Test kits

Abstract

The application discloses a detection kit, the kit body is equipped with liquid absorption pad storage cavity, the liquid absorption pad storage cavity is equipped with liquid absorption pad, the liquid absorption pad storage cavity and the inner cavity have communication port, the sidewall of the liquid absorption pad storage cavity is equipped with the first exhaust hole which is communicated with the outside of the kit body. The first exhaust hole is arranged on the sidewall of the liquid absorption pad storage cavity and communicated with the outside of the kit body, so that the air pressure in the liquid absorption pad storage cavity is balanced when the waste liquid is recovered by the liquid absorption pad after the detection, and the waste liquid is smoothly recovered by the liquid absorption pad.

Description

Technical Field

[0001] This invention belongs to the field of biological sample detection, and specifically relates to detection kits for detection. Background Technology

[0002] In vitro diagnostics plays a vital role in the modern medical industry. It can qualitatively or quantitatively measure changes in various biological indicators in human body fluids to provide information such as disease diagnosis or treatment indicators. For example, the detection of glycated hemoglobin (HbA1c) in the blood is crucial for the diagnosis and control of diabetes.

[0003] Glycated hemoglobin (HbA1c) is a product of the binding of hemoglobin in red blood cells with glucose. When blood glucose concentration is high, the level of HbA1c produced by the body will also be relatively high. The average lifespan of red blood cells in the human body is 120 days. Before cell death, the level of HbA1c in the blood remains relatively constant. Therefore, HbA1c testing can usually reflect a patient's blood glucose control over the past 8-12 weeks and is not affected by occasional increases or decreases in blood glucose.

[0004] There are various existing detection kits for detecting the concentration of analytes.

[0005] Test kits such as WO2017005123A1 and CN106124780A contain a reagent storage section, a reagent release section, a reaction section, a detection area, a sampler, and a liquid absorption pad. The sampling swab is used to collect liquid samples such as blood and urine and add them to the test kit. After the test is completed, the liquid absorption pad recovers the liquid (waste liquid) remaining in the test kit after the reaction, preventing leakage and environmental pollution. However, the liquid absorption pad is often located in a corner of the kit's interior. When using the liquid absorption pad to recover waste liquid, poor venting of gas (air) from the pad and surrounding interior can hinder waste liquid absorption. Summary of the Invention

[0006] This invention addresses the aforementioned technical problems in existing test kits where waste liquid is absorbed by a liquid absorption pad after testing. It provides a test kit with a vent hole, which allows for venting during waste liquid recovery by the liquid absorption pad to balance the air pressure and ensure successful waste liquid recovery.

[0007] The test kit includes a kit body with an inner cavity. The kit body also has a liquid absorbent pad storage cavity with a liquid absorbent pad inside. The liquid absorbent pad storage cavity has a communication port with the inner cavity. The side wall of the liquid absorbent pad storage cavity has a first vent hole communicating with the outside of the kit body.

[0008] The first vent can be located on any side wall of the liquid absorption pad storage chamber, as long as it can communicate with the outside. When using the liquid absorption pad to recycle waste liquid, it can perform the venting function and maintain the air pressure balance in the liquid absorption pad storage chamber.

[0009] When the vent and the connecting port are located on the same side of the liquid absorbent pad storage chamber, there will be tiny gaps between the liquid absorbent pad and the side wall of the liquid absorbent pad storage chamber. Some capillary action will cause the liquid to extend along the gaps. Therefore, there is a certain probability that the waste liquid that is not absorbed by the liquid absorbent pad in time will flow along the side of the liquid absorbent pad and seep out of the test kit directly through the vent along the gap between the liquid absorbent pad and the chamber wall, thus contaminating the external space.

[0010] To better prevent waste liquid from leaking out of the test kit, a further improvement of this invention is to utilize a reasonable channel design to achieve solution recovery, thus preventing leakage. Preferably, the first vent hole is located on a different side from the connecting port in the liquid absorption pad storage cavity.

[0011] The first vent is specifically positioned so that it is not on the same side as the connecting port in the liquid absorbent pad storage cavity. This prevents waste liquid from flowing directly along the side of the liquid absorbent pad and seeping out of the test kit through the vent along the gap between the liquid absorbent pad and the cavity wall, thus preventing contamination of the external space, which would otherwise occur if the vent and the connecting port were located on the same side of the liquid absorbent pad storage cavity.

[0012] Preferably, the reagent kit body is further provided with a clamping cavity outside the liquid absorption pad storage cavity, the first vent is provided on the cavity wall between the liquid absorption pad storage cavity and the clamping cavity, and the side wall of the clamping cavity is further provided with a second vent communicating with the outside of the reagent kit body.

[0013] More preferably, the reagent kit body is further provided with a sampling rod placement area communicating with the inner cavity, the sampling rod placement area having an opening on one side of the reagent kit body, and the clamping cavity being located on the side of the opening.

[0014] More preferably, the first vent is located at one end away from the sampling rod placement area, and the second vent is located on the cavity wall between the clamping cavity and the sampling rod placement area, or the second vent is located on the cavity wall of the clamping cavity on the same side as the opening.

[0015] More preferably, the communication port is located at the end away from the clamping cavity.

[0016] Preferably, the reagent kit body includes a front cover and a rear cover that fit together, and the first vent and the second vent are located at the interface between the front cover and the rear cover.

[0017] Preferably, a liquid cartridge is installed inside the cavity of the reagent kit body.

[0018] More preferably, the sampling rod placement area divides the inner cavity into two sides, with the liquid box located on one side and the liquid absorption pad storage cavity located at one end of the other side.

[0019] Preferably, the reagent kit body has a detection area, which is made of a transparent material that allows light to pass through.

[0020] Preferably, the reagent kit body is also provided with a foolproof structure.

[0021] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0022] In the test kit of the present invention, a first vent hole is provided on the side wall of the liquid absorption pad storage cavity, which communicates with the outside of the test kit body. This ensures that when the liquid absorption pad is used to recover waste liquid after the test, the air pressure in the liquid absorption pad storage cavity is kept balanced due to the presence of the vent hole, so that the waste liquid can be smoothly recovered by the liquid absorption pad. Attached Figure Description

[0023] Figure 1 This is a three-dimensional structural diagram of the front cover of the test kit in the first implementation scheme.

[0024] Figure 2 This is an intermediate state diagram of the test kit being used to dispose of waste liquid in the first implementation scheme.

[0025] Figure 3 This is a diagram showing the inverted state of the test kit when the waste liquid is poured out, according to the first implementation scheme.

[0026] Figure 4 This is a three-dimensional structural diagram of the detection structure of the detection kit in the second implementation scheme.

[0027] Figure 5 This is a schematic diagram of the three-dimensional structure of the detection kit in the second implementation scheme.

[0028] Figure 6 This is an exploded view of the test kit in the second implementation scheme.

[0029] Figure 7 This is a top view of the test kit in the second implementation scheme.

[0030] Figure 8 for Figure 7 A cross-sectional view along the AA direction.

[0031] Figure 9 for Figure 7 A cross-sectional view along the BB direction.

[0032] Figure 10 This is a three-dimensional structural diagram of the back cover of the test kit in the second implementation scheme.

[0033] Figure 11 This is a three-dimensional structural diagram of the front cover of the test kit in the second implementation scheme.

[0034] Figure 12 for Figure 11 Enlarged view of part C.

[0035] Figure 13 This is an intermediate state diagram of the test kit being used to dispose of waste liquid in the second implementation scheme.

[0036] Figure 14 This is a diagram showing the test kit being inverted when the waste liquid is being poured out, according to the second implementation scheme.

[0037] Figure 15 This shows the path that the waste liquid must take to seep out of the vent when the test kit is poured out, as shown in the first implementation scheme (left figure) and the second implementation scheme (right figure).

[0038] Figure labels: reagent kit 1', sampling rod 2', inner cavity 3', liquid absorption pad storage cavity 4', liquid absorption pad 5', cavity wall 6', first vent hole 7'.

[0039] The test kit 100 includes a front cover 101, a bevel 1011, an extension 1012, a rear cover 102, a test area 1021, an inner cavity 103, a drainage structure 1031, a liquid absorption pad storage cavity 104, a connecting port 1041, a clamping cavity 105, a first vent 1051, a second vent 1052, a sampling rod placement area 106, an opening 1061, a liquid box 107, a sampling rod 108, a liquid absorption pad 109, a sealing element 110, a test box 200, a light transmission hole 201, and a waste liquid 300. Detailed Implementation

[0040] In the first implementation scheme, such as Figures 1-3 As shown, the liquid absorbent pad 5' is disposed in the liquid absorbent pad storage cavity 4' above one side of the test kit 1'. A sampling rod 2' is provided adjacent to the liquid absorbent pad storage cavity 4'. The test kit 1' has a sampling rod placement area for placing the sampling rod 2' at the position where the sampling rod 2' is placed. A first vent hole 7' is left on the cavity wall 6' between the liquid absorbent pad storage cavity 4' and the sampling rod placement area, which directly communicates with the liquid absorbent pad storage cavity 4'.

[0041] like Figure 2 and Figure 3 As shown, when using the liquid absorption pad 5' to recover the waste liquid remaining in the inner cavity 3' of the test kit 1' after the detection reaction, the test kit 1' is arranged according to... Figure 2 and Figure 3 The placement direction is rotated sequentially so that the waste liquid can be smoothly absorbed by the liquid absorption pad 5'. The function of the first vent hole 7' is to facilitate venting when recycling waste liquid, maintain the air pressure balance in the liquid absorption pad storage cavity 4', and ensure that the waste liquid can be smoothly absorbed by the liquid absorption pad 5'.

[0042] In the first embodiment, there are tiny gaps between the liquid absorbent pad 5' and the side wall of the liquid absorbent pad storage cavity 4'. Some capillary action will cause the liquid to extend along the gaps. Therefore, waste liquid that is not absorbed by the liquid absorbent pad 5' in time may flow along the side of the liquid absorbent pad 5' and seep directly through the first vent hole 7' into the test kit 1' along the gap between the liquid absorbent pad 5' and the cavity wall 6', thereby contaminating the external space.

[0043] Therefore, the structure is further improved in the second embodiment. Furthermore, the structure in the first embodiment is the same as that in the second embodiment, except for the structure related to balancing the air pressure inside the liquid absorption pad storage cavity 4'. Therefore, the detailed description of the remaining structure is the same as in the second embodiment.

[0044] In the second implementation scheme, such as Figure 4 As shown, the test kit 100 and an external detection device constitute a detection system for the rapid detection of the concentration of the analyte in a biological sample. The external detection device is any device other than the test kit 100, including a detection cartridge 200. The test kit 100 and the detection cartridge 200 are used together. The test kit 100 serves as a reaction container, enabling the storage of multiple reagents, the sequential addition of multiple reagents, and waste liquid recovery. The detection cartridge 200 holds the test kit 100 and is mounted on the detection device. The detection device provides the mechanical power and control for rotating the test kit 100, mixing the reagents within the test kit 100, and releasing the reagents. The external device also includes optical components for detecting the concentration of the analyte in the liquid sample.

[0045] like Figures 5-12 As shown, the test kit 100 includes a kit body, which includes a front cover 101 and a rear cover 102 that fit together. The kit body has an inner cavity 103. The direction in which the front cover 101 and the rear cover 102 fit together is taken as the thickness direction of the test kit 100.

[0046] The reagent kit body also includes a sampling rod placement area 106 communicating with the inner cavity 103. The sampling rod placement area 106 has an opening 1061 on one side of the reagent kit body. In the structure shown in the figure, the sampling rod placement area 106 is vertically arranged, dividing the inner cavity 103 into two chambers, left and right. The two chambers are interconnected in the area below the sampling rod placement area 106 to allow liquid to flow through. The sampling rod placement area 106 is at least connected to the inner cavity 103 at its lower part, so that when the sampling rod 108 is inserted into the sampling rod placement area 106 after sampling, the sampling end of the sampling rod 108 is close to the connection point between the two chambers, and this position is located in the bottom area of ​​the inner cavity 103. This allows the test reagent to contact the sampling end of the sampling rod 108 after being released, mixing the sample to be tested into the test reagent.

[0047] Of the two chambers on the left and right sides of the inner cavity 103, one chamber serves as the detection chamber, and a liquid container 107 is installed inside it. The liquid container 107 contains the detection reagent. Preferably, the liquid container 107 is set independently of the front cover 101 and the rear cover 102, and then assembled together for convenient production and use.

[0048] The liquid cartridge 107 includes at least one reagent receiving cavity containing a test reagent. The reagent receiving cavity is sealed by a seal 110, which may be aluminum foil. When the seal 110 is torn open, the test reagent in the reagent receiving cavity is released to the bottom of the inner cavity 103. The sealing method of the seal 110 and the method of tearing open the seal 110 can be found in application publication number WO2017005123A1. A drainage structure 1031 is also provided on one side of the inner cavity 103. When the liquid cartridge 107 is installed in the test kit 100, the bottom of the liquid cartridge 107 abuts against the drainage structure 1031, facilitating the drainage and release of the test reagent into the inner cavity 103.

[0049] The detection chamber is also equipped with a detection area 1021. The detection area 1021 can be located at any convenient detection position on the test kit 100, preferably near the bottom of the inner cavity 103. This ensures that the liquid level of the test reagent is above the detection area 1021 when the test kit 100 is placed vertically. The detection area 1021 is generally made of a transparent material to allow transmitted or scattered light emitted by the optical device to enter the reaction chamber 100. In the structure shown in the figure, the detection area 1021 is located at the bottom corner of the back cover 102.

[0050] Of the two chambers on the left and right sides of the inner cavity 103, the other chamber has a slope 1011 on the side away from the chamber used for detection. The slope 1011 slopes from top to bottom toward the bottom of the sampling rod placement area 106, which reduces the space of the inner cavity 103 on the side of the sampling rod 108. When the test reagent washes the sample to be tested off the sampling rod 108, it is beneficial for the sample to be tested on the sampling rod 108 to fully contact the test reagent, and avoids that the test reagent is too little and cannot contact the sample to be tested.

[0051] In the structure shown in the figure, a bevel 1011 is provided on one side of the front cover 101. The front cover 101 has an extension 1012 on its side wall opposite to the rear cover 102, and the extension 1012 extends outward to the outside of the bevel 1011. Simultaneously, the bevel 1011 and the extension 1012 facilitate human differentiation of the front and back of the test kit 100, preventing the test kit 100 from being inserted backward into the test box 200 during testing. Essentially, the bevel 1011 and the extension 1012 also serve as a foolproof structure.

[0052] The reagent kit body is also provided with a liquid absorption pad storage cavity 104, and a liquid absorption pad 109 is provided in the liquid absorption pad storage cavity 104. The liquid absorption pad 109 is used to absorb the waste liquid (i.e. the test reagent containing the sample to be tested after the test) into the liquid absorption pad 109 after the test is completed, so as to prevent the waste liquid from leaking out of the test kit 100 and thus contaminating the external space.

[0053] In a preferred embodiment, the liquid absorption pad storage cavity 104 is located in the left and right chambers of the inner cavity 103, in the chambers without the liquid box 107. Preferably, the liquid absorption pad storage cavity 104 is located at the top, away from the bottom of the inner cavity 3, to prevent the test reagent from being absorbed by the liquid absorption pad 109 during the testing process.

[0054] The liquid absorbent pad storage cavity 104 and the inner cavity 103 have a communication port 1041. A first vent 1051, communicating with the outside of the reagent kit body, is provided on the side wall of the liquid absorbent pad storage cavity 104. The first vent 1051 communicates directly or indirectly with the outside of the reagent kit body. The position of the first vent 1051 and the communication port 1041 are not on the same side of the liquid absorbent pad storage cavity 104. Because they are not on the same side, when waste liquid flows from the communication port 1041 to the first vent 1051, it cannot flow directly along the side of the liquid absorbent pad 109 to the first vent 1051, but must pass through the liquid absorbent pad 109. This prevents waste liquid generated because the first vent 1051 and the communication port 1041 are located on the same side of the liquid absorbent pad storage cavity 104 from flowing directly along the side of the liquid absorbent pad 109 and seeping out of the test kit through the first vent 1051 along the gap between the liquid absorbent pad 109 and the cavity wall, thus preventing contamination of the external space.

[0055] In a preferred embodiment, the reagent kit body further includes a clamping cavity 105 on the outer side of the liquid absorption pad storage cavity 104. The clamping cavity 105 is preferably located on the side of the liquid absorption pad storage cavity 104 in the thickness direction, so that the shape of the liquid absorption pad storage cavity 104 remains unchanged in the thickness direction. The clamping cavity 105 can be located on the top surface of the test kit 100, i.e., on the side where the opening 1061 is located; the clamping cavity 105 can also be located on the side of the test kit 100, opposite to the sampling rod placement area 106 on both sides of the liquid absorption pad storage cavity 104.

[0056] The connecting port 1041 is located at the end away from the clamping cavity 105, so that the waste liquid has a longer path from the connecting port 1041 to the first vent 1051 and needs to pass through the liquid absorption pad 109 to reach it directly.

[0057] The side wall of the clamp 105 is also provided with a second vent 1052 that communicates with the outside of the reagent kit body. By setting the clamp 105, the possibility of waste liquid seeping out of the test kit along the first vent 1051 is further avoided. Even if a small amount of waste liquid seeps out of the first vent 1051, it will still be collected in the clamp 105.

[0058] When the clamping cavity 105 is located on the top surface of the test kit 100, in a more preferred embodiment, the first vent 1051 is located at one end away from the sampling rod placement area 106, and the second vent 1052 is located on the cavity wall between the clamping cavity 105 and the sampling rod placement area 106, or the second vent 1052 is located on the cavity wall of the clamping cavity 105 on the same side as the opening 1061. Preferably, the second vent 1052 is located on the cavity wall between the clamping cavity 105 and the sampling rod placement area 106. This allows the first vent 1051 and the second vent 1052 to be as far apart as possible. Furthermore, when the waste liquid is collected into the liquid absorption pad 109 after the test is completed, the test kit 100 is tilted or even inverted. Compared to placing the second vent 1052 on the cavity wall of the clamping cavity 105 on the same side as the opening 1061, it is less likely for the waste liquid to leak out. This is because the cavity wall of the clamping cavity 105 on the same side as the opening 1061, which is the top surface of the test kit 100, is located at a lower position when inverted, making it easier for the waste liquid to leak out.

[0059] To facilitate manufacturing, the first vent 1051 and the second vent 1052 are provided on the mating interface of the front cover 101 and the rear cover 102.

[0060] like Figure 13 , Figure 14As shown, in the second embodiment of this application, when using the test kit 100, a sample is first taken from the object to be tested using a sampling rod 108, so that the sampling end of the sampling rod 108 adheres to the sample to be tested. Then, the sampling rod 108 is inserted into the opening 1061 on the top surface of the test kit 100, so that the sampling end extends into the inner cavity 103. The test reagent in the liquid box 107 is released into the inner cavity 103. By shaking, the test reagent comes into contact with the sampling end of the sampling rod 108, mixing the sample to be tested into the test reagent. After the components react, the test kit is used as follows: Figure 4 The external testing device shown performs the test. The test box 200 has a light-transmitting hole 201 for testing. After the test kit 100 is inserted into the test box 200, the light-transmitting hole 201 is aligned with the detection area 1021 on the test kit 100. After the test is completed, the test reagent mixed with the sample to be tested is the waste liquid 300. After tilting the test kit 100, as shown... Figure 13 As shown, waste liquid 300 accumulates at the bottom of one side of the inner cavity 103, and continues to tilt until it reaches the bottom. Figure 14 As shown, the test kit 100 is inverted, causing the waste liquid 300 to accumulate in one corner of the liquid absorption pad storage cavity 104. The waste liquid 300 gradually enters the liquid absorption pad storage cavity 104 through the connecting port 1041 and is absorbed by the liquid absorption pad 109. During the process of the waste liquid 300 being absorbed by the liquid absorption pad 109, the gas originally located in and near the liquid absorption pad 109 is discharged sequentially through the first exhaust port 1051 and the second exhaust port 1052.

[0061] Figure 15 The diagram illustrates the path that waste liquid must take to seep out of the vent when the test kit is poured out, according to the first implementation scheme (left figure) and the second implementation scheme (right figure). In the first implementation scheme, the vent 7' is used to balance the air pressure in the liquid absorption pad storage chamber 4'. In the second implementation scheme, the improved position of the vent makes the path that waste liquid must take to seep out of the test kit 100 more complex. The waste liquid is less likely to complete the entire path, and it needs to be in contact with the liquid absorption pad 109 for a longer period of time. The waste liquid is more likely to be absorbed by the liquid absorption pad 109, further increasing the difficulty for the waste liquid to complete the entire path.

Claims

1. A test kit, comprising a kit body having an internal cavity, characterized in that, The reagent kit body also has a liquid absorption pad storage cavity, in which a liquid absorption pad is provided. The liquid absorption pad storage cavity has a communication port with the inner cavity, and a first vent hole communicating with the outside of the reagent kit body is provided on the side wall of the liquid absorption pad storage cavity. The reagent kit body also has a clamping cavity outside the liquid absorption pad storage cavity. The first vent is located on the cavity wall between the liquid absorption pad storage cavity and the clamping cavity. The side wall of the clamping cavity is also provided with a second vent that communicates with the outside of the reagent kit body.

2. The detection kit according to claim 1, characterized in that, The first vent hole is located on a different side from the connecting port in the liquid absorption pad storage cavity.

3. The detection kit according to claim 1, characterized in that, The reagent kit body also has a sampling rod placement area that communicates with the inner cavity. The sampling rod placement area has an opening on one side of the reagent kit body, and the clamping cavity is located on the side of the opening.

4. The detection kit according to claim 3, characterized in that, The first vent is located at one end away from the sampling rod placement area, and the second vent is located on the cavity wall between the clamping cavity and the sampling rod placement area, or the second vent is located on the cavity wall of the clamping cavity on the same side as the opening.

5. The detection kit according to claim 1, characterized in that, The connecting port is located at the end away from the clamping cavity.

6. The detection kit according to claim 1, characterized in that, The reagent kit body includes a front cover and a rear cover that fit together, and the first vent and the second vent are located at the interface between the front cover and the rear cover.

7. The detection kit according to claim 1, characterized in that, A liquid cartridge is installed inside the cavity of the reagent kit body.

8. The detection kit according to claim 7, characterized in that, The reagent kit body also has a sampling rod placement area that communicates with the inner cavity. The sampling rod placement area divides the inner cavity into two sides, with the liquid box located on one side and the liquid absorption pad storage cavity located at one end of the other side.

9. The detection kit according to claim 1, characterized in that, The reagent kit body has a detection area, which is made of a transparent material that allows light to pass through.

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