COVID-19 IgG/IgM Antibody Rapid Test Cassette – FDA Emergency Use Authorized
INGM-MC42_BX*For Emergency Use Authorization only
*For Prescription use only
*For in vitro diagnostic use only
*Clia Certificate Required
The Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow immunochromatographic assay for the detection of SARS-CoV-2 antibodies in venous whole blood, serum or plasma. The COVID-19 IgG/IgM Rapid Test Cassette is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
- Developer: Hangzhou Biotest Biotech
- Test: RightSign COVID-19 IgG/IgM Rapid Test Cassette
- Technology: Lateral Flow
- Target: Spike
| IgM+ | Sensitivity | 100% (30/30) | (87.7%; 100%) |
| IgM- | Specificity | 100% (80/80) | (95.4%; 100%) |
| IgG+ | Sensitivity | 93.3% (28/30) | (78.7%; 98.2%) |
| IgG- | Specificity | 100% (80/80) | (95.4%; 100%) |
| Combined | Sensitivity | 100% (30/30) | (87.7%; 100%) |
| Combined | Specificity | 100% (80/80) | (95.4%; 100%) |
| Combined | PPV at prevalence = 5% | 100% | (50.5%; 100%) |
| Combined | NPV at prevalence = 5% | 100% | (99.4%; 100%) |
