section of the inner cover 25 are the same as the shape and the side length of the cross section of the cup body 5, and the inner cover 25 is also in an irregular pentagonal shape, so that the inner cover 25 can tightly cover the opening of the cup body 5, and the side lengths of the inner cover do not extend out of the side surface of the cup body 5, so that the cup body 5 can be horizontally and stably laid on the side.

The fixed seat 6 and the cup body 5 can be polyhedrons with the same number of faces or polyhedrons with different numbers of faces. In the illustrated embodiment, as shown in fig. 1, the fixing seat 6 and the cup body 5 are both irregular pentahedrons, and after the fixing seat 6 completely covers the cup body 5, one side surface with the largest area of the fixing seat 6 is aligned in parallel with one side surface with the largest area of the cup body, so that it is also convenient to confirm that the fixing seat 6 completely covers the cup body 5. The length of a side of 6 cross sections of fixing base and 5 cross sections pentagons of cup is close, and when 6 complete lid of fixing base closed cup 5, every side of fixing base 6 was close to flush with every side of cup 5, was in the coplanar almost for the device that completely covers closed can stably lie horizontally and put on one's side, the scanning of the testing result of being convenient for.

In the embodiment shown, the cup body 5 is made of a transparent material, so that the test result can be observed conveniently.

In the illustrated embodiment, the cup body 5 is provided with a secondary sampling port 11 at one side, and as shown in fig. 2, the cup body 5 is provided with an arch-shaped depression at a lower portion of one side, and the secondary sampling port 11 is provided at the arch-shaped depression. The secondary sampling port 11 can be plugged by the plug 12, and after the secondary sampling port 11 is plugged by the plug 12, the side surface provided with the secondary sampling port 11 can still be stably laid horizontally and laterally. In some embodiments, the secondary sampling port 11 may be capped with a plug 12 for sealing during testing of the sample and transport device. When the device is received in a clinical testing facility, the stopper 12 may be removed and the user may remove a sample from the secondary port 11 for a secondary confirmation test, and the secondary port 11 may be configured to facilitate the user's addition of a solvent or other desired substance from the secondary port 11, such as adding a solvent to increase the volume of the liquid sample, diluting the sample solution, or adding a solvent to decrease the viscosity of the liquid sample. In some embodiments, when the stopper 12 is opened, the operator may conveniently remove the sample using a pipette or other sampling device. The sample receiving cup 1 can be conveniently held in a closed position and still allow the removal of a liquid sample.

In the illustrated embodiment, the outer side surface of the cup body 5 is provided with an anti-slip structure 13, as shown in fig. 1, the anti-slip structure 13 is a convex strip, and the convex strip is arranged so that a user can easily grab or hold the sample receiving cup 1, and the sample receiving cup 1 is prevented from being damaged by slipping of the hand and dropping. In some embodiments, the outer side of the cup body 5 is provided with other anti-slip structures 13, such as dimples or any other suitable structure.

In the embodiment shown, as shown in fig. 2 and 5, the sample receiving cup 1 is provided with a first receiving area 20 for receiving and storing a sample; the sample receiving cup 1 is also provided with a flow guide channel 21 through which a sample can be added or collected; the first receiving area 20 communicates with the flow guide channel 21 so that the sample can move therebetween. The first receiving area 20 and the flow guide channel 21 are both arranged at the bottom of the cup body 5.

The sample receiving cup 1 may contain at least one detection element for detecting the presence or amount of an analyte in a sample. The detection elements may be distributed on one of the lateral inner walls of the device of the invention or on a plurality of lateral inner walls of the device of the invention. The cup body 5 is further provided on the inner side wall thereof with a placement part 22 for placing a detection element, and the detection element can be placed in the placement part 22. The placing component 22 and the inner wall of the side surface of the cup body can be fixedly connected, and the placing component 22 and the inner wall of the side surface of the cup body can also be detachably connected. In some preferred forms, the placement member 22 is removably attached to the side interior wall of the cup. In some preferred forms, the placement member 22 may be a test plate. In some preferred forms, the placement member 22 may have a slot 28 formed therein, and in some preferred forms, the sensing element may be a strip or the like that is placed within the slot 28. In some preferred forms, one slot 28 may be provided in one detector board, and in other preferred forms, a plurality of slots 28 may be provided in one detector board. In the embodiment shown, as shown in fig. 6 and 8, the cup 5 is an irregular pentahedron, that is, the cross section of the cup 5 is an irregular pentagon. The placing component 22 can be inserted into the cup body 5, the placing component 22 is tightly attached to the side face with the largest area of the cup body, the two side faces adjacent to the side face with the largest area of the cup body are respectively provided with the barrier strips 30, the planes of the barrier strips 30 are parallel to the side face with the largest area, the barrier strips 30 can block the placing component 22, the placing component 22 is stably placed in the cup body 5, the placing component 22 is prevented from shaking in the cup body 5, and the placing component 22 is allowed to be inserted into the space between the barrier strips 30 and the side face with the largest area. In the illustrated embodiment, the placement member 22 is provided with a slot 28.

The "detection element" may be any test device that provides a test result. In some embodiments, the detection element is a test strip. The test strip may have specific binding molecules immobilized on the test strip and reagents for performing an immunoassay. However, in other embodiments, the test element may also contain a chemical reaction-based test agent, a biological-based test agent (e.g., an enzyme or ELISA assay), or a fluorescent-based test agent, among others. In addition, in other embodiments, the test element may have other reagents thereon that can be used to detect the presence or quantity of the analyte in the sample. In one embodiment, the detection element comprises a reagent for detecting the presence of a drug of abuse. However, in other embodiments, the detection element may be any element that provides an indication of the result of the assay. For example, some chemical or biological indicator reagents may be used.

When the detection element is a test strip, it may comprise a bibulous matrix (e.g. nitrocellulose) and/or other suitable material. The substrate may have a sample loading zone, a reagent or label zone, and a detection zone. These types of test strips are well known in the art, and those of ordinary skill in the art will recognize a variety of test strips that may be used in the present invention in view of the present disclosure. In some embodiments, the sample loading area is located at one end of the test strip for applying the sample to the test strip. The reagents for conducting the assay or conditioning the sample may also be located at the sample loading zone, or they may be located in separate reagent or labeling zones on the test strip. These reagents can be used for various purposes, such as preparing a sample for desired binding to a specific binding molecule, or improving the stability of an analyte of interest.

The sample in which the analyte is detected in the present invention may be any fluid sample. Fluid samples suitable for testing using the present invention include oral fluid, saliva, whole blood, serum, plasma, urine, spinal fluid, biological extracts, mucus, and tissue. "saliva" refers to the secretions of the salivary glands. An "oral fluid" is any fluid present in the oral cavity.

The analyte to be detected may be any analyte for which the detection element may be made. In one embodiment, the analyte is a drug of abuse. Other examples of analytes of interest include hormones, proteins, peptides, nucleic acid molecules, pathogenic agents and specific binding pair members. A "drug of abuse" (DOA) is a drug used for non-medical purposes, usually for hallucinogenic effects. Abuse of such drugs can lead to physical and mental harm and, in some cases, dependence, addiction, and even death. Examples of DOAs include cocaine, amphetamines (e.g., black beans, whitetebernies, amphetamine tablets, dextrorotation amphetamines, dexes, beans), methamphetamines (crank, methamphetamine, crystal, speed), barbiturates (RochePharmaceuticals, Nutley, New Jersey), sedatives (i.e., hypnotics), lysergic acid diethylamide (LSD), sedatives (downs, gofiballs, barbs, blueviruses, yelljacks, lues), tricyclic antidepressants (TCAs, e.g., imipramine, atratinin, and doxepin), phencyclidine (PCP), tetrahydrocannabinol, and opiates (e.g., morphine, opium, codeine, heroin).

In the embodiment shown, as shown in FIG. 5, the first receiving area 20 is disposed at the lower part of the detecting element, and the liquid sample in the first receiving area 20 can reach the detecting element, so that the detecting element can detect the sample. In some embodiments, the bibulous material absorbs the liquid sample from the first receiving area 20 and transports it to the test element, thus providing fluid communication between the first receiving area 20 and the test element, such that the bibulous material does not absorb and transport more liquid sample than can be loaded onto the test element, thereby causing no overflow onto the test element. A structure that is "in fluid communication" means that fluid from one structure will encounter another structure with which it is in fluid communication. Thus, when the first receiving area 20 is in fluid communication with the detection element, the liquid sample of the first receiving area 20 reaches the detection element through the absorbent material. The first receiving area 20, the bibulous material and the sensing member may be in direct physical contact, or there may be a gap between them but fluid communication is maintained. A "water-absorbent material" is a material that absorbs liquid and can transport it by capillary action. Absorbent materials include, but are not limited to, filter paper or other types of absorbent paper, certain nylons, nitrocellulose, and other materials having the described properties. In some embodiments, the bibulous material may be absent and fluid communication between the first receptive zone 20 and the detection element may still be maintained.

The guide passage 21 connects the first receiving area 20 with the inner wall of the other side of the cup body 5. Preferably, the side is the side of the cup where the secondary sampling port 11 is located. The flow guide channel 21 may be a groove, which comprises a bottom surface 31 and a side wall 32, and provides a flow passage for the liquid sample, and a second receiving area is arranged in the groove and connected with the inner wall of the side surface of the cup body 5. The arrangement of the groove is convenient for guiding and collecting the liquid sample, so that the liquid sample is prevented from randomly flowing to all positions in a large area, the collection of the liquid sample is not facilitated, and secondary detection is carried out; the waste of liquid samples can be avoided, particularly for liquid samples with poor flowability and/or small sample amount, the arrangement of the grooves is very important, and the liquid samples with poor flowability and/or small sample amount are prevented from being retained at the bottom of the cup body in a large area, so that the liquid samples are not beneficial to collection and even cannot be collected, and secondary detection cannot be carried out.

When the liquid sample is extruded from the nozzle 19 of the sleeve 16, the liquid sample flows into the first receiving area 20 along the bottom surface 31 of the groove, and after the liquid sample is extruded from the nozzle 19, the liquid sample is subjected to an impact force, so that the liquid sample is rapidly collected in the first receiving area 20 and is not retained on a contact surface contacted with the liquid, for the liquid sample with poor fluidity and/or a small amount of sample, the downward impact force of the liquid sample is crucial, and the liquid sample with poor fluidity and/or a small amount of sample cannot smoothly reach the first receiving area 20, so that detection is not influenced; the liquid sample is extruded from the nozzle 19 and then flows into the first receiving area 20 along the bottom surface 31 of the groove, the bottom surface 31 of the groove is provided with an inclined surface, and the first receiving area 20 is positioned at the lower end of the inclined surface, so that the smooth flowing of the liquid sample into the first receiving area 20 can be accelerated, and the liquid sample with poor liquidity and/or small sample amount can be effectively prevented from being retained on a contact surface contacted with the liquid to influence the detection of the liquid sample; if the bottom surface 31 of the recess is arranged to be flat, the liquid sample will be subjected to a downward force after it has been expelled from the nozzle and will flow along the flat surface, a portion of the liquid sample will flow towards the first receiving area 20, but another portion of the liquid sample will flow along the recess towards the other end of the recess, i.e. a portion of the liquid sample will not flow directly towards the first receiving area 20, which will lose the only amount of valuable sample for liquid samples having poor flow and/or a smaller amount of sample. In summary, the liquid sample is extruded from the nozzle and subjected to an impulse, and the groove bottom surface 31 is provided as a slope, which enables the liquid sample to flow into the first receiving area 20 conveniently, which is a preferred embodiment.

In the embodiment shown, the nozzle 19 is arranged eccentrically to the closing surface 27, as shown in fig. 4 and 8. The nozzle 19 extends into the well but does not contact the well floor so that the liquid sample, after being expelled from the nozzle, contacts the well floor 31, the side walls 32 of the well block some of the liquid sample from splashing out of the well, and the liquid sample then flows along the well floor 31 into the first receiving area 20. The nozzle is closer to the groove inlet 24, so that the nozzle 19 is closer to the first receiving area 20, the flow path of the liquid sample is shortest, the liquid sample can reach the first receiving area 20 more quickly, and waste and loss of the liquid sample with poor fluidity and/or less sample amount can be effectively avoided for the liquid sample with poor fluidity and/or less sample amount. In the embodiment shown, as shown in fig. 5, the bottom surface 31 of the groove is an inclined surface, the inlet 24 of the groove is lower than the outlet of the groove, the inlet 24 of the groove is connected with the first receiving area 20, the first receiving area 20 is arranged at the lower part of the detection element, and the outlet of the groove is connected with an opposite surface of the side surface where the detection element is located, where the opposite surface is a side surface of the cup body which is not adjacent to the side surface where the detection element is located, and the side surface is the side surface where the secondary sampling port is located. The liquid sample in the first receiving area 20 can enter the groove from the groove entrance 24 and flow along the channel of the groove towards the second receiving area.

In some embodiments, the second receiving area may include a corner region 29, and the corner region 29 is used to collect samples to facilitate sub-sampling. In the illustrated embodiment, as shown in fig. 5 and 8, one side wall 32 of the groove is provided with a corner 23, the corner 23 can be a right angle, a rounded corner, a chamfer, a scalloped corner, or other suitable shape, and the corner 23 is provided to facilitate collection of the liquid sample and collection of the aspirated liquid sample.

When the secondary sampling is required, the liquid in the first receiving area is firstly allowed to flow into the second receiving area, but a pipette or a pipette is generally used for sampling to suck the sample, or a pipette gun is used for sampling. Since the amount of the collected sample is small and it is not easy to extend the pipette into the first receiving area, because the first receiving area 20 is generally a plane structure, and the first receiving area 20 is further away from the secondary sampling port 11, the pipette cannot reach the first receiving area 20 when the sampling tube is not long enough, and the amount of the sample is small, and it is not easy to suck a sufficient sample. With the present invention, a corner region 29 is provided near the secondary sampling port 11, and when sampling is required, the cup structure is slightly tilted to allow the sample to flow from the first receiving area 20 to the corner region 29 through the groove, at which time, a straw or the like can be conveniently inserted from the secondary sampling port 11, and the absorption of the sample in the corner region can be easily achieved. Because the corner regions have a pooling function, enough samples can be pooled for subsampling if the sample size is small.

In some embodiments, as shown in FIG. 9, the corner region 29 is not directly opposite the subsampling port 11, but is offset. The offset means that the corner region 29 is not on the same line as the central axis of the secondary sampling port 11, but is offset from the central axis, so that a pipette is inserted obliquely through the secondary sampling port 11 and reaches the corner region 29 for sampling at the time of sampling.

In some embodiments, the outlet of the recess is connected to the secondary sampling port 11, the secondary sampling port 11 is above the outlet of the recess, and the outlet of the recess overlaps the secondary sampling port 11. In the embodiment shown, one half of the area of the secondary sampling port 11 overlaps the outlet of the recess, the secondary sampling port 11 and the corner region 29 cooperate to facilitate insertion of a suction device into the secondary sampling port 11 to remove a liquid sample from the corner region 29 for secondary testing or for another use, and a solvent or other desired substance may be added to the secondary sampling port, such as adding a solvent to increase the volume of the liquid sample, diluting the liquid sample, or adding a solvent to reduce the viscosity of the liquid sample.

The present invention also provides a method of using a device for detecting an analyte in a liquid sample, which will now be described with reference to the embodiments of FIGS. 1-9. The sample collector's collection element 15 is placed in the user's mouth, with the collection element 15 continuously absorbing saliva. Then the collecting element 15 is taken out from the mouth of a user and put into a sleeve 16 matched with the collecting element 15, the fixed seat 6 is rotated until the opening of the sleeve 16 is completely covered, the liquid sample cannot leak from the device through the covered part, and meanwhile, the positioning block 7 is screwed into the positioning groove to give a prompt of rotating to the position; during the rotation, the collecting element 15 which has absorbed the liquid sample is pressed, so that the liquid sample in the collecting element 15 can be extruded from the nozzle 19, the liquid sample flows from the bottom surface 31 of the groove through the groove inlet 24 and into the first receiving area 20, and the liquid sample in the first receiving area 20 reaches the detecting element, and the detection is performed on the detecting element. After a period of time required to complete the detection assay, the presence and amount of analyte in the liquid sample is determined. When a double confirmation test is required, the stopper 12 is opened, the sample receiving cup 1 is tilted, the remaining liquid sample in the first receiving area 20 enters the well from the well inlet 24, flows along the well, pools in the corner area 29, and the sampler may be extended from the secondary sampling port 11 into the liquid sample in the corner area 29 to aspirate the liquid sample and leave it for the double confirmation test.

Claims

1. A device for detecting an analyte in a liquid sample, the device comprising a cup; a first receiving area for receiving a liquid sample;

a flow-through channel through which a sample can be added or collected;

the flow guide channel is communicated with the first receiving area, and the bottom surface of the flow guide channel is an inclined surface; wherein, the first receiving area and the flow guide channel are arranged in the cup body.

2. The device of claim 1, further comprising a secondary sampling port in communication with the flow channel.

3. The device according to claim 1, wherein the cup has a cross-sectional shape of five sides.

4. The device of claim 1, wherein the first receiving area has a sensing element disposed therein.

5. The device of claim 2, wherein the flow channel is a groove.

6. The device according to claim 5, wherein the recess is connected at one end to the first receiving area and at the other end to a side surface of the cup body, the secondary sampling port being provided on the side surface.

7. The device of claim 5, wherein the well comprises a bottom surface and a sidewall, wherein the bottom surface of the well is sloped.

8. The device for detecting an analyte in a liquid sample according to claim 5, wherein the recess has a second receiving area.

9. The device of claim 1, further comprising a sample collector capable of being received and retained within the cup, the sample collector capable of transporting the collected sample through the flow channel into the first receiving area.

10. The device of claim 9, wherein the sample collector comprises a collecting element and a push rod.

11. The device of claim 10, wherein the cup includes a sleeve for engaging the capture element, the sleeve having a pentagonal inner cover at one end thereof and fixedly attached to the cup, the inner cover having an opening therethrough, the sleeve having a closed end at an opposite end thereof, the closed end being offset from the opening and having a nozzle.

12. The device of claim 1, wherein the cup includes at least one test element.

13. The device according to claim 12, wherein the cup further comprises a placement member for placing the test element on the inner side wall of the cup.

14. The device for detecting an analyte in a liquid sample of claim 10, wherein the capture element is compressible.

15. The device for detecting an analyte in a liquid sample according to claim 14, wherein the collection element is a sponge.

16. The device of claim 11, wherein the push rod has a connector at one end for securing the collection element and the other end connected to the holder.

17. The device for detecting an analyte in a liquid sample according to claim 16, wherein the connector has a sealing structure.

18. The device of claim 16, wherein the holder is adapted to cover the cannula, and the holder has a protrusion or recess on the cover.

19. The device according to claim 18, wherein the upper surface of the inner cap has a positioning recess that mates with the positioning protrusion on the seating surface of the stationary base or the upper surface of the inner cap has a positioning protrusion that mates with the positioning recess on the seating surface of the stationary base.

20. The device of claim 16, wherein the holder has a cylindrical protrusion, and wherein the cylindrical protrusion has an external thread on its outer periphery.

21. The device for detecting an analyte in a liquid sample according to claim 20, wherein the upper opening of the inner cap has internal threads that mate with external threads on the outer periphery of the cylindrical protrusion.

22. The device for detecting an analyte in a liquid sample according to claim 16, wherein the holder has a cross-section in the shape of five sides.

23. The device according to claim 1, wherein the cup body has an anti-slip structure on an outer surface thereof.

24. The device for detecting an analyte in a liquid sample according to claim 23, wherein the anti-slip structure is a rib or a dimple.

25. The device for detecting an analyte in a liquid sample according to claim 8, wherein the second receiving area comprises a corner region for pooling subsampling.

26. The device for detecting an analyte in a liquid sample according to claim 25, wherein the corner region is adjacent to the secondary proximal sampling port.

27. The device for detecting an analyte in a liquid sample according to claim 25, wherein the corner region is offset from a central axis of the secondary port.