| What is NAT? |
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| Nucleic Acid Testing (NAT) is a genetic fingerprint test which
is able to detect extremely small amounts of viruses in the blood. |
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| Who is performing NAT? |
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| OBI has one of only 17 blood banking laboratories in the United
States that began performing NAT testing on donated blood in
April 1999. OBI has the only NAT laboratory in Oklahoma. |
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Why is NAT important? |
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| Because this test is more sensitive and will detect viral infections
much more quickly than current testing technology. Currently
NAT is available for hepatitis C, HIV, and West Nile Virus. For
hepatitis C NAT, will close the "window" of infectious transmission
opportunity (the period of time when an infectious virus is present
in the blood but not yet detectable by standard serological testing
technology) from 8 - 10 weeks down to 10 - 14 days. The
current window for HIV of 6 - 10 days will almost be eliminated. |
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| With NAT in place, what are the risks associated with receiving
a blood transfusion? |
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HCV
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Current risk is 1 per 10,000 - 1 per 150,000 (with an
estimated 150 infected units in the window being
transfused per year in the US. Risk with NAT -
1 per 1 million - 1 per 1.5 million (with NAT detecting
135 of the current 150 that are currently undetected).
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HIV
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Current risk is 1 per 600,000 - 1 per 1 million nationally & 1
per 1.5 million - 1 per 2 million in Oklahoma. Oklahoma
is already an incredibly low risk area for HIV
and with HIV NAT the risk will virtually be eliminated.
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| Is NAT required by the FDA? |
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| No, at this time the FDA is endorsing but not requiring blood
centers to utilize NAT. NAT is being performed under an investigational
new drug (IND) exemption from the FDA and is expected to become a
required test in the future. |
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| Why is OBI becoming a NAT lab instead of sending its blood samples
to another laboratory? |
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| OBI is going to a great deal of expense to build its NAT laboratory
in Oklahoma City because of its strong commitment to perform
all testing in its own laboratories. Dr. Gilcher believes that
patients in Oklahoma benefit by having blood that is tested by
OBI. Testing in OBI labs ensures that OBI maintains control
of the quality of testing and is able to provide tested blood
in a timely manner for Oklahomans. Again, OBI is the only NAT
laboratory in the state of Oklahoma. |
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| Quote from Ronald O. Gilcher, MD, FACP. |
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| "Nucleic Acid Testing will add a small but measurable
additional margin of safety in terms of preventing hepatitis C transmission
through a blood transfusion. The additional margin of safety
in the prevention of HIV in Oklahoma may be essentially unmeasurable
because the risk is already so low in this state. However,
at the Oklahoma Blood Institute we are committed to taking
every step possible to eliminate any risk associated with a
blood transfusion. The people of Oklahoma deserve the safest
blood supply possible." |