Features:
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
Range
- Working range: 0.1-30.0 ng/mL
Precision
Intra-lot Precision
- Intra-lot precision was determined by testing of fPSA reference materials using 10 test devices from the same lot. CV ≤ 15%.
Inter-lot Precision
- Inter-lot precision was determined by testing of fPSA reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
Accuracy
- fPSA control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
Linearity
- A serial concentration of fPSA reference materials at 0.1-30.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
- 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
- Individually sealed foil pouches containing: