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Full-range C-reactive protein detection kit

A technology for detecting kits and reactive proteins, applied in the field of medical immunity, can solve the problems of increasing the demand for raw materials, increasing the production cost, increasing the operation steps, etc., and achieves the effects of ratio optimization, sensitivity assurance, and sensitivity improvement.

Pending Publication Date: 2020-01-17
南京欧凯生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the two disclosed C-reactive protein detection kits of CN105158476 B and CN 101769932 B in these detection kits can guarantee high sensitivity and wide detection range at the same time, the R2 preparation process in the detection kits used in them adopts a two-step method , it takes 1-2 days to coat the monoclonal antibody of the antigen to be tested on the latex microspheres, which not only increases the operation steps, is time-consuming and laborious, but also increases the demand for raw materials, the sensitivity is not high, and the production cost is increased

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0030]A full-scale C-reactive protein detection kit, the kit includes reagent R1 and reagent R2, the components of the reagent R1 are, 50m phosphate buffer solution, 0.1% tween-20, 0.1% BSA, 2 % PEG-6000 and 0.1% preservative; the reagent R2 is a conjugate formed by cross-linking two kinds of latex microspheres with large and small particle sizes and two anti-human CRP monoclonal antibodies respectively; the latex microspheres It is carboxylated polystyrene latex microspheres modified by carboxyl groups; the cross-linking mode of the anti-human CRP monoclonal antibody and the carboxylated polystyrene latex microspheres is a combination of covalent cross-linking and chemical cross-linking;

[0031] The preparation method of the reagent R2 is as follows: two kinds of anti-human CRP monoclonal antibodies are respectively sensitized to two kinds of carboxylated polystyrene latex microspheres with different large and small particle sizes, wherein the carboxylated polystyrene latex m...

Embodiment 2

[0050] Determination of various performance indicators of the full-scale CRP detection kit

[0051] Sensitivity experiment:

[0052] Carboxylated polystyrene latex microspheres with particle sizes of 60nm and 278nm were respectively coated with two different anti-human CRP monoclonal antibodies, mixed 3:1 and tested 6 samples with different dilutions. The results are shown in Table 1 and figure 1 .

[0053] Table 1

[0054] CRP concentration (mg / L) Sensitivity△A 0 45.5 5 664 10 1257.5 40 3636.5 160 10316 320 15566

[0055] The precision test between the detection reagent of the present invention and the CRP detection reagent of a well-known foreign brand:

[0056] Randomly select 30 examples of samples from a laboratory department of a certain hospital, respectively adopt the detection reagent of the present invention (using the R1 and R2 reagents prepared in Example 1) and the CRP detection kit reagents of foreign imported well...

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Abstract

The invention discloses a full-range C-reactive protein detection kit. The content of C-reactive protein in a sample is detected by an immune transmission turbidimetry method, so that the aim of quantitative detection is fulfilled. The kit comprises a reagent R1 and a reagent R2, wherein the reagent R1 is a phosphate buffer solution; and the reagent R2 is a conjugate formed by crosslinking latex with two particle sizes and two anti-human C-reactive protein antibodies respectively. Meanwhile, the kit is combined with a full-automatic biochemical analyzer for use, so that the detection sensitivity and accuracy are improved, and the detection time is shortened. The full-range C-reactive protein detection kit can be used for measuring the content of high-concentration CRP (C reactive protein)and the content of low-concentration CRP, has high sensitivity, high stability, wide linear range, high repeatability, high interference resistance, high accuracy and high precision, and can meet theclinical examination requirement.

Description

technical field [0001] The invention belongs to the field of medical immunity, and relates to a full-range C-reactive protein detection kit, in particular to a full-range C-reactive protein latex-enhanced immune turbidity detection kit. Background technique [0002] C-reactive protein (C-reactive protein, CRP) is an acute phase reaction protein, which is secreted by the liver when the body is stimulated by microbial invasion or tissue damage. Its content decreases rapidly during the recovery period of the disease, so it has important clinical significance in the early diagnosis, course and prognosis of infection, inflammation and other diseases. Its production mechanism is: when the body is infected or the tissue is damaged, macrophages and other white blood cells are activated to produce interleukin-6 (IL-6), interleukin-1 (IL-1), tumor necrosis factor (TNF-a) and other cytokines and other mediators, these cytokines and mediators reach the liver, stimulate liver cells and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/537G01N21/31G01N21/82
CPCG01N33/537G01N21/31G01N21/82
Inventor 戴瞻
Owner 南京欧凯生物科技有限公司
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