Description

The CareStart™  COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2.

Features

• Fast and easy to self-test at anywhere
• Easy to interpret the results using mobile application
• Qualitatively detect the SARS-CoV-2 nucleocapsid protein
• Use with nasal swab specimen
• Fast results only in 10 minutes

Kit Contents

• Fast and easy to self-test at anywhere
• Easy to interpret the results using mobile application
• Qualitatively detect the SARS-CoV-2 nucleocapsid protein
• Use for nasal swab specimen
• Fast results only in 10 minutes

Performance Measures

• 87% Sensitivity
• 98% Specificity

Disclaimer

In the USA, this product has not been FDA cleared or approved; but has been authorized by the FDA under an Emergency Use Authorization (EUA). 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. §360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.