Interpretive Data

1. Performance data for this test SARS-CoV-2/Flu/RSV test has only been established in nasopharyngeal swab specimens. Use of the Xpert Xpress SARS-CoV-2/Flu/RSV test with other specimen types has not been assessed and performance characteristics are unknown.
2. Nasal swabs (self-collected under supervision of, or collected by, a healthcare provider) and nasal wash/aspirate specimens are considered acceptable specimen types for use with the Xpert Xpress SARS-CoV-2/Flu/RSV test but performance with these specimen types has not been established.
3. As with any molecular test, mutations within the target regions of the Xpert Xpress SARS-CoV-2/Flu/RSV test could affect primer and/or probe binding resulting in failure to detect the presence of virus or the virus being detected less predictably.
4. Erroneous test results might occur from improper specimen collection; failure to follow the recommended sample collection, handling, and storage procedures; technical error; or sample mix-up. Careful compliance with the instructions in this insert is necessary to avoid erroneous results.
5. False negative results may occur if virus is present at levels below the analytical limit of detection.
6. Negative results do not preclude SARS-CoV-2, influenza or RSV infection and should not be used as the sole basis for treatment or other patient management decisions.
7. Results from the Xpert Xpress SARS-CoV-2/Flu/RSV test should be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient. Viral nucleic acid may persist in vivo, independent of virus viability. Detection of analyte target(s) does not imply that the corresponding virus(es) are infectious or are the causative agents for clinical symptoms.
8. Results from analytical studies with contrived co-infected samples showed potential for competitive interference when SARS-CoV-2, Flu or RSV was present at 1X LoD levels.
9. Cross-reactivity with respiratory tract organisms other than those described herein can lead to erroneous results.
10. As the Xpert Xpress SARS-CoV-2/Flu/RSV test does not differentiate between the N2 and E gene targets, the presence of other coronaviruses in the B lineage, Betacoronavirus genus, including SARS-CoV-1 may cause a false positive result. None of these other coronaviruses is known to currently circulate in the human population.
11. This test has not been FDA cleared or approved.
12. This test is only 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.