- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
RANGES
- Working range: 0.4–100.0 μIU/mL
PRECISION
- Intra-lot Precision: Intra-lot precision was determined by testing of TSH reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot Precision: Inter-lot precision was determined by testing of TSH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤20%.
ACCURACY
- TSH 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 TSH reference materials at 0.4-100.0 μIU/mL was tested, and the correlation coefficient (R) is ≥0.9900.
