Severe Acute
Respiratory Syndrome (SARS) |
The Centers for Disease Control and Prevention (CDC) and public health laboratories
are using an investigational laboratory test to test for the virus that causes "severe
acute respiratory syndrome" or (SARS). The Food and Drug Administration (FDA)
has not licensed this test. The FDA has agreed that we can use this test
under an investigational device exemption (IDE). We don't know for sure if
this test can find all people who may get sick with SARS. There are no FDA
approved tests that quickly find the virus.
Your State or Local Health Department and CDC are using the results of this
test as one piece of information to help us find out if people are sick with
SARS and to limit the spread of this illness. Your (or your child's) doctor
will use other information along with this test result to decide what is
best for you (your child).
Because SARS can be a serious illness, your State or Local Health Dept and/or
CDC have used this test on samples from you (your child).
BACKGROUND
SARS is a respiratory illness that can start as fever and cough. It may
go on to pneumonia in some people. SARS seems to be spread by close person
to person contact. This can occur when a person who is sick with SARS coughs
or sneezes onto themselves, other people, or nearby surfaces. Droplets from
the cough or sneeze can travel a short distance through the air and land
on the mouth, nose, or eyes of persons who are nearby. The virus also can
spread when a person touches a surface or object with infectious droplets
and then touches his or her mouth, nose, or eye(s). It also is possible that
SARS can be spread through the air or by other ways that we don't yet know
about.
WHY SHOULD MY (MY CHILD'S) SAMPLE BE TESTED?
You (or your child) may be asked to have SARS testing done when there are
no reported cases of SARS in the world or when and if SARS returns. It is
important to test for SARS when there are no reported SARS cases so that
public health efforts could quickly identify a case and limit its spread.
The results of this test, along with other information, may also help your
(your child's) doctor take better care of you (your child). You (or your
child) may be asked to be tested for the SARS virus because:
- You (or your child) are being hospitalized for symptoms like pneumonia and within
10 days of the start of symptoms you (or your child):
- Have traveled to an area that had reported SARS cases in
the past, or
- Had close contact with an ill person who just came back
from these areas, or
- Had close contact with person(s) who have pneumonia like
symptoms and have not been diagnosed, or
- Are employed in a job that may put you at risk for SARS,
such as a healthcare worker with direct patient contact or a worker in
a laboratory that has live SARS virus.
OR
- There are reported cases of SARS in the world and you (or your
child) have symptoms which may be early symptoms of SARS, such as
fever or lower respiratory symptoms or other symptoms your doctor
feels might be SARS and :
- Recent close contact with persons thought to have SARS, or
- Recent exposure to areas (in the U.S. or outside the U.S.
) with confirmed or suspected SARS (or close contact with ill persons with
a history of these exposures)
The samples used to do this laboratory test may have come from extra nasal
swab or aspirate, throat swab samples, blood, serum, plasma, or stool taken
from you (or your child) to do this test. These samples may have been taken
as part of your routine care to find out what illness you (or your child)
have. Your (your child's) doctor may also ask to take more samples in the
future.)
WHAT ABOUT PRIVACY?
We will keep all facts about you (your child) as private as the law allows.
CDC, FDA, the Local/State Health Department staff and the person(s)
who ordered your test (such as your Doctor) may see your/your child's results.
When we present or publish papers about these tests, neither you (nor your
child) will be named.
WHAT ARE THE COSTS?
The test will be done by CDC or your health department at no cost. You,
your insurer, Medicare or Medicaid will need to pay for other costs related
to the testing, such as Doctor's visits.
WHAT HAPPENS IF YOU (YOUR CHILD) ARE HARMED?
If you (your child) are harmed as a result of taking the samples, CDC will
not pay the costs for hospital and medical care. You, your insurer, Medicare
or Medicaid will need to pay those costs. Y ou (or your child) do not give
up any legal rights that otherwise would be available to you (or your child).
IF THIS TEST IS POSITIVE, DOES THAT MEAN I (MY CHILD) HAVE SARS?
There is a small chance that this test may give a positive result for the
SARS virus when the virus is not there (false positive). If your (your child's)
result from this test is positive:
- You (your child) could be asked to limit contact outside the home
by not going to work, school, out-of-home childcare, church, or other
public areas. You may also be asked to use a mask at home to limit
the risk of spread of the virus. If you (your child) have had symptoms
of SARS, you might be asked to follow these limits because of these
symptoms and not because of the test results. If your (your child's)
tests are positive, there is a small chance that you (your child)
may be asked to follow these limits even if you (your child) do not
seem sick.
- There is no proven treatment for SARS at this time. If you (your
child) your child is very ill, in rare cases, you (your child) may
be advised to take an antiviral drug. If this happens, your (your
child's) doctor will discuss the risks and benefits and obtain your
consent.
- Your (or your child's) doctor may decide how to care for you based
on the test results along with other factors.
IF THIS TEST IS NEGATIVE, DOES THAT MEAN I (MY CHILD) DO NOT HAVE SARS?
This test may give a negative result when you (or your child) do have the
virus (false negative). A false negative result should not effect your (or
your child's) care. CDC has told doctors that a negative test alone does
not prove that a person does or does not have the SARS virus. No changes
in your medical care or how you interact with other people should be based
on a negative result.
WHOM TO CALL IF YOU HAVE QUESTIONS
Please call your doctor if you have any questions about this testing. If
you have questions about your (or your child's) rights as a participant in
this testing program, please call the CDC Associate Director for Science
at 1-800-584-8814. Leave a message with your (or your child's) name, phone
number and that the protocol # is 3911. Someone will call you back as soon
as possible.
CONSENT FOR SAMPLE STORAGE
We are asking for your consent to store any remainders of your (your child's)
samples used for SARS virus testing at CDC for future SARS-related investigations.
If the results of any future tests are important for your medical care we
will make every effort to notify your doctor.
We will not do human genetic testing or HIV testing unless we contact you
and ask for your consent. If you agree to storage and change your mind later
please call Dr. Dean Erdman at 404-639-3727.
Signature
I have been
provided with the above information about my (my child’s) test results.
I have stated
whether or not I agree to long-term specimen storage.
I have read
the above and have had my questions answered by ______________.
Print
Patient's Name: |
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Patient's/Parent's
Signature: |
__________________________ |
Date: |
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Legally
Authorized
Representative Signature: |
__________________________ |
Date: |
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Witness
to signature:
(required by FDA) |
__________________________ |
Date: |
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NOTE:
PLEASE RETURN OR FAX A SIGNED COPY OF THIS FORM TO CDC AND THE STATE OR LOCAL HEALTH DEPARTMENT.
CDC contact:
Dr. Dean Erdman
Centers for Disease Control and Prevention
1600 Clifton Rd.
Atlanta , GA 30333
FAX: 404-639-4416
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