Stable preservation diluent and anti-nuclear antibody detection reagent, and preparation method and application thereof

Abstract

The invention discloses stable preservation diluent, anti-nuclear antibody detection reagent for the stable preservation diluent, a preparation method thereof and an anti-nuclear antibody detection kit of the anti-nuclear antibody detection reagent. The pH of the stable preservation diluent is 5-8, and the stable preservation diluent includes a buffer solution, salt, osmotic substances and a preservative; the osmotic substances are selected from at least one substance of polyol, methylamine and amino acid. The anti-nuclear antibody detection reagent suspends a coupling matter of anti-nuclear antibody target antigens and magnetic microspheres in the stable preservation diluent for storage to stably store the diluent including the buffer solution, the salt, the osmotic substances and the preservative, thereby providing the coupling matter of the anti-nuclear antibody target antigens and the magnetic microspheres with a stable liquid storage environment.

Description

technical field [0001] The present invention relates to the field of immune detection, in particular to a stable storage diluent, an anti-nuclear antibody detection reagent comprising the stable storage diluent and a preparation method thereof, and an anti-nuclear antibody detection kit comprising the above-mentioned anti-nuclear antibody detection reagent. Background technique [0002] Autoimmune diseases are a type of diseases in which the body produces pathological immune responses against self-antigens due to immune dysfunction, causing organ or system damage. At present, the pathogenesis of autoimmune diseases is still not fully understood. It is generally believed that autoimmune diseases are caused by genetically susceptible individuals under the joint action of environmental factors such as infection, ultraviolet rays, tumors, and drugs. [0003] Antinuclear antibody (antinuclear antibody, ANA) is a general term for a group of autoantibodies that use various compone...

AI Technical Summary

Problems solved by technology

Indirect immunofluorescence is still the gold standard for ANA screening. Generally, mouse hepatocytes or Hep-2 cell slices are fixed on glass slides as the target antigen. Positive, the detection time is long, the result is difficult to judge, and it is difficult to standardize and automate; enzyme-linked immunosorbent assay, western blot and dot immunocombination methods have become more and more widely used in ANA detection in recent years. Naturally recombined and purified antigens are coated on microwell plates or fiber membranes. This method can avoid various cytoplasmic interferences to a certain extent. Compared with indirect immunofluorescence, it has better specificity, but it also has cumbersome operations, accuracy and precision. Poor accuracy, limited detection item portfolio, difficulty in automation and technical bottlenecks such as high-throughput quantitative detection

[0006] The target antigens of antinuclear antibodies are mainly extracted from Hep-2 cells, HeLa cells, pig heart tissue or calf thymus tissue, or obtained through prokaryotic cell expression or eukaryotic cell expression, but the target antigens in the cytoplasm and nucleus are complex due to the three-dimensional structure Most of them are complex proteins, and some of the ribonucleoprotein complexes need to be connected by RNA, which makes the target antigen sensitive to temperature after extraction and purification, and sensitive to RNase, DNase and protease

At present, ANA target antigens need to be stored at -20°C or even -70°C, which is not conducive to the development of high-sensitivity quantitative diagnostic reagents

Images