SCoV-2 Detect™ IgM ELISA
FDA Emergency Use Authorized
The SCoV-2 Detect™ IgM ELISA is an in vitro diagnostic test for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum.
The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The SCoV-2 Detect™ IgM ELISA should be used to diagnose acute SARS‑CoV‑2 infection.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high complexity tests.
Click Downloads Below For:
- Letter of Authorization
- Package Insert
- Package Insert (Spanish)
- Recipient Fact Sheet
- Health Care Provider Fact Sheet
- SDS (US)
- FDA Emergency Use Authorized
- For use in diagnosing acute SARS‑CoV‑2 infections
- First EUA granted for an ELISA that specifically detects IgM antibodies to SARS-CoV-2
- Tests 90 unknown specimens
- Sensitivity: 92.50%
- Specificity: 98.95%
| Catalog No. | Format | Quantity/Kit | Incubation Time | Sample type | Storage | Shelf life |
|---|---|---|---|---|---|---|
| COVE-M | Indirect | 96 Wells/Plate | 111 minutes | Serum | 2-8℃ | TBD |