- The CareStart™ COVID-19 Antigen Home Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2, not for any other viruses or pathogens.
- The intended use of this test is for testing twice over two or three days with at least 24 hours and no more than 48 hours between tests.
- For use with direct anterior nasal and nasopharyngeal swab specimens, non-invasive test procedures
- Detect SARS-CoV-2 nucleocapsid protein antigen
- PPA: 87%
- NPA: 98%
- Variant-ready solution
- For use under an Emergency Use Authorization (EUA) only for the duration of the COVID-19 declaration justifying the emergency use of in vitro diagnostics (IVD), unless it is terminated or revoked by the FDA (after which the test may no longer be used)
- The CareStart™ COVID-19 Antigen Home Test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected direct anterior nasal swab samples from individuals aged two years or older.
|Product||Covid Test Kit|
|Packaging||2 tests per pack|
|Dimensions||4" x 3" x 1", .2lb|
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