The CareStart™ COVID-19 Antigen test is a visually read lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens directly collected, or collected in BD universal transport media, from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset.
Test results are interpreted at 10 minutes. Use of this test is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The CareStart™ COVID-19 Antigen test from access bio, Inc. has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories operating minimally with a CLIA Certificate of Waiver. This test has been authorized only for the detection of proteins from SARS-CoV-2, 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 Federal food, drug, and cosmetic act, 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Delivery information: This test contains:
20 Foil pouched test devices containing one test strip which is encased in plastic device cassette
20 Extraction vials and caps, each containing 400 µl extraction buffer solution
20 Nasopharyngeal swabs
1 positive control swab
1 negative control swab
Package insert
Quick reference instructions
