CRSP BATESCOL1

320 Charles St.CAMBRIDGE MA 02141 Bates College

617-714-7000 130 Central Ave
LEWISTON, ME 04240

PATIENT NAME PATIENT ID LAB MRN PHONE DOB AGE SEX

Moutou , Mathieu 001103087 C2619 267-266-0298 02/09/1998 22 Yrs M
REQUISITION # COLLECTED DATE RECEIVED DATE ORDERING MD

QKJJPRBSET3RPXG 11/16/2020 2:28 PM 11/17/2020 3:40 PM Bennett, Siiri

Test Description Results Abnormal Reference Range Units Lab
Covid19_Diagnostic Source: AN SWAB (Status: F 11/17/2020 15:40)
SARS-CoV2 Real-time Reverse NEGATIVE Negative CRSP
Transcriptase (RT)-PCR Diagnostic
Assay
2019-novel Coronavirus (2019-nCoV) not detected by the qRT-PCR 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 has been authorized by FDA under an EUA for this
laboratory. This test is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of
emergency use of in vitro diagnostic tests for detection and/or
diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C.
360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner. This test has been authorized only for the detection of nucleic
acid from SARS-CoV-2, not for any other viruses or pathogens. The test
was validated for use with respiratory specimens obtained via
nasopharyngeal, oropharyngeal, or nasal swabs in liquid transport media
or saline. Nasal swabs may also be sent dry. The performance of this
test has not been established for other specimens. Specimens collected
using other FDA recommended Specimen Collection Materials listed in the
FDA COVID-19 Diagnostic Technologies communication (March 26, 2020) are
processed with the caveat that they were not all validated for use with
this test and the result must be interpreted in this context. Method:
RNA is isolated from respiratory specimens in approved media using
MagMAX-96 Viral RNA Isolation Kits (Thermo Fisher Scientific, AMB18365),
is reverse transcribed to cDNA, and subsequently amplified in the
Applied Biosystems ViiA7 Real-Time PCR Instrument. This system provides
qualitative detection of nucleic acid from SARS-CoV-2. For more detailed
information on the test methods and limitations see
https://covid-19-test-info.broadinstitute.org/ 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 definite 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 amplification 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. An interference study evaluating the effect of
common cold medications was not performed.

Continued on Next Page Page 1

 CRSP BATESCOL1
320 Charles St.CAMBRIDGE MA 02141 Bates College
617-714-7000 130 Central Ave
LEWISTON, ME 04240

PATIENT NAME PATIENT ID LAB MRN PHONE DOB AGE SEX

Moutou , Mathieu 001103087 C2619 267-266-0298 02/09/1998 22 Yrs M
REQUISITION # COLLECTED DATE RECEIVED DATE ORDERING MD

QKJJPRBSET3RPXG 11/16/2020 2:28 PM 11/17/2020 3:40 PM Bennett, Siiri

Test Description Results Abnormal Reference Range Units Lab

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 has been authorized by FDA under an EUA for this laboratory. This test is
only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in
vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.
· This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
· The test was validated for use with respiratory specimens obtained via nasopharyngeal, oropharyngeal, or nasal swabs in liquid
transport media or saline or sent dry. The performance of this test has not been established for other specimens. Specimens
collected using other FDA recommended Specimen Collection Materials listed in the FDA COVID-19 Diagnostic Technologies
communication (March 26, 2020) are processed with the caveat that they were not all validated for use with this test and the
result must be interpreted in this context.
· Method: RNA is isolated from respiratory specimens in approved media using MagMAX™-96 Viral RNA Isolation Kits (Thermo
Fisher Scientific, AMB18365), is reverse transcribed to cDNA, and subsequently amplified in the Applied Biosystems® ViiA7
Real-Time PCR Instrument. This system provides qualitative detection of nucleic acid from SARS-CoV-2. For more detailed
information on the test methods and limitations see https://covid-19-test-info.broadinstitute.org/
· 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 definite 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 amplification 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. An interference study evaluating the effect of
common cold medications was not performed.

Performing Laboratory Information

CRSP - Broad Institute - Clinical Research Sequencing Platform, LLC 320 Charles Street CAMBRIDGE MA 02141 Heidi
Rehm, Ph.D.

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