Features:

• Quantitative, non-subjective results
• Increased sensitivity and broader detection range compared to rapid tests

1. Range

Working range: 0.5-200.0 ng/mL

2. Precision

Intra-lot Precision

Intra-lot precision was determined by testing of tPSA reference materials using 10 test devices from the same lot. CV ≤ 15%.

Inter-lot Precision

Inter-lot precision was determined by testing of tPSA reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

3. Accuracy

tPSA control materials with two different concentrations were tested by every lot of test device, and the deviations were within ± 15%.

4. Linearity

A serial concentration of tPSA reference materials at 0.5-200.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.

Reagents and Materials provided:

1. Individually sealed foil pouches containing:
   1. One test device
   2. One desiccant
2. Detection buffer tubes
3. SD card
4. Instructions for Use

Materials required but not provided:

1. Clock or timer
2. RaFIA Immunofluorescence Analyzer
3. RaFIA Immunofluorescence Incubator