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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

COVID-19 IgG/IgM Rapid Test CE

  Features:
  • The OnSite COVID-19 IgG/IgM Rapid Test is designed to detect anti-SARS-CoV-2 IgG and IgM antibodies in either human serum, plasma or whole blood within 15 minutes.
  • This test is easy-to-use, with basic equipment needs.
  • The OnSite COVID-19 IgG/IgM Rapid Test has 97.1% sensitivity and 97.8% specificity, making it one of the most effective tests for detecting previous exposure to anti-SARS-CoV-2 virus.
  • Finger prick specimen allows testing at point-of-care, saving crucial time.
  • Complementary to PCR by detecting immune response
  • Compatible with CTK Rapid Test Reader (RTR-1)
    • 200 tests per hour in batch mode
    • Capable of connecting to Laboratory Information System (LIS)
    • Built-in barcode reader provides faster test setup
    • Stores up to 1,000 results, presented on screen, via printout, or uploaded to database
    • Reagents and Materials provided:
      1. Individually sealed foil pouches containing:
        1. One cassette device
        2. One desiccant
      2. Disposable capillary tubes, marked for 10 µL and 20 µL
      3. Detection buffer (tris-based buffered solution with preservatives)
      4. Instructions for Use
      Materials Required but not provided:
      1. Clock, watch or other timing device
      2. Pipettor capable of delivering 10-20 μL of sample, that can be used instead of the disposable capillary tube for greater accuracy
      3. Sterile lancets, sterile gauze and wipes for fingerstick whole blood specimens
      4. Collection devices for venous whole blood, serum, plasma
      5. Disposable gloves, biohazard disposal container
CATALOG # PRODUCT QUANTITY SPECIMEN

R0180C

COVID-19 IgG/IgM Rapid Test CE

30/kit

S, P &WB

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

Dengue IgG/IgM Combo Rapid Test CE

Features:
  • Utilizes recombinant chimeric dengue virus licensed from the US CDC
  • Detects all four dengue serotypes
  • IgM detection indicates recent infection
  • IgG detection indicates recent or previous infections
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • 5 µL capillary tubes
  • Sample diluent (REF SB-R0061, 5 mL/bottle)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0061C

Dengue IgG/IgM Combo Rapid Test CE

30/kit

S, P &WB
 

GE100 Blood Glucose Test Strips

Features:
  • Packaging: 2 vials of 25 strips
  • Gold electrode test strips
  • Auto coding
  • Minimum sample volume
  • Test Time: 5 seconds
  • Storage Condition: 4 – 30 °C ( 39 – 86 °F ), <90% Relative Humidity

RSV Ag Rapid Test CE

  Features:
  • No cross-reactivity with 30+ common pathogens
  • CE mark approved for sale in Europe
  • Ergonomic, user-friendly extraction tube that minimizes contamination
  • Initial patient care action can begin during the patient’s visit as positive results are visible in as soon as 3 minutes
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Sample extraction tubes
  • Sample extraction buffer
  • Nozzle with Filter
  • Sterile swabs, each sealed in a plastic-paper pouch
  • Instructions for Use
CATALOG # PRODUCT QUANTITY SPECIMEN

R0186C

RSV Ag Rapid Test CE

20/kit

Swab

COVID-19 Ag Rapid Test CE

  Features:
  • The OnSite COVID-19 Ag Rapid Test has 92.3% sensitivity and 100% specificity, aiding in early diagnosis by detecting viral components.
  • The OnSite COVID-19 Ag Rapid Test is a qualitative antigen detection test that provides results in 15 minutes.
  • This test is easy to use and does not require the use of laboratory equipment.
  • Compatible with CTK Rapid Test Reader (RTR-1)
    • 200 tests per hour in batch mode
    • Capable of connecting to Laboratory Information System (LIS)
    • Built-in barcode reader provides faster test setup
    • Stores up to 1,000 results, presented on-screen, via printout, or uploaded to a database
    • Reagents and Materials Provided:
      1. Individually sealed foil pouches containing:
        1. One cassette device
        2. One desiccant
      2. Sample extraction tubes
      3. Sample extraction tube rack
      4. Sample extraction buffer
      5. Nozzles
      6. Sterile swabs, each sealed in a plastic-paper pouch
      7. Instructions for Use
      Materials Required but Not Provided:
      • Clock or timer
      Materials May be Required but Not Provided:
      • Positive control
      • Negative control
      • Nasal swab
CATALOG # PRODUCT QUANTITY SPECIMEN

R0182C

COVID-19 Ag Rapid Test CE

20/kit

Swab

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