In response to recent MSF publication on quality of HIV test kits

Questions and answers - 25 July 2017

Why this Q&A?

Recent publications from Médecins Sans Frontières’s (MSF) have raised quality issues regarding WHO prequalified HIV rapid diagnostic tests (RDTs), including how the performance of individual HIV RDTs and testing algorithms can vary in field settings. WHO has responded to their discussion of the results and the conclusions drawn, which were somewhat misleading, and have led to media reports raising alarm.

Countries should be reassured that WHO prequalified RDTs provide highly accurate and reliable HIV diagnoses when used within an appropriate testing strategy based on HIV prevalence and a validated testing algorithm, and with a quality assurance system in place.

Correct results are one of WHO’s “5Cs”, and a guiding principle for all HIV testing services. For many years, WHO has focused on quality of testing, and supported countries by:

  • conducting performance evaluations and prequalifying HIV RDTs that achieve ≥99% sensitivity and ≥98% specificity (through these processes, Member States are able to procure highly accurate WHO prequalified HIV RDTs);
  • establishing standardized HIV testing strategies for high-prevalence settings (≥5%) and low-prevalence settings (<5%), and providing product selection guidance;
  • developing quality assurance and quality improvement systems and training tools on delivering HIV testing services; and
  • providing ongoing technical support to countries regarding specific issues related to the quality of HIV testing.

To help inform people reading the MSF report, WHO has produced this Q&A to provide useful information and reiterate its existing guidelines and recommendations on how to provide correct test results and HIV diagnoses. Relevant WHO guidelines and information are available at the following links.