Lab Solutions

LabSolution Technologies, Inc. is supported by leading global diagnostic companies.

LabSolution Technologies, Inc. prioritizes service above all other things. We have long term client and relationship because of how we stand firmly in providing the best support we give to them.

FEATURE PRODUCTS

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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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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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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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T4 FIA Test

Features:

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

Range

Working range: 10.0-320.0 nmol/L

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%.

Accuracy

T4 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 T4 reference materials at 20.0-320.0 nmol/L was tested, and the correlation coefficient (R) is ≥ 0.9900.

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:

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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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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Goldsite GBA-1000

Features:

Methods: End-point, fixed time, kinetic, turbidimetry
Throughput: up to 100 test per hour
Reagent Position: 45 positions
Display: 10.4 inch color touch screen
Reaction Disk: 8 x 10 cuvettes
Printer: Built-in thermal printer

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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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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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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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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:

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

MATERIALS REQUIRED BUT NOT PROVIDED:

Clock or timer
RaFIA Immunofluorescence Analyzer
RaFIA Immunofluorescence Incubator

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
F1030	TSH FIA Test	25/kit	Serum, Plasma

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Rubella IgG/IgM Rapid Test

Features:

For obstetric and symptomatic patient screening, an easy to use, fast, cost-effective test for determining specific antibody levels for Rubella
The first rapid test to discriminate between patients at risk for, protected from or currently experiencing rubella infection
Four line format allows simultaneous detection of IgM and IgG anti-rubella virus saving time and cost
Single test differentiates high (≥250 IU/mL) and low (15-250 IU/mL) IgG anti-rubella virus levels, no need for ELISA test
Ten minute test time reduces result turn around time
Standardized with the WHO 1st International Standard for anti-rubella immunoglobulin (RUBI-1-94)
High correlation with ELISA results on the BBI Mixed Titer Performance Panel PTR-201
Individually sealed foil pouches containing:
- One cassette device
- One desiccant
Capillary tubes (10 µL)
Sample diluent (REF SB-R0243, 5 mL/bottle)
Package insert (instruction for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0243C	Rubella IgG/IgM Rapid Test	30/kit	S,P& WB

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VIEW ALL PRODUCTS

LabSolution Technologies, Inc. is supported by leading global diagnostic companies.

FEATURE PRODUCTS

Adenovirus Ag Rapid Test CE

R0189C

Adenovirus Ag Rapid Test CE

20/kit

AFP FIA Test

AMH FIA Test

CEA FIA Test

Chagas Ab Combo Rapid Test CE

R0171C

Chagas Ab Combo Rapid Test CE

30/kit

CATEGORIES

Blood Gas and Electrolytes Machine (3)

Hematology (4)

Chemistry (17)

Chemistry Machine (9)

Immunology (32)

CTK Biotech (41)

MORE PRODUCTS

F6100

HbA1c FIA Test

25/kit

F1080

PRL FIA Test

25/kit

F0410

CRP FIA Test

25/kit

F1030

TSH FIA Test

25/kit

R0243C

Rubella IgG/IgM Rapid Test

30/kit