Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV
Status:
Completed
Trial end date:
2002-10-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the accuracy of an experimental test method called nucleic acid
amplification technology (NAT) in detecting human immunodeficiency virus (HIV) and hepatitis
C virus (HCV). This test amplifies the nucleic acid in a virus more than a million-fold,
allowing early detection of minute quantities of virus in the blood.
Blood donors to the National Institutes of Health's Department of Transfusion Medicine (blood
bank) will have their blood screened with transcription mediated amplification, a type of NAT
test. Donors whose blood is found positive for HIV or HCV by NAT testing will be notified and
asked to participate in this study. Those who agree will provide a blood sample about once a
week for 3 months. The samples will be tested with additional assays to detect evidence of
HIV or HCV infection. If the test results are confirmed positive, no more blood samples will
be collected. The results of the tests and their significance will be explained to
participants.
It is anticipated that NAT screening will reduce the risk of transfusion-related HIV
transmission from the current 1 in 650,000 to 1 in a million and the risk of HCV transmission
from the current 1 in 100,000 to 1 in 350,000. It is possible that these tests will
completely eliminate the risk of transmitting these diseases through blood transfusion.
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)