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Microbiology Report Oct 22, 2020, 07:53 p.m.

Patient: SERGIU BURLADEAN

DOB: Mar 05, 1985

Specimen Type: COVID19 Screen (ER/In Patient)

Result: COVID19 Screen (ER/In Patient)
Collected Date: Oct 22, 2020, 01:46 p.m.
Document Type: Unclassified Report

The information was last updated on Oct 22, 2020, 05:32 p.m.

Report
Unknown
Status:
Additional SARS-CoV-2 Not Detected Reference: Not Detected Method: Amplified Probe
Information: Test ***** ***** The Hologic SARS-CoV-2 assay is designed to detect two
conserved regions of the ORF1ab gene of SARS-CoV-2 using nucleic acid
amplification. A 'Not Detected' result does not preclude the possibility of SARS-
CoV-2 infection since the adequacy of sample collection and/or low viral
burden may result in the presence of viral nucleic acid below the analytical
sensitivity of this test method. Test results should be used along with other
clinical and laboratory data in making the diagnosis. This test has received FDA
Emergency Use Authorization (EUA) and has been verified by the John H.
Stroger, Jr. Hospital Microbiology and Virology Laboratory. This test is only
authorized for the duration of the declaration and the circumstances that exist
to justify the authorization of the emergency use of in vitro diagnostic tests for
the detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection
under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the
authorization is terminated or revoked sooner. The John H. Stroger, Jr.
Microbiology and Virology Laboratory is certified under CLIA-88 as qualified to
perform high complexity testing.