Scribd
Upload
48 views2 pages

Kevin Fenning CUR152331536 71c0d4ec88d12564045bf8a8

Uploaded by

Kevin Fenning
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
48 views2 pages

Kevin Fenning CUR152331536 71c0d4ec88d12564045bf8a8

Uploaded by

Kevin Fenning
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
You are on page 1/ 2

Curative Labs Inc

3301 Green St
Claymont, DE 19703
[email protected]
Final Results
Report

Patient Name: FENNING, KEVIN Facility: State of Delaware

Patient MRN: CUR152331536 Facility Type: Public Testing, Nursing Home

Requisition: 59315595

Date of Birth: 09/03/1961 (60 years old) Kit ID: ACC590269069764

Sex: MALE Collected: 07/27/2022 11:10:39 AM EDT

113 CARLIE RD
Address: Received: 07/27/2022 12:03:21 PM EDT
WILMINGTON, DE 19803

Phone Number: 12676501811 Released: 07/27/2022 12:03:21 PM EDT

Email: [email protected] Specimen Type: Accula COVID-19 Rapid PCR shallow nasal swab

Physician: Zalzala, Sajad


(1639311509)

Test Result

Rapid COVID-19 RT-PCR Test Positive

Interpretation:

Positive: SARS-CoV-2 (RNA) was detected


Negative: SARS-CoV-2 (RNA) was not detected
Indeterminate: the assay is invalid; test should be repeated.

The Accula™ SARS-CoV-2 Test performed on the Accula Dock or the Silaris™
Dock is a molecular in vitro diagnostic test utilizing polymerase chain
reaction (PCR) and lateral flow technologies for the qualitative, visual
detection of nucleic acid from SARS-CoV-2 in clinician-collected nasal or
nasal mid-
turbinate swab specimens or clinician-instructed self-collected
(collected on site) nasal swab specimens, collected from individuals
suspected of COVID-
19 by their healthcare provider. Testing is limited to
laboratories certified under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA), 42
U.S.C. §263a, that meet requirements to perform high,
moderate, or waived complexity tests. The Accula SARS-CoV-2 Test is
authorized for use at the
Point of Care (POC), i.e., in patient care
settings operating under a CLIA Certificate of Waiver, Certificate of
Compliance, or Certificate of Accreditation.

Accula SARS-CoV-2 Test results are for the identification of SARS-CoV-2 RNA.
The SARS-CoV-2 RNA is generally detectable in upper respiratory
specimens
during the acute phase of infection. Positive results are indicative of the
presence of SARS-CoV-2 RNA; clinical correlation with patient history
and
other diagnostic information is necessary to determine patient infection
status. Positive results do not rule out bacterial infection or co-infection
with
other viruses. Testing facilities within the United States and its
territories are required to report all results to the appropriate public
health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used
as the sole basis for patient management decisions. Negative results
must be
combined with clinical observations, patient history, and epidemiological
information.

The Accula SARS-CoV-2 Test is only for use under the Food and Drug
Administration’s Emergency Use Authorization.

Patient Fact Sheet:


https://www.fda.gov/media/136349/download

Health Care Provider Fact Sheet:


https://www.fda.gov/media/136347/download
Lab director: Arthur M Baca MD Ph.D; CLIA #
45D2192800; Sample reviewed at: 07/27/2022 11:33:21 AM EDT; Report generated at:
07/27/2022
12:39:22 PM EDT

You might also like