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750 Hamburg Tpk, Pompton Lakes, NJ 07442-9998

Phone: (862)330-3500 Fax: (862)330-3501


Director: Martin King Ph.D CLIA #: 31D2175510

LABORATORY REPORT
PATIENT SPECIMEN CLIENT INFORMATION
Name: SANCHEZ, MARIA Specimen Type: Client: COMMUNITY MEDICAL CARE
Address: 1630 ESSEX ST Collection Date: 06/23/21 11:00 Client ID: 57
RAHWAY, NJ 07065 Received Date: 06/23/21 20:38 Provider:EDWARD RAKLER PA-C
Phone: (908) 908-1994 Reported Date: 06/23/21 22:53 Address: 120 ELMORA AVE
DOB: 03/23/1981 ELIZABETH, NJ 07202
Gender: Female Accession #: 2106230092 Phone: (908) 994-1500

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Test Name Result Reference Range
SARS-CoV-2 (COVID-19) PCR NEGATIVE NEGATIVE

ASSAY INFORMATION: Diagnovital HS SARS-CoV-2 Real-Time PCR Test.


The performance characteristics of this test were validated by Rightway
Diagnostics Laboratory in agreement with the FDA guidance document. This
test uses RT-PCR followed by bead hybridization for detection of SARS-CoV-2
specific targets N1 gene and N2 gene. Rightway Laboratory is designated as
a High Complexity Laboratory by the CLIA and is qualified to perform this
test. This test has been authorized as a Laboratory Developed Test (LDT).
A nasopharyngeal/oropharyngeal specimen is the preferred choice for swab-
based SARS-CoV-2 testing. Per the FDA, sub-optimal specimen collections may
be accepted for analysis although these specimens may have decreased
sensitivity, so caution should be exercised when interpreting negative
results.

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