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JCM Accepts, published online ahead of print on 21 November 2007
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J. Clin. Microbiol. doi:10.1128/JCM.01229-07
Copyright (c) 2007, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Testing strategy to identify cases of acute hepatitis C virus (HCV) infection and project HCV incidence rates

Kimberly Page-Shafer, Brandee L Pappalardo, Leslie H Tobler, Bruce H Phelps, Brian R Edlin, Andrew R Moss, Teresa L Wright, David J Wright, Thomas R O'Brien, Sally Caglioti, and Michael P Busch*

University of California, San Francisco, CA, USA; Blood Systems Research Institute, San Francisco, CA, USA; Chiron Corporation, Emeryville, CA, USA; Center for the Study of Hepatitis C, Weill Medical College of Cornell University, New York, NY; San Francisco Veterans Administration Medical Center; Westat Inc., Rockville, MD, USA; Viral Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Rockville, MD; Blood Systems, Inc., Scottsdale, AZ, USA

* To whom correspondence should be addressed. Email: Mbusch{at}bloodsystems.org.


   Abstract

Background: Surveillance for hepatitis C virus (HCV) is limited by the challenge of differentiating between acute and chronic infections. In this study we evaluate a cross-sectional testing strategy that identifies individuals with acute HCV, and estimate HCV incidence.

Methods: Anti-HCV negative persons from four populations with varying risk: blood donors, Veteran Administration (VA) patients, young injection drug users (IDU), and older IDU were screened for HCV RNA by mini-pool or individual sample nucleic acid testing (NAT). The number of detected viremic seronegative infections were combined with the duration of the pre-seroconversion NAT-positive window period (derived from analysis of frequent serial samples from plasma donors followed from NAT detection to seroconversion), to estimate annual HCV incidence rates. Projected incidence rates were compared to observed incidence rates.

Results: Projected HCV incidence rates per 100 person-years were 0.0042 (95% CI: 0.0025-0.007) in blood donors, 0.86 (95% CI: 0.02-0.71) in VA patients, 39.8 (25.9, 53.7) in young IDU, and 53.7 (95% CI: 23.4-108.8) in older IDU. Projected rates were most similar to observed incidence rates in young IDU (33.4 95% CI 28.0, 39.9).

Conclusions: This study demonstrates the value of applying a cross-sectional screening strategy to detect acute HCV infections and estimate HCV incidence.







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