Diagnostic Kit for Anti-mullerian hormone    

(fluorescence immunochromatographic assay)

For in vitro diagnostic use only 

Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

INTENDED USE

Diagnostic Kit for Anti-mullerian hormone (fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of Anti-mullerian hormone (AMH) in human serum or plasma, which is mainly used to assist the evaluation of ovarian reserve function. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.

SUMMARY

AMH is a member of the transformed growth factor beta superfamily. AMH, an active factor secreted by granulosa cells of ovarian sinus follicles, was not expressed in primobasal follicles, but was weakly expressed in primary follicular granulosa cells, and was strongly expressed in sinus follicles ≤4mm, while the expression was gradually reduced to complete disappearance in > 4mm sinus follicles. In males, initial expression in fetal testicular sertoli cells at 8 weeks inhibited the development of muller’s canal. In women, initially expressed in the ovaries of the fetus at 36 weeks, the mullerian tube eventually develops into fallopian tubes, uterus, and upper vaginal segments.

PRINCIPLE OF THE PROCEDURE

The membrane of the test device is coated with anti AMH antibody on the test region and goat anti rabbit IgG antibody on the control region. Lable pad are coated by fluorescence labeled anti AMH antibody and rabbit IgG in advance. When testing positive sample, the AMH antigen in sample combine with fluorescence labeled anti AMH antibody, and form immune mixture. Under the action of the immunochromatography, the complex flow in the direction of absorbent paper, when complex passed the test region, it combined with anti AMH coating antibody, forms new complex. AMH level is positively correlated with fluorescence signal, and the concentration of AMH in sample can be detected by fluorescence immunoassay assay.