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LIMITATIONS
3. The test should be used for the detection of SARS-CoV-2 antigen from human nasopharyngeal swab specimens. 11. Positive tests do not differentiate between SARS-CoV-2 and SARS-CoV 1.
8. Negative results should be treated as presumptive and confirmed with an FDA authorized molecular assay, if necessary, for clinical management, including infection control.
9. If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with state or local public health departments, is required.
10. Positive test results do not rule out co-infections with other pathogens.
13. HBV, HCV, HIV, Pneumocystis jirovecii (PJP) and Staphylococcus salivarius are not tested.
Rothia mucilaginosa is a normal inhabitant of the human oral cavity and respiratory tract. It is an infrequent pathogen, mostly affecting severely immunocompromised patients.
Obsolete names for R. mucilaginosa are Staphylococcus salivarius, Micrococcus mucilaginosus and Stomatococcus mucilaginosus.
15. Performance of this device has not been assessed on specimens from individuals who have been infected with emerging new variants of SARS-CoV-2, including the UK SARS-CoV-2 variant, SARS-CoV-2 VOC 202012/01 (B.1.1.7) or the new South Africa SARS-CoV-2 variant, 501Y.V2
16. The performance of this device has not been assessed in a population vaccinated against COVID-19.
The Biden administration struck a $137 million deal to build a new factory in the U.S. to ramp up production of COVID-19 testing kits – but the new facility won't be completed until late 2024 at the earliest........