Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00004846 |
Recruitment Status :
Completed
First Posted : March 3, 2000
Last Update Posted : March 4, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment |
---|---|
Hepatitis C HIV Infection | Drug: ABC/Gen-Probe/Chiron HIV-1/HCV 001 |
Study Type : | Observational |
Enrollment : | 30000 participants |
Official Title: | Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV |
Study Start Date : | December 1999 |
Study Completion Date : | October 2002 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
All eligible, volunteer NIH blood donors will be tested by NAT. Thus, any donor who enters the system and has blood drawn for viral testing will be a potential candidate for the follow-up study if he/she tests NAT positive for HCV or HIV.
Only potential donors who exclude themselves from the donation process will be excluded from the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004846
United States, Maryland | |
Warren G. Magnuson Clinical Center (CC) | |
Bethesda, Maryland, United States, 20892 |
ClinicalTrials.gov Identifier: | NCT00004846 |
Other Study ID Numbers: |
000048 00-CC-0048 |
First Posted: | March 3, 2000 Key Record Dates |
Last Update Posted: | March 4, 2008 |
Last Verified: | October 2002 |
Viral Gene Amplification Blood Transmitted Infections Transfusion Risks |
Transcription Mediated Analysis Viral Detection Assays HIV Seronegativity |
Hepatitis C Infections Hepatitis Liver Diseases Digestive System Diseases Blood-Borne Infections |
Communicable Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections |