On July 16, 2021, FDA granted an extension of the shelf-life of CareStartTM COVID-19 ANTIGEN point-of-care tests when stored at 1–30°C.
Accordingly, certain CareStartTM 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.
- Lateral flow assay
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Rapid results within 10-15 minutes
- Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
- For use under the Emergency Use Authorization (EUA) only
- For in vitro diagnostic use only
- For prescription use only
- For use with direct anterior nasal and nasopharyngeal swab specimens