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】
- 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.
- Venous blood was collected according to routine laboratory methods
to avoid hemolysis.
- 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.
- 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.
| Sex | Age | Reference Interval (ng/mL) |
| Adult male | ～ | 0.92～13.89 |
| Female | 20～29 | 0.88～10.35 |
| 30～39 | 0.31～7.86 |
| 40～50 | ≤5.07 |
It is strongly recommended that each laboratory should determine
its own normal and abnormal values.
【Interpretation of test results】
- The kit can be used for auxiliary test only. If test result is
abnormal, retest timely and judge combined with clinical symptoms.
- 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%.
- Precision
The within and between assay coefficient of variations are within
15%.
- Linear range
Within the linear range (0.10 ~ 16.00) ng/mL, the linear
correlation coefficient R≥0.990.
WWHS Assay List
| Fertility | | | | | |
| 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 |
