Features:
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Range
Working range: 10.0-320.0 nmol/L
- Precision
Intra-lot Precision
Intra-lot precision was determined by testing of T4 reference materials using 10 test devices from the same lot. CV ≤ 15%.
Inter-lot Precision
Inter-lot precision was determined by testing of T4 reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
- Accuracy
T4 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 T4 reference materials at 20.0-320.0 nmol/L was tested, and the correlation coefficient (R) is ≥ 0.9900.
- Specificity
The concentration of T4 is not greater than 15 nmol/L when the concentration of T3 is 500.0 ng/mL.
The concentration of T4 is not greater than 15 nmol/L when the concentration of rT3 is 50.0 ng/mL.
Product Specifications
Reagents and Materials provided:
- Individually sealed foil pouches containing:
- One test device
- One desiccant
- Detection buffer tubes
- SD card
- Instructions for Use
Materials required but not provided:
- Clock or timer
- RaFIA Immunofluorescence Analyzer
- RaFIA Immunofluorescence Incubator