Testing for HCV Infection

Jane P. Getchell, DrPH; Kelly E. Wroblewski, MPH; Alfred DeMaria Jr, MD; Christine L. Bean, PhD; Monica M. Parker, PhD; Mark Pandori, PhD; D. Robert Dufour, MD; Michael P. Busch, MD, PhD; Mark E. Brecher, MD; William A. Meyer, PhD; Rick L. Pesano, MD, PhD; Chong-Gee Teo, MD, PhD; Geoffrey A. Beckett, MPH; Aufra C. Araujo, PhD; Bernard M. Branson, MD; Jan Drobeniuc, MD, PhD; Rikita Hatia, MPH; Scott D. Holmberg, MD, MPH; Saleem Kamili, PhD; John W. Ward, MD

Disclosures

Morbidity and Mortality Weekly Report. 2013;62(18):362-365. 

In This Article

Introduction

In the United States, an estimated 4.1 million persons have been infected with hepatitis C virus (HCV), of whom an estimated 3.2 (95% confidence interval [CI] = 2.7–3.9) million are living with the infection.[1] New infections continue to be reported particularly among persons who inject drugs and persons exposed to HCV-contaminated blood in health-care settings with inadequate infection control.[2]

Since 1998, CDC has recommended HCV testing for persons with risks for HCV infection.[3] In 2003, CDC published guidelines for the laboratory testing and result reporting of antibody to HCV.[4] In 2012, CDC amended testing recommendations to include one-time HCV testing for all persons born during 1945–1965 regardless of other risk factors.[1]

CDC is issuing this update in guidance because of 1) changes in the availability of certain commercial HCV antibody tests, 2) evidence that many persons who are identified as reactive by an HCV antibody test might not subsequently be evaluated to determine if they have current HCV,[5] and 3) significant advances in the development of antiviral agents with improved efficacy against HCV.[6] Although previous guidance has focused on strategies to detect and confirm HCV antibody,[3,4] reactive results from HCV antibody testing cannot distinguish between persons whose past HCV infection has resolved and those who are currently HCV infected. Persons with current infection who are not identified as currently infected will not receive appropriate preventive services, clinical evaluation, and medical treatment. Testing strategies must ensure the identification of those persons with current HCV infection.

This guidance was written by a workgroup convened by CDC and the Association of Public Health Laboratories (APHL), comprising experts from CDC, APHL, state and local public health departments, and academic and independent diagnostic testing laboratories, in consultation with experts from the Veterans Health Administration and the Food and Drug Administration (FDA). The workgroup reviewed laboratory capacities and practices relating to HCV testing, data presented at the CDC 2011 symposium on identification, screening and surveillance of HCV infection,[7] and data from published scientific literature on HCV testing. Unpublished data from the American Red Cross on validation of HCV antibody testing also were reviewed.

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