CareStart COVID-19 Antigen Test Kit
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. On July 16, 2021, FDA granted an extension of the shelf-life of CareStart COVID-19 ANTIGEN point-of-care tests when stored at 1–30°C.
Accordingly, certain CareStart COVID-19 Antigen point-of-care tests that are currently labeled with expiration dates between February 2021 and July 2021 in fact have longer shelf lives than indicated by the expiration date on the label. A list of the affected lots can be found at the following link . If you have any questions please contact us at firstname.lastname@example.org. A copy of FDA’s letter to Access Bio regarding the shelf-life extension is available at the following link: https://www.fda.gov/media/150840/download.
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