CareStart Covid 19 Antigen Rapid POC Test - 20 Count

The Covid 19 Antigen Rapid POC Tests are lateral flow immunochromatographic assays, which are intended for the qualitative detection of the nucleocapsid protein antigens from SARS-CoV-2. The procedure for collecting a sample is simple and straightforward: collect the nasopharyngeal or anterior nasal swab, place and rotate the swab in the extraction vial, and squeeze three drops of the sample into the sample well. Within ten minutes, you will have one of three results: positive, negative, or invalid. 

This test is perfect for healthcare providers who are offering testing to symptomatic or close-contact patients who are either suspected of COVID-19 within the first five (5) days of symptom onset or those 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. The speed of the test distinguishes the CareStart rapid POC tests from others on the market, and will help you better inform your patients and protect your communities.

• Tests are only authorized for Point-of-Care use by qualified healthcare professionals;
• 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;

INSTRUCTIONS FOR USE (Updated April 2021)

**Due to the nature of this product, all sales are final. Not eligible for returns.**

EUA Fact Sheets for Patients

EUA Fact Sheets for Healthcare Providers

EUA Letter of Authenitcation