Division of Viral Hepatitis
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Centers for Disease Control and Prevention
1600 Clifton Road, Mailstop G–37
Atlanta, Georgia 30333
Subject: Docket No. CDC–2012–0005
The American Society for Microbiology (ASM) is pleased to comment on the Draft Recommendations for the Identification of Hepatitis C Virus (HCV) Chronic Infection Among Persons Born during 1945 through 1965. ASM is the largest educational, professional, and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents more than 38,000 microbiologists, including scientists working in a variety of areas. Many of ASM’s members are individuals responsible for directing clinical microbiology, clinical immunology and molecular diagnostic laboratories, individuals licensed or accredited to perform such testing, and researchers involved in developing and evaluating the performance of new technologies. The ASM supports these draft recommendations and believes the guidance, if adopted, would contribute greatly to the recognition of the burden of chronic HCV infection and provide an opportunity for appropriate management of infected individuals.
The ASM agrees with the CDC’s conclusion, based on its review of scientific evidence to date, that age cohort based testing and linkage to care of infected persons born 1945-1965 is important to a national strategy to reduce HCV-related morbidity and mortality. However, we believe that the guidance would be strengthened by addressing aspects of the laboratory testing process; a key component to the diagnosis, prognosis, and monitoring of HCV infection. In particular, we would like to raise these specific questions for your consideration for inclusion in the final recommendations:
- Following initial screening for the presence of antibody to HCV, and confirmation with HCV Nucleic Acid testing, should positive patients also have liver function enzyme testing performed to evaluate disease progression? It is our recommendations that this should be performed.
- Should HCV- positive samples be genotyped so that if reinfection occurs in the future it can be identified as such? It is our recommendation that genotyping be performed.
- What is the positive predictive value in the general population (those with no known risk factors) of this guideline? It is our recommendation that information on predictive value of the testing approach recommended be included.
We appreciate the opportunity to comment and would be pleased to assist the CDC in any way.
Susan E. Sharp, Ph.D., Chair, Committee on Laboratory Practices
Vickie Baselski, Ph.D., Chair, Committee on Professional Affairs