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

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.

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Key information

Conditions

Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations Digestive System Diseases Hepatitis Liver Diseases

Age range

17 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Blood Center Taiwan Blood Service Foundation (TBSF)

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood test

Device

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

Primary outcomes

Sensitivity and Specificity

Time frame: 01 August 2007 to 31 December 2007

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Nov 1, 2007
Registry last updated: Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed