- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
RANGES:
- Working range: 0.1–50.00 ng/mL
PRECISION:
- Intra-lot Precision: Intra-lot precision was determined by testing of cTnI reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot Precision: Inter-lot precision was determined by testing of cTnI reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
ACCURACY:
- cTnI control materials with two different concentrations were tested by every lot of test device, and the deviations were within ±15%.
LINEARITY:
- A serial concentration of cTnI reference materials at 0.1–50.00 ng/mL was tested, and the correlation coefficient (R) is ≥0.9900.