COVID PCR Test

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Berklee School Testing 12/19/21, 5:25 PM

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NAME REQUISITION # SEX D.O.B


STACEY CHAN BC147544B F 1999-05-13

PROVIDER OFFICE ID COLLECTED DATE RESULTED DATE


LAURA KOGELMAN 0858781 2021-12-17 18:37:05 2021-12-18 09:49:27

TEST PERFORMED
SARS-CoV2 / COVID-19 PCR Diagnostic Assay

DESCRIPTION RESULTS

2019-novel Coronavirus (2019-nCoV) not detected by the qRT-PCR


NEGATIVE
assay. Consider testing for other respiratory viruses or re-collecting for
2019-nCoV testing. Note: Optimum timing for peak viral levels during
infections caused by 2019-nCoV have not been determined. Collection of
multiple specimens from the same patient may be necessary to detect the
virus. Methods and Limitations: This Laboratory Developed Test is a high-
throughput version of the CDC 2019-nCoV Realtime RT-PCR test and has
been validated in accordance with the guidance issued by the College of
American Pathologists (Mar 19,2020) and the FDA (Feb 29th, 2020). This
test has not been FDA cleared or approved but is being run under the
FDAs Emergency Use Authorization (EUA) mechanism. This test was
validated for dry nasal swabs. Method: RNA is isolated from respiratory
specimens using MagMAX-96 Viral RNA Isolation Kits (Thermo Fisher
Scienticc); RNA is reverse transcribed to cDNA, and subsequently
ampliced in a Real-Time PCR Instrument (Applied Biosystems ViiA7). This
system provides qualitative detection of nucleic acid from SARS-CoV-2.
For more detailed information on the test methods and limitations as well
as for Fact Sheets for both Patients and Healthcare providers see
https://broad.io/covid19test-factsheetv3. Positive results are indicative of
active infection with SARS-CoV-2 but do not rule out bacterial infection or
co-infection with other viruses. The agent detected may not be the decnite
cause of disease. Negative results do not preclude SARS-CoV-2 infection
and should not be used as the sole basis for patient management
decisions. False negative results may occur if ampliccation inhibitors are
present in the specimen or if inadequate numbers of organisms are
present in the specimen due to improper collection, transportation, or
handling. If the virus mutates in the RT-PCR target region, SARS-CoV-2
may not be detected or may be detected less predictably. Inhibitors or
other types of interference may produce a false negative result.

Per forming Laborator y


CRSP - Broad Institute - Clinical Research Sequencing Platform, LLC
320 Charles Street CAMBRIDGE MA 02141

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