Positive test results do not rule out co-infections with other pathogens.
Positive test results do not differentiate between SARS-CoV and SARS-CoV-2.
Negative test results are not intended to rule in other non-SARS viral or bacterial infections.
for clinical management, including infection contro
when symptoms are present
recommended by physici
Negative results should be treated as presumptive and confirmed with an FDA authorized molecular assay, if necessary,
This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared testsavailable, and other criteria are met, FDA can make tests available under an emergency access mechanism called
Emergency Use Authorization (EUA
The EUA for this test is supported by the Secretary of Health
and Human Service’s
(HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or
diagnosis of the virus that causes COVID
19. This EUA will remain in effect (meaning this test can be used) for
duration of the COVID
19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after
which the test may no longer be used
This test alone is not meant to diagnose any specific disease or condition. These results must be combined with a full clinical evaluation and examination by a licensed healthcare provider to be interpreted appropriately. Patients with positive test results should consult a licensed health care provider immediately for full clinical evaluation and take appropriate measures to minimize virus spread per CDC guidelines.