Blood detection device and use method thereof

Abstract

The invention provides a blood detection device and a use method thereof, the detection device comprises a reagent card and a buffer bottle, the reagent card comprises a quantitative component, a test strip and a shell, and the quantitative component comprises a cylinder and a quantitative piston. The cylinder is provided with a sample inlet and a sample outlet, the sample inlet is positioned below the reagent card sample adding hole, and the sample outlet is positioned above the reagent strip; the quantitative piston comprises a push rod and a movable quantitative cavity, and one end of the push rod is connected with the cavity wall of the movable quantitative cavity. During use, a blood sample is added into the buffer bottle, uniformly mixed and then poured into the sample adding hole, the sample enters the movable quantitative cavity through the sample inlet, the push rod is pushed to enable the movable quantitative cavity to reach the position of the sample outlet, and the sample flows to the test strip to start reaction. The device is simple in structure and easy to operate, solves the problem that the detection result is easy to have errors due to lack of a quantitative structure in the existing product, and improves the accuracy of the detection result.

Description

Technical Field

[0001] The present invention belongs to the technical field of blood testing, and in particular relates to a blood testing device and a method for using the same. Background Art

[0002] As self-test rapid diagnostic products are increasingly accepted by end users, many self-test products have been launched on the market, including blood self-test products. Since blood self-test products mostly use fingertip blood when in use, the operator needs to use a quantitative dropper to draw a certain amount of blood and add it to the sample well of the reagent card, and then add buffer to the sample well to help the reagent card work better. In this process, the operator needs to prick the needle himself and use a dropper to measure a certain amount of blood, which is very inconvenient. At the same time, after adding blood, it is necessary to add buffer to help the reagent card work. General products have very strict requirements on the amount of buffer added, otherwise it is easy to have false positive results or false negative results due to insufficient sensitivity. However, due to differences in knowledge background, operating habits, etc., self-test users often do not strictly follow the sample addition amount in the instructions, resulting in incorrect results.

[0003] Therefore, there is an urgent need to provide a blood self-testing device to solve the problems of inaccurate results and complicated processes in the current blood self-testing technology. Summary of the invention

[0004] In view of the shortcomings of the prior art, the present invention provides a blood testing device and a method for using the same, wherein the testing device comprises a reagent card and a buffer bottle, wherein the reagent card comprises a quantitative component, a test strip and a housing. The device not only simplifies the sample addition steps, but also the quantitative component can play a quantitative role, thereby further improving the accuracy of the blood test results.

[0005] In one aspect, the present invention provides a blood testing device, including a reagent card and a buffer bottle, wherein the reagent card includes a quantitative component, and the quantitative component includes a cylinder and a quantitative piston.

[0006] There are many integrated sampling and testing devices in the current market, such as early pregnancy test pens, fecal occult blood test tubes, saliva drug test pens, urine drug test cups, etc. These devices reduce the operation steps, facilitate user operation and improve the accuracy of test results. However, in self-testing of blood, most existing products require users to quantitatively collect fingertip blood and then add a quantitative buffer solution to the blood sample. This process is not only cumbersome to operate, but also requires the buffer to be added strictly according to the dosage during the sampling process. For users who use the product for the first time, it is not only inconvenient to use, but also easy to cause mistakes and product waste.

[0007] Therefore, the present invention provides a blood testing device containing a quantitative component, the device comprises two parts, a reagent card and a buffer bottle, the quantitative component is placed in the reagent card, and a certain amount of buffer solution is contained in the buffer bottle. When in use, the user first drips a drop of blood sample into the buffer bottle, mixes the blood and the buffer solution by inverting and mixing, and then directly pours them into the sample addition hole, and then pushes the push rod of the quantitative component to make the mobile quantitative cavity in the reagent card reach the sample outlet from the position of the sample inlet, and the sample flows from the sample outlet to the test strip for reaction. The amount of solution provided in the buffer bottle is just quantitatively mixed with a drop of whole blood, avoiding the cumbersome operation of first quantitatively dripping blood sample and then dripping buffer solution in traditional blood testing products, and also avoiding the sample addition error caused by the inaccurate precision of the dropper and the buffer bottle dripper. In addition, the device increases the sample addition hole aperture of the reagent card, which is convenient for the user to directly pour the mixed solution in the buffer bottle directly into the sample addition hole, further avoiding the result error caused by operating errors.

[0008] Furthermore, the quantitative piston includes a push rod and a movable quantitative chamber, the push rod includes a handle end and a connecting end, the movable quantitative chamber includes a first chamber wall, a second chamber wall and a cylinder inner wall, the connecting end of the push rod is used to connect the first chamber wall and the second chamber wall of the movable quantitative chamber, and a sealing ring is installed circumferentially between the first chamber wall and the second chamber wall.

[0009] The structure of the quantitative component is similar to that of a syringe, including a cylinder and a quantitative piston, and the quantitative piston includes a push rod and a mobile quantitative chamber. One end of the push rod is connected to the first cavity wall and the second cavity wall of the mobile quantitative chamber, so that the cavity wall of the mobile quantitative chamber and the push rod form an integrated structure, and the first cavity wall, the second cavity wall and the inner wall of the cylinder are enclosed to form a chamber of the mobile quantitative chamber for containing sample liquid. Before use, the mobile quantitative chamber is located below the sample addition hole. When the sample is added to the sample addition hole, the solution flows into the mobile quantitative chamber from the injection port of the cylinder. The push rod is pushed to the bottom by pressing the push rod, and the first cavity wall and the second cavity wall move together with the push rod, so that the solution of the mobile quantitative chamber moves to the sample outlet position at the same time. At this time, the sample flows from the sample outlet to the test strip, and the reaction begins. After the sample addition is completed, the user only needs to push the push rod. When the push rod touches the bottom and can no longer move, it prompts the user that the blood sample has entered the test strip and started to react. The whole operation is simple.

[0010] In some embodiments, sealing rings are installed on the circumference of the first cavity wall and the second cavity wall of the movable quantitative cavity. During the movement of the movable quantitative cavity, the sealing ring structure ensures the sealing of the quantitative cavity and avoids leakage during movement.

[0011] Furthermore, the cylinder is provided with a sample inlet and a sample outlet, the sample inlet is located below the sample addition hole of the reagent card, and the sample outlet is located above the test strip of the reagent card.

[0012] In the detection device provided by the present invention, a sample inlet corresponding to the position of the sample adding hole and a sample outlet corresponding to the position of the test strip are respectively arranged on the cylinder of the quantitative component. When the sample is added, the positions of the sample adding hole, the sample inlet and the movable quantitative cavity correspond one to one from top to bottom, and the sample solution enters from the sample adding hole and flows into the movable quantitative cavity through the sample inlet; then the movable quantitative cavity reaches the sample outlet position under the push of the push rod, and the sample solution flows out of the sample outlet to the test strip to start the reaction. The position design of the sample inlet, the sample outlet and the movable quantitative cavity of the cylinder improves the simplicity of operation of the entire device.

[0013] Furthermore, the cylinder is provided with a liquid storage cavity, and the liquid storage cavity comprises a first cavity wall, a third cavity wall and an inner wall of the cylinder.

[0014] The first cavity wall and the second cavity wall of the mobile quantitative cavity are movable cavity walls, which are integrally connected to the push rod, so they can move with the push rod to drive the mobile quantitative cavity to move. At the same time, a third cavity wall is also provided in the cylinder, which is fixed to one side of the mobile quantitative cavity. Since the volume of the blood sample added to the sample addition hole is generally 200 μl, which is larger than the volume of the mobile quantitative cavity, in order to prevent the excess blood sample from overflowing from the cylinder after the mobile quantitative cavity moves from the position of the injection port to the position of the outlet port, a liquid storage cavity is provided in the cylinder, and the first cavity wall of the mobile quantitative cavity, the fixed third cavity wall and the inner wall of the cylinder together form a liquid storage chamber. The liquid storage cavity is used to store the excess blood sample flowing in from the sample addition hole, thereby improving the simplicity of the detection device.

[0015] Furthermore, the cavity wall material of the movable quantitative cavity includes any one or more of polyvinyl chloride, polytetrafluoroethylene, and high-impact polystyrene (HIPS); the sealing ring material includes any one or more of silicone rubber, fluororubber, nitrile rubber, and polypropylene.

[0016] Since the volume of the reaction sample stored in the mobile quantitative cavity is relatively small, generally 80 μl, the solution that enters the test strip reaction after the blood flows through the mobile quantitative cavity may be lost due to adhesion of the cavity wall material, etc. In addition, during the movement process, errors are easily generated due to its small volume, so the sealing performance of the quantitative cavity is also a key factor affecting the accuracy of the test results. Therefore, in some embodiments, the present invention verifies the influence of different cavity wall materials and sealing ring materials on the detection process through comparative experiments. The results show that the cavity wall made of TPE material can significantly reduce the loss of blood samples, and the sealing ring made of nitrile rubber material can further improve the sealing of the mobile quantitative cavity, thereby reducing the loss of the test sample and improving the accuracy of the test results.

[0017] Furthermore, the reagent card also includes a test strip and a shell, the shell covers the quantitative component and the test strip, and the quantitative component is located above the test strip.

[0018] Furthermore, the shell of the reagent card is provided with a sample addition hole, the aperture of the sample addition hole is 1-2 cm, and the volume of the mobile quantitative cavity is 50-100 μl.

[0019] In some embodiments, the sample loading hole diameter of the reagent card provided by the present invention adopts an aperture of 1 cm, which is larger than the sample loading hole diameter of existing self-test products, making it convenient for users to add the solution in the buffer bottle directly into the sample loading hole without spilling, thereby improving the convenience of operation.

[0020] Preferably, the volume of the movable quantitative chamber is 80 μl.

[0021] In some embodiments, the whole blood testing device provided by the present invention can detect single or multiple infectious diseases simultaneously.

[0022] Furthermore, the buffer solution in the buffer bottle includes any one or more defoaming agents selected from polysorbate 20 (Tween-20), polysorbate 80 (Tween-80), dimethyl silicone oil, and silicon dioxide.

[0023] Preferably, the buffer solution in the buffer bottle includes a defoaming agent composition of polysorbate 20 (Tween-20), polysorbate 80 (Tween-80) and dimethyl silicone oil.

[0024] Since the user first needs to drip blood into the buffer bottle, mix it and pour it into the sample addition hole. However, during the inversion and mixing process, the sample may generate bubbles due to overly violent operation, resulting in insufficient volume of solution entering the mobile quantitative cavity, further affecting the subsequent reaction results, so it is necessary to add a defoamer to the buffer solution to reduce the generation of bubbles. In some embodiments, the present invention verifies the necessity of adding Tween-20, Tween-80 and dimethyl silicone oil at the same time through experiments. The results show that the defoaming effect of adding a defoamer alone is general, and the detection accuracy of the composition of adding Tween-20 and Tween-80 defoamers at the same time is not as good as the effect of adding three defoamers in combination at the same time. Only when the defoamer composition of Tween-20, Tween-80 and dimethyl silicone oil is added to the buffer solution at the same time can the bubbles generated during sample mixing be effectively reduced, and the accuracy of the detection results is effectively improved.

[0025] Furthermore, the buffer bottle includes any one or more buffer reagents selected from the group consisting of NaCl, Na2HPO4, casein, and polyvinyl alcohol (PVA).

[0026] In some embodiments, the buffer bottle contains 80-200 μl of a buffer solution, and the buffer solution includes NaCl, Na2HPO4, casein, PVA, a preservative, and a defoaming agent.

[0027] In some embodiments, the present invention verifies the necessity of using NaCl, Na2HPO4, casein, PVA, preservatives in combination with a defoamer composition of Tween-20, Tween-80 and dimethicone through experiments. The results show that after using other substances to replace any of the substances, the accuracy of the detection after the buffer solution and blood are mixed is reduced. Therefore, only by using NaCl, Na2HPO4, casein, PVA, preservatives in combination with Tween-20, Tween-80 and dimethicone defoamer composition can the detection accuracy be effectively improved.

[0028] In some embodiments, the preservative is P300.

[0029] In some embodiments, the whole blood detection device provided by the present invention can be used to detect infectious diseases such as AIDS, syphilis, hepatitis B, and hepatitis C. Among them, the detection accuracy of AIDS and syphilis viruses can reach more than 93%, and the detection accuracy of HIV is the highest, which is 100%.

[0030] In another aspect, the present invention provides a blood testing method, which uses the blood testing device as described above in the claim for testing.

[0031] Furthermore, it is characterized in that the method comprises the following steps:

[0032] (1) Add blood sample to the buffer bottle and mix thoroughly by inverting;

[0033] (2) Pour the mixed sample solution into the sample well;

[0034] (3) Press the push rod to push the piston to the bottom, and the sample enters the test strip to start reacting;

[0035] (4) Observe and record the results.

[0036] On the other hand, the present invention provides the use of a defoaming agent for preparing a reagent for improving the accuracy of AIDS and syphilis virus detection, wherein the defoaming agent comprises a composition consisting of polysorbate 20, polysorbate 80 and dimethyl silicone oil, and the reagent comprises any one or more buffer reagents selected from the group consisting of NaCl, Na2HPO4, casein and PVA.

[0037] Compared with the prior art, the present invention has the following beneficial effects:

[0038] 1. The built-in quantitative component in the detection device improves the accuracy of the test results; the quantitative component can be flexibly moved to store the sample solution required for the reaction, which improves the convenience of blood self-testing;

[0039] 2. The quantitative buffer bottle and the enlarged sample injection hole are used together to improve the convenience of operation;

[0040] 3. The entire device does not require the use of other tools for quantification, which simplifies the operation steps. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 It is a three-dimensional structural diagram of a single-item detection reagent card in Example 1;

[0042] Figure 2 Schematic diagram of a single-item test reagent card in Example 1;

[0043] Figure 3 This is a disassembled structural diagram of a single-item detection reagent card in Example 1;

[0044] Figure 4 is a cross-sectional structural diagram of a single-item detection reagent card in Example 1;

[0045] Figure 5 Schematic diagram of the movement of the quantitative piston in Example 1;

[0046] Figure 6 It is a three-dimensional structural diagram of the four detection reagent cards in Example 1;

[0047] Figure 7 Schematic diagram of the four-item detection reagent card in Example 1;

[0048] Figure 8 This is a disassembled structural diagram of the four detection reagent cards in Example 1. DETAILED DESCRIPTION

[0049] The present invention is further described in detail below in conjunction with the accompanying drawings and specific examples of the specification. The examples are only used to explain the present invention and are not used to limit the scope of the present invention. The test methods used in the following examples are conventional methods unless otherwise specified; the materials and reagents used are reagents and materials that can be obtained from commercial channels unless otherwise specified.

[0050] In the description of the present invention, it is necessary to understand that the directions or positional relationships indicated by terms such as “upper”, “lower”, “front”, “back”, “left”, “right”, “inside” and “outside” are based on the directions or positional relationships shown in the accompanying drawings and are only for the convenience of describing the present invention. They do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction. Therefore, they cannot be understood as limitations on the present invention.

[0051] Embodiment 1: Whole blood testing device provided by the present invention

[0052] The whole blood testing device provided by the present invention has a structure as follows Figures 1 to 6 As shown, Figure 1 It is a three-dimensional structural diagram of a single-item test reagent card; Figure 2 It is a plan view of a single test reagent card; Figure 3 This is a split structure diagram of a single test reagent card; Figure 4 It is a cross-sectional structural diagram of a single-item test reagent card; Figure 5 Schematic diagram of the movement of the quantitative piston; Figure 6 It is a three-dimensional structure diagram of four test reagent cards; Figure 7 It is a plan view of four test reagent cards; Figure 8 This is a diagram of the disassembled structure of the four test reagent cards.

[0053] like Figure 1-2As shown, the whole blood detection device 1 provided by the present invention comprises a reagent card 2 and a buffer bottle 3. The reagent card 2 comprises a quantitative component 21, a test strip 22 and a housing 23. The housing 23 is provided with a sample addition hole 231 and an observation window 232. The sample addition hole 231 has a pore size of 1 cm and a volume of 200 μl. The buffer bottle 3 contains 160 μl of a buffer solution, which comprises 0.5 M Na2HPO4 (purchased from Merck, model 94046) and NaCl with a mass percentage concentration of 0.9% (purchased from Sinopharm Chemical Reagent Co., Ltd., model 10019308), 0.5% casein (purchased from Merck, model C8654), 1% polyvinyl alcohol (PVA, purchased from Merck, model 341584), 0.1% P300 (purchased from Merck, model 48915U), 0.5% defoaming agent, the defoaming agent includes 0.2% polysorbate 20 (Tween-20) (purchased from Shanghai Zeye Biotechnology Co., Ltd., model ZY-25-06990), 0.2% polysorbate 80 (Tween-80) (purchased from Thermo Fisher Scientific, model 28329), and 0.1% dimethyl silicone oil (purchased from Shanghai Yuanye Biotechnology Co., Ltd., model S30499).

[0054] like Figure 3As shown, the quantitative component is composed of a cylinder 211 and a quantitative piston 212. The cylinder 211 is provided with an inlet 2111 and an outlet 2112. The quantitative piston 212 includes a push rod 2121 and a movable quantitative cavity 2122. The movable quantitative cavity 2122 includes a first cavity wall 2123 and a second cavity wall 2124. The two cavity walls are made of TPE (purchased from Suzhou Bost New Material Technology Co., Ltd.), and the cavity wall is circumferentially coated with a sealing ring 2125. The sealing ring is made of nitrile rubber (purchased from Shanghai Tiansong Rubber Products Co., Ltd.). The first cavity wall 2123 and the second cavity wall 2124 are surrounded by the inner wall of the cylinder 211 to form a movable quantitative cavity 2122. The volume of the movable quantitative cavity 2122 is 80 μl. The connecting end 2121a of the push rod 2121 is connected to the first cavity wall 2123 and the second cavity wall 2124 to form an integrated structure. The test strip 22 can detect HIV, syphilis, hepatitis B (HBV) or hepatitis C (HCV) infectious diseases. When detecting HIV infectious diseases, the coating on the conjugation pad of the test strip 22 is HIV antigen gp120 and gp41, and the T detection line marker is HIV antigen gp120 and gp41; when detecting syphilis infectious diseases, the coating on the conjugation pad of the test strip 22 is syphilis chimeric antigen, and the T detection line marker is syphilis chimeric antigen; when detecting hepatitis B infectious diseases, the coating on the conjugation pad of the test strip 22 is anti-HBsAg antibody, and the T detection line marker is anti-HBsAg antibody; when detecting hepatitis C infectious diseases, the coating on the conjugation pad of the test strip 22 is HCV recombinant antigen, and the T detection line marker is HCV recombinant antigen. The C detection line of the test strip 22 is coated with anti-human IgG antibody.

[0055] like Figure 4 As shown, the cylinder 211 is further provided with a liquid storage chamber 2113, which includes a fixed third chamber wall 2114 and a movable first chamber wall 2123. The sample inlet 2111 is located below the sample addition hole 231, and the sample outlet 2112 is located above the test strip 22. Figure 5 , push the push rod 2121 by hand until it touches the bottom, and move the quantitative cavity 2122 from the position of the injection port 2111 to the position of the outlet port 2112.

[0056] like Figure 6-8 As shown, the reagent card 2 of the whole blood detection device 1 provided by the present invention can simultaneously detect four infectious diseases, namely, AIDS, syphilis, hepatitis B and hepatitis C. The reagent card 2 includes four quantitative components 21 , four sample addition holes 231 and an observation window 232 .

[0057] The whole blood detection device provided by the present invention can be used to detect whether the blood sample to be tested carries AIDS, syphilis, hepatitis B or hepatitis C pathogens. Among them, the detection accuracy of hepatitis B and hepatitis C pathogens can reach 86.7%; the detection accuracy of AIDS and syphilis infectious diseases can be as high as over 93%, and the detection accuracy of HIV is the highest, which can reach 100%.

[0058] Example 2: Method of using the whole blood testing device

[0059] The specific steps of the method for using the whole blood testing device provided in Example 1 are as follows:

[0060] (1) Open the buffer bottle containing 160 μl buffer solution, add a drop of blood sample (40 μl) into the buffer bottle, and invert to mix;

[0061] (2) Pour the mixed sample solution into the sample well;

[0062] (3) Press the push rod to push the piston to the bottom, and the sample solution enters the test strip to start the reaction;

[0063] (4) Observe and record the results.

[0064] Example 3: Cavity wall material screening

[0065] Since the blood sample after entering the sample adding hole needs to be transported through the mobile quantitative cavity to reach the test strip for reaction, the mobile quantitative cavity for temporarily storing blood is very important for the accuracy of the results of the subsequent reaction. On the one hand, the cavity wall material of the mobile quantitative cavity needs to have good biocompatibility and will not have adverse effects on the blood sample; on the other hand, the cavity wall has low adhesion to the blood sample and will not affect the volume of the sample solution for the subsequent reaction; finally, the production cost should also be considered to select a material with high cost performance. Therefore, this embodiment provides four cavity wall materials shown in Table 1. First, the adhesion of the cavity wall materials is screened and compared; then the material with low blood adsorption is used to prepare a whole blood detection device. The rest of the structure is the same as Example 1. According to the method of use of Example 2, 30 blood samples are tested, of which 15 samples contain different concentrations of HIV virus (2~50 NCU / ml) and 15 samples contain different concentrations of syphilis (6~50 mIU / ml). The final test results are recorded, and the results are shown in Table 2.

[0066] Table 1 Detection of blood adhesion of cavity walls of different materials

[0067]

[0068] It can be seen from Table 1 that among the above four materials, PVC material has greater adhesion to blood, obvious blood residue can be observed, and the fluidity of blood is poor; while the other three materials have less adhesion to blood, the fluidity of blood in PTFE and HIPS materials is average, and the fluidity in TPE material is better. Therefore, PTFE, HIPS and TPE are selected for subsequent sample testing.

[0069] Table 2 Effects of different cavity wall materials on whole blood test results

[0070]

[0071] Note: “+” indicates positive, “±” indicates weak positive, and “-” indicates negative.

[0072] It can be seen from the data in Table 2 that when TPE is used as the cavity wall material of the mobile quantitative cavity, the detection accuracy of the whole blood detection device for blood samples containing different infectious viruses is significantly higher than the detection results of the other two cavity wall materials. The detection accuracy of HIV virus can reach 100%, and the detection accuracy of syphilis can reach 93.3%. When PTFE or HIPS is used as the cavity wall material, the detection device has erroneous results in the detection of blood samples containing different concentrations of viruses, and false positives or negatives appear. This may be due to the general fluidity of blood samples in these two materials, resulting in loss of samples after passing through the mobile quantitative cavity, insufficient sample volume for subsequent reactions, and weak positive or negative results. Similarly, when using the device prepared with the above materials to detect blood samples containing hepatitis B or hepatitis C viruses, the detection accuracy of PTFE or HIPS materials can only reach 66.7%, while TPE materials can reach more than 86.7%. Therefore, this embodiment preferably uses TPE material for the preparation of the detection device for the mobile quantitative cavity wall, which can achieve high-accuracy detection of HIV, syphilis, hepatitis B and hepatitis C viruses, among which the detection accuracy of HIV virus is the highest, achieving 100% accurate detection.

[0073] Embodiment 4, sealing ring material screening

[0074] Since the amount of sample to be tested stored in the mobile quantitative chamber is small, only 80 μl, it is very easy to produce errors during the movement of the mobile quantitative chamber. If the chamber is not sealed enough, it will cause further leakage during the movement, affecting the subsequent test results. In order to further explore the sealing ring material that can improve the sealing performance of the mobile quantitative chamber, this embodiment provides 4 different materials of sealing rings to prepare a whole blood detection device. The rest of the structure is the same as Example 1. According to the method of Example 2, 30 blood samples were tested, of which 15 samples contained different concentrations of HIV virus (2~50 NCU / ml), and 15 samples contained different concentrations of syphilis (6~50 mIU / ml). The final test results were recorded, and the results are shown in Table 3.

[0075] Table 3 Effects of different sealing rings on whole blood test results

[0076]

[0077] Note: “+” indicates positive, “±” indicates weak positive, and “-” indicates negative.

[0078] According to the data in Table 3, the detection device prepared by the sealing ring of polypropylene and silicone rubber material has leakage due to poor sealing, resulting in insufficient amount of some samples entering the subsequent reaction, and the accuracy of the blood test results containing two viruses is low. The device prepared by the sealing ring of fluororubber and nitrile rubber material has improved detection accuracy, but the accuracy of nitrile rubber is higher, which can achieve 100% detection accuracy for HIV virus and 93.3% detection accuracy for syphilis. It is speculated that it may be because fluororubber is not as good as nitrile rubber in elasticity and wear resistance, and a certain loss occurs during use, resulting in deviations in the results. When the detection device prepared by the sealing ring of the above several materials detects blood samples containing hepatitis B and hepatitis C viruses, its detection accuracy is similar to the results of HIV and syphilis, but the highest accuracy is only 86.7%. Therefore, the sealing ring of nitrile rubber material is preferably used to prepare the blood detection device, which can achieve high-accuracy detection of HIV, syphilis, hepatitis B and hepatitis C viruses, among which the detection accuracy of HIV virus is the highest.

[0079] Example 5, defoamer screening

[0080] When the blood sample is added to the buffer solution and inverted to mix, bubbles should be avoided, otherwise the sample volume poured into the sample well will be insufficient and affect the experimental results. Therefore, in order to further improve the accuracy of the test results, this embodiment compares and screens the defoaming effects of 4 different defoamers and their compositions. In terms of mass percentage concentration, the mass percentage concentrations of Tween-20, Tween-80, dimethyl silicone oil and silicon dioxide are all 0.2%, composition 1 is 0.2% Tween-20 and 0.2% Tween-80, composition 2 is 0.2% Tween-20, 0.1% dimethyl silicone oil and 0.1% silicon dioxide, and composition 3 is a composition of 0.2% Tween-20, 0.2% Tween-80 and 0.1% dimethyl silicone oil. Take 1 ml of blood as the experimental sample, add 20 μl of defoamer to the blood, invert 5 to 6 times, and observe and record the sample state after mixing. The results are shown in Table 4.

[0081] Afterwards, several defoaming agents and compositions were used for whole blood testing. The structure of the whole blood testing device was the same as that of Example 1. According to the method of Example 2, 30 blood samples were tested, of which 15 samples contained different concentrations of HIV virus (2-50 NCU / ml) and 15 samples contained different concentrations of syphilis (6-50 mIU / ml). The sample concentrations were consistent with those in Table 2. The final test results were recorded. The results are shown in Table 5.

[0082] Table 4 Defoaming effects of different defoamers and their compositions

[0083]

[0084] Note: “+” indicates positive, “±” indicates weak positive, and “-” indicates negative.

[0085] According to the results in Table 4, it can be seen that the defoaming effects of Tween-80 and silicon dioxide are average, and obvious bubbles can be observed; while the defoaming effects of Tween-20, dimethyl silicone oil and the three combinations are better, and no obvious bubbles are generated.

[0086] Table 5 Effects of different defoamers on whole blood test results

[0087]

[0088] Note: “+” indicates positive, “±” indicates weak positive, and “-” indicates negative.

[0089] It can be seen from Table 5 that the defoaming effect of using a single defoaming agent is not as good as the effect of using two or three defoaming agents in combination, and when using silicon dioxide or dimethicone defoaming agents alone to detect AIDS and syphilis, the accuracy and sensitivity of the results are obviously not as good as Tween-20 and Tween-80 defoaming agents. The accuracy of the results of the test after the composition containing two or three defoaming agents is mixed with blood is significantly improved, among which, the detection accuracy of compositions 1 and 2 for HIV and syphilis viruses is only 93.3%, while the detection accuracy of composition 3 composed of three defoaming agents, Tween-20, Tween-80 and dimethicone, for HIV virus can reach 100%, and the detection accuracy of syphilis, hepatitis B and hepatitis C viruses can reach 93.3%. Therefore, the composition of Tween-20, Tween-80 and dimethicone is preferably used as a defoaming agent for blood testing, which effectively provides the detection accuracy and sensitivity of HIV, syphilis, hepatitis B and hepatitis C viruses.

[0090] Example 6, screening of buffer solution formulation

[0091] Since buffer solutions containing different components have different stabilizing effects on blood samples, and different buffer components have different effects on defoaming agents, they will affect the blood state and test results. In order to further verify the necessity of the buffer components provided in Example 1 to improve the detection accuracy and sensitivity of the device, this example further compares the effects of 8 combinations of buffer solutions on the detection accuracy of AIDS and syphilis viruses in the blood. The components and contents of the buffer solutions (in terms of mass percentage concentration) are shown in Table 6. The structure of the whole blood detection device and the remaining components in the buffer solution are the same as in Example 1. According to the method of use in Example 2, 30 blood samples were tested, of which 15 samples contained 2NCU / ml of HIV virus and 15 samples contained 6 mIU / ml of syphilis. The results are shown in Table 6.

[0092] Table 6 Effects of different buffer solutions on whole blood test results

[0093]

[0094] As shown in the results of Table 6, compared with combinations 1-4, after Tris, bovine serum albumin (BSA) and polyvinyl pyrrolidone (PVP) were used to replace the buffer substances such as Na2HPO4, casein, polyvinyl alcohol (PVA) in the buffer solution, the accuracy and sensitivity of the detection when used in combination with the defoaming agent of Tween-20, Tween-80 and dimethyl silicone oil were significantly reduced. The reason may be that after the buffer substance Na2HPO4 was replaced by Tris, the pH value of the blood was unbalanced, resulting in errors in the detection; and when BSA was used instead of casein or PVP was used instead of polyvinyl alcohol (PVA), the biocompatibility between the buffer solution and the blood was poor, and the blood fluidity was average, resulting in insufficient sample volume for detection, resulting in reduced detection accuracy.

[0095] By comparing combinations 1, 5-8, it can be seen that the combination of Tween-20, dimethyl silicone oil and silica defoamer composition with NaCl, Na2HPO4, casein and PVA (combination 5) is obviously not as good as combination 1, and the use of Tris, BSA and PVP to replace some buffer substances will lead to further reduction in accuracy. The reason may be that the defoaming effect of the defoamer composition of Tween-20, dimethyl silicone oil and silica is poor, which further affects the effect of the use with other buffer substances, resulting in a large error in the device detection. Similarly, when the present invention uses the 8 combinations of buffer solutions shown in Table 6 for the detection of blood containing hepatitis B and hepatitis C viruses, the test results are similar to the above. Only the buffer solution of combination 1 can effectively improve the detection accuracy, reaching an accuracy rate of more than 86.7%. In summary, the use of a buffer reagent of NaCl, Na2HPO4, casein and PVA in combination with a defoaming agent composition of Tween-20, Tween-80 and dimethyl silicone oil can significantly improve the detection accuracy of the device, achieve 100% detection of HIV virus, the detection accuracy of syphilis can reach 93.3%, and the detection accuracy of hepatitis B and hepatitis C viruses can reach 86.7%.

[0096] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the scope defined by the claims.

Claims

1. A blood testing device, characterized in that: The invention comprises a reagent card and a buffer bottle. The reagent card comprises a quantitative component, and the quantitative component comprises a cylinder and a quantitative piston.

2. The device according to claim 1, characterized in that The quantitative piston includes a push rod and a movable quantitative chamber, the push rod includes a handle end and a connecting end, the movable quantitative chamber includes a first chamber wall, a second chamber wall and a cylinder inner wall, the connecting end of the push rod is used to connect the first chamber wall and the second chamber wall of the movable quantitative chamber, and the first chamber wall and the second chamber wall are circumferentially installed with sealing rings.

3. The device according to claim 2, characterized in that The cylinder is provided with an inlet and an outlet, the inlet is located below the sample addition hole of the reagent card, and the outlet is located above the test strip of the reagent card; the cylinder is provided with a liquid storage cavity, and the liquid storage cavity includes a first cavity wall, a third cavity wall and an inner wall of the cylinder.

4. The device according to claim 3, characterized in that The material of the cavity wall of the movable quantitative cavity includes any one or more of polyvinyl chloride, polytetrafluoroethylene, and high-impact polystyrene; the material of the sealing ring includes any one or more of silicone rubber, fluororubber, nitrile rubber, and polypropylene.

5. The device according to claim 1, characterized in that The buffer bottle includes any one or more defoaming agents selected from the group consisting of polysorbate 20, polysorbate 80, dimethyl silicone oil and silicon dioxide.

6. The device according to claim 5, characterized in that The buffer bottle comprises a defoamer composition of polysorbate 20, polysorbate 80 and dimethyl silicone oil.

7. The device according to claim 6, characterized in that The buffer bottle includes any one or more buffer reagents selected from the group consisting of NaCl, Na2HPO4, casein, and PVA.

8. The device according to claim 7, characterized in that The reagent card also includes a test strip and a shell, the shell covers the quantitative component and the test strip, and the quantitative component is located above the test strip; the shell of the reagent card is provided with a sample addition hole, the aperture size of the sample addition hole is 1-2 cm, and the volume of the mobile quantitative cavity is 50-100 μl.

9. A method for testing using the blood testing device according to any one of claims 1 to 8, characterized in that: The following steps are involved: (1) Add blood sample to the buffer bottle and mix well; (2) Pour the mixed sample solution into the sample well; (3) Press the push rod to push the piston to the bottom, and the sample enters the test strip to start reacting; (4) Observe and record the results.

10. Use of a defoaming agent for preparing a reagent for improving the accuracy of AIDS and syphilis virus detection, characterized in that: The defoamer comprises a defoamer composition of polysorbate 20, polysorbate 80 and dimethyl silicone oil, and the reagent comprises NaCl, Na Any one or more buffer reagents including 2HPO4, casein, and PVA.

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