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Alpha fetoprotein detection kit and preparation method thereof

A detection kit and alpha-fetoprotein technology, which is applied in the field of immunoassay, can solve the problems of long detection time and narrow linear range, and achieve the effects of excellent accuracy, high sensitivity and high accuracy

Inactive Publication Date: 2018-11-23
山东康华生物医疗科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The detection methods of alpha-fetoprotein in the prior art mainly include enzyme-linked immunoassay, time-resolved fluorescent immunoassay, chemiluminescence, etc. However, these methods have shortcomings such as narrow linear range and long detection time, which cannot meet the clinical needs. A more effective detection method has become the key to clinical application

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  • Alpha fetoprotein detection kit and preparation method thereof
  • Alpha fetoprotein detection kit and preparation method thereof
  • Alpha fetoprotein detection kit and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] A detection kit for alpha-fetoprotein, comprising magnetic microsphere suspension coated with AFP antibody, AFP calibrator, AFP quality control product, AFP tracer, concentrated washing solution and substrate solution.

[0047] The concentration of magnetic microsphere suspension coated with AFP antibody is 1:2000, the AFP tracer is acridinium ester-labeled AFP monoclonal antibody, and the concentration of AFP tracer working solution is 1:1000; AFP calibrator and quality control substances are prepared from AFP standard substance and calibrator solution, and the concentration of AFP calibrator is 0ng / mL, 5ng / mL, 20ng / mL, 100ng / mL, 400ng / mL, 1000ng / mL; The concentration of AFP quality control substance is 20ng / mL, 400ng / mL.

[0048] The calibrator solution is pH7.2PB buffer solution, and each 1L buffer solution also contains 8 casein, 20gNa 2 HPO 4 12H 2 O, 2g Na 2 h 2 PO 4 2H 2 O, 5 mL of calf serum and 0.3 mL of Proclin-300.

[0049] The concentrated washing so...

Embodiment 2

[0071] A detection kit for alpha-fetoprotein, including magnetic microsphere suspension coated with AFP antibody, AFP calibrator, AFP quality control product, AFP tracer working solution, concentrated washing solution, substrate solution and sample diluent .

[0072] The concentration of the magnetic microsphere suspension coated with AFP antibody is prepared according to the ratio of 1:4500; the AFP tracer working solution is the AFP monoclonal antibody solution labeled with acridinium ester according to its dilution ratio of 1:4200 The ratio of AFP calibrator and AFP quality control are prepared by AFP standard and calibrator diluent, the concentrations of AFP calibrator are 0ng / mL, 5ng / mL, 20ng / mL, 100ng / mL , 400ng / mL, 1000ng / mL; the concentration of AFP quality control substance is 20ng / mL, 400ng / mL.

[0073] The concentration of the magnetic microsphere suspension coated with AFP antibody is prepared according to the ratio of 1:4500, and the AFP tracer working solution i...

Embodiment 3

[0100] A detection kit for alpha-fetoprotein, the detection kit includes magnetic microsphere suspension coated with AFP antibody, AFP calibrator, AFP quality control product, AFP tracer working solution, concentrated washing solution, substrate solution and sample diluent. The concentration of the magnetic microsphere suspension coated with AFP antibody is prepared according to the ratio of 1:6000; the AFP tracer working solution is the AFP monoclonal antibody solution labeled with acridinium ester according to its dilution ratio of 1:4500 The ratio of AFP calibrator and the AFP quality control substance are prepared from AFP standard substance and calibrator diluent, and the concentration of AFP calibrator is 0ng / mL, 5ng / mL, 20ng / mL, 100ng / mL, 400ng / mL, 1000ng / mL; the concentration of AFP quality control substance is 20ng / mL, 400ng / mL.

[0101] The calibrator diluent is PB buffer at pH 7.5, and every 1L of buffer also contains 18g casein, 20-35gNa 2 HPO 4 12H 2 O, 4g Na...

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Abstract

The invention relates to the field of immunodetection, and specifically to an alpha fetoprotein detection kit. The alpha fetoprotein detection kit comprises a magnetic microsphere suspension coated with an AFP antibody, an AFP calibrator, an AFP control product, an AFP tracer working solution, a washing concentrate, a substrate solution and a sample diluent. The invention also relates to a preparation method of the kit. The detection kit of the invention has the advantages of accurate detection results, good stability, high specificity, high sensitivity, wide linear range, short detection period and convenient use, and is suitable for popularization and application.

Description

technical field [0001] The invention relates to the field of immune detection, in particular to an alpha-fetoprotein detection kit and a preparation method thereof. Background technique [0002] Alpha-fetoprotein is derived from related tissue cells derived from the embryonic endoderm, mainly produced by fetal stem cells, yolk sac, gastrointestinal tract and reproductive organs, and is the main serum protein of the fetus. With the maturation and differentiation of tissues and organs, the level of AFP gradually decreased. AFP belongs to the albumin-like family. The coding gene is located in the 25th region of the q arm of chromosome 4. The coding product is a glycoprotein containing 591 amino acids with a molecular weight of 68kpa. During mammalian embryonic development, AFP can bind and transport substances such as estradiol, bile pigment, and copper ions, and prevent the masculinization of the fetus. [0003] Studies have shown that there is a close relationship between e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/577G01N33/543
CPCG01N33/54326G01N33/577G01N33/68G01N2333/47
Inventor 杨致亭邱香廷任婧婧翟玉娥杨锋斌
Owner 山东康华生物医疗科技股份有限公司