- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
LIMITS AND RANGES:
- Working range: 5.0-200000.0 mIU/mL
- Limit of Detection (LoD): 5.0 mIU/mL
- Intra-lot Precision: Intra-lot precision was determined by testing of β-hCG reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot Precision: Inter-lot precision was determined by testing of β-hCG reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
- β-hCG control materials with two different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- A serial concentration of β-hCG reference materials at 5.0-200000.0 mIU/mL was tested, and the correlation coefficient (R) is ≥0.9900.