Other Diagnostic Tests for SARS-CoV-2
Throughout the COVID-19 pandemic, NAATs and antigen tests have been the primary diagnostic tests to identify current infection. However, the Food and Drug Administration (FDA) may authorize or clear tests that use other methods to detect SARS-CoV-2, the virus that causes COVID-19. To separate tests in this category from more traditional viral tests, NAATs and antigen tests, the FDA has created a page dedicated to other diagnostic tests for SARS-CoV-2 detection.
Other diagnostic tests may be used to detect SARS-CoV-2 from non-traditional respiratory specimens, such as breath. Rapid gas chromatography-mass spectrometry (GC-MS) is one technique that can be used to detect volatile organic compounds (VOCs) associated with SARS-CoV-2 infection from a person’s breath and can provide results in as few as a couple minutes. Positive test results from the first breath test authorized to test for SARS-CoV-2 by FDA should be interpreted as presumptive and be confirmed by NAAT. This page will be updated if additional diagnostics tests are authorized or cleared by the FDA that do not fall into the NAAT (molecular) or antigen viral test categories.
All FDA-authorized or -cleared tests have instructions for use that must be explicitly followed. Although breath is not a specimen type that is covered by CLIA considerations, these other diagnostic tests are specifically required to be performed in authorized settings noted as “Near Patient/Point-of-Care” where the patient specimen is both collected and analyzed, such as within doctors’ offices, hospitals, and mobile testing sites. The test must be performed by a qualified, trained operator under the supervision of a healthcare provider licensed or authorized by state law to prescribe tests. Facilities using this test must have a process in place to ensure that the product is used only in these authorized settings, as defined within the EUA.