Quality Assurance Real-Time

Laboratory Report

Genesys BioLabs

A Division of 20/20 GeneSystems

CLIA # 21D2037411

FINAL COPY

Collection Date: TB

Patient #:

Willette, Jeanette

Birth:

Acc #:

***-*-000*******

Carter, Ernest Lorenza Age:

7/17/1960

61 years

161640

Provider: 12/27/2021 3:08 PM

Home Phone: 571-***-**** Gender: Female Received in Lab: 12/27/2021 7:00 PM TB Patient:

Specimen Source Nasophyrangeal Swab

Requisition Form #TT298443

Test Name Result Units Flag Reference Range

Panel 9461

SARS-CoV-2 RT-PCR 9461 Run by: AM on 12/28/2021 8:30 PM SARS-CoV-2 RT-PCR 9461 Positive ABNORMAL

This test was performed by FDA EUA DiaCarta QuantiVirusTM SARS-CoV-2 Multiplex Test Kit with modification of extraction and real-time PCR instrumentation. This test has not been FDA cleared or approved. Genesys BioLabs is a CLIA compliant lab to perform high complexity testing and is regulated under CLIA. What does it mean if the specimen tests positive for the virus that causes COVID-19? A positive test result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and the patient is infected with the virus and presumed to be contagious. Nucleic acids may persist independently of SARS-CoV-2 transmissibility or it may be asymptomatically carried. Therefore, a positive result does not necessarily indicate the presence of transmissible virus level. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. 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. Patient management should follow current CDC guidelines.

The DiaCarta SARS-CoV-2 Assay has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects.

Notes:

Reviewed By:

Zao, Chih-Ling

SARS-CoV-2 RT-PCR 9461 (12/28/2021 8:57 PM)

9430 Key West Avenue, Suite 100

Rockville, MD 20850

Fax: 240-***-**** / Ph: 240-***-****

.

REP-D-001 version 5 \ Effective Date: 03/16/2014

Printed: 12/28/2021 8:57 PM

Page 1 of 1

Accession: 161640 Patient ID:

807-R-000*******

Originally Reported On:

STAT[S] Corrected [C] Added [A]

12/28/2021 8:54 PM

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