Sample detection kit

Abstract

The invention discloses a sample detection kit which comprises a detection test strip and a sample processing reagent, and the detection test strip comprises a sample pad, a hydrophobic pad, a marking pad and a detection pad which are connected in sequence; the sample treatment reagents comprise two reagents, the sample pad comprises one sample treatment reagent, and the other sample treatment reagent is stored in the reagent bottle. In the detection field in which a sample needs to be pretreated and an analyte in the sample is fully released, the kit provided by the invention simplifies operation steps, can avoid wrong results caused by manual misoperation, and is high in detection sensitivity and strong in specificity.

Description

Technical Field

[0001] The invention relates to the field of biological sample detection, in particular to a sample detection kit which requires temporary mixing of two sample processing fluids. Background Art

[0002] Immunochromatographic detection technology is used to detect analytes in samples. This technology has been gradually applied since the 1980s. It is widely used, easy to operate, and has high economic benefits. It can be used to detect analytes in samples such as blood, saliva, urine, and lesion secretions to diagnose the patient's health. This detection technology is based on the principle of specific binding of immune molecules. The corresponding immune molecules are solid-phased on chromatographic carriers such as PVC bottom plates and glass. At the same time, the immune molecules are combined with latex, colloidal gold, fluorescent microspheres, quantum dots and other groups to develop colors or excite specific wavelengths to display the test results.

[0003] According to the principle of immunochromatographic detection, there are usually two methods, the double antibody sandwich method and the competitive method, of which the double antibody sandwich method is the most widely used in antigen detection. Test strips using the double antibody sandwich method are, for example, Chinese patent application CN202010893746.5 for detecting Streptococcus A. The appearance of a color line on the test area line T line of the test strip indicates that the test result is positive, that is, the analyte is present in the test sample. On the contrary, when the test line T line does not appear, it indicates that the test result is not negative, that is, the analyte is not present in the test sample.

[0004] However, the existing test strips have some problems in the practical application of some detection samples. For example: usually in the process of detecting some samples, the samples need to be pretreated so that the analyte in the sample is fully released. Therefore, pretreatment of the sample becomes an important link that is indispensable for accurate test results. In some tests, two sample treatment liquids (liquid A and liquid B) need to be mixed in proportion to fully pretreat the sample, but the two sample treatment liquids are not easy to store for a long time after mixing in advance, or the effect of treating the sample is greatly reduced after long-term storage, and the mixing ratio is improper, which is easy to cause inaccurate test results. Therefore, the two sample treatment liquids are usually separated into two reagent bottles and stored separately. However, the two treatment liquids are stored separately and packaged together with the test strips, which increases the production process; the space occupied during packaging and storage is large, and it is also inconvenient to transport; on the other hand, during operation, the two treatment liquids need to be mixed and then added to the sample to mix, and finally added to the test strips for detection. The steps are cumbersome and complicated. For ordinary operators, in addition to inconvenience, it also increases the risk of operating errors. Summary of the invention

[0005] In order to solve the above technical problems, the technical solution adopted by the present invention is as follows: Provided is a detection kit, comprising a detection test strip and a sample processing liquid. The detection test strip comprises a sample pad, a marking pad and a detection pad connected in sequence. The sample processing reagent comprises two reagents, one of which is included in the sample pad and the other is in a reagent bottle.

[0006] When in use, only one sample processing reagent is needed to pre-treat the sample, thus eliminating the step of mixing two sample processing reagents in proportion, thus simplifying the operation.

[0007] Furthermore, the test strip also includes a hydrophobic pad, which is connected between the sample pad and the marking pad.

[0008] There is a hydrophobic pad between the sample pad and the marking pad, which slows down the speed of the sample passing through the hydrophobic pad, so that the sample is fully processed on the sample pad, so that the detected object in the sample is fully released, increasing the concentration of the detected object, thereby maintaining the detection sensitivity of the test strip.

[0009] Furthermore, the hydrophobic pad is made of a hydrophobic polyester film.

[0010] Furthermore, the hydrophobic pad is made of polyester film and contains EPS, sucrose and starch.

[0011] Furthermore, the hydrophobic pad is made of a polyester film and is treated with a hydrophobic treatment liquid; the hydrophobic pad treatment liquid contains EPS, sucrose and starch.

[0012] Furthermore, the hydrophobic treatment solution contains 5 g / L EPS, 25 g / L sucrose, 10 g / L starch, and has a pH value of 8.0.

[0013] Furthermore, the sample detection kit is used for the detection of Group A Streptococcus and Group B Streptococcus.

[0014] Furthermore, the sample processing reagent on the sample pad contains sodium nitrite, and the sample processing reagent in the reagent bottle contains glacial acetic acid.

[0015] Furthermore, the sample processing reagent on the sample pad is a 4M aqueous solution of sodium nitrite, and the sample processing reagent in the reagent bottle is a 2M aqueous solution of glacial acetic acid.

[0016] Furthermore, the sample detection kit is used for Chlamydia trachomatis detection.

[0017] Furthermore, the sample processing reagent on the sample pad contains sodium hydroxide, and the sample processing reagent in the reagent bottle contains tartaric acid.

[0018] Furthermore, the sample treatment reagent on the sample pad is a 0.5 M aqueous solution of sodium hydroxide, and the sample treatment reagent in the reagent bottle is a 0.5 M aqueous solution of tartaric acid.

[0019] Furthermore, the test strip also includes an absorbent pad and a bottom PVC base plate, and the sample pad, and / or the hydrophobic pad, the marking pad, the test pad, and the absorbent pad are all connected to the PVC base plate.

[0020] Compared with the prior art, the present invention has the following advantages: First, in the test strip preparation process, the present invention processes the effective component of one of the two sample processing reagents in the sample pad. Therefore, when the test strip is used, one sample processing reagent is directly used to pre-treat the sample, eliminating the step of mixing the two sample processing reagents in proportion, which simplifies the use operation.

[0021] Second, the sample pad treatment uses one of the two sample treatment reagents as an effective ingredient, eliminating the step of mixing the two sample treatment reagents in proportion, thus avoiding the situation where the incorrect mixing ratio of the two treatment reagents leads to inaccurate test results.

[0022] Third, the sample pad treatment uses an effective ingredient substance of one of the two sample treatment reagents, eliminating the filling process of one sample treatment reagent, reducing production processes, improving production efficiency, and reducing production costs.

[0023] Fourth, the active ingredient of one of the two sample processing reagents is processed in the sample pad, which reduces a reagent bottle for storing the processing reagent, saves costs, and further saves packaging space of the detection kit, reducing storage and transportation costs.

[0024] Fifth, the present invention adds a hydrophobic pad between the sample pad and the labeling pad, so that the flow rate of the sample is slowed down when passing through the hydrophobic pad, so that the sample has enough time to be fully processed on the sample pad before flowing into the labeling pad, so that the detected substance in the sample is fully released, thereby maintaining the detection sensitivity of the test strip without reducing one sample processing reagent. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 The figure is a schematic diagram of the operation steps of an existing conventional group A Streptococcus (Strep A) or group B Streptococcus (StrepB) detection kit.

[0026] Figure 2 It is a schematic diagram of the structure of an existing conventional test strip.

[0027] Figure 3 It is a schematic diagram of the structure of the test strip of the present invention.

[0028] Figure 4 It is a schematic diagram of a detection board equipped with the detection test strip of the present invention.

[0029] Figure 5 Schematic diagram of the operation steps of the detection kit of the present invention. DETAILED DESCRIPTION

[0030] The embodiments of the present invention are described in detail below, wherein the same or similar reference numerals throughout represent the same or similar elements or elements with similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention and cannot be used as a limitation of the present invention.

[0031] The numbers of the steps mentioned in each embodiment are only for the convenience of description and have no substantial sequence relationship. Different steps in each specific embodiment can be combined in different sequences to achieve the purpose of the invention.

[0032] The present invention is further described below in conjunction with the accompanying drawings and specific embodiments.

[0033] like Figure 1 As shown, the conventional detection kit includes two sample processing reagents, reagent A and reagent B, stored in reagent bottles. The operation steps of the conventional detection kit are as follows Figure 1 Steps a to f shown include: during detection, two sample processing reagents, reagent A and reagent B, are mixed in proportion, the sampled swab is inserted into the mixed solution to fully pre-treat the sample so that the analyte in the sample is fully released, and then the solution treated with the mixed reagent is dripped onto the sample pad, the sample pad collects the treated sample solution and filters the impurities in the sample that may affect the detection result, the specific molecules marked with the chromogenic group contained on the marking pad are combined with the analyte to form a complex of the chromogenic group-specific molecule-analyte, and the detection pad is usually a nitrocellulose membrane with fixed specific molecules, which can capture the complex of the chromogenic group-specific molecule-analyte, so that a detection line representing the result appears on the detection pad.

[0034] like Figure 2 As shown, the conventional test strip is composed of a sample pad 1, a marking pad 2, a detection pad 4, a water-absorbing pad 5 and a bottom PVC bottom plate 6. The sample pad 1, the marking pad 2, the detection pad 4 and the water-absorbing pad 5 are usually assembled on the PVC bottom plate 6. Usually, when preparing the test strip, the detection pad 4 is first placed on the bottom PVC bottom plate, the downstream end of the detection pad 4 is connected to the water-absorbing pad 5, the upstream end is connected to the marking pad 2, and the upstream end of the marking pad 2 is connected to the sample pad 1. In a specific design, the length of the PVC bottom plate is usually between 4cm-12 and the width is between 2mm-10mm. In a specific embodiment, the length is 6cm and the width is 3.5mm.

[0035] In actual operation, two sample processing reagents, one processing reagent, such as reagent A, and another processing reagent, such as reagent B, are first mixed in proportion to pre-process the sample, and then the processed sample solution is dripped onto the sample pad, the sample solution is adsorbed in the sample pad, and flows horizontally along the test strip, the analyte in the sample solution passes through the label pad, reacts with the specific molecules in the label pad to form a complex, and continues to flow along the test strip to reach the detection line 41 (T line) and the control line 42 (C line) on the detection pad to react, so that color lines appear to show the test results. The excess sample solution continues to flow along the test strip to the downstream of the detection pad and is absorbed by the absorbent pad, and finally the test is completed.

[0036] In actual operation, conventional test kits require two sample processing solutions, reagent A and reagent B, to be mixed first, which is cumbersome. In addition, the sample needs to be processed within a short time (e.g., 1 hour) after mixing, otherwise the effect of the mixed sample processing solution will be reduced, affecting the detection sensitivity of the test strip. In addition, incorrect mixing ratios are prone to lead to erroneous test results.

[0037] It is found through analysis that the substances in the two sample treatment reagents, i.e., reagent A and reagent B, cannot be stored for a long time when mixed together, and need to be mixed in proportion. Adding more or less reagent A or reagent B will affect the test results. Using reagent A alone or reagent B alone to treat the sample cannot effectively release the analyte in the sample, resulting in low sensitivity. For example, in Example 1, the active ingredient of reagent A is sodium nitrite, and the active ingredient of reagent B is acetic acid. After reagent A and reagent B are mixed, a chemical reaction occurs to produce nitrous acid and sodium acetate, wherein nitrous acid can effectively degrade the cell wall of group A streptococci, so that the analyte in the cell wall is fully released. However, the chemical properties of nitrous acid in the solution state are unstable and gradually decompose, and the effect of treating samples with nitrous acid solution stored for a long time is greatly reduced. For another example, in Example 2, the principle of sample treatment reagents A reagent and reagent B to treat samples is similar to that in Example 1, except that it degrades the cell wall of group B streptococci, so that the analyte is fully released. In Example 3, the active ingredient of reagent A is sodium hydroxide, and the active ingredient of reagent B is tartaric acid. The sample is first treated in an acidic environment, and then sodium hydroxide is added to treat the sample to fully release the analyte.

[0038] To solve this problem, it is necessary to make the active ingredients in reagent A and reagent B mix and react so that the sample analyte is fully released. At the same time, simple operating steps are required so that the active ingredients in reagent A and reagent B react more easily in the correct proportion. Therefore, an improved test strip of the present invention includes a sample pad that processes a sample treatment reagent component, and another sample treatment reagent is present in a reagent bottle. For example, one sample treatment reagent included in the sample pad is reagent A, and another sample treatment reagent present in the reagent bottle is reagent B. When in use, only another sample treatment reagent present in the reagent bottle, such as reagent B, needs to be mixed with the sample and then added to the sample pad, so that the sample treatment reagent on the sample pad, such as reagent A, is mixed with reagent B and mixed with the sample at the same time. In this way, both the timely mixing of reagent A and reagent B as well as the sample is achieved, and the function of mixing in a fixed ratio is achieved.

[0039] Hydrophobic pad 3 Figure 3 As shown, the improved test strip 10 comprises a sample pad 1, a hydrophobic pad 3, a marking pad 2, a test pad 4, a water-absorbing pad 5 and a bottom PVC base plate 6. On the basis of the conventional test strip, the reagent bottle containing the A reagent in the sample processing reagent is omitted, and the sample pad 1 contains a certain amount of the active ingredient of the A reagent, and a hydrophobic pad 3 is added between the sample pad 1 and the marking pad 2. The operating steps of the test kit of the present invention are as follows Figure 5 Steps a to d shown include: using reagent B to pre-treat the sample, and then dripping the treated sample solution onto the sample pad 1, the sample solution is adsorbed in the sample pad, the hydrophobic pad 3 at the downstream end of the sample pad needs a certain time to be wetted, and before being wetted, the sample solution is blocked by the hydrophobic pad 3, so that the sample solution is gathered on the sample pad 1, and the sample pad contains a certain amount of active ingredients of reagent A to fully react with the sample solution, so that the analyte in the sample is fully released, and then the hydrophobic pad begins to be wetted, and the fully released analyte reaches the label pad through the hydrophobic pad, reacts with the specific molecules in the label pad 2 to form a complex, and continues to flow along the test strip to reach the detection line 41 (T line) and the control line 42 (C line) on the detection pad to react, so that color lines appear to show the test results. The excess sample solution continues to flow along the test strip to the downstream of the detection pad and is absorbed by the absorbent pad, and finally the test is completed.

[0040] like Figure 4 The test board 20 shown includes an upper cover 20, a lower plate 21 and a test strip 10 installed between the upper cover and the lower plate. As required, the test strip can be used to test the sample, or the test board can be used for testing. The test kit includes a test strip and a sample processing reagent, and the test kit can also include a test board and a sample processing reagent.

[0041] Example 1: Comparison of conventional test strips and improved test strips in which the A reagent component is processed in the sample pad and a hydrophobic pad is added in the detection of Streptococcus A (Strep A).

[0042] Materials: sampling swab; conventional test strips are products of Hangzhou Lin'an Aikang Biotechnology Co., Ltd.; the present invention processes the A reagent component in the sample pad and adds a layer of hydrophobic pad to the test strip; the sample is an inactivated strain of Group A Streptococcus.

[0043] step: 1. Prepare inactivated strains of group A streptococci. Mix 2*10 8 CFU / ml Group A streptococcus inactivated strains were diluted to 2*10 7 CFU / ml, 2*10 6 CFU / ml, 2*10 5 CFU / ml, 2*10 4 CFU / m.

[0044] 2. Preparation of positive samples. Take 20ul of the prepared fire-extinguishing strain and place it on the head of the sampling swab to prepare gradient positive swabs with different concentration gradients. Positive swab 1 (containing 20ul 2*10 7 CFU / ml strain), positive swab 2 (containing 20ul 2*10 6 CFU / ml strain), positive swab 3 (containing 20ul 2*10 5 CFU / ml strain), positive swab 4 (containing 20ul 2*10 4 CFU / ml strain).

[0045] 3. Preparation of negative samples: Use sampling swabs to collect pharyngeal secretions from different people.

[0046] 4. Sample preprocessing.

[0047] Conventional test strips: first mix 8 drops (about 200ul) of reagent A and reagent B, then place the prepared positive or negative sample into the mixture of reagent A and reagent B, rotate and stir 15 times, let it stand for 1 minute, and then discard the swab.

[0048] Improved test strip: Place the prepared positive or negative sample into reagent B and rotate it 15 times, let it stand for 1 minute, and then discard the swab.

[0049] 5. Add sample for testing. Add 4 drops (about 100ul) of the pre-treated sample to the sample pad. Use the test strip reading to compare the color depth on the test pad with the color card to get the value.

[0050] 6. Conventional test strips are prepared according to the following method: 6.1 Preparation of sample treatment reagents, namely reagent A and reagent B. Reagent A is a 4M aqueous solution of sodium nitrite, and reagent B is a 2M aqueous solution of glacial acetic acid.

[0051] 6.2 Preparation of test pad. The test pad uses nitrocellulose membrane as the carrier, and there are two lines on the NC membrane, namely the test line T line and the control line C line. The test line T line is fixed with anti-Group A Streptococcus antibody-1, and the control line C line is fixed with goat anti-rabbit IgG polyclonal antibody. The T line and C line are fixed on the NC membrane by a film dispenser. The concentration of anti-Group A Streptococcus antibody-1 in the T line solution is 0.5 mg / ml, the dilution buffer is a borate buffer, and the pH is 8.0. The concentration of goat anti-rabbit IgG polyclonal antibody in the C line solution is 2.0 mg / ml, and the dilution buffer is a borate buffer, and the pH is 8.0. After the film dispenser is processed, place the test pad in a 37°C oven to dry.

[0052] 6.3 Preparation of label pad. The label pad uses glass fiber as a carrier, and the label solution is processed on the glass fiber by a spraying machine. The label solution can be obtained by mixing anti-group A streptococcus antibody-2 with latex microspheres for covalent coupling, wherein the dilution buffer is 0.8% BSA, pH 8.0. After the spraying machine is finished, the label pad is placed in a 37°C oven to dry.

[0053] 6.4 Sample pad preparation. The sample pad uses glass fiber as a carrier, and sprays the sample pad treatment solution on the glass fiber. The sample pad treatment solution is: borate 20g / L, calcium dodecyl phenyl yellow acid 5g / L, PVP 10g / L, BSA 10g / L, pH 8.0. Place the treated sample pad in a 37℃ oven to dry.

[0054] 6.5 Assembling the test strips. Assemble the processed structures according to the conventional test strips. Figure 2 Assemble in the order shown, first assemble the detection pad, one end of the absorbent pad covers the downstream end of the detection pad, the downstream end of the marker pad covers the upstream end of the detection pad, and the downstream end of the sample pad covers the upstream end of the marker pad.

[0055] 7. The improved test strip in which the A reagent component is processed in the sample pad and a layer of hydrophobic pad is added is prepared according to the following method: 7.1 Preparation of sample treatment reagent, i.e. reagent B: Reagent B is the same as reagent B in conventional test strips.

[0056] 7.2 The preparation method of the detection pad and the marking pad is the same as that of the conventional test strips.

[0057] 7.3 Sample pad preparation: Compared with conventional sample pads, only 4 M sodium nitrite (reagent A) is added to the sample pad treatment solution, and the other components and treatment methods remain unchanged.

[0058] 7.4 Preparation of hydrophobic pad: The hydrophobic pad uses polyester film as a carrier, and the hydrophobic pad treatment liquid is sprayed on the polyester film. The hydrophobic pad treatment liquid is: EPS 5g / L, 25g / L sucrose, starch 10g / L, pH 8.0.

[0059] 7.5 Test strip assembly. Assemble the processed structures according to the improved test strips. Figure 3 Assemble in the order shown, first assemble the detection pad, one end of the absorbent pad covers the downstream end of the detection pad, the downstream end of the marking pad covers the upstream end of the detection pad, the downstream end of the hydrophobic pad covers the upstream end of the marking pad, and the downstream end of the sample pad covers the upstream end of the hydrophobic pad.

[0060] Test result interpretation: Colorimetric card: The color range of the colorimetric card is between 0-10, i.e. L0-L10. The color level increases from 0 to 10. When the color level of the test line T is between L3 (including L3)-L10, the test result is positive. When the color level of the test line T is between L0-L3 (excluding L3), the test result is negative.

[0061] Table 1: Group A Streptococcus positive sample test results

[0062] Table 2: Negative sample test results

[0063] Test result analysis: The results in Table 1 show that the sensitivity of the improved test strip is consistent with that of the conventional test strip, and the sensitivity performance is not negatively affected. Reagent A and reagent B were mixed 4 hours in advance, and the sensitivity was 10 times weaker.

[0064] The results in Table 2 show that the specificity of the improved test strips is consistent with that of the conventional test strips, and the specificity performance is not negatively affected.

[0065] Without reducing the sensitivity and specificity performance, the improved detection kit eliminates the reagent bottle for storing reagent A and the operation step of mixing reagent A and reagent B, thereby simplifying the operation, reducing the production process, increasing production efficiency and reducing production costs.

[0066] Example 2: Comparison of conventional test strips and improved test strips in which reagent component A is processed in the sample pad and a hydrophobic pad is added for detecting Streptococcus B.

[0067] 1. The operation steps of this example are the same as those of Example 1 except that the strain used for preparing the positive sample is different, and the labeling solution and the antibody for the detection line T line are different. The rest of the operation is the same as that of Example 1.

[0068] 2. Prepare inactivated strains of group B streptococci. 8 CFU / ml Group A Streptococcus inactivated strains were diluted to 3.8*10 7 CFU / ml, 3.8*10 6 CFU / ml, 3.8*10 5 CFU / ml, 3.8*10 4 CFU / ml.

[0069] 3. Preparation of positive samples. Take 20ul of the prepared fire-extinguishing strain and place it on the head of the sampling swab to prepare gradient positive swabs with different concentration gradients. Positive swab 1 (containing 20ul 3.8*10 7 CFU / ml strain), positive swab 2 (containing 20ul3.8*10 6 CFU / ml strain), positive swab 3 (containing 20ul 3.8*10 5 CFU / ml strain), positive swab 4 (containing 20ul 3.8*10 4 CFU / ml strain).

[0070] 4. The detection line T line is fixed with anti-B group streptococcus antibody-1. The labeling solution can be obtained by mixing anti-B group streptococcus antibody-2 with latex microspheres for covalent coupling. The rest of the process is the same as in Example 1.

[0071] Table 3: Group B Streptococcus positive sample test results

[0072] Table 4: Negative sample test results

[0073] Test result analysis: The results in Table 3 show that the improved test strips are slightly more sensitive than the conventional test strips, and the sensitivity performance is not negatively affected. Similarly, the sensitivity of reagent A and reagent B mixed 4 hours in advance is nearly 10 times weaker.

[0074] The results in Table 4 show that the specificity of the improved test strips is consistent with that of the conventional test strips, and the specificity performance is not negatively affected.

[0075] Without reducing the sensitivity and specificity performance, the improved detection kit eliminates the reagent bottle for storing reagent A and the operation step of mixing reagent A and reagent B, thereby simplifying the operation, reducing the production process, increasing production efficiency and reducing production costs.

[0076] Example 3: Comparison of the detection of Chlamydia trachomatis between a conventional test strip and an improved test strip in which the A reagent component is processed in the sample pad and a layer of hydrophobic pad is added.

[0077] Except for the following steps which are different from those in Example 1, the remaining steps of this embodiment are the same as those in Example 1.

[0078] 1. Conventional test strips 1.1 The sample treatment solution is reagent A and reagent B. Reagent A is a 0.5M aqueous solution of sodium hydroxide, and reagent B is a 0.5M aqueous solution of tartaric acid.

[0079] 1.2 Sample pretreatment: Place the sample in 4 drops of reagent A and rotate and stir 15 times, let it stand for 1 minute, then add 4 drops of reagent B and rotate and stir 15 times, let it stand for 1 minute, and then discard the swab.

[0080] 1.3 Prepare the inactivated Chlamydia trachomatis quality control product. 7 The inactivated Chlamydia trachomatis quality control product was diluted in a gradient manner to 4.5*10 6 copies / ml, 4.5*10 5 copies / ml, 4.5*10 4 copies / ml.

[0081] 1.4 Preparation of positive samples. Take 20ul of the prepared inactivated quality control product and place it on the head of the sampling swab. Prepare gradient positive swabs with different concentration gradients. Positive swab 1 (containing 20ul 4.5*10 6 CFU / ml strain), positive swab 2 (containing 20ul 4.5*10 5 CFU / ml strain), positive swab 3 (containing 20ul 4.5*10 4 CFU / ml strain).

[0082] 1.5 Preparation of negative samples: Use sampling swabs to collect female cervical swabs / male urethral swabs from different people.

[0083] 1.6 Detection line T line is fixed with anti-Chlamydia trachomatis lipopolysaccharide monoclonal antibody-1. The labeling solution can be obtained by mixing anti-Chlamydia trachomatis lipopolysaccharide monoclonal antibody-2 with latex microspheres for covalent coupling. The rest of the process is the same as in Example 1.

[0084] 2. Improved test strips 2.1 Sample pretreatment: Same as Example 1.

[0085] 2.2 Preparation of sample treatment solution, i.e. reagent B: Reagent B is the same as reagent B in conventional test strips.

[0086] 2.3 The preparation method of the detection pad and the marking pad is the same as that of the conventional test strips.

[0087] 2.4 Sample pad preparation: Compared with conventional sample pads, only 0.5 M sodium hydroxide (reagent A), pH 12.0, was added to the sample pad treatment solution, and the other components and treatment methods remained unchanged.

[0088] Table 5: Test results of Chlamydia trachomatis positive samples

[0089] Table 6: Negative sample test results

[0090] Test result analysis: The results in Table 5 show that the improved test strips have the same sensitivity as the conventional test strips, and the sensitivity performance is not negatively affected. The conventional test strips have reagents A and B mixed in advance, and the sensitivity is significantly reduced.

[0091] The results in Table VI show that the specificity of the improved test strips is consistent with that of the conventional test strips, and the specificity performance is not negatively affected.

[0092] In this way, without reducing the sensitivity and specificity performance, the improved detection kit eliminates the reagent bottle for storing reagent A and the operation step of mixing reagent A and reagent B, thereby simplifying the operation, reducing the production process, increasing production efficiency and reducing production costs.

[0093] The above is only a preferred embodiment of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and modifications without departing from the concept of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A sample detection kit, comprising a test strip and a sample processing reagent, characterized in that: The test strip comprises a sample pad, a marking pad and a test pad connected in sequence; the sample processing reagent comprises two reagents, one of which is included in the sample pad and the other is in a reagent bottle; the test strip also comprises a hydrophobic pad connected between the sample pad and the marking pad.

2. The sample detection kit according to claim 1, characterized in that: The material of the hydrophobic pad is a hydrophobic polyester film.

3. The sample detection kit according to claim 1, characterized in that: The hydrophobic pad is made of a polyester film and is treated with a hydrophobic treatment liquid, wherein the hydrophobic pad treatment liquid contains EPS, sucrose and starch.

4. The sample detection kit according to claim 3, characterized in that: The hydrophobic pad treatment solution contained EPS 5 g / L, sucrose 25 g / L, starch 10 g / L, and the pH value was 8.

0.

5. The sample detection kit according to claim 1 or 3, characterized in that: The sample detection kit is used for the detection of group A streptococci and group B streptococci.

6. The sample detection kit according to claim 5, characterized in that: The sample treatment reagent on the sample pad contains sodium nitrite, and the sample treatment reagent in the reagent bottle contains glacial acetic acid.

7. The sample detection kit according to claim 6, characterized in that: The sample treatment reagent on the sample pad is a 4M aqueous solution of sodium nitrite, and the sample treatment reagent in the reagent bottle is a 2M aqueous solution of glacial acetic acid.

8. The sample detection kit according to claim 1 or 3, characterized in that: The sample detection kit is used for detecting Chlamydia trachomatis.

9. The sample detection kit according to claim 8, characterized in that: The sample treatment reagent on the sample pad contains sodium hydroxide, and the sample treatment reagent in the reagent bottle contains tartaric acid.

10. The sample detection kit according to claim 9, characterized in that: The sample treatment reagent on the sample pad is a 0.5 M aqueous solution of sodium hydroxide, and the sample treatment reagent in the reagent bottle is a 0.5 M aqueous solution of tartaric acid.

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