Features

• Lateral flow assay
• Rapid results in 10 minutes
• Minimally invasive specimen collection (nasopharyngeal)
• Intended at POC setting (i.e., in patient care settings) by medical professionals

Clinical Features

• Detect SARS-CoV-2 nucleocapsid protein antigen
• Identify acute infection with high sensitivity and
• 100% specificity

The CareStartTM COVID-19 Antigen test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories and at the Point of Care by medical professionals. This test has been authorized only to detect the presence of the SARS-CoV-2 nucleocapsid protein antigen,, not for any other viruses or pathogens; this test 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 Act, 21 U.S.C. § 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.