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

1. Range

Working range: 1.0-1000.0 IU/mL

2. Precision

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

3. Accuracy

IgE 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 IgE reference materials at 1.0-1000 IU/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.

5. Specificity

No cross reactivities were observed while testing following immunoglobulins with indicated concentrations:

Immunoglobulins	Concentrations	Test Results
IgG	200 mg/mL	≤ 1.0 IU/mL
IgA	20 mg/mL	≤ 1.0 IU/mL
IgM	20 mg/mL	≤ 1.0 IU 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

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

Features:

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

1. Range

Working range: 0.5–10.0 nmol/L

2. Precision

Intra-lot Precision Intra-lot precision was determined by testing of T3 reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of T3 reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

3. Accuracy

T3 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 T3 reference materials at 0.8-10.0 nmol/L was tested, and the correlation coefficient (R) is ≥ 0.9900.

5. Specificity

The concentration of T3 is not greater than 1.0 nmol/L when the concentration of T4 is 500.0 ng/mL. The concentration of T3 is not greater than 1.0 nmol/L when the concentration of rT3 is 50.0 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