SARS-CoV-2 Antigen, Client Inactivated

Nasopharyngeal (NP) swab or anterior nasal swab

0.5 mL

0.4 mL (Note: This volume does not allow for repeat testing)

Provided pre-filled tube containing inactivation buffer. Any swab of appropriate size and configuration with a synthetic tip can be used except for calcium alginate tips, swabs with preservatives, and swabs with wood shafts. Specific collection materials are required for this test and can be ordered from Labcorp. Use PeopleSoft No. 130597 for collection tubes containing inactivation buffer (boxes of 100), and PeopleSoft No. 129238 for swabs (packages of 100).

Qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in individuals suspected to have COVID-19 by their healthcare provider within the first 10 days from the onset of symptoms. Antigen tests can be used for screening testing in high-risk congregate settings in which repeat testing could quickly identify persons with a SARS-CoV-2 infection to inform infection prevention and control measures, thus preventing transmission. Additionally, there are increasing amounts of data to help guide the use of antigen tests as screening tests on asymptomatic persons to detect or exclude COVID-19, or to determine whether a person who previously was diagnosed with COVID-19 remains infectious. See FDA's Recommendations for healthcare providers using SARS-CoV-2 diagnostic tests for screening asymptomatic individuals for COVID-19. Also see information from the Centers for Medicare and Medicaid Services (CMS) on Enforcement discretion for the use of SARS-CoV-2 point-of-care testing on asymptomatic individuals. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results do not rule out COVID-19 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. Positive results in a person who has symptoms associated with COVID-19, indicating that pretest probability is high, can generally be interpreted to indicate that the person is infected with SARS-CoV-2. Positive results in a person who is asymptomatic and has had exposure to a person with COVID-19 within the last 14 days, indicating that the pretest probability is moderate, be confirmed with an FDA-authorized NAAT. In instances of higher pretest probability, such as high incidence of infection in the community, or a person with household or continuous contact to a person with COVID-19, clinical judgement should determine if a positive antigen result for an asymptomatic person should be followed by a confirmatory NAAT.

FDA-authorized Fact sheets for patients and providers can be accessed at the following link: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2

This test has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization (EUA for use by authorized laboratories certified under CLIA that meet the requirements to perform moderate or high complexity tests. This test has been authorized only for the detection of proteins from SARS-Cov-2, not for any other viruses or pathogens. The emergency use of this test is authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)

This test detects both viable (live) and non-viable, SARS-CoV, and SARS-CoV-2. Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample.

Performance has not been established for use with specimens other than those collected in the upper and lower respiratory tract in humans.

A negative test result may occur if the level of antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly.

If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with state or local public health departments, is required.

The results obtained with this test should only be interpreted in conjunction with clinical findings, and the results from other laboratory tests and evaluations. This is especially important if the patient has had recent exposure to COVID-19, or clinical presentation indicates that COVID-19 is likely and diagnostic tests for other causes of illness (eg, other respiratory illness) are negative. In this case, direct testing for the SARS-CoV-2 virus (eg, PCR testing) should be considered.

Positive results do not rule out co-infections with other pathogens.

Positive test results do not differentiate between SARS-CoV-2 and SARS-CoV.

Chemiluminescent Immunoassay