Magnetic microparticle alpha-fetoprotein chemiluminescent immunoassay kit and preparation method thereof

Abstract

The invention belongs to the technical field of biomedicine, and relates to a magnetic microparticle alpha-fetoprotein chemiluminescent immunoassay kit and a preparation method thereof. The magnetic microparticle alpha-fetoprotein chemiluminescent immunoassay kit comprises a: magnetic microparticle suspension coated with an alpha-fetoprotein monoclonal antibody, wherein the coating concentration of the magnetic microparticle solid-phase antibody is 1.0-2.0 [mu]g / T; a series of alpha-fetoprotein calibration products, wherein an alpha-fetoprotein WHO standard substance, bovine serum albumin anda stabilizer are added to a Tris dilution liquid matrix (pH value of 7.4) to prepare the alpha-fetoprotein calibration products; horseradish peroxidase labeled alpha-fetoprotein monoclonal antibody, wherein the horseradish peroxidase labeled alpha-fetoprotein monoclonal antibody is prepared by using a sodium periodate oxidation method; a luminescent substrate solution A; a luminescent substrate solution B; and a washing solution, wherein the washing solution is a phosphate buffer solution containing a stabilizer and a surfactant. According to the present invention, the magnetic microparticle alpha-fetoprotein chemiluminescent immunoassay kit has advantages of low cost, easy automation, simple preparation method, simple and convenient operation and the like, wherein the detection performance meets the international advanced level.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and relates to a magnetic particle alpha-fetoprotein chemiluminescent immunoassay kit and a preparation method thereof. Background technique [0002] Alpha-fetoprotein (AFP) is an embryo-specific alpha-globulin in human fetal serum. It is a single multimer peptide bond protein, composed of 590 amino acids, with a molecular weight of about 70KD and a sugar content of 4%. It is mainly composed of Synthesized by fetal liver and yolk sac, followed by gastrointestinal mucosa, and a small amount by kidney. [0003] Alpha-fetoprotein (AFP) is the most sensitive and specific tumor marker for primary liver cancer discovered so far, and 75-90% of patients with primary liver cancer show elevated levels. By observing the dynamic changes of serum AFP, the patient's disease progression status can be understood. A decrease in the concentration of AFP in a patient's serum after treatment usually indicates ...

AI Technical Summary

Problems solved by technology

[0005] (1) Colloidal gold immunochromatography test (GICA) is a chromatographic detection technology using nitrocellulose membrane as a carrier. Its reagents are stable and easy to store, and it is equipped with a quality control tape for quality monitoring. It is suitable for basic unit detection and easy to operate. A good detection method that is fast and requires no equipment, but the sensitivity is slightly lower and it is only suitable for primary screening

[0006] (2) Solid-phase assay (ELISA) is an enzyme-linked immunosorbent assay. Due to its advantages of long storage time, no hazard and pollution, stable reagents, and automatic detection, it can be rapidly popularized and applied. At present, the detection of various hepatitis virus antigen antibodies is still It is an important diagnostic condition that is widely used, but the sensitivity and linear range of this method are still difficult to meet the requirements of clinical application

[0007] (3) Solid-phase radioimmunoassay (SPRIA) is widely used in the detection of trace amounts of soluble antigens and antibodies, and can also be used in solid tissue immunohistochemistry with a detection sensitivity of ng~fg / ml, but there are still some shortcomings. Recording instruments for measuring radioactive particles are very expensive, and because radioactivity is harmful to operators, and limited by the half-life, specimens cannot be stored for a long time, which limits their wide application, and is currently declining in the clinical diagnostic market in China.

Domestic medical alpha-fetoprotein magnetic particle chemiluminescence diagnostic testing instruments rely on imports, which is the main reason for the high cost of domestic alpha-fetoprotein medical testing

Images