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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