Approaches for simplified HCV diagnostic algorithms

Abstract

Introduction: In the light of the advances in HCV antiviral therapy, global control of HCV infection becomes feasible but depends on the capacity of countries to identify infected people and to offer them treatment. To achieve the WHO goal which targets a diagnosis rate of 90% by 2030, simplification of screening and diagnosis will be crucial.

Methods: Published literature, unpublished data and expert consensus were used to determine key parameters, including point-of-care, rapid diagnostic testing, screening, the use of HCV core Ag and dried blood spots; starting from 2008 until November 2017. In addition, a manual search was undertaken to detect relevant papers or websites related to specific data from countries which underwent or are planning a programme of HCV elimination.

Results: Several strategies have been developed and evaluated these last years to simplify and facilitate access to screening and diagnosis, the development of reliable HCV core antigen tests and new nucleic acid amplification technologies for use in decentralized settings. In high prevalence settings, a one-step screening and diagnosis strategy could simplify diagnostic algorithms provided the cost is reduced. Finally, genotyping may no longer be required in the context of availability of pangenotypic antiviral therapy.

Conclusions: Despite relevant advances in HCV screening and diagnosis, the overall diagnosis package is still too expensive today and efforts must be made to allow generalized implementation of reliable tests in low and middle income countries. These efforts will be key factors to foster a real public health approach to HCV elimination.

Keywords: HCV; diagnosis; point-of-care; rapid diagnostic test; screening.

Figure 1

Proposed simplified algorithms using serological and virological tools for HCV screening, diagnosis and treatment follow‐up. Several strategies are suggested with varying combinations (S1 to S4). EIA, enzyme immunoassay; RDT, rapid diagnostic test; NAAT, nucleic acid amplification technologies; POC, point‐of‐care; HCV cAg, HCV core antigen.