- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Working range: 0.30-200.00 mIU/mL
- Intra-lot Precision
Intra-lot precision was determined by testing of FSH reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot Precision
Inter-lot precision was determined by testing of FSH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
- FSH control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%
- A serial concentration of FSH reference materials at 1.00-200.00 mIU/mL was tested, and the correlation coefficient (R) is ≥0.9900.