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HomeImmunologyFluorescence Immunoassay Tests tPSA FIA Test
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CTK Biotech

tPSA FIA Test

Features:

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

Working range: 0.5-200.0 ng/mL

  1. Precision

Intra-lot Precision

Intra-lot precision was determined by testing of tPSA reference materials using 10 test devices from the same lot. CV ≤ 15%.

Inter-lot Precision

Inter-lot precision was determined by testing of tPSA reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

  1. Accuracy

tPSA 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 tPSA reference materials at 0.5-200.0 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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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: 0.5-200.0 ng/mL

  1. Precision

Intra-lot Precision

Intra-lot precision was determined by testing of tPSA reference materials using 10 test devices from the same lot. CV ≤ 15%.

Inter-lot Precision

Inter-lot precision was determined by testing of tPSA reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

  1. Accuracy

tPSA 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 tPSA reference materials at 0.5-200.0 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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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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Edan M16

Features:
  • Principle: GMR Technology
  • Innovative micro-array sensor and micro-fluidic technology
  • Sample Volume: 50μl
  • Display: 8.9 inch color LCD Display
  • Throughput: Results in 15 minutes after sample aspiration
  • Built-in thermal printer
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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

Serum, Plasma
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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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MAU FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES:
  • Working range: 2.0-300.0 mg/L
PRECISION:
  • Intra-lot Precision: Intra-lot precision was determined by testing of MAU reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of MAU reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
ACCURACY:
  • MAU 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 MAU reference materials at 2.0-300.0 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

F2020

MAU FIA Test

25/kit

Urine
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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:
  • A serial concentration of NT-proBNP reference materials at 15–35000 pg/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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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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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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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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