Kit for determination of human alpha-fetoprotein content by latex-enhanced immunoturbidimetry

Abstract

The invention relates to a kit for determination of human alpha-fetoprotein content by a latex-enhanced immunoturbidimetry. The kit provided by the invention comprises an alpha-fetoprotein R1 reagent, an alpha-fetoprotein R2 reagent and an alpha-fetoprotein calibrator, wherein the alpha-fetoprotein R1 reagent comprises one or more electrolytes, a coagulation accelerator, one or more stabilizing agents, one or more surfactants, an antiseptic and a buffer solution; the alpha-fetoprotein R2 reagent comprises latex particles coated by polyclonal antibodies capable of resisting a human alpha-fetoprotein, one or more electrolytes, one or more stabilizing agents, one or more surfactants, an antiseptic and a buffer solution; and the alpha-fetoprotein calibrator comprises an antiseptic, one or more electrolytes, one or more stabilizing agents, alpha-fetoprotein antigens and a buffer solution. The kit has strong specificity and high sensitivity, is homogeneous and stable, can be used fast and conveniently and can be used for various biochemical analyzers.

Description

technical field [0001] The invention relates to a kit for measuring alpha-fetoprotein content in human body fluids (including serum and amniotic fluid) by using a latex-enhanced immune turbidimetric method, which belongs to the field of in vitro medical immunodiagnosis. Background technique [0002] Alpha-fetoprotein (α-fetoprotein, or AFP), with a molecular weight of 68kD, is a polypeptide chain glycoprotein consisting of 590 amino acids and containing 4% sugar. The gene of alpha-fetoprotein is located in the 4q11-q22 region of the autosome, the gene is about 20kb long, contains 15 exons, and 14 introns, and belongs to the same family as serum albumin and vitamin D binding protein, and is related to albumin 50% of the amino acids are the same, the isoelectric point is 4.7-4.8, and it is located between albumin and α-globulin during electrophoresis. [0003] During fetal development, the liver is the main site for the synthesis of alpha-fetoprotein, followed by the yolk sac...

AI Technical Summary

Problems solved by technology

Among them, the sensitivity and linearity of the chemiluminescence method are relatively high, and the detection range can reach 1-1000 ng / mL, but the reagent cost is relatively high and the supporting large-scale instruments are relatively expensive

Enzyme-linked immunoassay is widely used, but this method is a heterogeneous immunoassay system. Its advantages are: high sensitivity and high level of accuracy can be achieved by using excessive amounts of immobilized antibodies and labeled antibodies; the disadvantages are: the determination process Washing and separation steps are required in the process, which takes a long time and lacks unit test running time; the degree of automation is not high, and the difference between batches and repeatability are relatively large; different steps need to be equipped with a variety of special equipment, which increases the product to a certain extent. cost

However, it is rare to apply it to clinical testing kits at present. The possible reasons are as follows: In terms of antibodies, the development of domestic antibodies is relatively slow and is still in its infancy. Conventional commercial antibodies mostly rely on imports. There are basically no manufacturers; in foreign countries, mainly in Europe and the United States, the antibody technology is very mature, and high-quality antibodies can be supplied in large quantities, but IgY currently has a small market share, fewer manufacturers and limited supply, and the price is much higher It is used in scientific research and is not suitable as a raw material for reagent manufacturing. At present, there are many main methods for AFP detection kits on the market, mainly chemiluminescence, ELISA, and radioimmunoassay. The latex enhanced method is applied to AFP The detection development is slow and the market share is limited, which is related to insufficient market investment

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