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T3 FIA Test

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
  1. 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%.
  1. Accuracy
T3 control materials with two different concentrations were tested by every lot of test device, and the deviations were within ± 15%.
  1. 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.
  1. 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
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T4 FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
  1. Range
Working range: 10.0-320.0 nmol/L
  1. Precision
Intra-lot Precision Intra-lot precision was determined by testing of T4 reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of T4 reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
  1. Accuracy
T4 control materials with two different concentrations were tested by every lot of test device, and the deviations were within ± 15%.
  1. Linearity
A serial concentration of T4 reference materials at 20.0-320.0 nmol/L was tested, and the correlation coefficient (R) is ≥ 0.9900.
  1. Specificity
The concentration of T4 is not greater than 15 nmol/L when the concentration of T3 is 500.0 ng/mL. The concentration of T4 is not greater than 15 nmol/L when the concentration of rT3 is 50.0 ng/mL. Product Specifications 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
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Testosterone FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
  1. Range
Working range: 0.2-20.0 ng/mL
  1. Precision
Intra-lot Precision Intra-lot precision was determined by testing of TES reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of TES reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
  1. Accuracy
TES control materials with two different concentrations were tested by every lot of test device, and the deviations were within ± 15%.
  1. Linearity
A serial concentration of TES reference materials at 0.2-20.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
  1. Specificity
Crossed Factors Concentration Test Result
Progesterone 500 ng/mL < 0.2 ng/mL
Estradiol 100 ng/mL < 0.2 ng/mL
Cortisol 500 ng/mL < 0.2 ng/mL
Aldosterone 500 ng/mL < 0.2 ng/mL
Estriol 100 ng/mL < 0.2 ng/mL
17α-Estradiol 500 ng/mL < 0.2 ng/mL
Oestrone 50 ng/mL < 0.2 ng/mL
Reagents and Materials provided:
  1. Individually sealed foil pouches containing:
    • One test device
    • 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
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Total IgE FIA Test

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
  1. 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%.
  1. Accuracy
IgE control materials with two different concentrations were tested by every lot of test device, and the deviations were within ± 15%.
  1. Linearity
A serial concentration of IgE reference materials at 1.0-1000 IU/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
  1. 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
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Total Vitamin D FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
  1. Range
Working range: 5.0-120.0 ng/mL
  1. Precision
Intra-lot Precision Intra-lot precision was determined by testing of Vitamin D reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of Vitamin D reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
  1. Accuracy
Vitamin D control materials with two different concentrations were tested by every lot of test device, and the deviations were within ± 15%.
  1. Linearity
A serial concentration of Vitamin D reference materials at 5.0-120.0ng/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. Solution A tube
  4. Solution B tube
  5. SD card
  6. Instructions for Use
  Materials required but not provided:
  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator
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tPSA FIA Test

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
  1. 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%.
  1. Accuracy
tPSA control materials with two different concentrations were tested by every lot of test device, and the deviations were within ± 15%.
  1. 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
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TSH FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES
  • Working range: 0.4–100.0 μIU/mL
PRECISION
  • Intra-lot Precision: Intra-lot precision was determined by testing of TSH reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of TSH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤20%.
ACCURACY 
  • TSH 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 TSH reference materials at 0.4-100.0 μIU/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

F1030

TSH FIA Test

25/kit

 Serum, Plasma
 
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β-hCG FIA Test

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
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