Human anti-mullerian hormone gold immunochromatographic detection kit and method thereof

Abstract

The invention discloses a human anti-mullerian hormone gold immunochromatographic detection kit and a method thereof. The detection kit comprises a reagent clamping shell, a baseboard arranged inside the reagent clamping shell, a sample pad disposed at one end of the baseboard, a colloidal gold pad with one end pressing against the sample pad, a detection pad with one end pressing against the other end of the colloidal gold pad and an absorption pad contacted with the other end of the detection pad, wherein the colloidal gold pad contains colloidal gold nanoparticles and a first antibody bound to mouse-anti-human AMH, and a detection line and a quality control line which are misaligned are distributed on the detection pad. The detection line contains a second mouse-anti-human AMH antibody, and the quality control line contains a third anti-first-antibody antibody. According to the invention, concentration of AMH in female serum can be rapidly and instantly detected so as to be used in evaluating activity and storing capacity of ovums in a woman's ovary. The detection kit is accurate and fast and has high sensitivity. No professionals are needed to operate the kit. In addition, the kit is low-cost and is convenient to promote and use.

Description

technical field [0001] The invention relates to the field of rapid detection of colloidal gold immunochromatography, in particular to a colloidal gold immunochromatographic detection kit and method for human anti-Müllerian hormone. Background technique [0002] Anti-Müllerian hormone (AMH), as a new indicator for evaluating women's ovarian function, compared with the traditional evaluation of follicle stimulating hormone (FSH) level, inhibin B (INH) level and number of ovarian follicles, etc. As an indicator of ovarian function, AMH remains constant during the menstrual cycle of the tester, and the level of serum AMH does not change with the fluctuation of gonadal hormones. Therefore, the detection of AMH is not restricted by the female menstrual cycle and can be detected at any time. One of the main problems faced by obstetrics and reproductive departments. AMH is a dimeric glycoprotein formed by two identical 70KD subunits through a disulfide bond. In women, AMH is direct...

AI Technical Summary

Problems solved by technology

The conventional European and American detection method is the method of enzyme-linked immunoassay AMH kit, but it is time-consuming, low sensitivity, high background value, easy to cause false positive and false negative results, and requires professional personnel to perform experimental operations

Therefore, methods such as chemiluminescence are gradually replaced at present, but such methods, such as Roche's ELECSYSAMH detector, are still closed systems, expensive, and require special training for instrument users, high maintenance and testing costs, and are not suitable for promotional use

The above are the main methods for detecting AMH in European and American countries. At present, there are no kits for detecting AMH with independent intellectual property rights in my country, and they mainly rely on imports. These imported reagents are expensive and require professional and technical personnel to operate. The detection is complicated. Time-consuming, not conducive to the widespread development of AMH testing in China

[0004] At present, my country has opened the two-child policy, and in vitro fertilization and other technologies have been promoted in my country to a certain extent, so the number of women who need to determine the ovarian level and prepare for pregnancy has increased sharply. However, there is no AMH clinical diagnostic kit with independent intellectual property rights in my country, which is currently used in the mainstream AMH detection kits mainly rely on imports and are not suitable for promotion and use

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