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CTK Biotech

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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Description

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
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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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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CK-MB FIA Test

Features:
        • Quantitative, non-subjective results
        • Increased sensitivity and broader detection range compared to rapid tests
        RANGES
        • Working range: 1.0-80.0 ng/mL
        PRECISION
        • Intra-lot Precision Intra-lot precision was determined by testing of CK-MB reference materials using 10 test devices from the same lot. CV ≤ 15%.
        • Inter-lot Precision Inter-lot precision was determined by testing of CK-MB reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
        ACCURACY
        • CK-MB 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 CK-MB reference materials at 2.5-80.0 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
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NT-proBNP FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES:
  • Working range: 15–35000 pg/mL
PRECISION:
  • Intra-lot Precision: Intra-lot precision was determined by testing of NT-proBNP reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of NT-proBNP reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
ACCURACY:
  • NT-proBNP control materials with two different concentrations were tested by every lot of test device, and the deviations were within ±15%.
LINEARITY:
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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
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PCT FIA Test

Features: PRODUCT FEATURES
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES
  • Working range: 0.1–100.0 ng/mL
PRECISION
  • Intra-lot Precision Intra-lot precision was determined by testing of PCT reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision Inter-lot precision was determined by testing of PCT reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
ACCURACY
  • PCT control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
LINEARITY
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  • 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
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F0400

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25/kit

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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
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  • 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

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Features:
    •  Quantitative, non-subjective results
    • Increased sensitivity and broader detection range compared to rapid tests
    RANGES
    • Working range: 2.5–200 mg/L
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    • Intra-lot Precision Intra-lot precision was determined by testing of CRP reference materials using 10 test devices from the same lot. CV ≤ 15%.
    • Inter-lot Precision Inter-lot precision was determined by testing of CRP reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
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      2. Detection buffer tubes
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      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

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25/kit

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Features:
    • Quantitative, non-subjective results
    • Increased sensitivity and broader detection range compared to rapid tests
    Range
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    Precision Intra-lot Precision
    •  Intra-lot precision was determined by testing of Cys-C reference materials using 10 test devices from the same lot. CV ≤ 15%.
    Inter-lot Precision
    • Inter-lot precision was determined by testing of Cys-C reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
    Accuracy
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    Linearity
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      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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