infectious diseases
Leaders in HCV Diagnostics Gather in Atlanta by Anne M. Gaynor, PhD, manager, HHST
While Hepatitis C virus( HCV) may not be considered fatal, data from the CDC reveals it kills more Americans than any other infectious disease including HIV, pneumococcal disease and tuberculosis. 1 For two days in September, more than 120 scientists gathered to discuss the latest developments in HCV diagnostic approaches, algorithms and technology. The summit, which was also live streamed to 100 viewers around the world, 2 was divided into five sessions examining different aspects of HCV: diagnosis and management; policy, practice and data; HCV diagnostics in global and resourcelimited settings; new and improved technologies; and the role of public health.
With the growing number of acute cases and concern over outbreaks... the public health system’ s role in outbreak response and surveillance has not diminished.
Scott Holmberg, MD, MPH, chief of CDC’ s Epidemiology and Surveillance Branch, emphasized the number of acute cases has more than doubled from 2010-2014. His presentation laid the groundwork for the first roundtable discussion about finding the most efficient methods to quickly diagnose patients and promptly link them to treatment. One challenge that received attention was the current HCV testing algorithm. The implementation of the recommended algorithm 3 requires an HCV antibody test and, when that is positive, an HCV RNA test. The first test is widely available, but the second can be more challenging to obtain, since it may not be available in all labs, specimen requirements are more stringent and, in most cases, it needs to be ordered separately due to regulatory restrictions on reflex testing.
In other sessions, Lesley Miller, MD, Grady Memorial Hospital and Rick Pesano, MD, PhD, Quest Laboratories presented on streamlining of HCV testing by instituting automatic reflex testing for HCV RNA. Implementation of automatic reflex testing at Grady required interacting with all parts of the hospital system, while Quest focused on educating ordering providers and ensuring that all samples sent for HCV antibody testing were reflexed to HCV RNA testing as appropriate— no small task for an organization testing millions of patient samples each year. Médecins Sans Frontières( Doctors Without Borders) also presented on their pilot HCV screening and treatment programs in multiple sites, demonstrating that it can be integrated as a service even in difficult settings.
However, even with creative solutions, there are still limitations with current technology. The Foundation for Innovative New Diagnostics( FIND) discussed its work to help manufacturers develop a one-step HCV test that can confirm current infection for less than $ 10 per test. Two manufacturers developing serologic assays that detect current infection presented their work on lab-based or point-of-care HCV core antigen assays. The trial of Cepheid’ s point-of-care HCV viral load assay also was mentioned in several global-focused presentations. APHL will monitor these promising assays as they potentially move to the commercial market in the US. As a community, we need to keep in mind the words of presenter Camila Graham, MD, and develop“ the right test for the right level of care.”
The summit concluded with a discussion about the role of public health in HCV diagnostics. Testing at PHLs for HCV has decreased from 76 % in 2009 to 61 % in 2015. While almost all PHLs that responded to an APHL survey offer HCV antibody testing( 42 / 45), only a quarter( 11 / 45) offer HCV RNA testing. 4 With the growing number of acute cases and concern over outbreaks similar to Scott County, IN, the public health system’ s role in outbreak response and surveillance has not diminished. The introduction of HCV sequencing and GHOST technology in several PHL pilots could bring more testing back to PHLs.
The summit reinforced the view that advances in HCV diagnostics cannot be accomplished in a vacuum. They rely on close collaboration with clinical partners, commercial laboratories, program and public health staff.
Hepatitis C virus. Photo by Getty Images
1. Ly KN, Hughes EM, Jiles RB, Holmberg SD. Rising Mortality Associated with Hepatitis C Virus in the United States, 2003-2013. Clin Infect Dis. 2016 62( 10): 1287-1288. [ cited 2016 Sep 30 ]. Available from: http:// cid. oxfordjournals. org / content / 62 / 10 / 1287
2. Hepatitis C Diagnostic Summit. September 8-9, 2016. Available at: http:// www. cdc. gov / hepatitis / resources / mtgsconf / hepcdiagsummit2016. htm.
3. Centers for Disease Control and Prevention. Testing for HCV Infection: An Update of Guidance for Clinicians and Laboratories. MMWR. 2013 May 7; 62. [ cited 2016 Sep 30 ]. Available from: http:// www. cdc. gov / mmwr / pdf / wk / mm62e0507a2. pdf
4. Association of Public Health Laboratories. 2014 HIV Diagnostics Survey. APHL Issues in Brief: Infectious Diseases. 2016 Mar. [ cited 2016 Sep 30 ]. Available from: https:// www. aphl. org / aboutAPHL / publications / Documents / ID _ HIV _ SurveyBrief _ 0316. pdf
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