Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens

Evaluation of a TMA Assay for the Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00552214

Enrollment

10290

Registered

2007-11-01

Start date

2007-08-08

Completion date

2008-07-01

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations

Keywords

Nucleic acid test, HIV-1, hepatitis, HBV, HCV, TMA, HIV Seronegativity

Brief summary

The purpose of this study is to validate the performance characteristics of an assay that tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration submission.

Interventions

DEVICEBlood test

Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* An acceptable blood donation health history and an EIA negative donation sample result with licensed EIA procedures in routine use at each facility

Exclusion criteria

* A positive (reactive) HIV and/or HCV and/or HBV test

Design outcomes

Primary

Measure	Time frame
Sensitivity and Specificity	01 August 2007 to 31 December 2007

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026