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Consent form (SARS Laboratory Testing Public Health Response ) : Reverse Transcription Polymerase Chain Reaction (RT-PCR) testing
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February 6, 2004
[PDF-127.38 KB]
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Description:CDC IRB approval as of 2/6/04
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).
rtpcr-consent.pdf
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Pages in Document:4 numbered pages
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