Features:

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

RANGES:

• Working range: 5.0-200000.0 mIU/mL

PRECISION:

• Intra-lot Precision: Intra-lot precision was determined by testing of β-hCG reference materials using 10 test devices from the same lot. CV ≤ 15%.

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

ACCURACY:

•  β-hCG 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 β-hCG reference materials at 5.0-200000.0 mIU/mL was tested, and the correlation coefficient (R) is ≥0.9900.
• REAGENTS AND MATERIALS PROVIDED:
  1. Individually sealed foil pouches containing: a. One test device b. 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
  4. REAGENTS AND MATERIALS PROVIDED:
     1. Individually sealed foil pouches containing: a. One test device b. 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

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
F1000	β-hCG FIA Test	25/kit	Serum, Plasma

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

RANGES

• Working range: 2.5-400.0 ng/mL

PRECISION

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

ACCURACY

• MYO 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 MYO reference materials at 20.0-400.0 ng/mL was tested, and the correlation coefficient (R) is ≥0.9900.
• REAGENTS AND MATERIALS PROVIDED:
  1. Individually sealed foil pouches containing: a. One test device b. 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

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
F3030	MYO FIA Test	25/kit	Serum, Plasma

 

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