A blood detection device and its usage method

Abstract

The present invention provides a blood detection device and a method for using the same. The detection device includes a reagent card and a buffer bottle. The reagent card includes a quantification component, a test strip, and a housing. The quantification component includes a cylinder and a quantification piston. 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. The quantification piston includes a push rod and a movable quantification chamber. One end of the push rod is connected to the chamber wall of the movable quantification chamber. During use, a blood sample is added to the buffer bottle, mixed evenly, and then poured into the sample addition hole. The sample passes through the sample inlet to the movable quantification chamber. The push rod is pushed to move the movable quantification chamber to the position of the sample outlet, and the sample flows to the test strip to start the reaction. The device has a simple structure and is easy to operate, solves the problem that the detection results of existing products are prone to errors due to the lack of a quantification structure, and improves the accuracy of the detection results.

Description

Technical Field

[0001] The present invention belongs to the technical field of blood detection, and particularly relates to a blood detection 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 most blood self-test products use fingertip blood during use, the operator needs to use a quantitative pipette to suck a certain amount of blood and add it to the sample hole of the reagent card, and then add buffer to the sample hole to help the reagent card work better. In this process, the operator needs to prick the finger by himself and measure a certain amount of blood with a pipette by himself, which is very inconvenient. At the same time, after adding blood, buffer needs to be added to help the reagent card work. General products have very strict requirements on the addition amount of buffer. Otherwise, false positive results or false negative results due to insufficient sensitivity are likely to occur. However, due to differences in knowledge background, operating habits, etc. among self-test users, they often do not operate strictly according to the sample addition amount in the instruction manual, resulting in incorrect results.

[0003] Therefore, there is an urgent need to provide a blood self-test device to solve the problems of inaccurate results and cumbersome processes in current blood self-test technologies. Summary of the Invention

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

[0005] On the one hand, the present invention provides a blood detection device, including a reagent card and a buffer bottle. The reagent card includes a quantitative component, and the quantitative component includes a cylinder and a quantitative piston.

[0006] There are many detection devices integrating sampling and testing in the existing 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 the operation of users, and improve the accuracy of detection results. However, in blood self-tests, most existing products require users to quantitatively collect fingertip blood and then drop a quantitative buffer solution into the blood sample. This process is not only cumbersome, but also requires strict dropping of buffer 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 prone to errors and product waste.

[0007] Therefore, the present invention provides a blood detection device containing a quantitative component, which device includes two parts: a reagent card and a buffer bottle. The quantitative component is placed inside the reagent card, and the buffer bottle contains a certain amount of buffer solution. 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 shaking, then directly pours the mixture into the sample adding hole, and then pushes the push rod of the quantitative component to move the movable quantitative chamber inside the reagent card from the position of the sample inlet to the sample outlet, and the sample flows from the sample outlet to the test strip for reaction. The amount of solution provided in the buffer bottle is exactly quantitatively mixed with a drop of whole blood, avoiding the cumbersome operation of first quantitatively adding a blood sample and then adding the buffer solution in traditional blood detection products, and also avoiding the sampling error caused by inaccurate precision of the dropper and the dropper head of the buffer bottle. In addition, the device increases the aperture of the sample adding hole of the reagent card, facilitating the user to directly pour the mixed solution in the buffer bottle into the sample adding hole, further avoiding the result error caused by operation mistakes.

[0008] Further, the quantitative piston includes a push rod and a movable quantitative chamber. The push rod includes a pressing end and a connecting end. The movable quantitative chamber includes a first chamber wall, a second chamber wall, and a cylindrical 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 sealing rings are installed around the circumferences of the first chamber wall and the second chamber wall.

[0009] The structure of the quantitative component is similar to a syringe, including a cylinder and a quantitative piston. The quantitative piston includes a push rod and a movable quantitative chamber. One end of the push rod is connected to the first chamber wall and the second chamber wall of the movable quantitative chamber, such that the chamber walls of the movable quantitative chamber and the push rod form an integral structure. The first chamber wall, the second chamber wall, and the inner wall of the cylinder enclose the chamber of the movable quantitative chamber for containing the sample liquid. Before use, the movable quantitative chamber is located below the sample adding hole. When adding a sample to the sample adding hole, the solution flows into the movable quantitative chamber from the sample inlet of the cylinder. Press the pressing end of the push rod to push the push rod to the bottom. The first chamber wall and the second chamber wall move together with the push rod, such that the solution in the movable quantitative chamber also moves to the position of the sample outlet. At this time, the sample flows from the sample outlet to the test strip and the reaction starts. After the sample addition is completed, the user only needs to push the push rod. When the push rod touches the bottom and cannot move anymore, it prompts the user that the blood sample has entered the test strip and the reaction starts. The whole operation is simple.

[0010] In some embodiments, sealing rings are installed around the circumferences of the first chamber wall and the second chamber wall of the movable quantitative chamber. During the movement of the movable quantitative chamber, the sealing ring structure ensures the tightness of the quantitative chamber and avoids liquid leakage and other situations during the movement.

[0011] Further, 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 addition hole and a sample outlet corresponding to the position of the test strip are respectively arranged on the cylinder of the quantitative component. When starting to add the sample, the positions of the sample addition hole, the sample inlet, and the moving quantitative chamber correspond one-to-one from top to bottom. After the sample solution enters from the sample addition hole, it flows into the moving quantitative chamber through the sample inlet. Subsequently, the moving quantitative chamber reaches the position of the sample outlet under the push of the push rod, and the sample solution flows out from the sample outlet to reach the test strip to start the reaction. The position design of the sample inlet, the sample outlet, and the moving quantitative chamber of the cylinder improves the simplicity of the operation of the entire device.

[0013] Further, the cylinder is provided with a liquid storage chamber, and the liquid storage chamber includes a first chamber wall, a third chamber wall, and the inner wall of the cylinder.

[0014] The first chamber wall and the second chamber wall of the moving quantitative chamber are movable chamber walls and are integrally connected to the push rod. Therefore, they can move along with the push rod to drive the movement of the moving quantitative chamber. At the same time, a third chamber wall is also arranged inside the cylinder and is fixed to one side of the moving quantitative chamber. Since the volume of the blood sample added in the sample addition hole is generally 200 μl, which is larger than the volume of the moving quantitative chamber, in order to prevent the excess blood sample from overflowing from the cylinder after the moving quantitative chamber moves from the position of the sample inlet to the position of the sample outlet, a liquid storage chamber is arranged inside the cylinder. The first chamber wall of the moving quantitative chamber, the fixed third chamber wall, and the inner wall of the cylinder enclose a liquid storage chamber. The liquid storage chamber is used to store the excess blood sample flowing in from the sample addition hole, which improves the simplicity of the detection device.

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

[0016] Since the volume of the reaction sample stored in the moving quantitative chamber is small, generally 80 μl, the solution of the blood flowing through the moving quantitative chamber and then entering the test strip for reaction may be lost due to adhesion to the chamber wall material, etc. In addition, during the movement process, errors are likely to occur due to its small volume. Therefore, the sealing performance of the quantitative chamber is also a key factor affecting the accuracy of the detection result. Therefore, in some embodiments, the present invention verified the influence of different chamber wall materials and sealing ring materials on the detection process through comparative experiments. The results show that using a chamber wall made of TPE material can significantly reduce the loss of the blood sample, and using a sealing ring made of nitrile rubber material can further improve the sealing performance of the moving quantitative chamber, thereby reducing the loss of the detection sample and improving the accuracy of the detection result.

[0017] Further, the reagent card further includes a test strip and a housing. The housing covers the quantitative component and the test strip, and the quantitative component is located above the test strip.

[0018] Further, a sample adding hole is provided on the housing of the reagent card. The aperture size of the sample adding hole is 1-2 cm, and the volume of the moving quantitative chamber is 50-100 μl.

[0019] In some embodiments, the reagent card provided by the present invention has a sample adding aperture with a diameter of 1 cm, which is larger than the sample adding aperture of existing self-test products. This facilitates the user to directly add the solution in the buffer bottle into the sample adding hole without overflowing or other phenomena, improving the convenience of operation.

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

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

[0022] Further, the buffer solution in the buffer bottle includes any one or more defoaming agents such as 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 add blood into the buffer bottle, mix it well, and then pour it into the sample adding hole. However, during the process of inverting and mixing, bubbles may be generated due to overly violent operation of the sample, resulting in insufficient volume of the solution entering the moving quantitative chamber and further affecting the subsequent reaction results. Therefore, a defoaming agent needs to be added to the buffer solution to reduce the generation of bubbles. In some embodiments, the present invention has verified the necessity of adding Tween-20, Tween-80, and dimethyl silicone oil simultaneously through experiments. The results show that the defoaming effect of adding a single defoaming agent is average, and the detection accuracy of the composition of adding Tween-20 and Tween-80 defoaming agents is also not as good as that of using a combination of three defoaming agents. Only by adding a defoaming agent composition of Tween-20, Tween-80, and dimethyl silicone oil to the buffer solution can the bubbles generated during sample mixing be effectively reduced and the detection result accuracy be effectively improved.

[0025] Further, the buffer bottle contains any one or more buffer reagents of NaCl, Na2HPO4, casein, and polyvinyl alcohol (PVA).

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

[0027] In some embodiments, the present invention verifies through experiments the necessity of using a combination of NaCl, Na2HPO4, casein, PVA, preservative, and a defoamer composition of Tween - 20, Tween - 80, and dimethyl silicone oil. The results show that after replacing any one of these substances with other substances, the detection accuracy of the buffer solution mixed with blood decreases. Therefore, only by using a combination of NaCl, Na2HPO4, casein, PVA, preservative, and a defoamer composition of Tween - 20, Tween - 80, and dimethyl silicone oil 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 for AIDS and syphilis viruses can reach over 93%, and the detection accuracy for the AIDS virus is the highest, which is 100%.

[0030] On the other hand, the present invention provides a blood detection method, which uses the blood detection device as described above for detection.

[0031] Further, the method includes the following steps:

[0032] (1) Drop the blood sample into the buffer bottle and invert to mix evenly;

[0033] (2) Pour the mixed sample solution into the sample - adding hole;

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

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

[0036] On the other hand, the present invention provides the use of an antifoaming agent for preparing a reagent for improving the detection accuracy of AIDS and syphilis viruses, wherein the antifoaming 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 NaCl, Na2HPO4, casein, and PVA.

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

[0038] 1. The internal quantitative component in the detection device improves the accuracy of the detection result; the quantitative component can be flexibly moved to store the sample solution required for the reaction, improving the simplicity of self-testing of blood.

[0039] 2. The quantitative buffer bottle and the enlarged sample addition hole are used in combination to improve the convenience of operation.

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

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

[0042] Figure 2 It is a planar schematic diagram of the single-item detection reagent card in Example 1;

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

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

[0045] Figure 5 It is a movement schematic diagram of the quantitative piston in Example 1;

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

[0047] Figure 7 It is a planar schematic diagram of the four-item detection reagent card in Example 1;

[0048] Figure 8 It is a disassembled structure diagram of the four-item detection reagent card in Example 1. DETAILED DESCRIPTION OF THE INVENTION

[0049] The present invention will be further described in detail below in conjunction with the accompanying drawings of the specification and specific embodiments. The embodiments are only used to explain the present invention and are not intended to limit the scope of the present invention. Unless otherwise specified, the test methods used in the following embodiments are all conventional methods; the materials, reagents, etc. used, unless otherwise specified, are reagents and materials that can be obtained commercially.

[0050] In the description of the present invention, it should be understood that the orientation or positional relationship indicated by the terms "upper", "lower", "front", "rear", "left", "right", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation of the present invention.

[0051] Example 1. The whole blood detection device provided by the present invention

[0052] The structure of the whole blood detection device provided by the present invention is as Figures 1 to 6 shown, Figure 1 which is a three-dimensional structure diagram of a single-item detection reagent card; Figure 2 which is a planar schematic diagram of a single-item detection reagent card; Figure 3 which is a disassembled structure diagram of a single-item detection reagent card; Figure 4 which is a sectional structure diagram of a single-item detection reagent card; Figure 5 which is a moving schematic diagram of a quantitative piston; Figure 6 which is a three-dimensional structure diagram of a four-item detection reagent card; Figure 7 which is a planar schematic diagram of a four-item detection reagent card; Figure 8 which is a disassembled structure diagram of a four-item detection reagent card.

[0053] As Figures 1 - 2As shown in the figure, the whole blood detection device 1 provided by the present invention includes a reagent card 2 and a buffer bottle 3. The reagent card 2 includes a quantification 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 aperture size of the sample addition hole 231 is 1 cm, and the volume is 200 μl. The buffer bottle 3 contains 160 μl of buffer solution. The buffer solution includes 0.5 M Na2HPO4 (purchased from Merck, model 94046), NaCl with a mass percentage concentration of 0.9% (purchased from Sinopharm Chemical Reagent Co., Ltd., model 10019308), casein with a mass percentage concentration of 0.5% (purchased from Merck, model C8654), polyvinyl alcohol (PVA) with a mass percentage concentration of 1% (purchased from Merck Co., Ltd., model 341584), P300 with a mass percentage concentration of 0.1% (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), 0.1% dimethyl silicone oil (purchased from Shanghai Yuanye Biotechnology Co., Ltd., model S30499).

[0054] As 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 Figures 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 a Whole Blood Detection Device

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

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

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

[0062] (3) Press the hand-held end of 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, Screening of the Cavity Wall Material

[0065] Since the blood sample after entering the sample injection hole needs to be transported through the moving metering cavity to reach the test strip for reaction, the moving metering cavity for temporarily storing blood is very important for the accuracy of the subsequent reaction results. On the one hand, the cavity wall material of the moving metering cavity needs to have good biocompatibility and will not have an adverse effect on the blood sample; on the other hand, the adhesion of the cavity wall to the blood sample is small and will not affect the volume of the sample solution in the subsequent reaction; finally, the production cost should also be considered, and a material with high cost performance should be selected. Therefore, this example provides 4 kinds of cavity wall materials shown in Table 1. First, the adhesion of the cavity wall materials is screened and compared; then, the materials with less blood adsorption are used to prepare the whole blood detection device, and the other structures are the same as those in Example 1. According to the usage method in Example 2, 30 blood samples are detected, 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 the Adhesion of Cavity Walls of Different Materials to Blood

[0067]

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

[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 a mobile quantitative cavity wall preparation detection device made of TPE material to 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 weakly positive, and "-" indicates negative.

[0078] According to the data in Table 3, for the detection device prepared with sealing rings made of polypropylene and silicone rubber, due to poor sealing performance, liquid leakage occurred, resulting in insufficient amounts of some samples entering the subsequent reactions, and the accuracy of blood detection results for samples containing two viruses was relatively low. For the device prepared with sealing rings made of fluororubber and nitrile rubber, the detection accuracy was improved, but the accuracy of nitrile rubber was higher. It could achieve 100% detection accuracy for HIV virus and 93.3% detection accuracy for syphilis. It was speculated that this might be because fluororubber was inferior to nitrile rubber in terms of elasticity and abrasion resistance, and certain losses occurred during use, leading to deviations in the results. When using the detection devices prepared with sealing rings of the above several materials to detect blood samples containing hepatitis B and hepatitis C viruses, the detection accuracy was similar to that of HIV and syphilis, but the highest accuracy only reached 86.7%. Therefore, it is preferred to use sealing rings made of nitrile rubber to prepare blood detection devices, which can achieve high-accuracy detection of HIV, syphilis, hepatitis B, and hepatitis C viruses, and the detection accuracy for HIV virus is the highest.

[0079] Example 5: Screening of Defoamers

[0080] When dripping blood samples into the buffer solution and mixing by inversion, the generation of bubbles should be avoided, otherwise it will lead to insufficient sample volume poured into the sample addition hole and affect the experimental results. Therefore, in order to further improve the detection result accuracy, in this example, the defoaming effects of 4 different defoamers and their compositions were compared and screened. In terms of mass percentage concentration, the mass percentage concentrations of Tween-20, Tween-80, dimethyl silicone oil, and silicon dioxide were all 0.2%. Composition 1 was 0.2% Tween-20 and 0.2% Tween-80, Composition 2 was 0.2% Tween-20, 0.1% dimethyl silicone oil, and 0.1% silicon dioxide, and Composition 3 was a composition of 0.2% Tween-20, 0.2% Tween-80, and 0.1% dimethyl silicone oil. Using 1 ml of blood as the experimental sample, 20 μl of defoamer was added to the blood respectively, inverted 5 - 6 times, and after mixing evenly, the state of the sample was observed and recorded. The results are shown in Table 4.

[0081] Afterwards, several defoamers and compositions were used for whole blood detection. The structure of the whole blood detection device was the same as that in Example 1. According to the usage method in Example 2, 30 blood samples were detected. Among them, 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 the same as those in Table 2, and the final detection results were recorded. The results are shown in Table 5.

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

[0083]

[0084] Note: "+" indicates positive, "±" indicates weakly positive, and "-" indicates negative.

[0085] According to the results in Table 4, it can be seen that the defoaming effects of Tween-80 and silica are average, and obvious bubbles can be observed; while the defoaming effects of Tween-20, dimethyl silicone oil and the three compositions 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 weakly positive, and "-" indicates negative.

[0089] According to Table 5, it can be seen that the defoaming effect of using a single defoamer is not as good as that of using a combination of two or three defoamers. And when using silica or dimethyl silicone oil defoamer alone for detecting AIDS and syphilis, the accuracy and sensitivity of the results are significantly inferior to those of Tween-20 and Tween-80 defoamers. The accuracy rate of the detection results of the compositions containing two or three defoamers after mixing the blood is significantly improved. Among them, the detection accuracy rates of compositions 1 and 2 for HIV and syphilis viruses only reach 93.3%. While when the composition 3 composed of Tween-20, Tween-80 and dimethyl silicone oil is used for detection, the detection accuracy rate for HIV virus can reach 100%, and the detection accuracy for syphilis, hepatitis B and hepatitis C viruses can reach 93.3%. Therefore, the composition of Tween-20, Tween-80 and dimethyl silicone oil is preferably used as a defoamer for blood detection to effectively improve the detection accuracy and sensitivity of HIV, syphilis, hepatitis B and hepatitis C viruses.

[0090] Example 6 Screening of buffer solution formula

[0091] Since buffer solutions with different components have different stabilizing effects on blood samples, and there are differences in the interactions between different buffer components and defoamers, it will have an impact on the blood state and test results. To further verify the necessity of the buffer components provided in Example 1 for improving the detection accuracy and sensitivity of the device, this example further compared the effects of 8 combinations of buffer solutions on the detection accuracy of HIV and syphilis viruses in blood. The components and contents (in mass percentage concentration) of the buffer solutions 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. Detect 30 blood samples according to the usage method in Example 2, among which 15 samples contain 2 NCU / ml of HIV virus and 15 samples contain 6 mIU / ml of syphilis. The results are shown in Table 6.

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

[0093]

[0094] As shown in the results of Table 6, when comparing Combinations 1-4, after using Tris, bovine serum albumin (BSA), and polyvinylpyrrolidone (PVP) to replace the buffer substances such as Na2HPO4, casein, and polyvinyl alcohol (PVA) in the buffer solution, and using them in combination with defoamers such as Tween-20, Tween-80, and dimethyl silicone oil for detection, the detection accuracy and sensitivity are significantly reduced. The reason may be that after replacing Na2HPO4 with Tris, the pH value of the blood is unbalanced, resulting in errors in detection; when using BSA instead of casein or PVP instead of polyvinyl alcohol (PVA), the biocompatibility between the buffer solution and the blood is poor, and the blood fluidity is average, resulting in insufficient sample volume for detection, leading to a decrease in detection accuracy.

[0095] As can be seen from Comparative Combinations 1, 5 - 8, the defoaming agent composition of Tween - 20, dimethyl silicone oil and silica used in combination with the combination of NaCl, Na2HPO4, casein and PVA (Combination 5) has significantly worse use effects than Combination 1. Moreover, replacing some buffer substances with Tris, BSA and PVP will further reduce the accuracy. The reason may be that the defoaming effect of the defoaming agent composition of Tween - 20, dimethyl silicone oil and silica is poor, which further affects the use effect in combination with other buffer substances, resulting in a large detection error of the device. Similarly, when the buffer solutions of the 8 combinations shown in Table 6 of the present invention are used for detecting blood containing hepatitis B and C viruses, the detection 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, only by combining the buffer reagent of NaCl, Na2HPO4, casein and PVA with the defoaming agent composition of Tween - 20, Tween - 80 and dimethyl silicone oil can the detection accuracy of the device be significantly improved, achieving 100% detection of HIV virus, 93.3% detection accuracy for syphilis, and 86.7% detection accuracy for hepatitis B and C viruses.

[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 should be subject to the scope defined by the claims.

Claims

1. A blood detection device, characterized in that, It includes a reagent card and a buffer bottle. The reagent card includes a quantification component, and the quantification component includes a cylinder and a quantification piston; the quantification piston includes a push rod and a movable quantification chamber. The push rod includes a pressing end and a connecting end. The movable quantification chamber includes a first chamber wall, a second chamber wall and the inner wall of the cylinder. The connecting end of the push rod is used to connect the first chamber wall and the second chamber wall of the movable quantification chamber, and sealing rings are installed circumferentially on the first chamber wall and the second chamber wall; 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. Push the push rod by hand until it reaches the bottom, and the movable quantification chamber moves from the position of the sample inlet to the position of the sample outlet; the cylinder is provided with a liquid storage chamber, and the liquid storage chamber includes a first chamber wall, a third chamber wall and the inner wall of the cylinder.

2. The device according to claim 1, characterized in that, The chamber wall material of the movable quantification chamber includes any one or more of polyvinyl chloride, polytetrafluoroethylene, and high impact polystyrene; the sealing ring material includes any one or more of silicone rubber, fluororubber, nitrile rubber, and polypropylene.

3. The device according to claim 1, characterized in that The buffer bottle contains any one or more defoaming agents such as polysorbate-20, polysorbate-80, dimethyl silicone oil, and silicon dioxide.

4. The device according to claim 3, characterized in that, The buffer bottle contains a defoaming agent composition of polysorbate-20, polysorbate-80 and dimethyl silicone oil.

5. The device according to claim 4, characterized in that, The buffer bottle contains any one or more buffer reagents such as NaCl, Na2HPO4, casein, and PVA.

6. The device according to claim 5, characterized in that The reagent card further includes a test strip and a housing. The housing covers the quantification component and the test strip, and the quantification component is located above the test strip; the housing 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 movable quantification chamber is 50-100 μl.

7. A method for sample introduction using the blood detection device according to any one of claims 1-6, characterized in that, It includes the following steps: (1) Drop the blood sample into the buffer bottle and mix well; (2) Pour the mixed sample solution into the sample addition hole; (3) Press the push rod to push the piston to the bottom, and the sample enters the test strip to start the reaction.

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