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 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. 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 swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but 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, the presence of clinical signs and symptoms consistent with COVID-19.
The CareStart™ COVID-19 Antigen is intended for use by medical professionals, trained operators who are proficient in performing tests, trained clinical laboratory personnel, or individuals trained in POC settings. CareStart™ COVID-19 Antigen is only for use under the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA).
20 TEST DEVICES
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 tests