Place of Origin:
ISO 13485, CE
WWHS AMH Rapid Test Kit Fertility IVD Clinical Diagnosis
Anti-Mullerian Hormone (AMH) Rapid Quantitative Test (Fluorescence immunoassay)
The kit is used for quantitative determination of AMH in human whole blood,serum or plasma. It is mainly used to evaluate ovarian reserve and assist in the diagnosis of polycystic ovary syndrome .
The product consists of fluorescent pat (coated with fluorescently-labeled AMH antibody), nitrocellulose membrane (coated with AMH antibody and Goat anti mouse IgG antibody), absorbent paper and PVC soleplate.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
Test and analyze the AMH from healthy people serum, and use the 95 percentile method to determine the AMH reference interval.
|Sex||Age||Reference Interval (ng/mL)|
It is strongly recommended that each laboratory should determine its own normal and abnormal values.
【Interpretation of test results】
1. Limits of detection
No higher than 0.10ng/mL
The relative deviation to the target value is limited to ±15.0%.
The within and between assay coefficient of variations are within 15%.
Within the linear range (0.10 ~ 16.00) ng/mL, the linear correlation coefficient R≥0.990.
WWHS Assay List
|cat#.||Product Item||Specimen||Reaction Time||Measure Range||Clinical Range||Itended Use|
|34||HCG / β-HCG||Serum/Plasma||10min.||5-20000mIU/ml||<5 mIU/mL||early pregrancy.|
|35||AMH||Serum/Plasma||10min.||0.1-16ng/ml||Male: 20-60 years old, 0.92-13.89 ng/mL
Female: 20-29 years old, 0.88-10.35 ng/mL
30-39 years old, 0.31-7.86 ng/mL 40 -50 years old, <5. 07 ng/mL
|ovarian reserve level|
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