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Webrep

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FINAL REPORT

1901 E. LINDEN AVE. SUITE 4 | LINDEN, NJ 07036-1195 | (908)474-1004

ALEF BEHAVIORAL GROUP, LLC WILLIAMS, MISTOR Accession #: 2129537682


3580 NC HWY 14 DOB: 03/10/1975 Age: 46 Specimen ID:
REIDSVILLE, NC 27320 Sex: M Date Collected:10/22/21 12:39 PM
Acct: 42093 ID#: Date Received: 10/23/21 06:04 AM
Phone: (336) 522-5095 Address: 619 ALAMANCE ST.
GIBSONVILLE, NC 27249 Date of Report:10/23/21
Provider: GABRIELLE NEWSAM M.D. Phone: 336-437-6930 First Reported:10/23/21

CLINICAL REPORT
Comments:

Fasting: NOT PROVIDED

2019 NOVEL CORONAVIRUS(COVID-19)


Test Result Abnormal Reference Units Previous Result Prev Dt
SARS CoV-2, SWAB (PCR) NEGATIVE Negative
Interpretation:
This test is intended for the qualitative detection of the Severe Acute
Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA in human respiratory
samples. The HDPCR SARS-CoV-2 assay from ChromaCode uses Reverse
Transcription Real-Time Polymerase Chain Reaction based on TagMan probe
chemistry and proprietary analysis. The HDPCR SARS-CoV-2 assay includes the
same N1 and N2 oligonucleotic primer, and probe sequences, for the
detection of the SARS-CoV-2 viral RNA and human RNase P gene used in the
CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel,
for Emergency Use Only. The performance characteristics of the test were
validated by ACCU Reference Medical Lab in agreement with the FDA’s
Guidance Document "Policy for Diagnostics Testing in Laboratories Certified
to Perform Complexity Testing under CLIA prior to Emergency Use
Authorization for Coronavirus Disease-2019 during the Public Health
Emergency" issued on February 29th, 2020. This test is a modification of
the FDA authorized Emergency Use Authorization (EUA). ACCU Reference
Medical Lab, LLC. is certified under the Clinical Laboratory Improvement
Amendments (CLIA) as qualified to perform high complexity clinical
laboratory testing. The modification of the test has been approved by
regulatory agencies. 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.
This test is used for clinical purposes. It should not be regarded as
investigational or for research. The FDA states sub-optimal specimen
collection may be accepted by laboratories for analysis; therefore when
diagnostic result is negative, the possibility of a false negative result
should be considered in the clinical context of the patient. Recent
exposures and/or clinical signs and symptoms consistent with COVID-19
should be considered when interpreting negative results.

------------------------------ END OF REPORT ------------------------------

Laboratory Director: Julian Arce, MD


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1901 E. LINDEN AVE. SUITE 4 | LINDEN, NJ 07036-1195 | (908)474-1004 Printed 10/23/21 19:05

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