WWHS AMH Rapid Test Kit Fertility IVD Clinical Diagnosis

AMH.pdf

【Product Name】

Anti-Mullerian Hormone (AMH) Rapid Quantitative Test (Fluorescence immunoassay)

【Intended Use】

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 .

【Components】

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.

【Applicable Instrument】

NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.

【Sample Requirements】

1. Plasma, serum and whole blood can be used as samples. The whole blood should be collected in a tube containing heparin, citrate or EDTA as the anticoagulant. If the serum procedure is used, collect blood in a tube without anticoagulant and allow clotting. Hemolyzed samples should not be used.
2. Venous blood was collected according to routine laboratory methods to avoid hemolysis.
3. It is highly recommended to use fresh samples instead of keeping the samples at room temperature for a long time. After samples were collected, the detection should be completed within 4 hours at room temperature (15℃~30℃). The whole blood sample can be stored at 2℃~8℃ for 24 hours. Plasma and serum samples can be stored at 2℃~ 8℃ for 7 days, -20℃for 30 days.
4. Before testing, the sample should return to room temperature (15℃~30℃). The frozen samples should be completely thawed, rewarming and mixed evenly before use. Repeated freeze-thaw cycles should be avoided

【Reference Interval】

Test and analyze the AMH from healthy people serum, and use the 95 percentile method to determine the AMH reference interval.

It is strongly recommended that each laboratory should determine its own normal and abnormal values.

【Interpretation of test results】

1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.
2. For samples whose AMH concentration is lower than 0.10ng/mL and higher than 16.00ng/mL, test result is “0.10ng/mL” and “16.00ng/mL” respectively

【Performance】

1. Limits of detection

No higher than 0.10ng/mL

2. Accuracy

The relative deviation to the target value is limited to ±15.0%.

3. Precision

The within and between assay coefficient of variations are within 15%.

4. Linear range

Within the linear range (0.10 ~ 16.00) ng/mL, the linear correlation coefficient R≥0.990.

WWHS Assay List