Stable and high-specificity calcitonin detection kit

[0028] Table 1 Example 1 Reagent detection method

[0029]

[0030] Calculation: Procalcitonin content (ng/mL) = (ΔA sample÷ΔA standard)×C standard.

[0031] Correlation experiment:

[0032] The reagent was prepared using the formula of Example 1, and compared with the procalcitonin determination kit of a company approved by the State Food and Drug Administration, which is common in the market, and 20 clinical serum samples were tested at the same time. The test results are shown in Table 2. . And obtained the correlation curve of the two reagents (such as figure 1 As shown, x is the concentration of procalcitonin in Example 1, and y is the concentration of procalcitonin in the control group. The test results show that the correlation coefficient of the two kits (R 2 ) Is 0.9996, indicating that the two have a great correlation. And when detecting low-value samples, compared with the control reagent, the probability of occurrence of zero value is lower than that of the control reagent, so the analysis sensitivity is higher.

[0033] Table 2 Comparison of test results between the reagents of Example 1 and the common and approved procalcitonin determination kit in the market

[0034]

[0035] Comparison test of reagent stability:

[0036] For the reagents in Example 1, the reagents in Example 1 were evenly divided into 13 groups, and the reagent volume of each group was 18mL for R1 and 6mL for R2; and the 13 groups were commonly used in the market for the determination of procalcitonin from a company approved by the State Food and Drug Administration The kit is used as a control. Place it in a refrigerator at 2-8°C, and take out a set of reagents to detect procalcitonin quality control products (target value 1.42ng/mL) on the same day of each month. The test results are as follows figure 2 As shown, the reagent of Example 1 is more stable than the common procalcitonin determination kit in the market under storage conditions of 2-8°C.

[0037] The advantages of the present invention are:

[0038] 1. Use biclonal antibodies to bind to calcitonin and anti-calcitonin respectively, and then couple with latex microspheres to form antibody latex microsphere particles, making it more specific and preventing cross-contamination.

[0039] 2. Use the surfactant lauryl trimethyl betaine and fatty alcohol polyoxyethylene ether sodium sulfate to make the reagent more stable.

[0040] 3. Use 3-N-morpholinopropanesulfonic acid (MOPS) buffer system to make the reagent reaction more sensitive.

[0041] Through verification, this reagent has a good correlation with similar detection reagents, and the clinical test sample results are consistent, which can meet the application requirements of the market for products, with high sensitivity and high specificity. It is a more stable and good procalcitonin detection reagent box.