Individual CareStart COVID-19 Rapid Antigen Test
When you purchase this test, you agree this item is NOT for resale and is being used for surveillance purposes only as described by the FDA
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 COVID-19 cases is critical.
As an intended point-of-care (POC) designated test with a 10 minute processing time, CareStart COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.
- Lateral flow assay
- Rapid results in 10 minutes
- Nasopharyngeal swab specimen collection
- 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
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Identify acute infection in symptomatic patients with 88.4% sensitivity and 100% specificity
- Designated as a CLIA waived test
Specimen Collection Procedure