Bibliographic information
GuidelineUpdated recommendations on treatment of adolescents and children with chronic HCV infection, and HCV simplified service delivery and diagnostics.
Year of Publication2022
Issuing InstitutionWorld Health Organization
Recommendation
Maintained
An assay to detect HCV core (p22) antigen, which has comparable clinical sensitivity to laboratory-based HCV RNA NAT assays, can be an alternative approach to diagnose HCV viraemic infection.
Recommended in favor
Conditional
Certainty of evidence
Moderate
Notes and Remarks
Implementation considerations See also Box 8.2 Case study: Operational considerations for implementation of point-of-care HCV viral load testing in community-based HCV clinic in Yangon, Myanmar
- Use of laboratory-based versus POC NAT platforms: The decision whether to use POC RNA NAT technologies or laboratory assays will depend on a variety of factors, including cost and ease of use and the characteristics of the testing site, such as storage facilities, infrastructure, level of staff skills and cost. Use of POC assays may also be considered in services caring for specific vulnerable populations such as people who inject drugs or people in prisons, with high loss to follow-up or in remote locations. Although POC assays may promote and expedite confirmation of viraemia, there are also many excellent examples in which a centralized laboratory-based system has been highly effective when supported by efficient specimen transport and rapid electronic delivery of results (254).
- Priority settings for placement of HCV RNA NAT POC platforms are likely to be where there are populations at high risk of loss to follow-up and at risk of greater morbidity, but where testing volume is not large, such as among people who inject drugs at harm reduction sites or those in prisons, where fast-tracking diagnosis and treatment initiation as soon as possible upon entry to prison increases their chance of finishing their treatment regimens before leaving prison (241, 255-257). There are other innovative strategies for delivering POC HCV RNA NAT assays to hard-to-reach populations – for example, through mobile units (258-262) that can offer testing and treatment initiation on the same day (263). The systematic review found strong evidence that the best turn-around times and cascade of care outcomes with POC assays are seen when they are, in fact, used at the point of care rather than placed in laboratories distant from the patients.
- The optimal placement of a POC instrument is where testing and treatment are at the same site – a “one-stop shops”. Use of POC platforms may not achieve expected outcomes if other aspects of the care pathway require patients to travel to another clinic for treatment, with associated transport and other costs. A recent systematic review (Web Annex A) has shown that one of the most important interventions to promote access and improve uptake of testing and treatment is delivery of fully decentralized HCV care (139). The POC evidence review (Web Annex A) showed that the best results for use of POC assays were when they were placed in clinics where HCV testing and treatment were available at the same site, especially for people who inject drugs at harm reduction sites, among people living with HIV in ART clinics, among prisoners and in primary care.
- Reflex HCV RNA testing after a positive HCV antibody result: WHO now recommends reflex HCV RNA testing of those with a positive HCV antibody test result as an additional strategy to promote uptake and reduce time to confirmation of viraemia and treatment (Chapter 9). This can be achieved either through laboratory-based reflex HCV RNA testing using a specimen already held in the lab or through clinic-based reflex testing in a health facility through immediate specimen collection for viraemic testing following a positive HCV antibody RDT result. Efforts should be made to minimalize risk of contamination when reflex testing from a stored specimen.
- Multi-disease testing platform and diagnostic integration across programmes: The introduction of multi-disease testing platforms, both high-throughput lab-based and POC devices, creates additional opportunities for integration that may further expand access and achieve significant system efficiencies and cost-savings. Countries with existing multidisease platforms for HIV viral load, HIV infant diagnosis, SARS-CoV-2, or TB diagnosis or those that are planning for their introduction can consider collaboration and integration of HCV RNA testing (186). Pilot programmes have demonstrated successes with lab-based and POC HIV/TB and HIV/HCV integration (264). Diagnostic network optimization and integrating platforms across disease areas (HIV, TB, SARS-CoV-2, HCV) can improve rational utilization of existing capacity and save costs.
Also Featured In
This recommendation also appears in the following guidelines:
Originally Developed
Guideline
WHO guidelines on hepatitis B and C testing.
Year2017
InstitutionWHO
Guideline
Updated recommendations on simplified service delivery and disagnostics for hepititis C infection: policy brief.
Year2022
InstitutionWorld Health Organization