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Anti-mullerian hormone magnetic particle chemiluminescence detection kit

A chemiluminescence reagent, Müllerian hormone technology, applied in chemiluminescence/bioluminescence, analysis by chemical reaction of materials, etc., can solve the problem of RIA method pollution, gas chromatography and mass spectrometry combined method is not suitable for clinical detection , ELISA method has low degree of automation and other problems

Inactive Publication Date: 2019-03-26
BEIJING LEADMAN BIOCHEM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are certain defects in these methods. The RIA method is highly polluted, the ELISA method is low in automation, and the operation is complicated and cumbersome. High performance liquid chromatography, gas chromatography, and gas chromatography and mass spectrometry are not suitable for widespread clinical testing.

Method used

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  • Anti-mullerian hormone magnetic particle chemiluminescence detection kit
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  • Anti-mullerian hormone magnetic particle chemiluminescence detection kit

Examples

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preparation example Construction

[0058] A preparation method of a magnetic particle chemiluminescence detection kit for measuring the content of human anti-Müllerian hormone (AMH), comprising the steps of:

[0059] Preparation of reagent R1: 1) Prepare buffer according to the content of reagent R1 buffer components, adjust pH; 2) Prepare fluorescein isothiocyanate-labeled anti-Müllerian hormone (AMH) monoclonal antibody; 3) Mix isothiocyanate Fluorescein cyanate-labeled anti-Müllerian hormone (AMH) monoclonal antibody was diluted with R1 buffer.

[0060] Preparation of reagent R2: 1) Prepare buffer according to the content of reagent R2 buffer components, and adjust pH; 2) Prepare alkaline phosphatase-labeled anti-Müllerian hormone (AMH) antibody; 3) Alkaline phosphatase-labeled Anti-Müllerian hormone (AMH) antibody was diluted with R2 buffer.

[0061] Preparation of magnetic separation reagents: 1) preparation of buffer solution according to the content of magnetic particle buffer components; 2) preparation...

Embodiment 1

[0072] Example 1 A magnetic particle chemiluminescence detection kit for determining the content of human anti-Müllerian hormone (AMH) includes R1 reagent, R2 reagent, magnetic separation reagent, calibrator solution series and substrate solution.

[0073] In this embodiment, the R1 reagents include: 1) R1 antibody: fluorescein isothiocyanate (FITC)-labeled anti-Müllerian hormone (AMH) monoclonal antibody at a concentration of 1.0-3.0 μg / mL; 2) buffer Solution: including sodium azide, the concentration is 0.989g / L; bovine serum albumin, the concentration is 4.5g / L; trishydroxymethyl aminomethane, the molar concentration is 0.05mol / L; the rest is deionized water. The buffer pH of the R1 reagent is preferably 7.0.

[0074] In this embodiment, the R2 reagent includes: 1) R2 antibody: alkaline phosphatase-labeled anti-Müllerian hormone (AMH) antibody at a concentration of 1.5 μg / ml; 2) buffer solution: including sodium azide at a concentration of 0.989g / L; bovine serum albumin, t...

Embodiment 2

[0078] Example 2 Performance evaluation of the anti-Müllerian hormone (AMH) magnetic particle chemiluminescent detection kit of the present invention

[0079] 1. Minimum detection limit

[0080] Method: Use the zero-concentration calibrator as a sample for detection, repeat the measurement 20 times, obtain the relative luminous intensity (RLU) value of the 20 measurement results, calculate the mean (M) and standard deviation (SD), and obtain M+ 2SD, according to the concentration-RLU between the zero concentration calibrator and the adjacent calibrator, a two-point regression fitting is performed to obtain a linear equation, and the RLU value of M+2SD (positive reaction) or M-2SD (negative reaction) is brought into In the above equation, the corresponding concentration value is obtained, which is the minimum detection limit.

[0081] Qualified standard: <0.05ng / ml

[0082]

[0083] Conclusion: The sensitivity is not greater than 0.05ng / mL, meeting the design requirements....

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Abstract

The invention discloses a preparation method of magnetic particle chemiluminescence detection kit for testing human body anti-mullerian hormone content. The kit contains anti-mullerian hormone R1 reagent, anti-mullerian hormone R2 reagent, a magnetic separation reagent, standard product liquid series and chemiluminescence substrate solution; the anti-mullerian hormone R1 reagent is anti-mullerianhormone monoclonal antibody diluent marked by fluorescein isothiocyanate, the anti-mullerian hormone R2 reagent is anti-mullerian hormone antibody diluent marked by alkaline phosphatase, the magneticseparation reagent is magnetic particle diluent coated by anti-fluorescein isothiocyanate monoclonal antibody, the anti-mullerian hormone standard product liquid is formed by synthesized anti-mullerian hormone and buffer liquid, and the chemiluminescence substrate solution is Tris-HCL buffer liquid which is catalyzed by alkaline phosphatase and contains dioxane. The method greatly improves the signal intensity and sensitivity of immunoreaction, can enable low-content substances to generate a strong chemiluminescence signal when performing immune binding, so as to provide a more accurate, accurate, convenient, rapid and simple method for detection of anti-mullerian hormone.

Description

technical field [0001] The invention relates to the field of medical diagnostic reagents, in particular to a magnetic particle chemiluminescence detection kit for detecting the content of anti-Müllerian hormone in human body by using magnetic particle chemiluminescence technology and antibody combination technology and a manufacturing method thereof. Background technique [0002] Anti-Mullerian hormone (AMH) is a member of the transforming growth factor β superfamily, which was first discovered by Professor Alfred Jost in 1974. AMH is a dimeric glycoprotein composed of two identical 72KD subunits connected by disulfide bonds, with a relative molecular mass of 140KD; the human AMH encoding gene is located on the short arm of chromosome 19, with a size of 2.4-2.8kb and contains 5 exosomes. Exon. [0003] Anti-Müllerian hormone AMH plays an important role in the development of gonad organs, and is one of the important markers of gonad function in men and women. In men, AMH is...

Claims

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Application Information

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IPC IPC(8): G01N21/76
CPCG01N21/76
Inventor 赵丽娜
Owner BEIJING LEADMAN BIOCHEM
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