tPSA FIA Test

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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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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Total IgE FIA Test

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

Range

Working range: 1.0-1000.0 IU/mL

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%.

Accuracy

IgE 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 IgE reference materials at 1.0-1000 IU/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.

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:

Individually sealed foil pouches containing:
1. One test device
2. One desiccant
Detection buffer tubes
SD card
Instructions for Use

Materials required but not provided:

Clock or timer
RaFIA Immunofluorescence Analyzer
RaFIA Immunofluorescence Incubator

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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	Plasma, Whole blood

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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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Immunofluorescence Analyzer

ACCURACY:

Less than 3% intra-run CV
Eliminates subjective interpretation by operator
Results comparable to lab-based CLIA analyzer

EASE-OF-USE:

System uses an SD card to ensure the proper test is being run
Able to run whole blood, serum, plasma and urine specimens
Touch screen interface for easy operation
Lightweight (2.9 kg) and portable

DATA MANAGEMENT:

Results presented on screen or via the built-in printer
Storage capacity of 10,000 test results

SPECIFICATIONS
Human Machine Interface:	4.3-inch LCD touch screen
Dimensions:	280(L)×256(W)×102(H)mm
Weight:	2.9 kg
Power Adapter:	100-240 VAC, 50-60Hz
Data output:	On screen/Printer

OPERATION ENVIRONMENT
Temperature:	10~30℃
Humidity:	≤70%
Atmosphere pressure:	85.0~106.0 Kpa
Operation Altitude:	＜2000m
Location:	Dry, clean, flat, horizontal surface, away from direct sunlight, mechanical vibration, and strong electromagnetic interference.