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Panbio™ COVID-19 IgG/IgM Rapid Test Device

Scale up COVID-19 antibody testing

An in vitro diagnostic rapid test for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma, venous and fingerstick whole blood.

Intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation. The test provides preliminary test results. Negative results will not preclude SARS-CoV-2 infection, and they cannot be used as the sole basis for treatment or other management decisions. The test is not intended to be used as a donor screening test for SARS-CoV-2.

For professional use only. Product not available in all countries. 

Please check with your local sales representative regarding availability in your area.

Benefits
  • Antibody tests are important to confirm that an infection has occurred.
  • Quickly scale up COVID-19 coronavirus testing.
  • Make testing more widely available. 
  • Decentralized testing can help to alleviate overcrowding in hospitals.
  • Time to result: 10 - 20 minutes.
  • Simple fingerstick blood sample.
Helpful Documents
  • Test Time: 10 minutes, do not read results after 20 minutes
  • Specimen Type: Fingerstick Whole blood, Venous Whole blood, Plasma/Serum
  • Sample Size: 20 μL fingerstick or venipuncture whole blood, or 10 μL serum or plasma
  • Fingerstick Whole Blood
    - Sensitivity: 96.2%
    - Specificity: 100.0%
  • Venous Whole Blood*
    - Sensitivity: 96.0%
    - Specificity: 95.8%
    *EDTA, heparin or sodium citrate can be used as anticoagulants
  • Plasma* / Serum**
    - Sensitivity: 97.8%
    - Specificity: 92.8%
    *EDTA, heparin or sodium citrate can be used as anticoagulants
    **Based on matrix equivalency studies
  • Storage: 2~30°C
  • Shelf Life: 12 months
  • CE Mark
  • ICO-T402 Kit Contents:
    • 25 Test devices individually foil pouched
    • 25 Specimen droppers
    • 1 Buffer (3mL/vial)
    • 1 Instructions for use
  • ICO-T40203 Kit Contents:
    • 25 Test devices individually foil pouched
    • 1 Buffer (3mL/vial)
    • 25 Specimen droppers (for fingerstick whole blood)
    • 25 Lancets (for fingerstick whole blood)
    • 25 Plasters
    • 26 Alcohol pads
    • 1 Instructions for use
    • 1 Quick reference guide (for fingerstick whole blood)
Panbio™ COVID-19 IgG/IgM Rapid Test Device Code
Panbio™ COVID-19 IgG/IgM Rapid Test Device ICO-T402 (not available in UK, Norway, Sweden, Denmark, Finland)
Panbio™ COVID-19 IgG/IgM Rapid Test Device (with fingerstick accessories) ICO-T40203 (not available in Germany)

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