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CTK Biotech

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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Description

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
Additional information
Brand

CTK Biotech

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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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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
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Immunofluorescence Incubator

ACCURACY: • Incubation system control temperature variation ≤± 0.1℃ EASE-OF-USE: • Simple temperature adjustment • Easy incubation time-setting for each channel • Portable and lightweight (1.4 kg) • Incubation completion reminder chime for user convenience • 6-channel incubator to increase throughput
SPECIFICATIONS
Dimensions: 255(L)×135(W)×40(H)mm
Weight: 1.4 kg
Power Adapter: 100-240 VAC, 50 Hz, 60W
Temperature Setting: 20~40℃
Time Setting: 3~30 min
OPERATION CONDITIONS
Temperature: 10~30℃
Humidity: ≤95%
Atmosphere Pressure: 85.0~106.0KPa
Operation Altitude: ＜2000m
STORAGE CONDITIONS
Temperature: 0~55℃
Humidity: ≤80%
 
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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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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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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

 Serum, Plasma
 
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SNIBE Maglumi 800

Features:
  • Principle: Chemiluminescence Immunoassay (CLIA) System
  • Throughput: up to 180 tests per hour
  • Sample Position: up to 40 sample tubes
  • Continuous sample loading, STAT available
  • Reagent Position: 9 reagents on board
  • Refrigerated reagent area
  • Reagent RFID Tag with built-in master curve and information
  • Calibration stability: maximum of 4 weeks
  • Probe: Liquid Level Detection, Clot Detection
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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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