A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
COVID-19, PCR
MessageFact Sheet for Healthcare Providers:
HCP Fact Sheet (quidel.com)
Fact Sheet for Patients:
Patient FS (quidel.com)
HCP Fact Sheet (quidel.com)
Fact Sheet for Patients:
Patient FS (quidel.com)
Test Code
30069
Alias/See Also
Coronavirus
SARS
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