The test will be performed multiple times per day with results reported within 6 hours of receipt of specimen in the laboratory contingent upon testing capacity.
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DiaSorin Molecular Simplex RT-PCR
The DiaSorin Molecular Simplexa™ COVID-19 Direct assay system is a real-time RT-PCR system that enables the direct amplification of Coronavirus SARS-CoV-2 RNA from LRT specimens from patients suspected of COVID-19 by their health care provider.
Michigan Medicine has independently validated this test for use for the following alternate specimens only: tracheal aspirates, endotracheal aspirates and bronchoalveolar lavage fluid. Oropharyngeal swabs can be tested but have not been independently validated for this assay by Michigan Medicine and results will include language attesting to this.
Results are for the identification of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in LRT specimens during the acute phase of infection.
The Simplexa™ COVID-19 Direct assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. Simplexa™ COVID-19 Direct is only for use under the Food and Drug Administration’s Emergency Use Authorization.
* Reference ranges may change over time. Please refer to the original patient report when evaluating results.