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CTK Biotech

CRP FIA Test

Features:

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

    RANGES

    • Working range: 2.5–200 mg/L

    PRECISION

    • 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%.

    ACCURACY

    • CRP 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 CRP reference materials at 2.5–200 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

F0410

CRP FIA Test

25/kit

 Serum, Plasma, Whole blood

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Description

Features:

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

    RANGES

    • Working range: 2.5–200 mg/L

    PRECISION

    • 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%.

    ACCURACY

    • CRP 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 CRP reference materials at 2.5–200 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

F0410

CRP FIA Test

25/kit

 Serum, Plasma, Whole blood
Additional information
Brand

CTK Biotech

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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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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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PRL FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES
  • Working range: 5.0-4000.0 μIU/mL
PRECISION
  • Intra-lot Precision Intra-lot precision was determined by testing of PRL reference materials using 10 test devices from the same lot. CV ≤ 15%
  • Inter-lot Precision Inter-lot precision was determined by testing of PRL reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
ACCURACY
  • PRL 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 PRL reference materials at 5.0-4000.0 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

F1080

PRL FIA Test

25/kit

 Serum, Plasma
 
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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
  • A serial concentration of PCT reference materials at 0.1–100.0 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

F0400

PCT FIA Test

25/kit

 Serum, Plasma, Whole blood
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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
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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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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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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