Description
Contents: Test device (20), Extraction vial (20), Cap (20)caps, swabs (20), Positive control swab (1), Negative control swab (1) each, Package insert (1), Instructions for use (1) Quick Reference Instructions (QRI) (1)
Regulatory Status: FDA EUA Authorized, CLIA Waived
Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen
Processing Time: 10 Minutes
The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
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