Kit for measuring antinuclear antibody in serum and preparation method thereof

An anti-nuclear antibody and kit technology, which is applied to a kit for determining anti-nuclear antibodies in serum and the field of preparation thereof, can solve the problem of time-consuming film reading, unsatisfactory inter-laboratory quality assessment results, expensive new methods and equipment, etc. question

Inactive Publication Date: 2018-02-23
SHANGHAI CHUANZHI BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The current gold standard method for detecting ANA is indirect immunofluorescence (Indirect Immune-Fluorescence, IIF), but this method takes a long time to read, and the correctness and accuracy of the results largely depend on the knowledge of the reader technology, highly subjective
At the same time, it is easily affected by the washing of fluorescent film, the concentration of fluorescent secondary antibody, the light intensity and resolution of fluorescent microscope, and the degree of automation is low, and the operation standardization is difficult, which may lead to missed diagnosis or misleading clinical diagnosis
For a long time, the national external quality assessment results of ANA testing have not been satisfactory
In addition, the fluorescence microsc

Method used

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  • Kit for measuring antinuclear antibody in serum and preparation method thereof
  • Kit for measuring antinuclear antibody in serum and preparation method thereof
  • Kit for measuring antinuclear antibody in serum and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Embodiment 1 measures the kit of antinuclear antibody in serum

[0073] The main components, concentrations and preparation methods of the kit are as follows:

[0074] (1) Main components and concentration of R1 reagent:

[0075]

[0076] The preparation method of R1 reagent: add the above-mentioned ingredients of corresponding concentrations in an appropriate container in sequence, stir at a low speed until they are completely dissolved, and adjust the pH to 7.5; store at 2-8°C after completion; obtain the R1 reagent of colorless or slightly yellow transparent liquid ;

[0077] (2) Main components and concentration of R2 reagent:

[0078]

[0079] The preparation method of R2 reagent:

[0080] S1. Latex activation: Take an appropriate amount of latex, wash it with Tris buffer solution 10 times the volume of the latex, pH 7.5, then dilute to 4 times the volume with Tris buffer solution, add 1% EDC 1 times the volume of the latex, shake evenly for activation, T...

Embodiment 2

[0093] Embodiment 2 is measured the test kit of antinuclear antibody in serum

[0094] The main components, concentrations and preparation methods of the kit are as follows:

[0095] (1) The main components, concentration and preparation method of R1 reagent are the same as in Example 1;

[0096] (2) In the main components, concentration and preparation method of R2 reagent, except that the ANA antigen is changed to Sm, Sm / RNP, SSA / Ro, SSB / La, dsDNA, Nucleosome (nucleosome), histone, CENPB; the rest are the same Embodiment 1;

[0097] (3) The main components, concentration and preparation method of the calibrator are the same as in Example 1.

Embodiment 3

[0098] Embodiment 3 is measured the test kit of antinuclear antibody in serum

[0099] The main components, concentrations and preparation methods of the kit are as follows:

[0100] (1) The main components, concentration and preparation method of R1 reagent are the same as in Example 1;

[0101] (2) In the main components, concentration and preparation method of the R2 reagent, except that the ANA antigen is replaced by the Hep-2 cell homogenate extract and the combined purified antigen of Sm, Sm / RNP, SSA / Ro, and SSB / La; the rest is the same as in the example 1;

[0102] (3) The main components, concentration and preparation method of the calibrator are the same as in Example 1.

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Abstract

The invention discloses a kit for measuring an antinuclear antibody (ANA) in serum and a preparation method thereof. The kit comprises an R1 reagent, an R2 reagent and a calibrator. The R1 reagent comprises a buffer solution, an electrolyte, a surfactant, a stabilizer, a reaction enhancer and a preservative. The R2 Reagent contains a buffer solution, an electrolyte, a surfactant, a stabilizer, a preservative and sensitized polystyrene latex particles coated with an ANA antigen. The calibrator contains a buffer solution, a surfactant, a stabilizer, a preservative and an antinuclear antibody. The kit utilizes Hep-2 cell homogenate extract and/or a combined purified antigen as a main antigen matrix, the main antigen matrix is bonded to surface of the latex particle, a serum specimen to be detected and a latex reagent are mixed in the buffer solution, and ANA in the specimen is bonded to the antigen on the latex particle surface so that adjacent latex particles are cross-linked to each other, solution turbidity of the measured solution close to a certain wavelength is increased, a increasing degree is associated with the ANA concentration of the specimen and ANA content of the specimenis calculated according to an absorbancy changing value.

Description

technical field [0001] The invention belongs to the field of in vitro diagnostic reagents, in particular to a kit for measuring antinuclear antibodies (ANA) in serum and a preparation method thereof. Background technique [0002] Autoimmune disease (autoimmune disease, AID) is a primary immune disease in which antibodies or sensitized lymphocytes produced by the body itself destroy and damage its own tissues and cell components, leading to tissue damage and organ dysfunction. one of the leading disabling diseases in the world. The incidence rate of autoimmune diseases is high, and the overall incidence rate of the global population accounts for 3%-5% of the total population. In my country, only rheumatism has more than 100 million patients. Antinuclear antibody (antinuclear antibody, ANA) is an important marker of AID, which plays an important role in explaining the pathogenesis of AID, diagnosis and differential diagnosis, disease monitoring, curative effect observation an...

Claims

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Application Information

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IPC IPC(8): G01N33/68G01N33/543G01N33/544G01N33/531
CPCG01N33/531G01N33/54313G01N33/544G01N33/6854
Inventor 陈明王妮妍
Owner SHANGHAI CHUANZHI BIOTECH CO LTD
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