Days Set Up
Daily
Analytic Time

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.

MiChart Code
COVSC
Soft Order Code
COVSC

Test Updated:

Synonyms
 

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Find a Requisition

All specimens should be accompanied by a requisition.

Submitting Specimens

Learn about how to properly label and where to ship specimens.

Order Kits and Supplies

MLabs provides all the supplies necessary for the collection of specimens.

Test FAQ

Visit our provider FAQ and learn about common questions to ordering tests.

Test Overview

Test Methodology

DiaSorin Molecular Simplex RT-PCR

Test Usage

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 Range

Not detected

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Specimen Requirements

Minimum Volume
 

Billing Information

CPT Code
87635
Pro Fee Code
 
LOINC
94306-8

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Our High Standard

Quality that sets us apart

As the reference laboratory division of Michigan Medicine's Department of Pathology, MLabs shares the institution's commitment to applying established quality principles to clinical laboratory testing. Like other large organizations in complex, consequential fields, we rely on an established approach to monitor quality throughout the testing process.