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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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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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D-Dimer FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES
  • Working range: 0.1–10.0 mg/L
PRECISION
  • Intra-lot Precision Intra-lot precision was determined by testing of D-Dimer reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision Inter-lot precision was determined by testing of D-Dimer reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
ACCURACY
  • D-Dimer 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 D-Dimer reference materials at 0.1–10.0 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

F3010

D-Dimer FIA Test

25/kit

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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

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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

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Progesterone FIA Test

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
  1. 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%.
  1. Accuracy
PROG 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 PROG reference materials at 3.00-80.00 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
  1. 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
Add to wishlist
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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

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MYO FIA Test

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
 
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HbA1c FIA Test

  Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES
  • Working range: 4%–15%
PRECISION
  • Intra-lot Precision Intra-lot precision was determined by testing of HbA1c reference materials using 10 test devices from the same lot. CV ≤ 15%
  • Inter-lot Precision Inter-lot precision was determined by testing of HbA1c reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
ACCURACY
  • HbA1c 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 HbA1c reference materials at 4%–15% 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

F6100

HbA1c FIA Test

25/kit

 Serum, Plasma
Add to wishlist
Read more