Curative Labs Inc

108 N 33rd Ct
Hollywood, FL 33021
support@curative.com
Final Results
Report

Patient Name: Saez, Beatriz Facility: City of Hollywood, Florida

Patient MRN: CUR164046280

Requisition: 56411336

Date of Birth: 1966-07-27 (55 years old) Kit ID: ACC500433727283

Sex: female Collected: 02/21/22 01:16:04 PM EST

Address: 12761 SW 26th St Davie, FL 33325 Received: 02/21/22 02:02:00 PM EST

Phone Number: 13053326878 Released: 02/21/22 02:02:00 PM EST

Email: Beasaez@aol.com Specimen Type: Accula COVID-19 Rapid PCR test

Physician: Zalzala, Sajad

(1639311509)

Test Result

Rapid COVID-19 RT-PCR Test Negative

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 Baca MD, PhD; CLIA #

45D2192800; Sample reviewed at: 02/21/22 01:32:00 PM EST; Report generated at:
02/21/22 03:45:14 PM
EST