The CareStartTM 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 suspected of COVID-19 by their healthcare provider within five days of symptom onset. 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., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen is generally detectable in nasopharyngeal or anterior nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
Negative results are presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between September 2020 and December 2020. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.
The CareStartTM COVID-19 Antigen is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in point of care settings. The CareStartTM COVID-19 Antigen is only for use under the Food and Drug Administration’s Emergency Use Authorization.