Binding pad diluent, and binding pad preparation liquid and application

Abstract

The application discloses a binding pad diluent, a binding pad preparation liquid and application. The binding pad diluent comprises a buffer and the following components: 0.5-1% of surfactant in mass fraction, 0.5-5% of saccharide in mass fraction, 0.5-2% of protein blocking agent in mass fraction, 0.1-0.5% of high molecular substance in mass fraction and 0.1-1 mg / mL of blocking agent in final concentration. The binding pad diluent is applied to preparation of the binding pad, so that the stability of the binding pad can be obviously improved, the quality control line signal can be effectively reduced, the detection line signal can be improved, and the detection sensitivity is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of immunoassay technology, in particular to a conjugate pad diluent and a conjugate pad preparation solution and application. BACKGROUND

[0002] As a POCT product, short detection time, high sensitivity or low sample volume is a core competitiveness of the product, and the improvement of these performances requires a high test signal as the optimization premise. At the same time, for the production enterprise, the stability of the semi-finished product is the guarantee of product quality, and the semi-finished product with longer storage period has better convenience and continuity in actual production activities.

[0003] In the prior art, in order to improve the detection signal, the concentration of detection antibody antigen can be increased, or the components of sample diluent, sample pad and conjugate pad treatment solution can be changed to improve the signal, but increasing the concentration of antibody will significantly increase the product cost.

[0004] Therefore, the present application is proposed. SUMMARY

[0005] The present application aims to provide a conjugate pad diluent and a conjugate pad preparation solution and application.

[0006] The present application is implemented as follows:

[0007] In a first aspect, the present application provides a conjugate pad diluent, which comprises a buffer and the following components: a surfactant with a mass fraction of 0.5-1%, a sugar with a mass fraction of 0.5-5%, a protein blocking agent with a mass fraction of 0.5-2%, a high molecular substance with a mass fraction of 0.1-0.5%, and a blocking agent with a final concentration of 0.1-1mg / mL.

[0008] In a second aspect, the present application provides a conjugate pad preparation solution, which comprises the conjugate pad diluent as described in the foregoing embodiments and a label connected with a detection antibody.

[0009] In a third aspect, the present application provides application of the conjugate pad diluent as described in the foregoing embodiments in preparation of a conjugate pad preparation solution.

[0010] In a fourth aspect, the present application provides application of the conjugate pad diluent as described in the foregoing embodiments or the conjugate pad preparation solution as described in the foregoing embodiments in preparation of a conjugate pad and / or an immunochromatographic test paper.

[0011] In a fifth aspect, the present application provides a conjugate pad, which is obtained by drying a fiber membrane soaked with the conjugate pad preparation solution as described in the foregoing embodiments.

[0012] In a sixth aspect, the embodiments of the present application provide an immunochromatographic test strip, comprising a base plate and a sample pad, a conjugate pad, a chromatographic membrane and a water absorption pad which are sequentially overlapped and carried on the base plate; wherein the conjugate pad is the conjugate pad as described in the foregoing embodiments.

[0013] The present application has the following beneficial effects:

[0014] The present application provides a new conjugate pad diluent by optimizing the components of the conjugate pad diluent, and the application of the conjugate pad diluent in the preparation of the conjugate pad can significantly improve the stability of the conjugate pad, effectively reduce the quality control line signal, improve the detection line signal, and thus improve the detection sensitivity. BRIEF DESCRIPTION OF DRAWINGS

[0015] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiments. It should be understood that the following drawings only show some embodiments of the present application, and therefore should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can also be obtained without creative labor on the basis of these drawings.

[0016] Figure 1 Baseline for detection of different buffers;

[0017] Figure 2 Baseline for Casein Na improvement;

[0018] Figure 3 Effect of different concentrations of trehalose on the detection baseline;

[0019] Figure 4 Stability monitoring;

[0020] Figure 5 Baseline for detection of control example and embodiment. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be described clearly and completely. The specific conditions not mentioned in the embodiments are carried out according to the conventional conditions or the conditions suggested by the manufacturer. The reagents or instruments not mentioned by the manufacturer are all conventional products which can be obtained by market purchase.

[0022] Firstly, the embodiments of the present application provide a conjugate pad diluent, which comprises a buffer and the following components: a surfactant with a mass fraction of 0.5% to 1%, a saccharide with a mass fraction of 0.5% to 5%, a protein blocking agent with a mass fraction of 0.5% to 2%, a high molecular substance with a mass fraction of 0.1% to 0.5%, and a blocking agent with a final concentration of 0.1 to 1 mg / mL.

[0023] It should be noted that the mass fraction or final concentration of each component refers to its mass fraction or final concentration in the binding pad diluent. Specifically, the mass fraction of the surfactant can be any one of 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0% or a range between any two of them. The mass fraction of the sugar can be any one of 0.5%, 0.6%, 0.8%, 1.0%, 1.2%, 1.4%, 1.6%, 1.8%, 2%, 2.2%, 2.4%, 2.6%, 2.8%, 3%, 3.2%, 3.4%, 3.6%, 3.8%, 4%, 4.2%, 4.4%, 4.6%, 4.8%, 5% or a range between any two of them. The mass fraction of the protein blocking agent can be any one of 0.5%, 0.6%, 0.8%, 1.0%, 1.2%, 1.4%, 1.6%, 1.8%, 2% or a range between any two of them. The mass fraction of the high molecular substance can be any one of 0.1%, 0.2%, 0.3%, 0.4%, 0.5% or a range between any two of them. The final concentration of the blocking agent can be any one of 0.1 mg / mL, 0.15 mg / mL, 0.2 mg / mL, 0.25 mg / mL, 0.3 mg / mL, 0.35 mg / mL, 0.4 mg / mL, 0.45 mg / mL, 0.5 mg / mL, 0.55 mg / mL, 0.6 mg / mL, 0.65 mg / mL, 0.7 mg / mL, 0.75 mg / mL, 0.8 mg / mL, 0.85 mg / mL, 0.9 mg / mL, 0.95 mg / mL, 1.0 mg / mL or a range between any two of them.

[0024] In some embodiments, the binding pad diluent comprises a buffer and the following components: a surfactant with a mass fraction of 0.5% to 1%, a sugar with a mass fraction of 1.5% to 3%, a protein blocking agent with a mass fraction of 0.5% to 2%, a high molecular substance with a mass fraction of 0.2% to 0.3%, and a blocking agent with a final concentration of 0.2 to 1 mg / mL.

[0025] Preferably, the high molecular substance comprises at least one of polyethylene glycol and polyvinylpyrrolidone. The polyethylene glycol comprises polyethylene glycol 8000. Polyethylene glycol 8000 can help improve the fluorescence signal resolution compared to other high molecular substances. The effect is better within a certain range.

[0026] Preferably, the surfactant comprises at least one of S9 and Tween 20.

[0027] Preferably, the sugar comprises at least one of trehalose and sucrose. Trehalose has a better effect and can more obviously improve the signal and resolution compared to other sugars such as sucrose.

[0028] Preferably, the protein blocking agent comprises at least one of casein and bovine serum albumin.

[0029] In some embodiments, the blocking agent comprises a blocking agent 1 comprising MAK series, preferably MAK33 series, and a blocking agent 2 being HBR, preferably HBR24.

[0030] In some embodiments, the binding pad diluent further comprises a preservative.

[0031] In some embodiments, the mass fraction of the preservative in the binding pad diluent is 0.02%-0.1%. Specifically, it can be any one of 0.02%, 0.04%, 0.06%, 0.08%, 0.1% or a range between any two of them.

[0032] In some embodiments, the preservative comprises at least one of sodium azide and Proclin300.

[0033] In some embodiments, the pH of the buffer is 7.8-8.2, specifically, it can be any one of 7.8, 7.9, 8.0, 8.1, 8.2 or a range between any two of them.

[0034] In some embodiments, the buffer can be selected from existing buffers such as PBS or Tris buffer, etc.

[0035] In some embodiments, the buffer contains a buffering substance, and the buffering substance comprises at least one of borax salt, tris, Na2HPO4 and NaH2PO4.

[0036] In some embodiments, the buffering substance comprises borax salt and tris.

[0037] In some embodiments, in the binding pad diluent, the mass fraction of borax salt is 0.5%-1%, specifically, it can be any one of 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0% or a range between any two of them; in the buffer, the mass fraction of tris is 1%-2%, specifically, it can be any one of 1%, 1.2%, 1.4%, 1.6%, 1.8%, 2% or a range between any two of them.

[0038] The embodiment of the present application provides a binding pad preparation liquid, which comprises the binding pad diluent according to any of the foregoing embodiments and a label connected with a detection antibody.

[0039] In some embodiments, the marker comprises at least one of fluorescent microspheres, magnetic microspheres, colloidal gold, fluorescent dyes, and fluorescein.

[0040] The embodiments of the present application also provide use of the diluent for conjugate pad in preparation of a preparation solution for conjugate pad.

[0041] The embodiments of the present application also provide use of the diluent for conjugate pad or the preparation solution for conjugate pad in preparation of a conjugate pad and / or an immunochromatographic test strip.

[0042] The method for preparing the conjugate pad and the immunochromatographic test strip can be any existing method. In some embodiments, the method for preparing the conjugate pad using the preparation solution can be as follows: soaking the fiber membrane with the preparation solution and drying after soaking. The drying can be vacuum drying, and the condition for vacuum drying can be 100 Pa below for 0.5-1 h.

[0043] The embodiments of the present application provide a conjugate pad, which is obtained by drying the fiber membrane soaked with the preparation solution for conjugate pad according to any of the preceding embodiments.

[0044] In some embodiments, the fiber membrane is selected from any of a glass fiber membrane and a nitrocellulose membrane.

[0045] In addition, the embodiments of the present application provide an immunochromatographic test strip, which comprises a base plate and a sample pad, a conjugate pad, a chromatographic membrane and a water absorption pad successively lapped and carried on the base plate, wherein the conjugate pad is the conjugate pad according to any of the preceding embodiments.

[0046] The features and performances of the present application are further described in detail in the following embodiments.

[0047] Test Example 1

[0048] (1) Effect of buffer substances on signal.

[0049] Prepare three groups of conjugate pad diluents with different buffer solutions according to the following Table 1.

[0050] Table 1 Conjugate pad diluent

[0051]

[0052] Note: The "%" in the table is mass volume ratio, for example, 1 g of solid is added to 100 ml of liquid, and the mass volume ratio of the solid is 1%.

[0053] Use 15 μL PCT (Fluo) fluorescent particles (containing detection antibodies) + 1.6 mL binding pad diluent, respectively, spread on 3 empty binding pad materials, evenly coated with a coating stick, and then placed in a vacuum pump for drying for standby. The dried binding pad semi-finished product and nitrocellulose film containing capture antibodies were assembled into a reagent sheet, and different concentrations of calibration samples were added to detect the signal. The baseline and signal level of the fluorescence signal spectrum of each group were observed.

[0054] The baseline test results are shown in Table 1. Figure 1 : The baseline of group 1 and group 2 appears to be warped, and the fluorescent particles of group 3 cannot be released to detect the signal.

[0055] The fluorescence signal results are shown in Table 2.

[0056] Table 2 Fluorescence signal

[0057]

[0058] Conclusion: Group 1 has a false positive of 0 value, and the discrimination degree of each concentration of group 2 is greater than that of group 1.

[0059] Based on the experimental results of baseline and fluorescence signal values, group 2 (1.5% Borax + 0.6% Tris) has better effect as a buffer material.

[0060] (2) Effect of protein blocking agent on detection results.

[0061] The binding pad diluent prepared according to the following Table 3 was observed whether it could improve the baseline of the fluorescence signal spectrum. The preparation of the binding pad and the assembly and testing of the reagent sheet were consistent with the steps in (1).

[0062] Table 3 Binding pad diluent

[0063]

[0064] Note: The "%" in the table is the mass volume ratio.

[0065] It should be noted that the components of the experimental groups refer to the components defined in the table, and group 2 in Table 3 is formed by adding new components to group 2 in Table 1, and the following is the same.

[0066] The baseline test results are shown in Table 1. Figure 2 : The baseline of group 4 is normal, that is, the addition of 1% Casina Na can improve the baseline.

[0067] (3) Effect of sugar on detection results.

[0068] On the basis of the composition of group 4 solution, the type and concentration of sugar were changed respectively, and the baseline and signal level of the fluorescence signal spectrum of each group (Tables 4, 6) were observed. The preparation of the coupling pad and the assembly and testing of the reagent sheet were consistent with the steps in (1).

[0069] Table 4 Coupling pad diluent

[0070]

[0071] Note: The "%" in the table is mass volume ratio.

[0072] The fluorescence signal is shown in Table 5.

[0073] Table 5 Fluorescence signal

[0074] Conc. (ng / mL) 0 0.05 0.1 0.5 10 Group 4 11.51 37.29 53.35 130.93 1150.37 Discrimination (0.05-0) N / A 25.78 16.06 77.58 1019.43 Group 5 15.52 48.22 63.55 244.90 2186.70 Discrimination (0.05-0) N / A 32.70 15.33 181.35 1941.79 Group 6 16.03 48.64 66.40 268.51 2331.91 Discrimination (0.05-0) N / A 32.61 17.76 202.11 2063.40

[0075] From the results, it can be seen that increasing the concentration of sucrose from 0.5% to 2.5% can significantly improve the signal and resolution, and compared with sucrose, the effect of trehalose is better.

[0076] Table 6 Coupling pad diluent

[0077]

[0078] Note: The "%" in the table is mass volume ratio.

[0079] The fluorescence signal is shown in Table 7.

[0080] Table 7 Fluorescence signal

[0081]

[0082]

[0083] From the results, it can be seen that ① with the increase of sucrose concentration, the high value TAP shows a slow downward trend (CA increases, TA remains unchanged), and the low value changes little; ② compared with 2.5% trehalose, there is no obvious trend when the concentration increases to 6%, and when the concentration increases to 7%, it has a slight negative effect on the signal and CV. In summary, 2.5% is still chosen as the optimal concentration of added trehalose.

[0084] (4) Effect of concentration of surfactant on detection results.

[0085] On the basis of the composition of group 6 solution, only the concentration of surfactant S9 was changed, and the baseline and signal level of the fluorescence signal spectrum of each group (Table 8) were observed. The preparation of the coupling pad and the assembly and testing of the reagent sheet were consistent with the steps in (1).

[0086] Table 8 Coupling pad diluent

[0087]

[0088] Note: "%" in the table is mass / volume ratio.

[0089] Baseline test see Figure 3 From baseline, increasing trehalose to 1.5% will raise the baseline of the original buffer, and increasing to 2.0% and above will raise the T section of the baseline.

[0090] The results of the fluorescence signal are shown in Table 9.

[0091] Table 9 Fluorescence signal

[0092]

[0093] Conclusion: ① From the signal, under the premise that the baseline is not raised (S9 concentration ≤1.5%), TA increases, CA is basically unchanged, and TAP increases, but when its concentration is greater than 1.0, false positive of 0 value will appear, even if it is only increased to 1%, its signal is increased by 40% while the 0 value is increased by 100%; ② From the CV, with the increase of S9 concentration, there is a risk of increasing CV;

[0094] From the results, it can be seen that the concentration of S9 in the granular diluent should not exceed 1%, but considering the stability of the coupling pad, S9 should also be kept at a low concentration, and 0.5% concentration of S9 is a better choice.

[0095] (5) The influence of the type and concentration of high molecular substances on the test results.

[0096] On the basis of the composition of solution 7, different components of high molecular substances were added, and the baseline and signal height of the fluorescence signal spectrum of each group (Table 10) were observed. The preparation of the coupling pad and the assembly and test of the reagent sheet were consistent with the steps in (1).

[0097] Table 10 Coupling pad diluent

[0098]

[0099]

[0100] Note: "%" in the table is mass / volume ratio.

[0101] The fluorescence signal is shown in Table 11.

[0102] Table 11 Fluorescence signal

[0103] Conc. (ng / mL) Group 6 Group 15 Group 16 Group 17 Group 18 0 16.47 22.61 15.27 14.98 14.97 0.05 33.33 35.15 27.76 25.64 29.53 Discrimination (0-0.05) 16.86 12.55 12.50 10.66 14.56 0.5 221.74 202.11 224.27 217.10 204.78 10 2003.48 1982.73 1996.76 2086.15 1901.58 80 3523.95 3506.51 3519.38 3602.95 3484.44 100 3633.13 3721.36 3660.26 3726.88 3631.46 Discrimination (80-100) 109.18 214.84 140.88 123.92 147.02

[0104] Conclusion: From the fluorescence signal, adding a certain amount of high molecular substances helps to improve the fluorescence signal of 80-100 ng / mL, which is beneficial to the testing of high concentration samples. Among them, PEG8000 has the best effect, and the differentiation degree of 80-100 ng / mL is significantly higher than that of other groups. Therefore, PEG8000 is a better choice as a high molecular substance component.

[0105] Add different concentrations of PEG8000 and observe the baseline and signal level of the fluorescence signal spectrum of each group (Table 12). The preparation of the pad, assembly of the reagent sheet and testing are consistent with step (1).

[0106] Table 12 Diluent for the pad

[0107]

[0108] Note: The "%" in the table is the mass-volume ratio.

[0109] The fluorescence signal is shown in Table 13.

[0110] Table 13 Fluorescence signal

[0111]

[0112]

[0113] From the results, as the concentration of PEG8000 increases, the high value differentiation decreases, and 0.25% has a better effect.

[0114] Test Example 2

[0115] Prepare 5 groups of pad diluents according to the following Table 14.

[0116] Table 14 Diluent for the pad

[0117]

[0118] Take each of the above substances and add them to a clean beaker, then add ultrapure water and stir thoroughly until completely dissolved. Adjust the pH to 8.00±0.05, and finally dilute to 500 mL. Prepare for use.

[0119] Prepare the pad preparation liquid according to Table 15, including diluent, blocking agent 1 and fluorescent microspheres labeled with antibodies.

[0120] Table 15 Pad preparation liquid

[0121]

[0122] Take the solution of fluorescent microspheres labeled with detection antibody from the storage environment, seal the storage container with sealing film, and then place it in an ultrasonic machine for ultrasonic treatment for 5-10 min to ensure that the antibody fluorescent microspheres are fully dispersed and uniform. According to the required amount, calculate the volume of the solution: for example, if 100 tests of binding pads are to be prepared, 100 tests x 17 μl / test = 1.7 mL of binding pad preparation solution is required. According to the required volume, take the appropriate centrifuge tube, and then add the binding pad dilution solution, blocking agent, and antibody fluorescent microsphere solution according to the concentrations in Table 14. Mix well and reserve. Prepare the binding pad preparation solution for 1 control example and 4 example groups according to the above method.

[0123] Stability monitoring:

[0124] Take the above 5 different binding pad preparation solutions and soak the binding pads for the PCT (fluorescent) lateral flow chromatographic test reagent strip (same as Test Example 1) and use a vacuum pump for vacuum drying (100 pa or less for 1 hour). Add a desiccant to the dried fluorescent binding pad semi-finished product and seal it at room temperature for storage. Then at 0, 7, 14, 30, 60, 90, 120, 150, 180 days, take the above binding pad semi-finished product and assemble it into a PCT (fluorescent) chromatographic test reagent strip, and use the prepared test strip to test the low concentration and high concentration calibrators. The low concentration is 0.5 ng / mL and the high concentration is 10 ng / mL. The stability test results are shown in Table 14, where the number of monitoring days is taken as the abscissa, the relative deviation of the concentration change of the calibrators is taken as the ordinate, and the stability test results are shown in Table 14. Figure 4 .

[0125] From Figure 4 It can be seen that, in terms of overall fluctuations, the control example and Examples 1, 2, and 3 all have significant fluctuations within the monitoring period. However, Example 4, which added 0.25% high molecular substance PEG8000, has the smallest fluctuations during the 180-day monitoring period, and the relative deviation of the concentration change of the test calibrators is within ±10%, i.e., it has very good stability effect, and the storage shelf life of the binding pad semi-finished product can be extended to 6 months. It can be seen that the addition of high molecular substance PEG8000 can improve the stability of the binding pad semi-finished product, and the stability is better when the concentration of PEG8000 is 0.25%.

[0126] Signal enhancement verification:

[0127] The fluorescence detection signal value refers to the fluorescence signal value obtained by detecting the fluorescence signal after the sample passes through the fluorescence immunoassay reagent strip by the instrument and then by a certain algorithm, which can reflect the concentration of the antigen to be detected in the sample. Since the fluorescence detection signal value in the algorithm of the detection method is inversely proportional to the quality control line signal, that is, the lower the quality control line signal, the higher the final calculated fluorescence detection signal value. Therefore, whether the quality control signal can be reduced by adding different types of blocking agents in the preparation of the conjugate pad can be tried. This time, 3 kinds of blocking agents were selected, as shown in Table 16.

[0128] Table 16: Conjugate pad preparation liquid

[0129]

[0130] 4 different conjugate pad preparation liquids were used to soak and dry the conjugate pad used in the PCT (fluorescence) lateral flow chromatographic test reagent strip. The dried fluorescence conjugate pad semi-finished product was assembled on the PCT (fluorescence) chromatographic test reagent strip, and the prepared test strip was used for fluorescence testing at zero concentration, low concentration and high concentration. Among them, the zero concentration is 0 ng / mL, the low concentration is 0.5 ng / mL, and the high concentration is 10 ng / mL. The zero concentration is mainly used to test whether the background signal will increase, and the rest of the concentration is mainly used to test the change of the fluorescence signal. The results are shown in Table 17 and Figure 5 .

[0131] Table 17: Fluorescence signal results

[0132]

[0133] From the data in Table 17, it can be seen that the three different blocking agents represented by Examples 5, 6 and 7 can all reduce the quality control line signal, thereby improving the fluorescence detection signal value.

[0134] From Figure 5 the data, it can be seen that the test baselines of Examples 5 and the control example are flat, while the two different blocking agents represented by Examples 6 and 7 have a significant baseline that is not flat during the test, which affects the authenticity of the fluorescence detection signal value. It can be seen that the blocking agent of Example 5 can better improve the fluorescence detection signal value while keeping the test baseline flat.

[0135] The concentration of the blocking agent affects the monitoring results:

[0136] The blocking agent 2 (HBR24) was added into the conjugate pad preparation solution at different concentrations, and other components and the preparation process of the conjugate pad were the same as those in Example 5. The following groups of dry fluorescent conjugate pad semi-finished products containing different concentrations (0 μg / test, 2 μg / test, 4 μg / test, 6 μg / test) of the blocking agent were assembled into PCT (fluorescent) chromatographic test strips, and the prepared test strips were used for fluorescent test. The test results are shown in Table 18.

[0137] Table 18 Fluorescent signal

[0138]

[0139]

[0140] The resolution represents the difference between the fluorescent detection signal values of two adjacent concentrations. In the low concentration area, the greater the difference, the higher the detection sensitivity and the lower the detection limit. In the high concentration area, the greater the difference, the higher the upper limit of linearity and the greater the linear range. Therefore, the greater the resolution in the high and low concentration areas, the better the detection performance of the test reagent.

[0141] As can be seen from the data in Table 18, as the concentration of the blocking agent increases, the quality control line signal decreases, and the fluorescent detection signal value gradually increases. However, as the fluorescent detection signal value increases, the resolution in the low concentration and high concentration areas both show a decreasing trend. Therefore, the effect of the blocking agent concentration of 2 μg / test is better as the use concentration.

[0142] The above only describes the preferred embodiments of the present application and is not used to limit the present application. For those skilled in the art, the present application can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A binder pad diluent, characterized by, The diluent solution comprises a buffer and the following components: a surfactant with a mass fraction of 0.5% to 1%, a saccharide with a mass fraction of 0.5% to 5%, a protein blocking agent with a mass fraction of 0.5% to 2%, a high-molecular substance with a mass fraction of 0.1% to 0.5%, and a blocking agent with a final concentration of 0.1 to 1 mg / mL. The high-molecular substance is polyethylene glycol 8000, the blocking agent comprises a blocking agent 1 and a blocking agent 2, the blocking agent 1 is MAK series, and the blocking agent 2 is HBR24.

2. The binding pad diluent of claim 1, wherein, The diluent solution comprises a buffer and the following components: a surfactant with a mass fraction of 0.5% to 1%, a saccharide with a mass fraction of 1.5% to 3%, a protein blocking agent with a mass fraction of 0.5% to 2%, a high-molecular substance with a mass fraction of 0.2% to 0.3%, and a blocking agent with a final concentration of 0.2 to 1 mg / mL.

3. The binding pad diluent of claim 1, wherein, The surfactant comprises at least one of S9 and Tween20.

4. The binding pad diluent of claim 2, wherein, The saccharide comprises at least one of trehalose and sucrose.

5. The binder pad diluent of claim 1, wherein, The protein blocking agent comprises at least one of casein and bovine serum albumin.

6. The binding pad diluent of claim 1, wherein, The protein blocking agent is Casein Na.

7. The binder pad diluent of any one of claims 1 to 6, wherein, The blocking agent 1 is MAK33.

8. The binder pad diluent of any one of claims 1-6, wherein, The diluent solution further comprises a preservative.

9. The binding pad diluent of claim 8, wherein, The mass fraction of the preservative in the diluent solution is 0.02% to 0.1%.

10. The binding pad diluent of claim 8, wherein, The preservative comprises at least one of sodium azide and Proclin300.

11. The binder pad diluent of any one of claims 1-6, wherein, The pH of the buffer is 7.8 to 8.

2.

12. The binder pad diluent of any one of claims 1-6, wherein, The buffer contains a buffer substance, and the buffer substance comprises at least one of borax salt, Tris, Na2HPO4, and NaH2PO4.

13. The binding pad diluent of claim 12, wherein, The buffer substance comprises borax salt and Tris.

14. The binding pad diluent of claim 13, wherein, In the diluent solution, the mass fraction of borax salt is 1.5%, and the mass fraction of Tris is 0.6%.

15. A bonding pad forming liquid characterized by comprising: The diluent solution comprises the diluent solution of any one of claims 1 to 14 and a label connected with a detection antibody.

16. The binder-making fluid of claim 15, wherein, The label comprises at least one of fluorescent microspheres, magnetic microspheres, colloidal gold, a fluorescent dye, and fluorescein.

17. Use of the diluent solution of any one of claims 1 to 14 in the preparation of a conjugate pad preparation solution.

18. Use of the diluent solution of any one of claims 1 to 14 or the conjugate pad preparation solution of claim 15 or 16 in the preparation of a conjugate pad and / or an immunochromatographic test strip.

19. A bonding pad characterized by, The conjugate pad is obtained after the fibrous membrane is soaked with the conjugate pad preparation solution of claim 15 or 16 and dried.

20. The bonding pad of claim 19, wherein, The fibrous membrane is selected from any one of a glass fiber membrane and a nitrocellulose membrane.

21. An immunochromatographic test strip, characterized by The conjugate pad preparation solution comprises: a base plate and a sample pad, a conjugate pad, a chromatographic membrane, and a water absorption pad successively overlapped and carried on the base plate, wherein the conjugate pad is the conjugate pad of claim 19 or 20.

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