Jan 2022

PATIENT/CLIENT Wendy Laurano

DOB: Apr 20,1984 ID: 75221396779

Sex: Female Requisition #: 6439284230

COVID-19 Test

ORDERING PROVIDER SPECIMEN

Report date: Jan 21,2022

Erica Pan Type: Anterior Nares (in

media)
California Department of Public Health Barcode: D-3695756449

Center for Infectious Diseases Date Collected: Jan 18, 2022

P.O. Box 997377-0 Time Collected: 4:08 p.m. PT

Sacramento, CA 95899 Received: Jan 18, 2022

N Pl: 1972697324

PRESUMPTIVE POSITIVE RESULT for SARS-CoV-Z.

This patient should self-isolate, except to submit a new sample for testing.
Submitting a new sample is required.

"Presumptive positive" means that the test was not able to confirm with adequate
certainty that the patientls sample

collected on Jan 18, 2022 had SARS-CoV-Z RNA present.

DETAILS Test
Results

SARS-CoV-2 amplification test

Presumptive Positive

To learn more about the technical details

of this test, please see the test methodology and

limitations section.

HELPFUL If you have symptoms of illness (such as fever,

cough, and/or shortness of breath), you should

INFORMATION discuss your symptoms and your test results with your
doctor, who can decide how to care for

FOR THE PATIENT you.

The US Centers for Disease Control and

Prevention (CDC) has provided useful information on

how to care for yourself at home and how

others in your household may protect themselves. The

CDC has also provided information on when

to seek medical attention. Key points are outlined

below for your reference, and you can find

more information at: https://www.cdc.gov/
coronavirus/2019-ncov.

It is important to stay at home except to

get medical care. You should self-isolate (or separate

yourself from others) within your home.

Self-isolation is critical to protecting those who you live

with as well as your community. Avoid

contact with anyone over age 65 or anyone who has a

health problem such as a chronic disease

(e.g., diabetes) or a weak immune system. If you must

be around other people, you should wear a

facemask or cloth face covering over your nose and

mouth and maintain a distance of at least

6 feet from others. Cover your coughs and sneezes,

wash your hands often, and avoid sharing

personal household items.

CDPH Branch Laboratory

28454 Lvingston Ave. Laboratory
Director: Adam Rosendorff, MD
Valencia, CA 91355 CLlA
#05D2197416
1/ 3
Jan 21, 2022

PATIENT/CLIENT Wendy Laurano

DOB: Apr 20,1984 ID: 75221396779

Sex: Female Requisition #: 6439284230

CONFIDENTIAL

The CDC recommends that individuals

experiencing the following symptoms get medical

attention immediately:

- Trouble breathing

- Persistent pain or pressure in the chest

- New confusion

Inability to stay awake or wake after

sleeping

- Bluish lips or face

As the CDC instructs, before seeking

medical care at an office, clinic, or hospital, please alert

healthcare providers to the results of

this test. However, do not delay seeking care if you are

experiencing a medical emergency.

If you are a healthcare professional,

first responder, or frontline worker with questions about

returning to work, consider contacting

your place of employment or local health department in

regards to discontinuation of self-

isolation, as they may differ from the CDCls guidelines.

TEST METHODOLOGY AND LIMITATIONS

The SARS-CoV-Z RT-PCR amplification test is a real-time polymerase chain reaction
(RT-PCR) based qualitative

diagnostic test for the direct detection of SARS-CoV-Z virus RNA in nasopharyngeal
swabs, oropharyngeal swabs, and

anterior nasal swabs from individuals suspected of SARS-CoV-Z infection. Additional

sample types may be accepted

subject to validation by the laboratory.

The SARS-CoV-Z RT-PCR amplification test was performed at the CDPH Branch
Laboratory, 28454 Livingston Ave.,

Valencia, CA 91355, CLIA #05D2197416). Data were transmitted to Color Genomics

(863A Mitten Road, Suite IOOF,

Burlingame, CA 94010, CLIA #05D2081492), for report generation and distribution.

The SARS-CoV-Z RT-PCR amplification test is not FDA approved; it is a laboratory-

developed test (LDT). The FDA has

determined that emergency use authorization (EUA) review of SARS-CoV-Z LDTs is not
required at this time.

References:

PerkinElmer@ New Coronavirus Nucleic Acid Detection Kit, 2019-nCoV-PCR-AUS

FDA Guidance on SARS-CoV-Z EUA Authorization:

https://www.fda.gov/medical-devices/emergency-situations-medical-
devices/emergency-use-authorizations

Disclaimer:

The detection of viral nucleic acids by this SARS-CoV-Z RT-PCR assay depends on
proper sample collection, handling,

transportation, storage, and preparation. False negative results may occur due to
improperly collected, transported, or

handled swab samples, inadequate numbers of organisms for amplification, or the

presence of inhibitors or sequence

variation in the targets of the assay. False positive results may occur due to
potential cross-contamination by target

organisms, their nucleic acid or amplified product, or from non-specific signals in

the assay. This SARS-CoV-Z RT-PCR
CDPH Branch Laboratory
28454 Lvingston Ave. Laboratory
Director: Adam Rosendorff, MD
Valencia. CA 91355 CLlA
#05D2197416
2 / 3
Jan 21. 2022

PATIENT/CLIENT Wendy Laurano

DOB: Apr 20,1984 ID: 75221396779

Sex: Female Requisition #: 6439284230

CONFIDENTIAL

test does not detect or differentiate any other respiratory virus types. Results
from this test should be interpreted in

conjunction with other clinical and laboratory findings.

This test was developed and its performance characteristics determined by the CDPH
Branch Laboratory, Valencia, CA. It

has not been cleared or approved by the U.S. Food and Drug Administration (FDA).
The FDA has determined that such

clearance or approval is not necessary.

CDPH Branch Laboratory
28454 Lvingston Ave.
Laboratory Director: Adam Rosendorff, MD

Valencia. CA 91355 CLlA

#05D2197416
3 / 3

01/22/2022
To: Wendy Laurano
DOB: 4/20/1984
The result of your COVID-19 Nasal RT-PCR test that was administered on 1/18/2022
4:00 PM is
Presumptive Positive.
You should self-isolate, except to submit a new sample for testing. Submitting a
new sample is required.
Presumptive positive means that the test was not able to confirm with adequate
certainty that the sample
collected had SARS-CoV-2 RNA present.
To learn more about the technical details of this test, please see the test
methodology and limitations
section.
HELPFUL INFORMATION FOR THE PATIENT
If you have symptoms of illness (such as fever, cough, and/or shortness of breath),
you should discuss
your symptoms and your test results with your doctor, who can decide how to care
for you.
The US Centers for Disease Control and Prevention (CDC) has provided useful
information on how to
care for yourself at home and how others in your household may protect themselves.
The CDC has also
provided information on when to seek medical attention. Key points are outlined
below for your
reference, and you can find more information at:
https://www.cdc.gov/coronavirus/2019-ncov.
It is important to stay at home except to get medical care. You should self-isolate
(or separate yourself
from others) within your home. Self-isolation is critical to protecting those who
you live with as well as
your community. Avoid contact with anyone over age 65 or anyone who has a health
problem such as a
chronic disease (e.g., diabetes) or a weak immune system. If you must
be around other people, you should wear a facemask or cloth face covering over your
nose and mouth
and maintain a distance of at least 6 feet from others. Cover your coughs and
sneezes, wash your hands
often, and avoid sharing personal household items.
The CDC recommends that individuals experiencing the following symptoms get medical
attention
immediately:
 Trouble breathing
 Persistent pain or pressure in the chest
 New confusion
 Inability to stay awake or wake after sleeping
 Bluish lips or face
As the CDC instructs, before seeking medical care at an office, clinic, or
hospital, please alert healthcare
providers to the results of this test. However, do not delay seeking care if you
are experiencing a medical
emergency.
If you are a healthcare professional, first responder, or frontline worker with
questions about returning to
work, consider contacting your place of employment or local health department in
regards to
discontinuation of self-isolation, as they may differ from the CDC’s guidelines.
TEST METHODOLOGY AND LIMITATIONS
The SARS-CoV-2 RT-PCR amplification test is a real-time polymerase chain reaction
(RT-PCR) based
qualitative diagnostic test for the direct detection of SARS-CoV-2 virus RNA in
nasopharyngeal swabs,
oropharyngeal swabs, and anterior nasal swabs from individuals suspected of SARS-
CoV-2 infection.
Additional sample types may be accepted subject to validation by the laboratory.
The SARS-CoV-2 RT-PCR amplification test was performed at the CDPH Branch
Laboratory, 28454
Livingston Ave., Valencia, CA 91355, CLIA #05D2197416). Data were transmitted to
Color Genomics
(863A Mitten Road, Suite 100F, Burlingame, CA 94010, CLIA #05D2081492), for report
generation and
distribution.
The SARS-CoV-2 RT-PCR amplification test is not FDA approved; it is a laboratory-
developed test
(LDT). The FDA has determined that emergency use authorization (EUA) review of
SARS-CoV-2 LDTs is
not required at this time.
References:
PerkinElmer® New Coronavirus Nucleic Acid Detection Kit, 2019-nCoV-PCR-AUS
FDA Guidance on SARS-CoV-2 EUA Authorization:
https://www.fda.gov/medical-devices/emergency-
situations-medicaldevices/emergency-use-authorizations
Disclaimer:
The detection of viral nucleic acids by this SARS-CoV-2 RT-PCR assay depends on
proper sample
collection, handling, transportation, storage, and preparation. False negative
results may occur due to
improperly collected, transported, or handled swab samples, inadequate numbers of
organisms for
amplification, or the presence of inhibitors or sequence variation in the targets
of the assay. False
positive results may occur due to potential cross-contamination by target
organisms, their nucleic acid or
amplified product, or from non-specific signals in the assay. This SARS-CoV-2 RT-
PCR test does not
detect or differentiate any other respiratory virus types. Results from this test
should be interpreted in
conjunction with other clinical and laboratory findings.
This test was developed and its performance characteristics determined by the CDPH
Branch
Laboratory, Valencia, CA. It has not been cleared or approved by the U.S. Food and
Drug Administration
(FDA). The FDA has determined that such clearance or approval is not necessary.
Lab Information:
CDPH Branch Laboratory
28454 Livingston Ave.
Valencia, CA 91355
Laboratory Director: Dr. Adam Rosendorff
CLIA #05D2197416

01/22/2022
Para: Wendy Laurano
Fecha de nacimiento: 4/20/1984
El resultado de su RT-PCR prueba de COVID-19 Nasal, realizada en 1/18/2022 4:00 PM
es
Presumptive Positive.
Debería aislarse, excepto para presentar una nueva muestra para analizar. Se
requiere presentar una
nueva muestra.
Presuntamente positivo significa que la prueba no pudo confirmar con una certeza
adecuada que la
muestra recolectada tenía presente el ARN de SARS-CoV-2.
Para obtener más información sobre los detalles técnicos de esta prueba, consulte
la sección de
metodología y limitaciones de la prueba.
INFORMACIÓN ÚTIL PARA EL PACIENTE
Si tiene síntomas de enfermedad (como fiebre, tos o dificultad para respirar)
debería hablar sobre sus
síntomas y los resultados de su prueba con su médico, quien puede decidir el tipo
de atención que
usted necesita.
Los Centros para el Control y la Prevención de Enfermedades (CDC) de los Estados
Unidos han
proporcionado información útil sobre cómo usted puede cuidarse en su casa y cómo se
pueden proteger
otras personas que viven con usted. Los CDC también proporcionaron información
sobre cuándo buscar
atención médica. A continuación se describen los puntos clave a modo de referencia,
y usted puede
encontrar más información en:
https://espanol.cdc.gov/coronavirus/2019-ncov/index.html.
Es importante que se quede en casa, excepto para recibir atención médica. Debería
aislarse (o
separarse de los demás) dentro de su hogar. El aislamiento es crucial para proteger
a las personas que
conviven con usted, así como a su comunidad. Evite el contacto con personas mayores
de 65 años o
que tengan un problema de salud como una enfermedad crónica (p. ej., diabetes) o un
sistema
inmunitario débil. Si debe estar cerca de otras personas, debería usar una
mascarilla o un barbijo de tela
que le cubra la nariz y la boca, y mantener una distancia de al menos 6 pies (2 m)
de los demás.
Cúbrase al toser y estornudar, lávese las manos con frecuencia y evite compartir
los artículos del hogar
de uso personal.
Los CDC recomiendan que las personas que presentan los siguientes síntomas reciban
atención médica
inmediatamente:
 Dificultad para respirar
 Dolor o presión persistente en el pecho
 Confusión repentina
 Incapacidad para mantenerse despierto o despertarse después de dormir
 Cara o labios azulados
Según las indicaciones de los CDC, antes de buscar atención médica en un
consultorio, una clínica o un
hospital, avise a los proveedores de atención de la salud los resultados de esta
prueba. Sin embargo, no
se demore en buscar atención si está teniendo una emergencia médica.
Si usted es un profesional de atención de la salud, un trabajador de los servicios
de emergencia o un
trabajador esencial de primera línea y quiere saber cómo reincorporarse al trabajo,
considere
comunicarse con su lugar de empleo o departamento de salud local para preguntar por
el final del
aislamiento, ya que podría haber diferencias con las pautas de los CDC.
METODOLOGÍA Y LIMITACIONES DE LA PRUEBA
La prueba de amplificación SARS-CoV-2 RT-PCR es una prueba de diagnóstico
cualitativa de la
reacción en cadena de la polimerasa en tiempo real (real-time polymerase chain
reaction, RT-PCR) para
la detección directa del ARN del virus SARS-CoV-2 en hisopados nasofaríngeos,
hisopados
orofaríngeos e hisopados de la cavidad nasal anterior de personas con presunta
infección por SARS-
CoV-2. Podrían aceptarse otros tipos de muestras, sujetos a la validación del
laboratorio.
La prueba de amplificación SARS-CoV-2 RT-PCR se realizó en CDPH Branch Laboratory,
28454
Livingston Ave., Valencia, CA 91355, CLIA #05D2197416. Los datos se transmitieron a
Color Genomics
(863A Mitten Road, Suite 100F, Burlingame, CA 94010, CLIA #05D2081492), para la
generación y
distribución de informes.
La prueba de amplificación de SARS-CoV-2 RT-PCR no está aprobada por la
Administración de
Alimentos y Medicamentos (Food and Drug Administration, FDA); es una prueba
desarrollada en
laboratorio (laboratory-developed test, LDT). La FDA determinó que en este momento
no se requiere
una revisión de la autorización de uso de emergencia (emergency use authorization,
EUA) de la LTD del
SARS-CoV-2.
Referencias:
PerkinElmer® New Coronavirus Nucleic Acid Detection Kit, 2019-nCoV-PCR-AUS
FDA Guidance on SARS-CoV-2 EUA Authorization:
https://www.fda.gov/medical-devices/emergency-
situations-medicaldevices/emergency-use-authorizations
Descargo de Responsabilidad:
La detección de ácido nucleico viral mediante este ensayo de SARS-CoV-2 RT-PCR
depende de la
correcta recolección, manipulación, transporte, almacenamiento y preparación de la
muestra. Los
resultados falso negativos pueden ocurrir debido a muestras de hisopados
manipuladas, transportadas
o recolectadas incorrectamente, a cantidades inadecuadas de organismos para la
amplificación o a la
presencia de inhibidores o variación en la secuencia de los objetivos del ensayo.
Los resultados falso
positivos pueden ocurrir debido a la posible contaminación cruzada de organismos
objetivos, su ácido
nucleico o producto amplificado, o de señales inespecíficas en el ensayo. Esta
prueba de SARS-CoV-2
RT-PCR no detecta ni distingue ningún otro tipo de virus respiratorio. Los
resultados de esta prueba se
deben interpretar junto con otros hallazgos clínicos y de laboratorio.
CDPH Branch Laboratory, Valencia, CA, desarrolló esta prueba y determinó sus
características de
eficacia. Esta prueba no ha sido autorizada ni aprobada por la Administración de
Alimentos y
Medicamentos (FDA) de los Estados Unidos. La FDA ha determinado que dicha
autorización o
aprobación no es necesaria.
Lab Information:
CDPH Branch Laboratory
28454 Livingston Ave.
Valencia, CA 91355
Laboratory Director: Dr. Adam Rosendorff
CLIA #05D2197416