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Quantitative detection kit combining magnetic particles with chemiluminescence immunoassay for beta human chorionic gonadotropin (beta-hCG), and preparation method of kit

A chorionic gonadotropin and chemiluminescence immunological technology, applied in the field of immunoassay medicine, can solve the problems of short validity period of reagents, narrow detection range, low sensitivity and the like, and achieve the effects of good stability, simple operation and high sensitivity

Active Publication Date: 2013-03-27
BIOSCIENCE (TIANJIN) DIAGNOSTIC TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The problem to be solved by the present invention is to provide β-hCG chemiluminescent immunoquantitative detection kit and its preparation method, avoiding the shortcomings of radioimmunoassay reagents such as short validity period, radioactive pollution, cumbersome operation, etc., and solve the problem of low sensitivity, detection Narrow scope, high cost defects

Method used

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  • Quantitative detection kit combining magnetic particles with chemiluminescence immunoassay for beta human chorionic gonadotropin (beta-hCG), and preparation method of kit
  • Quantitative detection kit combining magnetic particles with chemiluminescence immunoassay for beta human chorionic gonadotropin (beta-hCG), and preparation method of kit
  • Quantitative detection kit combining magnetic particles with chemiluminescence immunoassay for beta human chorionic gonadotropin (beta-hCG), and preparation method of kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1: Preparation of β-human chorionic gonadotropin (β-hCG) magnetic particle chemiluminescent immunoquantitative assay kit I

[0037] (1) Preparation of β-hCG calibrator:

[0038] The β-hCG antigen was prepared into a calibrator concentrated stock solution with a calibrator diluent containing 50% bovine serum, calibrated with the enterprise calibrator, and diluted with the calibrator diluent to the working concentration, respectively 0, 5, 25, 100, 250, 1000mIU / mL;

[0039] The preparation method of the above-mentioned β-hCG enterprise standard product: the β-hCG antigen is made into the calibrator concentrated stock solution with the calibrator diluent of 50% bovine serum, and the value is determined by the national standard product. The concentrated stock solution of the calibrator is diluted with the diluent of the calibrator to each point of the working concentration, and then each point of the working concentration is calibrated with the national standard; s...

Embodiment 2

[0065] Example 2: Preparation of β-human chorionic gonadotropin (β-hCG) magnetic particle chemiluminescent immunoquantitative assay kit II

[0066] (1) Preparation of β-hCG calibrator:

[0067] Same as the preparation of Example 1β-hCG calibrator.

[0068] (2) Preparation of β-hCG quality control substance:

[0069] Dilute the β-hCG antigen with the calibrator diluent containing 50% bovine serum to make a concentrated stock solution, and after setting the value with the enterprise calibrator, dilute it with the calibrator diluent to 10mIU / mL low-value quality control And 500mIU / mL high-value quality control.

[0070] (3) Preparation of magnetic particle-streptavidin suspension:

[0071] Take 100mL0.1mol / L 2-morpholineethanesulfonic acid solution (MES solution), add 10mg magnetic particles and 3mg streptavidin (SA) in turn, stir for 30min, then add 10mg / mL carbodiimide hydrochloride Solution (1-ethyl-(3-dimethylaminopropyl, EDC) 3.5uL, after reacting for 1h, use a magnetic ...

Embodiment 3

[0082]Example 3: Preparation of β-human chorionic gonadotropin (β-hCG) magnetic particle chemiluminescent immunoquantitative assay kit III

[0083] (1) Preparation of β-hCG calibrator:

[0084] With the preparation of embodiment 1β-hCG calibrator

[0085] (2) Preparation of β-hCG quality control substance:

[0086] Dilute the β-hCG antigen with the calibrator diluent containing 50% bovine serum to make a concentrated stock solution, and after setting the value with the enterprise calibrator, dilute it with the calibrator diluent to a low-value quality control product of 12mIU / mL And 400mIU / mL high-value quality control.

[0087] (3) Preparation of magnetic particle-streptavidin suspension:

[0088] Take 100mL0.1mol / L 2-morpholineethanesulfonic acid solution (MES solution), add 10mg magnetic particles and 3mg streptavidin (SA) in turn, stir for 30min, then add 10mg / mL carbodiimide hydrochloride Solution (1-ethyl-(3-dimethylaminopropyl, EDC) 3.5uL, after reacting for 1h, use...

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Abstract

The invention discloses a quantitative detection kit combining magnetic particles with chemiluminescence immunoassay for beta human chorionic gonadotropin (beta-hCG). The kit comprises beta-hCG calibrators, magnetic particle suspension coupled with streptavidin, a beta-hCG antibody labeled with biotin, a beta-hCG abzyme combination, a beta-hCG quality controller, chemiluminescence liquor A, chemiluminescence liquor B, 20 times concentrated washing liquor, and a reaction tube, wherein enzyme adopted by the beta-hCG abzyme combination is horse radish peroxidase with the purity RZ being more than or equal to 3.0 and the activity being more than or equal to 250U / ml. The invention also discloses a preparation method of the kit. Compared with the conventional kit, the quantitative detection kit is simple and convenient to operate, is safe, does not cause environment pollution, and also has the advantages of wide concentration range, low cost, good stability and the like of detection samples.

Description

technical field [0001] The invention relates to the field of immunoanalysis medicine. Specifically, the invention provides a β-human chorionic gonadotropin (β-hCG) magnetic particle chemiluminescent immunoquantitative detection kit and a preparation method thereof. Background technique [0002] Human chorionic gonadotropin (Human Chorionic Gonadotropin, HCG) is a glycoprotein hormone secreted by placental trophoblast cells, which is specifically secreted during pregnancy, and is also secreted by trophoblast lesions and some incompletely differentiated tumors. Its physiological function is to delay the degeneration of the corpus luteum of the ovary, thereby maintaining the physiological level of progesterone, which plays an important role in the early stages of pregnancy. HCG also affects immune tolerance during pregnancy, ensuring that the fetus is not attacked by the mother's immune system. In addition, HCG has also been reported to be related to embryo implantation and ea...

Claims

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Application Information

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IPC IPC(8): G01N33/76
Inventor 刘萍张影宋启超范利花
Owner BIOSCIENCE (TIANJIN) DIAGNOSTIC TECH CO LTD
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