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Duo Dengue Ag-IgG/IgM Rapid Test CE

Features:
  • Utilizes recombinant chimeric dengue virus licensed from the US CDC
  • Detects all four dengue serotypes
  • Duo test format minimizes processing time
  • IgM detection indicates recent infection
  • IgG detection indicates recent or previous infections
  • Ag detection indicates a current infection
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • 5 µL Capillary tubes (for Dengue IgG/IgM test)
  • Plastic droppers (for Dengue Ag test)
  • Sample diluent (REF SB-R0062, 5 mL/bottle)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0062C

Duo Dengue Ag-IgG/IgM Rapid Test CE

30/kit

S, P &WB

HSV-1 IgG/IgM Rapid Test CE

Features:
    • Type-specific detection by utilizing glycoprotein G1.
    • Single test that detects and differentiates IgG and IgM anti-HSV-1.
    • High confidence as test is in agreement with market leading ELISA test: 90.7% IgG; 85.0% IgM.
    • Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation.
    • Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient.
    • Initial treatment action can begin during the patient’s visit as test results are available in 10 minutes.
    • Easily transported, and can be stored for 24 months, 2-30oC.
    • Individually sealed foil pouches containing:
      • One cassette device
      • One desiccant
    • Capillary tubes (10 µL)
    • Sample diluent (REF SB-R0203, 5 mL/bottle)
    • Package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0203C

HSV-1 IgG/IgM Rapid Test CE

30/kit

S,P& WB

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:
  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

F1030

TSH FIA Test

25/kit

Serum, Plasma
 

Ferritin FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES
  • Working range: 1.0-1000.0 ng/mL
PRECISION
  • Intra-lot Precision Intra-lot precision was determined by testing of Ferritin reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision Inter-lot precision was determined by testing of Ferritin reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
ACCURACY
  • Ferritin 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 Ferritin reference materials at 2.0-1000.0 ng/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

F5010

Ferritin FIA Test

25/kit

Serum, Plasma
 

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

Malaria Pf/Pv Ab Combo Rapid Test CE

Features:
  • Uses serum, plasma or whole blood specimens
  • Utilizes highly purified antigen to ensure test sensitivity and specificity
  • Detects total antibodies to Pf and Pv
  • Ease of use, requires minimal training of personnel
  • Quick turnaround time to results
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Two-mark capillary tubes (10/20 µL)
  • Sample diluent (REF SB-R0111, 5 mL/bottle)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0111C

Malaria Pf/Pv Ab Combo Rapid Test CE

30/kit

 S, P &WB

Strep A Rapid Test (strip) CE

Features:
  • High confidence as test has no cross-reactivity with 22 common organisms
  • Convenient all-in-one package designed for use at point of care that requires minimal training
  • Safe for patients as it includes a CE marked high-quality reliable swab
  • Comfortable to handle with an ergonomic, user-friendly extraction tube that minimizes contamination
  • Initial patient care action can begin during the patient’s visit as results are available within 5 minutes
  • Individually sealed foil pouches containing:
    • One strip device
    • One desiccant
  • Sample extraction tubes
  • Sterile swabs, each sealed in a plastic-paper pouch
  • Extraction Reagent A (REF SB-R0184A,10 mL/bottle)
  • Extraction Reagent B (REF SB-R0184B,10 mL/bottle)
  • Strep A Positive Control (200 µL/vial)
  • Strep A Negative Control (200 µL/vial)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0184S

Strep A Rapid Test (strip) CE

25/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