SARS-CoV-* Results

Test Result Reference Range

Patient Name:

Date of Birth:

Gender:

Accession #:

Specimen Type:

Collection Date:

Received Date:

Reported Date:

Ordering Personnel:

Address:

Testing Ordered SARS-CoV-2

Accession #49528 Manuel Avila Status: Final Page 1 of 1 Manuel Avila

09/23/1958

Other

Nasopharyngeal Swab

2021-10-06

2021-10-06

495**-****-**-**

Not Detected

San Marcos District Office

Not Detected

SARS-CoV-2

This test was developed and its performance characteristics determined by Osang Healthcare. This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of time the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for 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.

Processing and Detection Methodology:

The Birdrock Laboratories SARSCoV2 by Molecular Assay is an RT-PCR test for the qualitative detection of nucleic acid from SARSCoV2 in nasopharyngeal swab specimens from individuals suspected of COVID19 by their healthcare provider. Patient specimens undergo nucleic acid extraction followed by singlestep reverse transcription real-time qPCR multiplexed for 3 SARSCoV2 specific target primer/probes with fluorescent detection of amplification

When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient's recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. An individual without symptoms of COVID-19 and who is not shedding SARS-CoV-2 virus would expect to have a negative (not detected) result in this assay. GEORGE JAYATILAKA

Birdrock Laboratories

10581 Roselle Street, Suite 120

San Diego, CA 92121

Michael Maymind, M.D. Lab Director; CLIA: #05D2158603 858-***-**** adzkph@r.postjobfree.com

n/a

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