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AMH FIA Test
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CTK Biotech

AFP FIA Test

Features:

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

Range

  • Working range: 3.0-2000.0 ng/mL

Precision

Intra-lot Precision

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

Inter-lot Precision

  • Inter-lot precision was determined by testing of AFP reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.

Accuracy

  • AFP 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 AFP controls at 3.0-2000.0 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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Description

Features:

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

Range

  • Working range: 3.0-2000.0 ng/mL

Precision

Intra-lot Precision

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

Inter-lot Precision

  • Inter-lot precision was determined by testing of AFP reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.

Accuracy

  • AFP 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 AFP controls at 3.0-2000.0 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

 

Additional information
Brand

CTK Biotech

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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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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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cTnI FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES:
  • Working range: 0.1–50.00 ng/mL
PRECISION: 
  • Intra-lot Precision: Intra-lot precision was determined by testing of cTnI reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of cTnI reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
ACCURACY:
  • cTnI 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 cTnI reference materials at 0.1–50.00 ng/mL was tested, and the correlation coefficient (R) is ≥0.9900.
    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

F3002

cTnI FIA Test

25/kit

  Plasma, Whole blood
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fPSA FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
Range
  • Working range: 0.1-30.0 ng/mL
Precision Intra-lot Precision
  • Intra-lot precision was determined by testing of fPSA reference materials using 10 test devices from the same lot.  CV ≤ 15%.
Inter-lot Precision
  • Inter-lot precision was determined by testing of fPSA reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
Accuracy
  • fPSA 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 fPSA reference materials at 0.1-30.0 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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FSH FIA Test

  Features:
    • Quantitative, non-subjective results
    • Increased sensitivity and broader detection range compared to rapid tests
    RANGES
    • Working range: 0.30-200.00 mIU/mL
    PRECISION
    • Intra-lot Precision Intra-lot precision was determined by testing of FSH reference materials using 10 test devices from the same lot. CV ≤ 15%.
    • Inter-lot Precision Inter-lot precision was determined by testing of FSH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
    ACCURACY
    • FSH 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 FSH reference materials at 1.00-200.00 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
CATALOG # PRODUCT QUANTITY SPECIMEN

F1100

FSH FIA Test

25/kit

 Serum, Plasma
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MAU FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES:
  • Working range: 2.0-300.0 mg/L
PRECISION:
  • Intra-lot Precision: Intra-lot precision was determined by testing of MAU reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of MAU reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
ACCURACY:
  • MAU 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 MAU reference materials at 2.0-300.0 mg/L 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

F2020

MAU FIA Test

25/kit

 Urine
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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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AMH FIA Test

Features:
    • Quantitative, non-subjective results
    • Increased sensitivity and broader detection range compared to rapid tests
    1. Range
    Working range: 0.1-25.0 ng/mL
    1. Precision
    Intra-lot Precision Intra-lot precision was determined by testing of AMH reference materials using 10 test devices from the same lot. CV ≤ 10%. Inter-lot Precision Inter-lot precision was determined by testing of AMH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
    1. Accuracy
    AMH 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 AMH reference materials at 0.1-25.0 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
Add to wishlist
Read more