CareStart™ COVID-19 Antigen Test
The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers.
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.
- Rapid results in 10 minutes
- Stand-alone test kit with no equipment needed
- Designed for use in point-of-care settings
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Lateral flow assay
- Minimally invasive specimen collection (nasopharyngeal)
Letter of Authorization: https://www.fda.gov/media/142916/download
Fact Sheet for Healthcare Providers: https://www.fda.gov/media/142917/download
Fact Sheet for Patients: https://www.fda.gov/media/142918/download
Instructions for Use: https://www.fda.gov/media/142919/download
The CareStart™ COVID-19 Antigen test Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients, and authorized labeling are available on the FDA website: https://www.fda.gov/medical-devices/coronavirus-disease2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.
· This test has not been FDA cleared or approved;
· This test has been authorized by FDA under an EUA for use by authorized laboratories;
· This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
· 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.