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 as part of the public health
response to SARS. 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 Was I (My Child) Tested?
You (or your child) may be tested for SARS 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 have been 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
blood, serum, or plasma samples taken from you (or your child). 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
If This Test Was Positive, Does That Mean I (My Child) Have
Or Had 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)
samples tested 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 or other treatment.
If this happens, your (your child's) doctor will discuss the risks
and benefits and obtain your consent or other treatment.
- 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 Was Negative, Does That Mean I (My Child) Do Not
Or Did Not Have Sars?
This test may give a negative result when you (or your child) actually
have the virus (false negative).
A false negative result should not have an effect on your (or your child's)
care. CDC has told doctors that a negative test 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 people around you should be based on a
negative result.
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 was 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) Have Been Harmed?
If you (your child) were 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. You (or your child)
do not give up any legal rights that otherwise would be available to
you (or your child).
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 3918. 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. Lia Haynes at 404-639-4004.
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. Lia Haynes
Centers for Disease Control and Prevention
1600 Clifton Rd.
Atlanta , GA 30333
FAX: 404-639-1307
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