Stable and high-specificity calcitonin detection kit

A technology for detecting kits and procalcitonin, which is applied in the direction of biological testing, material inspection products, etc., can solve the problems of low specificity, long detection time, high price, etc., and achieve high reaction sensitivity and good reagent stability Effect

Inactive Publication Date: 2018-02-02
山东诺安爱迪尔生物工程有限公司
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AI-Extracted Technical Summary

Problems solved by technology

The radioimmunoassay method uses artificially synthesized polyclonal antibodies to specifically recognize and link the synthetic amino acid procalcitonin. This method can detect serum procalcitonin in normal people, but it takes a long time to detect (19-22h), and Contaminated use of radioactive elements is restricted
Double-antibody sandwich immunochemiluminescence assay (ILMA) uses double monoclonal antibodies, one of which is a calcitonin antibody and the other is an anti-calcitonin antibody, which bind to the calcitonin and anti-calcitonin molecules of the procalcitonin molecule, res...
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Method used

1, use biclonal antibody, after combining with calcitonin and anti-calcitonin respectively, then form antibody latex microsphere particle with latex microsphere coupling, make its specificity higher, prevent cross-contamination.
2, us...
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Abstract

The invention relates to a stable and high-specificity calcitonin detection kit. A biclonal antibody is used and bonded to calcitonin and anti-calcitonin separately, and then coupled with latex microspheres to form antibody latex microsphere particles, so that the specificity is higher; surfactants, namely dodecyl trimethyl betaine and sodium alcohol ether sulphate, are used, so that the reagent stability is better; a 3-N-morpholine propanesulfonic acid (MOPS) buffer system is used, so that the reaction sensitivity of a reagent is higher.

Application Domain

Biological testing

Technology Topic

ChemistryAntibody +12

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  • Stable and high-specificity calcitonin detection kit
  • Stable and high-specificity calcitonin detection kit
  • Stable and high-specificity calcitonin detection kit

Examples

  • Experimental program(1)

Example Embodiment

[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.

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