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Retrovirus Epidemiology Donor Study - II (REDS-II) Molecular Surveillance (MS)

Clinical Trials URL:
Study Type: Epidemiology Study
Prepared on November 16, 2012
Last Updated on November 16, 2012
Study Dates: 2006 - 2009
Consent: Restricted Consent
Consent Restrictions: Restrictions are related to specimen use by research topic
Commercial Use Restrictions: No
NHLBI Division: DBDR
Collection Type: Open BioLINCC Study - See bottom of this webpage for request information


The objective of the study was to conduct a genetic analysis of incident and prevalent strains of HIV, HCV and HBV by testing blood specimens from HIV, HCV or HBV positive blood donors who gave blood at REDS-II centers, as well as at UBS, NYBC and ARC blood centers between 2006 and 2009.


Genetic variations of human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) can affect diagnostic assays and therapeutic interventions. Recent changes in prevalence of subtypes/genotypes and drug/immune-escape variants were characterized by comparing recently infected vs. more remotely infected blood donors.


This study included qualifying donations from 1 January 2006 through 31 December 31 2009 from 3 Retrovirus Epidemiology Donor Study-II (REDS-II) blood centers (Blood Centers of the Pacific, Blood Center of Wisconsin, and Hoxworth Blood Center/University of Cincinnati), all American Red Cross Blood Services regions, United Blood Services regions and the New York Blood Center. Together, these centers account for approximately 70% of the US blood supply.


Infected donors were identified among approximately 34 million US blood donations, 2006–2009 based on screening and confirmatory tests for HIV and HCV nucleic acid testing, HIV and HCV antibody, HBsAg, and anti-HBV core antibody; incident infections were defined as having no or low antiviral antibody titers. Viral genomes were partially sequenced.


Viral genetic variant distribution in blood donors was similar to that seen in high-risk US populations. Blood-borne viruses detected through large-scale routine screening of blood donors can complement molecular surveillance studies of highly exposed populations. (Delwart et. al. 2012)

Primary Outcome Paper


Delwart E, Slikas E, Stramer SL, Kamel H, Kessler D, Krysztof D, Tobler LH, Carrick DM, Steele W, Todd D, Wright DJ, Kleinman SH, Busch MP; NHLBI-REDS-II Study Group. Genetic diversity of recently acquired and prevalent HIV, hepatitis B virus, and hepatitis C virus infections in US blood donors. J Infect Dis. 205(6):875-85, 2012. PMID: 22293432; PMCID: PMC3282564.