Partners urge action to tackle HIV misdiagnosis

Participants at the WHO meeting on the social, public health, human rights, ethical and legal implications of the misdiagnosis of HIV status, 2-3 March 2016, Geneva, Switzerland

5 May 2016 – The World Health Organization (WHO) has identified a number or reports of poor HIV testing practices with some reports showing HIV misdiagnosis rates as high as 10.5%. In response, WHO convened a global meeting on 2–3 March 2016 with its partner organizations, including Médecins Sans Frontières and the Liverpool School of Tropical Medicine, to discuss the extent of HIV misdiagnosis and ways to improve implementation of the "Consolidated guidelines on HIV testing services". The meeting was organized with the support of the Brocher Foundation.

According to WHO’s systematic review within the guidelines, many of the tester errors were preventable and related to suboptimal testing strategies; testers having difficulty interpreting weak reactive results; poor management and supervision of testers and of quality systems in laboratories and facilities.

Based on the findings, the WHO guidance advised countries to improve the quality of HIV testing services by taking following actions:

  • use WHO recommended testing strategies for low prevalence (<5%) and high prevalence (≥5%) settings;
  • use national validated testing algorithms;
  • retest all people diagnosed with HIV prior to enrolment in care or initiation of treatment using a second specimen, ideally using a second tester;
  • monitor HIV testing data through external quality assessment and quality control to assess the issue of misdiagnosis at the country-level;
  • adhere to the 12 Quality System Essentials, including training, support and supervision of testers; and
  • use the same HIV testing strategy for diagnosis, including highly sensitive tests followed by more specific tests, for all HIV surveillance, even if results are not returned to study participants (e.g. unlinked anonymous surveys).
Patrick Eba, Human Rights and Law Division, UNAIDS Geneva, Switzerland, addressing the WHO Meeting on the social, public health, human rights, ethical and legal implications of the misdiagnosis of HIV status, 2–3 March 2016, Geneva, Switzerland
P. Eba, UNAIDS, presenting on human rights implications of misdiagnosis of HIV status

It should be noted that while these actions can help countries address many of the quality issues in HIV testing services, the full extent and consequences of poor quality HIV testing and misdiagnosis – as well as the subsequent social, public health, human rights, ethical and legal implications – remain poorly understood. The need for correct results and quality HIV testing services are also further underscored by new WHO guidelines which recommend the offer of treatment to all people diagnosed with HIV without the requirement of immunological assessment.

At this meeting, participants agreed that funding should be prioritized to support quality HIV testing services and to address and prevent misdiagnosis when it occurs. Meeting participants also supported further study of misdiagnosis, in order to document and measure the extent and consequences of the problem.

The partner organizations suggested WHO provide guidance to countries on how to address misdiagnosis and implement quality systems, highlighting country examples of retesting before initiation of antiretroviral therapy and validation of national testing algorithms. WHO is taking action to develop a policy brief on the issue, with plans to publish later this year.