Features:

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

1. Range

Working range: 0.30-80.00 ng/mL

2. Precision

Intra-lot Precision Intra-lot precision was determined by testing of PROG reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of PROG reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

3. Accuracy

PROG 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 PROG reference materials at 3.00-80.00 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.

5. Specificity

Crossed Factors	Concentration	Test Result
Estradiol	500 ng/mL	< 0.3 ng/mL
Testosterone	500 ng/mL	< 0.3 ng/mL
Cortisol	500 ng/mL	< 0.3 ng/mL
Aldosterone	500 ng/mL	< 0.3 ng/mL
Estriol	100 ng/mL	< 0.3 ng/mL
17-β Estradiol	100 ng/mL	< 0.3 ng/mL
Oestrone	100 ng/mL	< 0.3 ng/mL
17-α hydroxyl progesterone	100 ng/mL	< 0.3 ng/mL

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