Due to the highly contagious nature and global health crisis, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVI D-19 cases is critical. As an intended point-of-care (POC) designated test with a 10 minute processing time, CareStart™ COVI D-19 Antigen Test allows effective screening of COVI D-19 infection on a large scale.
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in regard to ordering CareStart Covid-19 Antigen
20 Test devices
20 Assay buffer
20 Extraction vials and caps
20 Specimen collection swabs
1 Positive and 1 negative control swabs
1 Instruction for Use
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.