Device for detecting analyte in liquid sample

Abstract

The present invention discloses a device for detecting analytes in liquid samples, the device comprising a cup body; a first receiving area for receiving liquid samples; a flow guide channel through which samples can be added or collected; the flow guide channel is connected to 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 provided in the groove; the second receiving area includes a corner area for collecting secondary samples. The present invention also discloses a method for using the device for detecting analytes in liquid samples. The device of the present invention can be used to detect the presence or quantity of analytes in liquid samples. When the fluidity of the liquid sample is extremely poor and / or the sample volume is extremely small, the device can still detect the liquid sample, and it is convenient for the operator to draw the liquid sample for secondary confirmation detection.

Description

Technical Field

[0001] The present invention relates to a device for detecting an analyte in a liquid sample. Background Art

[0002] Currently, various sample collection and testing devices for clinical or home use are available on the market, and some documents also describe devices for detecting analytes in samples. U.S. Patent No. 5,376,337 discloses a saliva sampling device, in which a piece of filter paper is used to collect saliva from the subject's mouth and transfer the saliva to an indicator reagent. U.S. Patent Nos. 5,576,009 and 5,352,410 each disclose a syringe-type fluid sampling device. In these devices, after obtaining the initial results, the collected fluid sample cannot be stored for subsequent confirmation testing. Chinese Patent No. CN1828307 B discloses a device for detecting analytes in fluid samples. This device facilitates sampling for confirmation testing. However, when the fluid sample has poor fluidity and / or the sample size is small, the device can only perform a limited test and cannot perform a secondary confirmation test. Even when the fluid sample has extremely poor fluidity and / or the sample size is extremely small, the device cannot be used for direct testing.

[0003] Many other sample collection and testing devices make it difficult to extract the sample from the device for secondary testing. Many devices are very complex in their design and manufacture and require the use of relatively expensive materials. Summary of the Invention

[0004] In response to the above-mentioned situation and to overcome the shortcomings of the prior art, the present invention aims to provide a device for detecting analytes in liquid samples. This device can be used to detect the presence or quantity of analytes in liquid samples. Even when the liquid sample has extremely poor fluidity and / or the sample volume is extremely small, the device can still detect the liquid sample. Furthermore, the device facilitates the operator to aspirate the liquid sample for secondary confirmation testing, preventing the liquid sample from accumulating over a large area at the bottom of the cup, hindering collection or even preventing collection and subsequent confirmation testing.

[0005] In order to solve the above technical problems, the present invention provides the following technical solutions:

[0006] The present invention provides a device for detecting the presence or quantity of an analyte in a liquid sample. The detection device may include a sample collector and a sample receiving cup. The sample collector is used to collect a sample directly or indirectly from a patient's body, a part to be collected, or a sample that has been removed from the patient's body. The sample receiving cup can receive and hold the sample collector. In some preferred embodiments, the sample receiving cup can receive the sample collector itself or a portion thereof. After collecting the sample, the sample collector can be placed in the sample receiving cup, and the sample therein can then be transferred into the sample receiving cup. In some preferred embodiments, the sample receiving cup can directly receive the sample collected by the sample collector.

[0007] In some preferred embodiments, the sample receiving cup comprises at least one detection element for detecting the presence or amount of an analyte in the sample.

[0008] In some preferred embodiments, the detection device may have a flat surface that allows the entire device to remain stationary when placed horizontally. This stationary state means that the device will not roll. Since the detection element may be planar, it needs to be placed flat for testing. In this case, it is necessary to ensure that it does not roll after placement, thereby affecting the detection. In some preferred embodiments, the detection device may have at least one such flat surface. In some preferred embodiments, the outer wall of the detection device may be composed of at least three such flat surfaces.

[0009] In some preferred embodiments, the sample collector includes a collecting element for collecting liquid samples and a push rod for fixing the collecting element.

[0010] In some preferred embodiments, the sample receiving cup includes a cup body, in which a sleeve for use with the collection element is fixedly connected, and the sleeve can receive and hold the sample collector.

[0011] In some preferred embodiments, the collection element is compressible, squeezing or absorbing the sample through compression and rebound. In some preferred embodiments, the collection element is fixedly mounted on the sample collector via a connector. In some preferred embodiments, the collection element is detachably connected to the sample collector. In some preferred embodiments, the sample collector is provided with a component for connecting the collection element, which may be a connecting rod, to facilitate the collection element extending into the sample collector after collecting the sample and placing the sample.

[0012] In some preferred embodiments, the collection element is a sponge, which can be natural or synthetic. In some preferred embodiments, the collection element is a cylindrical sponge material suitable for placement in a subject's mouth to collect saliva. In certain embodiments, the collection element is treated with a chemical component (e.g., citrate or other chemical) to promote saliva secretion and facilitate absorption by the collection element.

[0013] In some preferred embodiments, the collection element is fixed to a connector at one end of the push rod. In some preferred embodiments, the collection element can be adhered or welded to the connector of the push rod using sealant, hot melt adhesive, or other glue. In some preferred embodiments, a sealing structure, such as a sealing ring, is provided on the connector. The sealing structure on the connector can fit against the inner wall of the cannula and ensure that the collected sample does not flow back when the connector is squeezed downward.

[0014] In some preferred embodiments, the end of the push rod distal from the connector is connected to a fixed base, and the cross-sectional area of ​​the fixed base is larger than that of the push rod. This arrangement facilitates the operator's grasping of the sample collector. In some preferred embodiments, the push rod and the fixed base can be fixedly connected by integral molding. In some preferred embodiments, other suitable connection methods are employed, such as a snap-fit ​​connection, adhesive bonding, or a mating of internal and external threads. In some preferred embodiments, the fixed base has a cylindrical protrusion on its mating surface. The mating surface refers to the contact surface that contacts the upper surface of the sleeve when the fixed base is mated to the sleeve. The push rod is fixedly connected to the cylindrical protrusion by integral molding. In some preferred embodiments, the cylindrical protrusion has external threads on its outer circumference. In some preferred embodiments, the fixed base has internal threads for detachable sleeve connection. In some preferred embodiments, the fixed base has other suitable structures for detachable sleeve connection, such as a snap-fit ​​structure or other features that fit snugly and hold the two components together.

[0015] In some preferred embodiments, the holder is capable of completely covering the cannula. Complete covering means that once the holder completely covers the cannula, a sealed structure is formed, and the liquid sample cannot leak out of the device through the covering portion. As the holder completely covers the cannula, the collection element is continuously compressed.

[0016] In some preferred embodiments, a positioning protrusion or a positioning recess is provided on the covering surface of the fixing seat. The positioning protrusion or the positioning recess is provided on the covering surface and will not affect the external structure of the fixing seat or the cup body, and the structure outside the device will not affect the positioning of the device. In some preferred embodiments, the positioning protrusion can be a positioning block and the positioning recess can be a positioning groove. In some preferred embodiments, an arc-shaped positioning block is provided on the covering surface of the fixing seat, and the arc-shaped positioning block is connected to the end of the cylindrical raised external thread, so that after the external thread is fully screwed, the arc-shaped positioning block is smoothly screwed into the corresponding positioning groove to achieve positioning.

[0017] In some preferred embodiments, a reinforcement structure is provided on the inner wall of the fixing base to reinforce the sidewalls of the fixing base, making the fixing base more secure and stable and less susceptible to damage. In some preferred embodiments, the reinforcement structure is a paddle-shaped structure. This paddle-shaped reinforcement structure provides a better reinforcement effect, makes the fixing base more secure and less susceptible to damage, and has an aesthetically pleasing appearance. In other embodiments, the reinforcement structure may be plate-shaped or have any other suitable structure.

[0018] In some preferred embodiments, one end of the cannula has a connecting member that not only connects to the cup but also facilitates its use with the sample collector. In some preferred embodiments, one end of the cannula has an inner cover that fits over the cup opening and has an opening to facilitate insertion of the collection element into the cannula. In some preferred embodiments, the other end of the cannula has a closing surface that seals the other end of the cannula. In some preferred embodiments, a nozzle is located eccentrically on the closing surface to facilitate extrusion of the liquid sample through the nozzle. In some preferred embodiments, the cannula is tapered, with the inner diameter of the inner cover opening being larger than the diameter of the closing surface, which in turn is larger than the outer diameter of the nozzle. The inner diameter of the inner cover opening is larger than the maximum cross-sectional width of the collection element, while the diameter of the closing surface is smaller than the minimum cross-sectional width of the collection element. After the collection element absorbs the liquid sample, it is inserted into the cannula through the inner cover opening. During insertion, the collection element is not only pushed by the push rod but also squeezed against its outer circumference by the inner wall of the cannula, allowing the liquid sample to be quickly and completely removed from the collection element. In other embodiments, the sleeve may also have other shapes that match the shape of the collection element.

[0019] In some preferred embodiments, the inner cover of the sleeve is fixedly connected to the cup body, and can be bonded or welded to the open end of the cup body. In other embodiments, it can also be fixed by other suitable methods. In some preferred embodiments, the opening of the inner cover of the sleeve is provided with an internal thread that cooperates with the external thread on the outer periphery of the fixed seat protrusion, and the upper surface of the inner cover of the sleeve is provided with an arc-shaped positioning groove that cooperates with the arc-shaped positioning block on the covering surface of the fixed seat. By rotating the fixed seat, the external thread on the fixed seat is continuously screwed into the internal 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. The arc-shaped positioning block and the arc-shaped positioning groove cooperate to restrict further movement of the fixing base in the tightening direction, but allow the fixing base to move in the opposite direction under the action of external force to open the fixing base. The arrangement of the positioning block and the positioning groove allows the operator to clearly feel that the fixing base has completely covered the inner cover, avoiding the user from tightening the fixing base again with greater force after tightening the inner cover due to uncertainty. This can easily damage the fixing base. Uncertainty of whether it is tight enough can also lead to the user tightening the fixing base multiple times, wasting time and affecting operational efficiency. After rotation is completed, the fixing base completely covers the sleeve opening, forming a sealed structure. The liquid sample cannot leak from the device through this covering. At the same time, the positioning block is screwed into the positioning groove, indicating that the rotation is in place, so that the operator can clearly understand that the device is completely covered and no further tightening of the fixing base is required. During rotation, the collection element, which has absorbed the liquid sample, is squeezed and squeezed out of the nozzle into the sample receiving cup.

[0020] In some preferred embodiments, the fixing seat and / or the cup body can be in the shape of a polyhedron. In some preferred embodiments, both the fixing seat and the cup body are in the shape of a polyhedron, that is, the cross-section of the fixing seat and the cup body is polygonal, which can be a triangular shape, a quadrilateral, a pentagon or other polygon, and can also be a regular polygon or an irregular polygon. In some preferred embodiments, one or more detection elements can be provided in the polyhedral cup body, so that different analytes in the sample can be detected simultaneously. In some preferred embodiments, the detection element can be provided on any side inner wall of the polyhedral cup body, and any side inner wall of the cup body can be provided with a placement component for placing the detection element. In some preferred embodiments, the cup body is an irregular pentahedron, that is, the cross-section of the cup body is in the shape of an irregular pentagon, wherein the side inner wall of the pentahedral cup body with the largest area is provided with a detection element placement component for placing the detection element. In some preferred embodiments, the shape and side length of the inner cover are the same as the cross-sectional shape and side length of the cup body, and are also an irregular pentagonal shape. Therefore, the inner cover can tightly cover the opening of the cup body, and the sides of the inner cover do not extend beyond the side of the cup body, so that the cup body can lie flat and stably on its side.

[0021] In some preferred embodiments, the fixing seat and the cup body can be polyhedrons with the same number of faces, or can be polyhedrons with different numbers of faces. In some preferred embodiments, the fixing seat and the cup body are both irregular pentahedrons. After the fixing seat completely covers the cup body, the largest area of ​​the fixing seat is aligned parallel to the largest area of ​​the side of the cup body, which also facilitates confirmation that the fixing seat has completely covered the cup body. In some preferred embodiments, the side lengths of the pentagonal cross-sections of the fixing seat and the cup body are close. When the fixing seat completely covers the cup body, each side of the fixing seat is nearly flush with each side of the cup body, almost in the same plane, so that the completely covered device can be stably laid flat on its side, facilitating scanning of the test results.

[0022] In some preferred embodiments, the cup body is made of a transparent material to facilitate observation of the test results.

[0023] In some preferred embodiments, a secondary sampling port is provided on one side of the cup body. In some preferred embodiments, an arch-shaped recessed portion is provided at the lower portion of one side of the cup body, and the secondary sampling port is provided in the arch-shaped recessed portion. A stopper can block the secondary sampling port. After the stopper blocks the secondary sampling port, the side with the secondary sampling port can still lie flat and stably. In some embodiments, the secondary sampling port can be covered with a stopper to seal it during the process of testing samples and transporting the device. When the device is received on a clinical testing device, the stopper can be removed and the user can remove the sample from the secondary sampling port for a secondary confirmation test. The provision of the secondary sampling port also makes it convenient for the user to add a solvent or other required substance from this secondary sampling port, such as adding a solvent to increase the sample volume of the liquid sample, diluting the sample solution, or adding a solvent to reduce the viscosity of the liquid sample. In some embodiments, when the stopper is opened, the operator can conveniently remove the sample using a pipette or other sampling device. The sample receiving cup can be conveniently kept in a closed state and still allow the liquid sample to be removed.

[0024] In some preferred embodiments, the outer surface of the cup body is provided with an anti-slip structure. In some preferred embodiments, the anti-slip structure is a ridge. The ridge makes it easier for the user to grasp or hold the sample receiving cup, preventing the user from slipping and dropping the sample receiving cup and damaging it. In some preferred embodiments, the outer surface of the cup body is provided with other anti-slip structures, such as pits or any other suitable structure.

[0025] In some preferred embodiments, the sample receiving cup is provided with a first receiving area for receiving and storing the sample; in some preferred embodiments, the sample receiving cup is further provided with a flow channel through which the sample can be added or collected; the first receiving area and the flow channel are connected, allowing the sample to move between the first receiving area and the flow channel. In some preferred embodiments, both the first receiving area and the flow channel are provided at the bottom of the cup body.

[0026] In some preferred embodiments, the sample receiving cup may include at least one detection element, which is used to detect the presence or quantity of an analyte in the sample. In some preferred embodiments, the detection element may be distributed on one of the side inner walls of the device of the present invention, or may be distributed on multiple side inner walls of the device of the present invention. In some preferred embodiments, the side inner wall of the cup body is further provided with a placement component for placing the detection element, and the detection element can be placed in the placement component. The placement component is connected to the side inner wall of the cup body, and in some preferred embodiments, the placement component and the side inner wall of the cup body are detachably connected.

[0027] In some preferred embodiments, the placement component can be a detection board. In some preferred embodiments, the placement component can be provided with a slot. In some preferred embodiments, the detection element can be a strip or similar strip, which can be placed in the slot. In some preferred embodiments, one detection board can be provided with one slot, and in other preferred embodiments, one detection board can be provided with multiple slots.

[0028] In some preferred modes, detecting element can be any test device that provides test result.In some preferred modes, detecting element is test strips, and test strips can have the specific binding molecule that is fixed on the test strips and the reagent that is used to carry out immunoassay.In some preferred modes, this detecting element can also be to contain based on chemical reaction test reagent, based on biological test reagent (for example enzyme or ELISA test) or based on fluorescent test reagent etc.In addition, in other embodiments, as long as there are some other reagents on the detecting element, this reagent can be used for detecting whether there is analyte or the quantity of analyte in the sample.In certain embodiments, detecting element comprises the reagent that is used to detect the existence of drugs of abuse.

[0029] In some preferred embodiments, the sample in which the present invention detects an analyte can 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. "Oral fluid" is any fluid present in the oral cavity. The analyte to be detected can be any analyte, and the detection element can be made for that analyte.

[0030] In some preferred embodiments, the first receiving area is located below the detection element, allowing the liquid sample in the first receiving area to reach the detection element, facilitating detection of the sample by the detection element. In some embodiments, an absorbent material absorbs the liquid sample in the first receiving area and transports it to the detection element, thereby providing fluid communication between the first receiving area and the detection element. This prevents the absorbent material from absorbing and transporting more liquid sample than the detection element can hold, thereby preventing overflow of the detection element. A "fluidically connected" structure means that fluid from one structure will encounter another structure in fluid communication with it. Therefore, when the first receiving area is in fluid communication with the detection element, the liquid sample in the first receiving area passes through the absorbent material and reaches the detection element. The first receiving area, the absorbent material, and the detection element may be in direct physical contact, or a gap may exist between them while maintaining fluid communication. An "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 with these properties. In some preferred embodiments, the absorbent material may be absent, and fluid communication between the first receiving area and the detection element is still maintained, allowing the liquid sample in the first receiving area to reach the detection element.

[0031] In some preferred embodiments, the diversion channel connects the first receiving area and the inner wall of the other side of the cup body. In some preferred embodiments, the diversion channel connects the first receiving area and the inner wall of the other side of the cup body, where the other side is the side where the secondary sampling port is located.

[0032] In some preferred embodiments, the diversion channel can be a groove, which includes a bottom surface and side walls, providing a channel for the liquid sample to circulate. In some preferred embodiments, a second receiving area is provided in the groove, and the second receiving area is connected to the inner wall of the side of the cup body, which is the side where the secondary sampling port is located. The provision of the groove facilitates the diversion and collection of liquid samples, preventing the liquid sample from flowing randomly over a large area, which is not conducive to collecting liquid samples for secondary testing; it can also avoid waste of liquid samples, which is particularly important for liquid samples with poor fluidity and / or small sample volumes, to prevent liquid samples with poor fluidity and / or small sample volumes from being retained over a large area at the bottom of the cup body, which is not conducive to collection or even impossible to collect, making secondary testing impossible.

[0033] In some preferred embodiments, the nozzle extends into the groove but does not contact the groove bottom surface. In this way, after the liquid sample is squeezed out of the nozzle, it contacts the groove bottom surface, and the sidewalls of the groove can block part of the liquid sample from splashing out of the groove. In some preferred embodiments, the nozzle is close to the groove entrance, and therefore the distance between the nozzle and the first receiving area is close, so that the flow path of the liquid sample is minimized and it can reach the first receiving area more quickly. For liquid samples with poor fluidity and / or small sample volume, this can effectively avoid waste and loss of liquid samples with poor fluidity and / or small sample volume.

[0034] In some preferred embodiments, the bottom surface of the groove is set to be a slope, and the first receiving area is at the lower end of the slope. This can accelerate the smooth flow of the liquid sample into the first receiving area, and can effectively avoid liquid samples with poor fluidity and / or small sample volume from being retained on the contact surface with the liquid, affecting the detection of the liquid sample.

[0035] In some preferred embodiments, the inlet of the groove is connected to the first receiving area, and the outlet of the groove is connected to a side surface of the cup body. In some preferred embodiments, the outlet of the groove is connected to a side surface opposite to the side surface where the detection element is located, where the opposite side is the side surface of the cup body that is not adjacent to the side surface where the detection element is located, and this side surface is the side surface where the secondary sampling port is located.

[0036] In some preferred embodiments, the groove inlet is lower than the groove outlet. When the liquid sample is ejected from the nozzle, it contacts the groove and flows along the groove into the first receiving area. The lower groove inlet can accelerate the liquid sample to flow smoothly into the first receiving area. When a secondary confirmation test is required, the stopper can be opened and the cup body can be tilted. The liquid sample in the first receiving area can enter the groove from the groove inlet and flow along the groove channel to the second receiving area, making it easier for the operator to absorb the liquid sample.

[0037] In some preferred embodiments, the second receiving area may include a corner area for collecting samples to facilitate secondary sampling. In some preferred embodiments, a side wall of the groove is provided with a corner. The corner may be a right angle, a rounded corner, a chamfered corner, a fan-shaped corner, or other suitable shapes. When the cup body is tilted, the corner facilitates the collection and aspiration of the liquid sample in the corner area.

[0038] In some preferred embodiments, a corner area is provided near the secondary sampling port. When sampling is required, the cup structure is slightly tilted to allow the sample to flow from the first receiving area through the groove to the corner area. This makes it easier to insert a straw, etc., through the secondary sampling port to easily reach the corner area and absorb the sample. Because the corner area has a collection function, even if the sample amount is small, it can still collect enough sample for secondary sampling.

[0039] In some preferred embodiments, the corner region is not directly opposite the secondary sampling port, but is offset. The offset means that the corner region is not aligned with the central axis of the secondary sampling port, but is offset from the central axis. Thus, when sampling, a straw is inserted obliquely through the secondary sampling port to reach the corner region for sampling.

[0040] In some preferred embodiments, the groove outlet is connected to a secondary sampling port, which is located above the groove outlet and overlaps with the secondary sampling port. In some preferred embodiments, half of the secondary sampling port's area overlaps with the groove outlet. The secondary sampling port and the corner region cooperate to facilitate insertion of a suction device into the secondary sampling port to remove a liquid sample from the corner region for secondary testing or other purposes. Solvents or other desired substances can also be added through the secondary sampling port, for example, to increase the sample volume of the liquid sample, dilute the liquid sample, or add a solvent to reduce the viscosity of the liquid sample.

[0041] The present invention also provides a method for using a device for detecting analytes in liquid samples. The sample collector absorbs a certain amount of liquid sample. The sample collector is then inserted into a cannula. The retaining seat is rotated until the cannula opening is completely closed, preventing the liquid sample from leaking out of the device through the closed portion. Simultaneously, the positioning block is screwed into the positioning groove, prompting the device to rotate into position. During this rotation, the collected sample is squeezed, squeezing the collected sample from the nozzle. The sample flows from the bottom surface of the groove through the groove inlet and into the first receiving area. The sample in the first receiving area reaches the detection element and is detected on the detection element. After a period of time required for the detection test, the presence and quantity of the analyte in the liquid sample are determined. When a secondary confirmation test is required, the stopper is opened and the sample receiving cup is tilted. The remaining sample in the first receiving area enters the groove through the groove inlet, flows along the groove, and collects in the corner area. The sampler can then be extended from the secondary sampling port into the liquid sample in the corner area to aspirate the sample for secondary confirmation testing.

[0042] The beneficial effects of the present invention are:

[0043] (1) The present invention provides a flow guide channel at the bottom of the device. The flow guide channel is a groove, which is conducive to the collection and detection of samples and prevents samples with poor fluidity and / or small sample volume from being retained in a large area at the bottom of the cup, wasting samples, making it difficult to collect, or even impossible to collect, and making secondary detection impossible.

[0044] (2) The bottom surface of the groove of the present invention is an inclined surface, and the groove inlet is lower than the groove outlet, which can accelerate the flow of liquid samples into the first receiving area, improve the efficiency of collection and detection, and avoid samples with poor fluidity and / or small sample volume from being retained on the inclined surface and unable to flow smoothly into the first receiving area, affecting the detection.

[0045] (3) One side wall of the groove of the present invention is provided with a corner. The corner facilitates the collection of samples in the corner area. When sampling is required, the cup body is slightly tilted to allow the sample to flow from the first receiving area through the groove to the corner area. At this time, a straw or the like can be conveniently inserted from the secondary sampling port to easily reach the corner area to absorb the sample. Because the corner area has a collection function, if the sample amount is small, sufficient sample can be collected for secondary sampling.

[0046] (4) The secondary sampling port of the present invention is located above the groove outlet, and the secondary sampling port overlaps with the groove outlet, making it easy to reach in from the secondary sampling port to take out samples for secondary confirmation testing, and also making it easy to add solvents or other required substances from this secondary sampling port.

[0047] (5) The cup body of the present invention is made of transparent material, which makes it easy to observe the test results.

[0048] (6) The present invention provides a positioning protrusion or a positioning recess on the cover surface of the fixing seat, and a recess is provided on the inner cover of the sleeve to cooperate with the positioning protrusion on the cover surface of the fixing seat, or the inner cover is provided with a protrusion to cooperate with the positioning recess on the cover surface of the fixing seat. The protrusion and the recess cooperate with each other, so that the operator can clearly feel that the fixing seat has completely covered the inner cover and the cup body, and avoid tightening the fixing seat again with greater force after tightening the cup body because the user is not sure whether it is tightened. This will easily damage the fixing seat. At the same time, because the user is not sure whether it is tightened, he will tighten the fixing seat multiple times, wasting time and affecting the operating efficiency. The positioning protrusion or the positioning recess is set on the cover surface, rather than at other locations, and will not affect the structure of the fixing seat or the outside of the cup body. At the same time, the structure outside the device will not affect the positioning of the device.

[0049] (7) The fixing seat and the cup body of the present invention are irregular pentahedrons, and the cross-sectional polygonal dimensions of the fixing seat and the cup body are close. When the fixing seat completely covers the cup body, one side of the fixing seat is nearly flush with one side of the cup body, so that the completely covered detection device can lie flat and sideways stably, which is convenient for scanning the test results and avoids the cup body rolling or sliding, which may damage the test cup and cause leakage and contamination of the sample in the cup body.

[0050] (8) The outer surface of the cup body of the present invention is provided with an anti-slip structure. The setting of the anti-slip structure makes it easy for the user to grab or hold the sample receiving cup, avoiding slipping and falling to damage the detection device.

[0051] (9) The inner wall of the fixing seat of the present invention is provided with a reinforcement structure. The setting of the reinforcement structure makes the fixing seat more firm and stable and not easily damaged. Furthermore, the paddle-shaped reinforcement structure is adopted, which has a better reinforcement effect. The fixing seat as a whole is firmer and not easily damaged, and has a beautiful appearance.

[0052] (10) The present invention sets the nozzle at an eccentric position on the closed surface. The nozzle extends into the groove but does not contact the bottom surface of the groove. In this way, after the liquid sample is squeezed out of the nozzle, it contacts the bottom surface of the groove. The side wall of the groove can block part of the liquid sample from splashing out of the groove. Moreover, the nozzle is close to the groove entrance, so that the distance between the nozzle and the first receiving area is close. Therefore, the flow path of the liquid sample is shortest and it can reach the first receiving area faster. For liquid samples with poor fluidity and / or small sample volume, the waste and loss of liquid samples with poor fluidity and / or small sample volume can be effectively avoided. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Figure 1 It is a structural schematic diagram of the device of the present invention.

[0054] Figure 2 It is an exploded view of the device of the present invention.

[0055] Figure 3 It is a structural schematic diagram of the fixing seat of the device of the present invention.

[0056] Figure 4 It is a structural schematic diagram of the casing of the device of the present invention.

[0057] Figure 5 It is a schematic diagram of the bottom structure of the device of the present invention.

[0058] Figure 6 It is an exploded view of the sample receiving cup of the present invention.

[0059] Figure 7 It is a top view of the device of the present invention in an assembled state.

[0060] Figure 8 yes Figure 7 Cross-sectional view in the BB direction (the collection components are hidden in the figure).

[0061] Figure 9 This is a schematic diagram of the internal structure of the sample receiving cup of the present invention (in order to clearly show the structure of the diversion channel, one side of the cup body is hidden).

[0062] : Numbers in the figure: sample receiving cup 1, cup body 5, fixing seat 6, positioning block 7, positioning groove 8, protrusion 9, secondary sampling port 11, stopper 12, anti-slip structure 13, reinforcement structure 14, collection element 15, sleeve 16, push rod 17, connector 18, nozzle 19, first receiving area 20, guide channel 21, placement component 22, corner 23, groove entrance 24, inner cover 25, covering surface 26, closing surface 27, slot 28, corner area 29, baffle 30, bottom surface 31, side wall 32, head 181, middle section 182, end section 183. DETAILED DESCRIPTION

[0063] The technical solution of the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the specific implementation methods are only detailed descriptions of the present invention and should not be regarded as limitations of the present invention.

[0064] like Figure 1 As shown, the present invention provides a device for detecting the presence or amount of an analyte in a liquid sample. The detection device is in an assembled state and may include a sample collector and a sample receiving cup 1. The sample collector is used to collect samples directly or indirectly from the patient's body or the part to be collected or in a certain scenario where the sample has been separated from the patient's body.

[0065] The sample receiving cup 1 can receive and hold the sample collector. In some preferred methods, the sample receiving cup 1 can receive the sample collector itself or a part of it. After collecting the sample, the sample collector can be placed in the sample receiving cup 1, and then the sample in it can be transferred into the sample receiving cup 1; in some preferred methods, the sample receiving cup 1 can directly receive the sample collected by the sample collector.

[0066] In some preferred embodiments, the sample receiving cup comprises at least one detection element for detecting the presence or amount of an analyte in the sample.

[0067] In some preferred embodiments, the various components of the detection device can be conveniently made of molded plastic parts, but any other suitable materials can also be used.

[0068] In some preferred embodiments, the detection device may have a flat surface that allows the entire device to remain stationary when placed horizontally. This stationary state means that the device will not roll. Since the detection element may be planar, it needs to be placed flat for testing. In this case, it is necessary to ensure that it does not roll after placement, thereby affecting the detection. In some preferred embodiments, the detection device may have at least one such flat surface. In some preferred embodiments, the outer wall of the detection device may be composed of at least three such flat surfaces.

[0069] exist Figure 2 , a sample collector and a sample receiving cup 1 are shown. In the illustrated embodiment, the sample collector 2 includes a collection element 15 for collecting a liquid sample and a push rod 17 for securing the collection element 15. The sample receiving cup includes a cup body 5, within which is fixedly connected a sleeve 16 for use with the collection element 15. The sleeve 16 is capable of receiving and retaining the sample collector.

[0070] In some preferred embodiments, the collection element 15 is compressible, squeezing or absorbing the sample through compression and rebound. In some preferred embodiments, the collection element 15 is fixedly mounted on the sample collector via a connector. In some preferred embodiments, the collection element 15 is detachably connected to the sample collector. In some preferred embodiments, the sample collector is provided with a component for connecting the collection element 15, such as a connecting rod, to facilitate the collection element extending into the sample collector after collecting the sample and placing the sample.

[0071] For example, the sample collector uses a compressible collection element 15 to absorb the liquid sample, where compressibility refers to the material property that the shape of the material can be deformed by mechanical pressure so as to squeeze the liquid out of the material while the material retains the liquid. The collection element 15 can be made of any material that absorbs and retains liquid. In some embodiments, the collection element is a sponge, but in other embodiments, it can be non-woven fabric, absorbent paper, nylon, cotton, or any other material that can absorb and retain liquid. When the material of the collection element 15 is a sponge, it can be natural or synthetic. In the embodiment shown, as Figure 2 As shown, collection element 15 is a cylindrical sponge material suitable for placement in a subject's mouth to collect saliva. However, in other embodiments, collection element 15 can be of any suitable and convenient shape. In certain embodiments, collection element 15 is treated with a chemical component (e.g., citrate or other chemical) to promote saliva secretion and facilitate absorption by collection element 15.

[0072] In the embodiment shown, Figure 2 As shown, the collection element 15 is connected to the connector 18 at one end of the push rod 17. In some preferred embodiments, the collection element 15 is detachably connected to the connector 18. In other embodiments, the collection element 15 is fixedly connected to the connector 18. In some preferred embodiments, the collection element 15 can be adhered or welded to the connector 18 of the push rod 17 by means of sealant, hot melt adhesive or other glue, or can be connected to the connector 18 by any applicable means. In some preferred embodiments, a sealing structure is provided on the connector 18, for example, the sealing structure is a sealing ring, and the sealing structure on the connector 18 can fit with the inner wall of the sleeve 16 and ensure that the collected sample does not flow back when the connector 18 is squeezed downward. In the embodiment shown, as Figure 3As shown, the connector 18 includes a head 181, a middle section 182, and a terminal section 183. In some preferred embodiments, the collection element 15 is connected to the end surface of the head 181. In some preferred embodiments, the collection element 15 can also be connected to the middle section 182. In some preferred embodiments, the collection element 15 can also be connected to the terminal section 183. In some preferred embodiments, the collection element 15 is closer to the head 181 of the connector 18 than the sealing structure. In some preferred embodiments, the sealing structure is connected to the middle section 182 of the connector, and the collection element 15 is connected to the end surface of the head 181 of the connector. In some preferred embodiments, the sealing structure is connected to the terminal section 183 of the connector.

[0073] The end of the push rod 17 away from the connector is connected to the fixing base 6. The cross-sectional area of ​​the fixing base 6 is larger than that of the push rod, so the setting of the fixing base makes it easier for the operator to grab the sample collector. The push rod 17 and the fixing base 6 can be fixedly connected by integral molding or by any other suitable connection method, such as by snap connection, or by bonding or by the cooperation of internal and external threads. In the embodiment shown, Figure 2-3 As shown, the fixing base 6 has a cylindrical protrusion 9 on its engagement surface. The fixing base engagement surface 26 refers to the contact surface with the upper surface of the sleeve 16 when the fixing base is engaged with the sleeve 16. The push rod is fixedly connected to the cylindrical protrusion 9 through an integral molding process. The cylindrical protrusion 9 has an external thread on its outer circumference. In some embodiments, the fixing base 6 has an internal thread for detachable connection to the sleeve 16. In other embodiments, the fixing base 6 has other structures for detachable connection to the sleeve 16, such as a snap-fit ​​structure or other features that fit snugly and hold the two components together.

[0074] The fixing base 6 can completely cover the sleeve 16. Complete covering means that after the fixing base 6 completely covers the sleeve 16, a sealed structure is formed, and the liquid sample cannot leak out of the device through the covering. During the process of the fixing base 6 completely covering the sleeve, the collection element 15 is continuously compressed.

[0075] The fixing seat cover surface 26 is provided with a positioning protrusion or a positioning recess. The positioning protrusion or the positioning recess is provided on the cover surface 26, which will not affect the external structure of the fixing seat 6 or the cup body 5, and the structure outside the device will not affect the positioning of the device. The positioning protrusion can be a positioning block 7, and the positioning recess can be a positioning groove 8. In the embodiment shown, Figure 2-3 As shown, an arc-shaped positioning block 7 is provided on the fixing seat cover surface 26, and the arc-shaped positioning block 7 is connected to the end of the cylindrical raised external thread, so that after the external thread is completely screwed, the arc-shaped positioning block 7 is smoothly screwed into the corresponding positioning groove to achieve positioning.

[0076] In the embodiment shown, the inner wall of the fixing seat 6 is provided with a reinforcement structure 14 for strengthening the side wall of the fixing seat, making the fixing seat 6 more firm and stable and not easily damaged. Figure 1 As shown, the reinforcement structure 14 is a paddle-shaped structure, which has a better reinforcement effect, makes the fixing base 6 more solid as a whole, is not easily damaged, and has a beautiful appearance. In some embodiments, the reinforcement structure 14 can be a plate or any other suitable structure.

[0077] In the embodiment shown, Figure 2 As shown, one end of the cannula 16 has an inner cover 25 that fits over the opening of the cup 5. The inner cover 25 has an opening to facilitate insertion of the collection element 15 into the cannula 16. The other end of the cannula 16 has a closing surface 27 that seals the other end of the cannula 16. A nozzle 19 is located eccentrically above the closing surface 27 to facilitate the flow of the liquid sample from this nozzle 19 after being squeezed. The cannula 16 is tapered. The inner diameter of the opening of the inner cover 25 is larger than the diameter of the closing surface 27, which in turn is larger than the outer diameter of the nozzle 19. The inner diameter of the opening of the inner cover 25 is larger than the maximum cross-sectional width of the collection element 15, while the diameter of the closing surface 27 is smaller than the minimum cross-sectional width of the collection element 15. After collecting element 15 absorbs the liquid sample, it is inserted into cannula 16 through the opening of the inner cover. During the insertion process, collecting element 15 is not only pushed by push rod 17 but also squeezed by the inner wall of cannula 16 against its outer circumference, allowing the liquid sample to be quickly and completely separated from collecting element 15. In other embodiments, cannula 16 can also have other shapes that complement the shape of collecting element 15.

[0078] The inner cover 25 of the sleeve 16 is fixedly connected to the cup body 5, and can be fixed to the open end of the cup body 5 by bonding or welding, or by any other suitable method. Figure 2 As shown, the opening of the sleeve inner cover 25 is provided with an internal thread that cooperates with the external thread on the outer periphery of the fixing seat protrusion 9, and the upper surface of the sleeve inner cover 25 is provided with an arc-shaped positioning groove 8 that cooperates with the arc-shaped positioning block 7 on the fixing seat cover surface 26.

[0079] By 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. The arc-shaped positioning block 7 cooperates with the arc-shaped positioning groove 8 to limit the fixing base 6 from moving further in the tightening direction, but allows the fixing base 6 to move in the opposite direction under the action of an external force to open the fixing base 6. The arrangement of the positioning block 7 and the positioning groove 8 can make the operator clearly feel that the fixing base 6 has completely covered the inner cover 25, avoiding the user from tightening the fixing base 6 again with greater force after tightening the inner cover 25 because the user is not sure whether it is tightened, which will easily damage the fixing base 6. At the same time, due to uncertainty about whether it is tightened, the user will tighten the fixing base multiple times, wasting time and affecting operating efficiency. After the rotation is completed, the fixing base 6 completely covers the opening of the sleeve 16, forming a sealed structure. The liquid sample cannot leak out of the device through this covering. At the same time, the positioning block 7 is screwed into the positioning groove, providing a prompt to indicate that the rotation is in place, so that the operator can clearly know that the device has been fully covered and there is no need to tighten the fixing base 1. During the rotation, the collection element 15 that has absorbed the liquid sample is squeezed, so that the liquid sample on the collection element 15 is squeezed into the sample receiving cup 1 through the nozzle 19.

[0080] The sample receiving cup 1 includes a cup body 5, such as Figure 1-2 As shown, the fixing base 6 in the sample collector can cover the inner cover 25 and then cover the cup body 5. The fixing base 6 can cover the cup body 5 tightly. After the fixing base 6 completely covers the cup body 5, it becomes a whole that can be transported, carried, used, stored or discarded as a whole.

[0081] The cup body 5 and / or the fixing seat 6 can be a polyhedron. Both the fixing seat 6 and the cup body 5 are polyhedrons, that is, the cross-sections of the fixing seat 6 and the cup body 5 are polygonal shapes, which can be triangular, quadrilateral, pentagonal or other polygons, and can also be regular polygons or irregular polygons. One or more detection elements 10 can be set in the polyhedral cup body 5, which can realize the simultaneous detection of different analytes in the sample. The detection element 10 can be set on any side inner wall of the polyhedral cup body, and any side inner wall of the cup body 5 can be provided with a placement component 22 for placing the detection element. Figure 2 As shown, 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. The inner wall of the side with the largest area of ​​the pentahedron cup body is provided with a detection element placement component 22 for accommodating the detection element 10. The cross-sectional shape and side length of the inner cover 25 are the same as those of the cup body 5, also an irregular pentagon. Therefore, the inner cover 25 can tightly cover the opening of the cup body 5, and the sides of the inner cover do not extend beyond the side of the cup body 5, allowing the cup body 5 to lie flat and stably on its side.

[0082] The fixing base 6 and the cup body 5 can be polyhedrons with the same number of faces, or polyhedrons with different numbers of faces. Figure 1 As shown, both the fixing base 6 and the cup body 5 are irregular pentahedrons. When the fixing base 6 completely covers the cup body 5, the side surface of the fixing base 6 with the largest area is aligned parallel to the side surface of the cup body with the largest area. This also facilitates confirmation that the fixing base 6 has completely covered the cup body 5. The cross-section of the fixing base 6 is close to the side length of the pentagonal cross-section of the cup body 5. When the fixing base 6 completely covers the cup body 5, each side surface of the fixing base 6 is nearly flush with each side surface of the cup body 5, almost in the same plane, so that the completely covered device can be stably laid flat on its side, facilitating the scanning of the test results.

[0083] In the illustrated embodiment, the cup body 5 is made of a transparent material to facilitate observation of the test results.

[0084] In the embodiment shown, a secondary sampling port 11 is provided on one side of the cup body 5. Figure 2 As shown, the lower portion of one side of the cup body 5 is provided with an arch-shaped recessed portion, and a secondary sampling port 11 is located in this arch-shaped recessed portion. A stopper 12 can block the secondary sampling port 11. After the stopper 12 blocks the secondary sampling port 11, the side of the cup body 5 with the secondary sampling port 11 can still lie flat and stably on its side. In some embodiments, the stopper 12 can be used to cover the secondary sampling port 11 during sample testing and transport to provide a seal. When the device is received at the clinical testing facility, the stopper 12 can be removed, and the user can remove the sample from the secondary sampling port 11 for secondary confirmation testing. The provision of the secondary sampling port 11 also facilitates the user to add solvents or other required substances through the secondary sampling port 11, such as adding solvents to increase the sample volume of a liquid sample, diluting a sample solution, or adding solvents to reduce the viscosity of the liquid sample. In some embodiments, when the stopper 12 is removed, the operator can conveniently remove the sample using a pipette or other sampling device. The sample receiving cup 1 can be conveniently maintained in the closed state while still allowing the removal of the liquid sample.

[0085] In the embodiment shown, an anti-slip structure 13 is provided on the outer side of the cup body 5. Figure 1 As shown, the anti-slip structure 13 is a ridge, which makes it easier for the user to grasp or hold the sample receiving cup 1, avoiding slipping and falling to damage the sample receiving cup 1. In some embodiments, other anti-slip structures 13 are provided on the outer surface of the cup body 5, such as pits or any other suitable structures.

[0086] In the embodiment shown, Figure 2 、 5As shown, the sample receiving cup 1 is provided with a first receiving area 20 for receiving and storing samples. The sample receiving cup 1 is also provided with a flow channel 21 through which samples can be added or collected. The first receiving area 20 and the flow channel 21 are connected, allowing the sample to move between the first receiving area 20 and the flow channel 21. Both the first receiving area 20 and the flow channel 21 are located at the bottom of the cup body 5.

[0087] The sample receiving cup 1 may include at least one detection element, which is used to detect the presence or amount of an analyte in the sample. The detection element may be distributed on one of the side inner walls of the device of the present invention, or may be distributed on multiple side inner walls of the device of the present invention. A placement component 22 for placing the detection element is also provided on the side inner wall of the cup body 5, and the detection element may be placed in the placement component 22. The placement component 22 may be fixedly connected to the side inner wall of the cup body, or the placement component 22 may be detachably connected to the side inner wall of the cup body. In some preferred embodiments, the placement component 22 may be detachably connected to the side inner wall of the cup body. In some preferred embodiments, the placement component 22 may be a detection board. In some preferred embodiments, a slot 28 may be provided on the placement component 22, and in some preferred embodiments, the detection element may be a strip or a similar strip, which may be placed in the slot 28. In some preferred embodiments, one slot 28 may be provided on a detection board, and in other preferred embodiments, multiple slots 28 may be provided on a detection board. In the embodiment shown, as Figure 6 、 8 As shown, the cup body 5 is an irregular pentahedron, meaning that the cross-section of the cup body 5 is an irregular pentagon. The placement component 22 can be inserted into the cup body 5, closely adjoining the largest side of the cup body. Baffles 30 are provided on both sides adjacent to the largest side of the cup body. The planes of the baffles 30 are parallel to the largest side. The baffles 30 block the placement component 22, ensuring that it is stably placed in the cup body 5 and preventing it from shaking. However, the placement component 22 can be inserted into the space between the baffles 30 and the largest side. In the illustrated embodiment, the placement component 22 is provided with a slot 28.

[0088] " detecting element " can be any test device that provides test result.In certain embodiments, detecting element is test strip.Test strip can have the specific binding molecule that is fixed on the test strip and the reagent that is used to carry out immunoassay.But in other embodiments, this detecting element can also be to contain the test reagent based on chemical reaction, based on the test reagent (for example enzyme or ELISA test) of biology or based on fluorescent test reagent etc.In addition, in other embodiments, as long as there are some other reagents on the detecting element, this reagent can be used for detecting whether there is analyte or the quantity of analyte in the sample.In one embodiment, detecting element comprises the reagent that is used to detect the existence of drug abuse.Yet, in other embodiments, detecting element can be any element that provides test result indication.For example, can use some chemical or biological indicator reagents.

[0089] When the detection element is a test strip, it may include a water-absorbing matrix (e.g., nitrocellulose) and / or other suitable materials. The matrix may have a sample loading area, a reagent or labeling area, and a detection area. These types of test strips are well known in the art, and those of ordinary skill in the art will recognize various test strips that can be used in the present invention with reference to this disclosure. In some embodiments, the sample loading area is located at one end of the test strip to facilitate the addition of the sample to the test strip. Reagents used to perform tests or condition the sample may also be located in the sample loading area, or they may be located in separate reagent or labeling areas on the test strip. These reagents can be used for various purposes, such as preparing a sample for optimal binding to a specific binding molecule or improving the stability of an analyte of interest.

[0090] The sample in which the present invention detects an analyte can 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. "Oral fluid" refers to any fluid present in the oral cavity.

[0091] The analyte to be detected can be any analyte, and the detection element can be made for that analyte. 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 components. A "drug of abuse" (DOA) is a drug used for non-medical purposes (usually for its psychedelic effects). The 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 beauties, white bennies, amphetamine pills, dexies, beans), methamphetamines (crank, methamphetamine, crystal, speed), barbiturates (Roche Pharmaceuticals, Nutley, New Jersey), sedatives (i.e., sleeping pills), lysergic acid diethylamide (LSD), tranquilizers (downers, goofballs, barbs, blue devils, yellow jackets, ludes), tricyclic antidepressants (TCAs, such as imipramine, amitriptyline, and doxepin), phencyclidine (PCP), tetrahydrocannabinol, and opiates (e.g., morphine, opium, codeine, heroin).

[0092] In the embodiment shown, Figure 5 As shown, the first receiving area 20 is located below the detection element. The liquid sample in the first receiving area 20 can reach the detection element, facilitating detection of the sample by the detection element. In some embodiments, an absorbent material absorbs the liquid sample in the first receiving area 20 and transports it to the detection element, thereby providing fluid communication between the first receiving area 20 and the detection element. This prevents the absorbent material from absorbing and transporting more liquid sample than the detection element can hold, thereby preventing overflow of the detection element. A "fluidically connected" structure means that fluid from one structure will encounter another structure in fluid communication with it. Therefore, when the first receiving area 20 is in fluid communication with the detection element, the liquid sample in the first receiving area 20 reaches the detection element through the absorbent material. The first receiving area 20, the absorbent material, and the detection element can be in direct physical contact, or a gap can exist between them while maintaining fluid communication. An "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 with these properties. In some embodiments, the absorbent material can be absent and still maintain fluid communication between the first receiving area 20 and the detection element.

[0093] The diversion channel 21 connects the first receiving area 20 with the inner wall of the other side of the cup body 5. As a preferred embodiment, this side is the side of the cup body where the secondary sampling port 11 is located. The diversion channel 21 can be a groove, which includes a bottom surface 31 and a side wall 32, providing a channel for the liquid sample to circulate. A second receiving area is provided in the groove, and the second receiving area is connected to the inner wall of the side of the cup body 5. The setting of the groove facilitates the diversion and collection of liquid samples, preventing the liquid samples from flowing randomly to various places over a large area, which is not conducive to collecting liquid samples for secondary testing; it can also avoid the waste of liquid samples, especially for liquid samples with poor fluidity and / or small sample volume. The setting of the groove is very important to avoid the liquid samples with poor fluidity and / or small sample volume from being retained over a large area at the bottom of the cup body, which is not conducive to collection or even impossible to collect, making secondary testing impossible.

[0094] When the liquid sample is squeezed out 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. After being squeezed out from the nozzle 19, the liquid sample is subjected to an impact force, which facilitates the liquid sample to quickly gather in the first receiving area 20 and not to be retained on the contact surface with the liquid. For liquid samples with poor fluidity and / or small sample volume, this downward impact force of the liquid sample is crucial to avoid the liquid samples with poor fluidity and / or small sample volume from not being able to reach the first receiving area 20 smoothly, thereby affecting the detection; the liquid sample is squeezed out 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 set as an inclined surface, and the first receiving area 20 Being at the lower end of the slope, this can accelerate the liquid sample to flow smoothly into the first receiving area 20, and can effectively prevent liquid samples with poor fluidity and / or a small sample volume from being retained on the contact surface in contact with the liquid, affecting the detection of the liquid sample; if the bottom surface 31 of the groove is set to a plane, after the liquid sample is squeezed out from the nozzle, the liquid sample is subjected to a downward impact and will flow along the plane. A portion of the liquid sample will flow to the first receiving area 20, but another portion of the liquid sample will flow along the groove to the other end of the groove, that is, some of the liquid sample will not be able to flow directly to the first receiving area 20. For liquid samples with poor fluidity and / or a small sample volume, the precious only sample volume will be lost. In summary, the liquid sample is squeezed out from the nozzle, subjected to an impact, and the bottom surface 31 of the groove is set to a slope, which can easily allow the liquid sample to flow into the first receiving area 20. This is a preferred embodiment.

[0095] In the embodiment shown, Figure 4 、 8As shown, the nozzle 19 is set at an eccentric position of the closing surface 27. The nozzle 19 extends into the groove, but does not contact the bottom surface of the groove, so that after the liquid sample is squeezed out of the nozzle, it contacts the bottom surface 31 of the groove. The side wall 32 of the groove can block part of the liquid sample from splashing out of the groove, and then the liquid sample flows into the first receiving area 20 along the bottom surface 31 of the groove. The nozzle is close to the groove inlet 24, so the distance between the nozzle 19 and the first receiving area 20 is close, so that the flow path of the liquid sample is the shortest and it can reach the first receiving area 20 faster. For liquid samples with poor fluidity and / or small sample volume, the waste and loss of liquid samples with poor fluidity and / or small sample volume can be effectively avoided. In the embodiment shown, as Figure 5 As shown, the bottom surface 31 of the groove is inclined, and the groove inlet 24 is lower than the groove outlet. The groove inlet 24 connects to the first receiving area 20, which is located below the detection element. The groove outlet connects to a side opposite the detection element. This side refers to a side of the cup body that is not adjacent to the detection element side and is the side where the secondary sampling port is located. The liquid sample in the first receiving area 20 can enter the groove through the groove inlet 24 and flow along the groove channel to the second receiving area.

[0096] In some embodiments, the second receiving area may include a corner region 29 for collecting samples to facilitate secondary sampling. Figure 5 、 8 As shown, a side wall 32 of the groove is provided with a corner 23, which can be a right angle, a rounded corner, a chamfered corner, a fan-shaped corner or other applicable shapes. The setting of the corner 23 facilitates the collection and absorption of liquid samples.

[0097] When secondary sampling is required, the liquid in the first receiving area must first be allowed to flow into the second receiving area. However, since sampling is generally performed using a straw, a pipette, or a pipette gun to absorb the sample. Since the amount of sample collected is very small, it is not easy to extend the straw into the first receiving area. This is because the first receiving area 20 is generally a planar structure. In addition, the first receiving area 20 is far away from the secondary sampling port 11. Therefore, when the sampling tube is not long enough, it cannot reach the first receiving area 20. In addition, the amount of sample is very small, and it is not easy to absorb enough sample. For the present invention, a corner area 29 is set near the secondary sampling port 11. When sampling is required, the cup body structure is slightly tilted to allow the sample to flow from the first receiving area 20 through the groove to the corner area 29. At this time, it is convenient to extend the straw from the secondary sampling port 11, and it is easy to reach the corner area to absorb the sample. In addition, because the corner area has a collecting function, if the amount of sample is very small, enough sample can also be collected for secondary sampling.

[0098] In some embodiments, as Figure 9 As shown, the corner region 29 is not directly opposite the secondary sampling port 11, but is offset. This offset means that the corner region 29 is not aligned with the central axis of the secondary sampling port 11, but is offset from the central axis. This allows the straw to be inserted obliquely through the secondary sampling port 11 to reach the corner region 29 for sampling.

[0099] In some embodiments, the outlet of the groove is connected to a secondary sampling port 11, which is located above the outlet of the groove and overlaps with the secondary sampling port 11. In the illustrated embodiment, half of the area of ​​the secondary sampling port 11 overlaps with the outlet of the groove. The secondary sampling port 11 cooperates with the corner area 29 to facilitate insertion of a suction device into the secondary sampling port 11 to remove a liquid sample from the corner area 29 for secondary testing or other purposes. Solvents or other desired substances can also be added through the secondary sampling port, for example, to increase the sample volume of the liquid sample, dilute the liquid sample, or add a solvent to reduce the viscosity of the liquid sample.

[0100] The present invention also provides a method for using the device for detecting analytes in liquid samples. Figure 1-9 The embodiment described in the accompanying drawings is described. The collection element 15 of the sample collector is placed in the user's mouth, where it continuously absorbs saliva. The collection element 15 is then removed from the user's mouth and placed into the sleeve 16 used in conjunction with the collection element 15. The fixing seat 6 is rotated until the opening of the sleeve 16 is completely covered, preventing the liquid sample from leaking out of the device through the covering portion. Simultaneously, the positioning block 7 is screwed into the positioning groove, prompting that the rotation is in place. During the rotation, the collection element 15 that has absorbed the liquid sample is squeezed, so that the liquid sample in the collection element 15 can be squeezed out of 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. The liquid sample in the first receiving area 20 reaches the detection element and is detected on the detection element. After a period of time required to complete the detection test, the presence and amount of the analyte in the liquid sample are determined. When a secondary confirmation test is required, open the stopper 12, tilt the sample receiving cup 1, and the remaining liquid sample in the first receiving area 20 enters the groove from the groove inlet 24, flows along the groove, and gathers in the corner area 29. The sampler can be extended from the secondary sampling port 11 into the liquid sample in the corner area 29 to absorb the liquid sample for secondary confirmation testing.

Claims

1. A device for detecting an analyte in a liquid sample, characterized in that: The device comprises a cup body; a first receiving area for receiving a liquid sample; a flow channel through which a sample can be added or collected; The diversion channel is connected to the first receiving area, and the bottom surface of the diversion channel is an inclined surface; wherein the first receiving area and the diversion channel are arranged in the cup body; It also includes a secondary sampling port, which is connected to the diversion channel; The cross section of the cup body is pentagonal; A detection element is provided in the first receiving area; The cup also includes a sample collector, which can be received and held in the cup body and can deliver the collected sample into the first receiving area through the diversion channel; the sample collector includes a collection element and a push rod; The cup body is provided with a sleeve for use with the collection element, one end of the sleeve is provided with a pentagonal inner cover, the inner cover is fixedly connected to the cup body, the inner cover is provided with an opening, the other end of the sleeve is provided with a closed surface, and an eccentric position of the closed surface is provided with a nozzle; One end of the push rod is provided with a connector for fixing the collection element, and the other end is connected to the fixing seat; a sealing structure is provided on the connector; the fixing seat can cover the sleeve, and a positioning protrusion or a positioning recess is provided on the covering surface of the fixing seat; the upper surface of the inner cover is provided with a positioning recess that cooperates with the positioning protrusion on the covering surface of the fixing seat, or the upper surface of the inner cover is provided with a positioning protrusion that cooperates with the positioning recess on the covering surface of the fixing seat; the fixing seat has a cylindrical protrusion, and the outer circumference of the cylindrical protrusion is provided with an external thread; the opening on the inner cover is provided with an internal thread that cooperates with the external thread on the outer circumference of the cylindrical protrusion; The cross section of the fixing seat is pentagonal.

2. The device for detecting an analyte in a liquid sample according to claim 1, wherein: The diversion channel is a groove.

3. The device for detecting an analyte in a liquid sample according to claim 2, wherein: One end of the groove is connected to the first receiving area, and the other end of the groove is connected to the side surface of the cup body, and the secondary sampling port is also arranged on the side surface.

4. The device for detecting an analyte in a liquid sample according to claim 2, wherein: The groove includes a bottom surface and side walls, wherein the bottom surface of the groove is an inclined surface.

5. The device for detecting an analyte in a liquid sample according to claim 2, wherein: A second receiving area is provided in the groove.

6. The device for detecting an analyte in a liquid sample according to claim 1, wherein: The cup body contains at least one detection element.

7. The device for detecting an analyte in a liquid sample according to claim 6, wherein: A placement component for placing a detection element is also provided on the inner wall of the side of the cup body.

8. The device for detecting an analyte in a liquid sample according to claim 1, wherein: The collecting element is compressible.

9. The device for detecting an analyte in a liquid sample according to claim 8, wherein: The collecting element is a sponge.

10. The device for detecting an analyte in a liquid sample according to claim 1, wherein: An anti-slip structure is provided on the outer surface of the cup body.

11. The device for detecting an analyte in a liquid sample according to claim 10, wherein: The anti-slip structure is a convex strip or a concave pit.

12. The device for detecting an analyte in a liquid sample according to claim 1, wherein: The second receiving region includes a corner region for collecting the subsamples.

13. The device for detecting an analyte in a liquid sample according to claim 12, wherein: The corner area is close to the secondary sampling port.

14. The device for detecting an analyte in a liquid sample according to claim 12, wherein: The corner area deviates from the central axis position of the secondary sampling port.

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