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Covid Test 6

The SARS-CoV-2 (COVID-19) RT-PCR test for Steven H Reiter was detected, indicating the presence of SARS-CoV-2 RNA in the nasopharynx sample. A detected result means the patient is presumed to be contagious, even if asymptomatic. The test was developed by UltimateDx and has been authorized by the FDA under an emergency use authorization for the duration of the COVID-19 pandemic.

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14 views1 page

Covid Test 6

The SARS-CoV-2 (COVID-19) RT-PCR test for Steven H Reiter was detected, indicating the presence of SARS-CoV-2 RNA in the nasopharynx sample. A detected result means the patient is presumed to be contagious, even if asymptomatic. The test was developed by UltimateDx and has been authorized by the FDA under an emergency use authorization for the duration of the COVID-19 pandemic.

Uploaded by

Djibzlae
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Saint Clare's Dover Hospital Lab

400 W BLACKWELL ST
DOVER, NJ 07801
Dr. SAFEDIN BEQAJ Ph.D.,HCLD,CC
CLIA# 05D2106322 CLF# 00348622
LABORATORY REPORT [email protected] (800)799-7248
PATIENT SPECIMEN PHYSICIAN
Name: Steven H Reiter Specimen Type: NASOPHARYNX Name: DAVID NAZARIAN M.D.
25 Oakmont Ln, Bay Shore, NY 11706
Collection Date: 03/02/24 10:52
Date of Birth:04/12/1948
Address: 400 W Blackwell St
Gender: Male Received Date: 03/02/24 18:01
Dover, NJ 07801
Accession #: 2011163771 Reported Date: 03/02/24 23:35 Phone: (310) 299-8959

SARS-CoV-2 (COVID-19)
Test Name Within Range Outside Range Prev. Result Reference Range Units
SARS-CoV-2 (COVID-19) RT-PCR
SARS-CoV-2 (COVID-19) PCR DETECTED DETECTED
RESULT INTERPRETATION

DETECTED (Positive) results do not rule out bacterial co-infection with


other viruses. A positive test result indicates that RNA from the
SARS-CoV-2 virus was detected in the patient sample. Patients infected with
this virus are presumed to be contagious and may be asymptomatic. Patient
results can change at every testing event.

NOT DETECTED (Negative) results do not preclude SARS-CoV-2 virus infection


and should not be used as the sole basis for diagnostic decisions. Negative
results must be combined with clinical observations, patient history, and
epidemiological information. A negative test result means that the virus
that causes COVID-19 was not found in your sample at the time the sample
was taken. For COVID-19, a negative test result for a sample collected
while a person has symptoms usually means that COVID-19 did not cause the
recent illness. However, it is possible for this test to give a negative
result that is incorrect (false negative) in some people with COVID-19.
This means that you could possibly still have COVID-19 even though the test
is negative.

INDETERMINATE (Borderline) results can occur when there is poor sample


collection or the viral load is very low at the time of collection so to
not warrant a positive or a negative result. This patient should be tested
again as soon as possible to determine efficacy.

The UDX SARS CoV-2 Molecular Assay is a laboratory developed test (LDT) for
the COVID-l9 disease. This test has not been FDA cleared or approved. This
test has been authorized by the FDA under an Emergency Use Authorization
(EUA) and it has been validated in accordance with the FDA’s Guidance
Document Policy for Diagnostics Testing in Laboratories Certified to
Perform High Complexity Testing under CLIA. 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.

Status: FINAL Page 1 of 1

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