Point of Care COVID-19 Antigen Test
The CareStart point of care COVID antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens collected from patients within 5 days of symptom onset. Test results ready in 10-15 min.
Authorized for use only in-patient care settings, this product is for licensed medical professional use only.
Clinical Performance (Anterior Nasal Swab Collection)
- 87.18% PPAa and 100% NPAb (see product insert for clinical results)
- aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement
- This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories.
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.