Global HIV Programme
The WHO Department of Global HIV, Hepatitis and Sexually Transmitted Infections Programmes leads the development and implementation of the global health sector strategy on the elimination of HIV as a public health threat.
Testing & Diagnostics
Testing and diagnostics are critical components of the United Nations’ 95-95-95 targets to end the HIV epidemic. HIV testing services and infant diagnosis support the first target of 95% of people living with HIV to know their HIV status. While HIV treatment monitoring supports the third target of 95% of people living with HIV to be virally suppressed.
However, gaps in meeting these targets remain across regions, countries, and populations. Improving, scaling up, and introducing new innovations in HIV testing and diagnostics will increase access and improve care for people living with HIV to meet global treatment and prevention targets.
Technical information
Normative guidance
In its normative and standard-setting work, WHO is an evidence-based organisation with a focus on public health. Ongoing reviews of studies and evidence in HIV testing and diagnostics has resulted in several recent guidelines. These include key recommendations in HIV testing services, infant diagnosis, treatment monitoring, and service delivery. Adopting and adapting these recommendations will support improved access, services and care towards national and international HIV elimination goals.
Technologies
To drive innovation and disseminate information, key WHO activities can support national and international uptake, scale-up, and access of HIV testing and diagnostic technologies. These include target product profiles, technology landscapes, and information on novel and innovative technologies, such as point-of-care technologies.
A target product profile (TPP) outlines the desired ‘profile’ or characteristics of a target product for a particular disease or condition. TPPs state intended use, target populations and other desired attributes of products, including safety and efficacy-related characteristics. Such profiles should guide funders and developers in product research and development as market indications of country needs.
Technology landscapes provide details and information of the variety of products available for a particular disease or condition. Though challenging to be completely exhaustive, these generally provide the availability and market considerations for a range of technologies. Technology landscapes have been created by WHO and/or partners. For HIV diagnostics, please see the detailed technology landscapes from Unitaid.
Innovations within testing and diagnostics progress rapidly. These novel and innovative technologies can support increased HIV testing, infant diagnosis, treatment monitoring, and service delivery in an effort to provide optimized services and care to people living with HIV and support national and international efforts towards HIV elimination goals.
Regulatory
WHO‘s prequalification of In Vitro Diagnostics (IVDs) is coordinated through the Department of Essential Medicines and Health Products (EMP). Focus is placed on in vitro diagnostics for priority diseases and their suitability for use in resource-limited settings.
More information
Treatment monitoring
Monitoring of individuals on antiretroviral therapy is important to ensure treatment efficacy and improved health outcomes. Further, HIV treatment monitoring supports the third target of the United Nations’ 95-95-95 within which 95% of people living with HIV are virally suppressed. This includes the preferred method for treatment monitoring of viral load testing as well as CD4 testing to identify people living with advanced HIV disease. Additionally, general monitoring tests complement a more comprehensive and patient-centred approach to treatment monitoring.
Drug resistance
The ability of HIV to mutate and reproduce itself in the presence of antiretroviral drugs is called HIV drug resistance (HIVDR). The consequences of HIV drug resistance include treatment failure and further spread of drug resistant HIV. This can compromise the effectiveness of the limited therapeutic options to reach the last 95 target (of achieving viral suppression) and further reduce HIV incidence, mortality and morbidity. Coordinated national and international efforts to prevent, monitor and respond to the emergence of HIV drug resistance are critical to strengthen country efforts to achieve the global HIV targets.
HIV drug resistance genotyping is the method of choice to detect the presence of drug resistance mutations through surveillance activities. WHO has developed guidance on methods for quality assurance of genotyping and criteria for HIV drug resistance assay validation. A manual describing methods for collection and HIV drug resistance testing using dried blood spots was developed, based on validated procedures in use in WHO HIVDR designated laboratories.
The WHO global HIV drug resistance laboratory network supports HIV drug resistance surveillance in low- and middle-income countries by providing accurate and comparable genotyping results that meet WHO specifications.