COVID-19, PCR

Message

Fact Sheet for Healthcare Providers:
HCP Fact Sheet (quidel.com)
Fact Sheet for Patients:
Patient FS (quidel.com)

Test Code

30069

Alias/See Also

Coronavirus
SARS

CPT Codes
U0003

Preferred Specimen

Nasopharyngeal Swab

Transport Container

Viral Transport Media

Transport Temperature

Specimens should be stored at 2°C to 8°C until tested. If specimens cannot be tested within 72 hours of collection, they should be frozen at -70°C or colder until tested.

Methodology
RT-PCR
The Lyra SARS-CoV-2 Assay has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner.

FDA Status
EUA

Setup Schedule

Daily, Sunday-Saturday

Report Available

1-2 days

Performed By
CoxHealth

Performing Laboratory
Cox South

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.