Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004846
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-03-02
Brief Title:
Nucleic Acid Amplification Testing NAT of Blood Donors for HCV and HIV
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Nucleic Acid Amplification Testing NAT of Blood Donors for HCV and HIV
Status:
COMPLETED
Status Verified Date:
2002-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Healths 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 650000 to 1 in a million and the risk of HCV transmission from the current 1 in 100000 to 1 in 350000 It is possible that these tests will completely eliminate the risk of transmitting these diseases through blood transfusion
Blood donors to the National Institutes of Healths 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 650000 to 1 in a million and the risk of HCV transmission from the current 1 in 100000 to 1 in 350000 It is possible that these tests will completely eliminate the risk of transmitting these diseases through blood transfusion
Detailed Description:
In order to narrow the infectious period window between the time of viral exposure and the time a virus can be serologically detected blood centers throughout the United States are implementing nucleic acid testing NAT for HIV and HCV Early studies have shown that NAT testing can significantly narrow the infectious window particularly for HCV There is the potential that NAT testing could completely eradicate the transfusion risk of HIV and HCV The test is thus likely to add substantially to the safety of blood transfusions and although not licensed has been implemented by all blood suppliers and transfusion services in the United States NAT testing is currently being used under an IND mechanism The IND stipulates that blood donors need to be informed through a supplemental information packet that such testing is being performed and that if found positive they may be recalled for additional testing At the time of recall an IRB approved study-specific informed consent is administered and additional tests are performed to verify the initial NAT result The Department of Transfusion medicine is participating in this national validation of NAT testing and will provide donor samples for centralized testing and statistical reporting to FDA The potential benefits of this testing for blood safety are great and the risk to donors is considered minimal Not seeking subjects for enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-CC-0048 | None | None | None |