Rheumatoid factor detection kit and detection method thereof

A detection kit and rheumatoid factor technology, applied in the biological field, can solve the problems of low and non-typing detection sensitivity, etc., and achieve the effect of strong anti-interference ability, high sensitivity, and wide linear range

Active Publication Date: 2019-03-01
SICHUAN MACCURA BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, latex agglutination and turbidimetry are mostly used for rheumatoid factor, but these two methods cannot be used for typing detection of RF and the sensitivity is not high

Method used

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  • Rheumatoid factor detection kit and detection method thereof
  • Rheumatoid factor detection kit and detection method thereof
  • Rheumatoid factor detection kit and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0047] 1. The preparation method of the kit is as follows:

[0048] 1) Reagent R1—magnetic particles coated with rabbit IgG, the specific process is as follows:

[0049] Antibody biotinylation: Take an appropriate amount of rabbit IgG, add an appropriate amount of biotin ester, mix and react on a mixer at room temperature for 0.5 to 3 hours, then add an appropriate amount of Tris aqueous solution, mix and react on a mixer at room temperature for 10 ~30 minutes, the mixture was dialyzed with phosphate buffer solution, and biotinylated rabbit IgG was obtained after dialysis;

[0050] Coating antibody: mix an appropriate amount of biotinylated rabbit IgG with streptavidin magnetic particles, mix and react on a mixer at room temperature for 0.5 to 3 hours, and use magnetic particle protection buffer for the coated magnetic particles After washing, resuspend to 0.2-2 mg / mL to obtain reagent R1. (The coating amount of biotinylated rabbit IgG ranges from 0.3 to 60 μg / mg). The form...

Embodiment 1

[0078] The components of reagent R3 in the kit of this embodiment are shown in the table below:

[0079] Table 8 is the composition of reagent R3 in embodiment 1

[0080]

[0081]

[0082] The detection CV value of the kit prepared using the reagent R3 of Example 1 is less than 3% when performing sample detection. See the table below for details.

[0083] Table 9 is the CV value repeated 10 times for the same sample

[0084]

[0085] In the kits of the following comparative examples, the reagents R1 and R2 are the same, and only the reagent R3 is different.

Embodiment 2

[0100] This embodiment is for the detection of samples with known concentrations. The reagent R1 and reagent R2 for detection are the same, and the reagent R3 is the use of Example 1, no reagent R3 and physiological saline instead of reagent R3. The detection method is the same as the detection method of rheumatoid factor concentration in human serum (plasma). The results are shown in the table below:

[0101] Table 13 is the chemiluminescent photon intensity detected for known samples

[0102]

[0103] As can be seen from Table 13, the detection sensitivity of the kit with reagent R3 is high, and the signal ratio between the concentrations is high; the detection sensitivity and the signal ratio between the concentrations without reagent R3 are low; the use of normal saline The detection sensitivity of the replacement reagent R3 is low, which is not conducive to the detection of low-concentration samples.

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Abstract

The invention discloses a rheumatoid factor detection kit and a preparation method thereof. The kit comprises a reagent R1, a reagent R2 and a reagent R3, wherein the reagent R1 contains magnetic particles coated with rabbit IgG; the reagent R2 contains markers of anti-human IgM / IgG / IgA antibodies or anti-human IgM antibodies or anti-human IgG antibodies or anti-human IgA antibodies; the reagent R3 is prepared by mixing a buffering system, inorganic salt, saccharides, proteins, a coloring agent, a nonionic surfactant and a preservative in a certain ratio. The rheumatoid factor detection kit ishigh in sensitivity, wide in linearity range, high in anti-interference capacity and capable of safely and quickly detecting rheumatoid factors.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a rheumatoid factor detection kit and a detection method thereof. Background technique [0002] Rheumatoid factor (RF) is an autoimmune antibody against denatured IgG, which can bind to the Fc segment of human and various animal IgG molecules. There are five types of RF: IgM, IgG, IgA, IgE, and IgD, among which IgM is the main one, and IgG and IgA can also be seen, while IgE and IgD are rare. Rheumatoid factor forms an immune complex with denatured IgG in the human body, activates complement, and causes tissue damage. RF can be detected in the serum of most patients with rheumatoid arthritis (RA), which is one of the important basis for clinical diagnosis of RA. Although the detection of RF cannot directly obtain the result of disease diagnosis, and the conclusion of disease diagnosis can only be obtained by combining multiple indicators such as clinical symptoms, the detection of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68
CPCG01N33/6854G01N2800/102
Inventor 王沙莉张凌燕
Owner SICHUAN MACCURA BIOTECH CO LTD
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