Improving quality of HIV diagnosis: do you know how to update your HIV national testing algorithms?

Satellite Session

The session will take place on 18 November 2021 from 8-9 am (UTC) at the  African Society of Laboratory Medicine Conference, 2021.

Obectives

Background

WHO revised its guidance on HIV testing services in 2019 and released updated recommendations including: 

• Moving toward using a prevalence-independent HIV testing strategy consisting of three consecutive reactive serology test results to provide an HIV-positive diagnosis;
• Use of dual HIV/syphilis rapid diagnostic tests as assay one in antenatal care settings;
• Move away from western blot and line immunoassays in HIV testing algorithms; and
• Reinforcing retesting prior to ART initiation.

As countries revise their national guidelines for HIV testing services and align to the standard HIV testing strategy, WHO encourages conducting a study to verify the national testing algorithms to ensure that the HIV products selected will not share false HIV-reactive test results for the same individual, minimizing in this way the risk of misdiagnosis. If a product is WHO prequalified, clinical evidence has already been submitted and assessed by WHO; therefore, there is little additional benefit in repeating clinical performance studies to reconfirm sensitivity and specificity.

To assist countries on how to conduct a testing algorithm verification study, WHO has developed a toolkit with resources and materials including a generic study protocol, a product selection tool and templates for ordering, budgeting, human resource planning and data analysis. A number of countries have undertaken such verification studies and sharing their practical experience will be beneficial for other countries intending to do the same.

Programme

Anita Sands, Regulation and Prequalification Department, WHO, Switzerland
Opening remarks