Kit for measuring antinuclear antibody in serum and preparation method thereof

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...

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 microscope and other equipment used in this method are expensive and complicated to operate, and it is difficult to promote them in primary hospitals. As a result, many AID patients in primary hospitals cannot receive correct diagnosis and treatment, and may eventually become disabled or even die.

Some detection methods based on purified antigen technology, such as enzyme-linked immunosorbent assay, western blotting, chemiluminescence, suspension microarray and liquid phase chip technology, are also being used in clinical practice. These methods are highly automated, easy to standardize, and convenient. It is operated in large quantities, but the new method still has problems such as expensive equipment, complicated operation, and difficulty in promoting it in primary hospitals

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