The test will be performed multiple times per day with results reported within 6 hrs 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 nasopharyngeal swabs (NPS). from patients suspected of COVID-19 by their health care provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in nasopharyngeal 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.
Nasopharyngeal Specimen: Gently insert mini-tipped flocked nasopharyngeal swab (swab on flexible plastic shaft) through the nostril and into the nasopharynx, reaching the posterior nasopharynx. Gently rotate swab, then remove, and break swab off into tube of transport media (M4RT). Make sure the swab is fully immersed in the transport media, and that the shaft is short enough to completely tighten the cap. Send to the laboratory as soon as possible. Obtaining columnar epithelial cells will enhance reliability of viral detection.
MLabs has limited supplies of NP swabs and transport media. Please contact client services at 800-862-7284 to determine availability of supplies for your testing needs. MLabs can accept testing from clients that provide their own collection supplies.
Specimen Collection: With the head in a tiled position, insert the swab into one nostril, advancing into the nasopharynx until resistance is felt. Rotate the swab several times on the nasopharyngeal membrane to allow adequate collection of epithelial cells - a minimum of 3 "full twists" is standard to obtain a good collection; if unsure you maintained contact with the membrane, add another 1-2 full twists.
Insert swab into viral transport media or phosphate buffered saline. Break off swab stick at the breakpoint to ensure it will fully fit into the closed tube. Fasten the cap tightly to prevent leakage. Refrigerate.