Genome Sciences Building SID: CTTP-005-8551 Final - Approved 01/14/2021 5:10PM Collected: 01/13/2021 1:39PM
Genome Sciences Building SID: CTTP-005-8551 Final - Approved 01/14/2021 5:10PM Collected: 01/13/2021 1:39PM
This test has received FDA Emergency Use Authorization to detect the ORF1ab gene, the N gene and the S gene of SARS-CoV-2 using nucleic acid amplification. A Not
Detected result does not preclude the possibility of 2019-nCoV infection since the adequacy of sample collection and/or low viral burden may result in the presence of viral
nucleic acids below the analytical sensitivity of this test method. Test results should be used along with other clinical and laboratory data in making the diagnosis. Information
for providers can be found https://www.fda.gov/media/136114/download. Information for patients can be found https://www.fda.gov/media/136111/download.
Reporting Laboratories:
(1) Genome Sciences Building (CLIA ID: 34D2199730), Lab Director: Fiscus, Susan A., PhD, 250 Belltower Dr, Genome Sciences
Bldg, Rm 2344, CB 7540, Mailbox 4, Chapel Hill, NC 27599, 919-966-0350
Results sent to: Hall Pass (Host Interface)
State Reportables (Host Interface)
Lab Report REPRINT: Orig. printing on 01/14/2021 Page 1 of 1 Crescenzi, James A., Order ID: 02983-on-21013