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HomeImmunologyFluorescence Immunoassay Tests Total IgE FIA Test
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CTK Biotech

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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Categories: Fluorescence Immunoassay Tests, Immunology
  • Description
  • Additional information
Description

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
Additional information
Brand

CTK Biotech

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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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LH FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES
  • Working range: 1.0-200.0 mIU/mL
PRECISION
  • Intra-lot Precision Intra-lot precision was determined by testing of LH reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision Inter-lot precision was determined by testing of LH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
ACCURACY
  • LH 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 LH reference materials at 1.0-200.0 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

F1090

LH FIA Test

25/kit

Serum, Plasma
 
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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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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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CEA FIA Test

Features:
      • Quantitative, non-subjective results
      • Increased sensitivity and broader detection range compared to rapid tests
      • Range
        •  Working range: 0.5-500.0 ng/mL
        Precision  Intra-lot Precision
        •  Intra-lot precision was determined by testing of CEA reference materials using 10 test devices from the same lot.  CV ≤ 15%.
        Inter-lot Precision
        •  Inter-lot precision was determined by testing of CEA reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
        Accuracy
        • CEA 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 CEA reference materials at 1-500.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
        Hook Effect
        •  There is no Hook effect when the level is 100000.0 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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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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SNIBE Maglumi 600

Features:
  • Principle: Chemiluminescence Immunoassay (CLIA) System
  • Throughput: up to 180 tests per hour
  • Sample Position: up to 16 sample tubes
  • Continuous sample loading, STAT available
  • Reagent Position: 4 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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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
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About LabSolution Technologies

LabSolution Technologies, Inc. has its headquarters in Cebu City, “The Queen City of the South”. A professional healthcare company established on March 2006 as ALP Diagnostix and later incorporated as LabSolution Technologies, Inc. on June 2008.

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Locations

  • Cebu: 3rd floor, ALP Tower, 609 Tres de Abril St, Cebu City, Cebu
  • Manila: Unit A, # 286 El Grande Avenue, Phase 3, BF Homes, Parañaque City
  • Davao: Gov. Generoso St., Osmeña, Davao City

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