The Panbio™ COVID-19 IgG/IgM Rapid Test Device (Fingerstick Whole Blood/Venous Whole Blood/Serum/Plasma) is 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.
For professional use only and is 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.
- Lateral Flow Rapid Test Device
- Detects IgG/IgM antibodies caused by SARS-CoV-2
- Antibody test are utilized to determine if someone was previously infected
- Separate test lines for IgG and IgM
- 20μL fingerstick blood sample
- Time to result: 10-20 minutes
- Simple test procedure
Sample Types | Fingerstick whole blood, venous whole blood, serum/plasma |
Sample Size | -Fingerstick and venipuncture whole blood: 20μL -Serum/plasma: 10μL |
Test Time | 10 minutes, do not read after 20 minutes |
CE Mark | Yes |
Sensitivity | 95.8% |
Specificity | 94.0% |
Storage | 2°–30°C |
Shelf Life | 12 months |
Qty per kit | 25 tests |
Control | Procedural control included within the test |
Cat No | ICO-T402 |
Materials Provided:
Materials Required but Not Provided:
- 25 Test Devices individually pouched
- 25 Specimen droppers (for fingerstick whole blood only)
- 1 Buffer (3mL/vial)
- 1 Instructions for Use
- Specimen collection equipment and containers
- Micropipette
- Lancet (for fingerstick whole blood only)
- Cotton wool or gauze pad (for fingerstick whole blood only)
- Centrifuge
- Timer
- Biohazard waste containers for sharps and non-sharps
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