SARS-CoV-2, RT-PCR

Test Code
COVID


Alias/See Also
Covid-19


CPT Codes
87635(HCPC: U0003)

Preferred Specimen
3 mL Universal Transport Media



Minimum Volume
1 swab • 3.0 mL


Instructions
Frederick Health Laboratory patient service centers do not collect respiratory specimens, including those from patients suspected to have COVID-19. Anterior nares specimens (use one swab for both nares) should be collected by a healthcare professional or self-collection in an appropriate clinical setting, such as drive-thru testing sites using a round foam swab. Cold packs/pouches must be used if placing specimens in a lockbox for courier pick-up. STAT pick-up cannot be ordered for this test. Each COVID-19 specimen transport vial that is submitted should be accompanied by its own separate requisition and transported in its own sealed bag.


Transport Temperature
Refrigerated (Cold Pack)


Specimen Stability
Room Temperature: Unacceptable
Refrigerated: 2-8 C up to 72 hours
Frozen: -20 C or below


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Samples not labeled with complete first and last name and date of birth.
No date/time of collection on sample or requisition.
Unlabeled specimen
Expired transport media
Improper transport media
Specimen leaked in transit
Swab not in transport media


Methodology
Cobas® SARS-CoV-2, Real Time RT- PCR (Primary) Lyra SARS-CoV-2, Real Time RT-PCR (Secondary)

Setup Schedule
Sun-Sat


Reference Range
Not detected


Clinical Significance
The SARS-CoV-2 RNA (COVID-19), Real-Time RT-PCR test is a qualitative multi-target molecular diagnostics test that aids in the detection of COVID-19. This test is intended to be performed on respiratory specimens collected from individuals who meet the Centers for Disease Control and Prevention (CDC) clinical and/or epidemiological criteria for COVID-19 testing. For details visit: https://www.cdc.gov/coronavirus/2019-ncov/hcp/index.html.

Result interpretation:
• A Detected result is considered a positive test result for COVID-19. This indicates that RNA from SARS-CoV-2 was detected and that the patient is considered infected with the virus and presumed to be contagious. If requested by public health authorities, specimens will be send for additional testing.
• A Not Detected (negative) test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. However, it does not rule out the possibility of COVID-19 and should not be used as the sole basis for patient management decisions.
• An Inconclusive result means not all of the testing targets were detected. This could be due to a sample with viral concentrations near the limit of detection of the test or other factors. An additional sample collection may be considered.

Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions.

Test results are typically available 3-4 days from the time of specimen pickup and may be impacted by high demand.


Performing Laboratory
Meritus Medical Laboratory 11100 Medical Campus Dr Hagerstown, MD. 21742


Last Updated: November 28, 2023


The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.