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COVID 19- DIASORIN
MessageThe Diasorin Molecular Simplexa COVID-19 Direct real-time RT-PCR assay is intended for use on the Liaison MDX instrument for the in vitro qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs (NPS) and nasal swabs (NS) from symptomatic individuals suspected of COVID-19 by their healthcare provider. The Simplexa COVID-19 Direct assay is an aid in the diagnosis of SARS-CoV-2 infection
Test Code
LAB1230656
Alias/See Also
SARS CoV2, COVID 19
Includes
Qualitative interpretation of COVID-19 presence.
Preferred Specimen
Acceptable specimen types include nasopharyngeal swabs (NPS) or nasal swabs (NS) in Universal Transport Media (UTM) or BD Universal Viral Transport (UVT)
Minimum Volume
1mL of nasopharyngeal swabs (NPS) or nasal swabs (NS) in Universal Transport Media (UTM) or BD Universal Viral Transport (UVT)
Transport Temperature
Refrigerated
Specimen Stability
Specimens in UTM/UVT can be stored up to 7 days at 2 to 8 °C.
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Samples that do not adhere to the above mentioned criteria, and/or samples that are leaking or sent in broken tubes cannot be used for testing due to possible contamination.
Calcium alginate swab: contains substance that inhibits PCR testing.
Non-validated sample type.
Specimen container not labeled properly with patient name, birth date, and hospital or accession number.
Calcium alginate swab: contains substance that inhibits PCR testing.
Non-validated sample type.
Specimen container not labeled properly with patient name, birth date, and hospital or accession number.
Methodology
Polymerase Chain Reaction (PCR) - Diasorin Simplexa COVID-19 Direct Assay (FDA Cleared)
Setup Schedule
Daily (Sunday – Friday)
Performing Laboratory
West Virginia University Hospitals, Inc.
WVUH - Molecular Diagnostics Laboratory-3040 Univeristy Ave, Suite 1300; Morgantown, WV 26505
