The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Testing 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 moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Lateral flow assay Detect SARS-CoV-2 nucleocapsid protein antigen Rapid results within 10-15 minutes 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 For use under the Emergency Use Authorization (EUA) only For in vitro diagnostic use only For prescription use only For use with direct anterior nasal and nasopharyngeal swab specimens Clinical Performance 93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab 87.18% PPAa and 100% NPAb when used with anterior nasal swab
