Testing & diagnostics
Appropriate sexually transmitted infections (STIs) diagnosis and treatment are crucial to prevent transmission, decrease deaths related to such infections (including still births and cervical cancer), while improving individual health, men’s and women’s sexual health, and the well-being of all people.
The accurate identification of asymptomatic and symptomatic STIs depends on the availability of quality diagnostic tests and a validated screening strategy.
Normative guidance
All →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 hepatitis, syphilis and HIV testing and diagnostics has resulted in recent guidelines. Adopting and adapting these recommendations will support improved access, services and care towards national STI prevention and treatment goals. Several laboratory tests and procedures for specific STIs are elaborated in the WHO "Laboratory diagnosis of sexually transmitted infections, including human immunodeficiency virus".
Updated recommendations for the treatment of Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema...
The objectives of these present guidelines are: to provide updated evidence-informed guidance on treating infections caused by N. gonorrhoeae and C. trachomatis...
Laboratory and point-of-care diagnostic testing for sexually transmitted infections, including HIV
This updated manual provides a basic understanding of the principles of laboratory and point-of-care (POC) testing in the context of screening and...
This document highlights the diagnostics available now to support scale-up and expanded access to screening to meet the growing testing demands in low-...
Despite the development of point-of-care diagnostic tests for syphilis, chlamydia, gonorrhoea, and trichomoniasis, none comply with all WHO criteria....
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Consolidated guidelines on HIV, viral hepatitis and STI prevention, diagnosis, treatment and care for...
The Consolidated guidelines on HIV, viral hepatitis and STI prevention, diagnosis, treatment and care for key populations outline a public health response...
Consolidated guidelines on HIV testing services
These consolidated guidelines on HIV testing services (HTS) bring together existing and new guidance on HTS across different settings and populations.In...
Dual HIV/syphilis rapid diagnostic tests can be used as the first test in antenatal care
WHO recommends that pregnant women receive testing for HIV, syphilis and hepatitis B (HBSAg) at least once during pregnancy, preferably in the first trimester....
This guideline provides updated recommendations for syphilis screening for pregnant women based on the most recent evidence and available serologic tests...
Technologies
To drive innovation and disseminate information, key WHO activities can support uptake, scale-up, and access of STI testing and diagnostic technologies. These include target product profiles, technology landscapes, and information on new and innovative technologies, such as point-of-care (POC) or near point of care tests.To drive innovation and disseminate information, key WHO activities can support uptake, scale-up, and access of STI testing and diagnostic technologies. These include target product profiles, technology landscapes, and information on new and innovative technologies, such as point-of-care (POC) or near point-of-care tests.
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 countries needs.
Technology landscapes provide details and information of the variety of products available or in the pipeline and market considerations for diseases or conditions, including STIs. Technology landscapes are often created by WHO and/or partners. The latest available was published by UNITAID in early 2018.
Innovations within testing and diagnostics progress rapidly. These new and innovative technologies can support increased STI testing coverage, drug resistance monitoring, and optimized service delivery. The availability of low-cost rapid screening test for syphilis have increased syphilis detection in antenatal care settings. Near point-of-care molecular assays for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis are commercially available, however none are currently prequalified by WHO. The prices of molecular tests remain the biggest barrier for their uptake in resource-constrained settings.
Rapid, simple to use, financially accessible and quality-assured POC tests are urgently needed to enable screening, diagnosis and, when possible, treatment at the first contact with patients. Such technologies can support national and international efforts to accelerate efforts towards elimination targets of priority STIs by 2030.
Regulatory
WHO 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. Serological tests for syphilis (both treponemal and non-treponemal), molecular essays for gonorrhea and chlamydia were defined as priority for WHO prequalification.
Drug resistance
Antimicrobial resistance in gonococci is a severe problem worldwide and, as culture is the only method allowing antimicrobial susceptibility testing, it is crucial to maintain and, where necessary, strengthen the culture capacity in all countries. On the other hand, there are several well-characterized molecular AMR determinants that can be used for effective prediction of AMR in gonorrhoea, particularly for ciprofloxacin, but less adequate prediction of resistance to azithromycin, cefixime and ceftriaxone. Laboratory procedures for antimicrobial susceptibility testing are detailed in “Laboratory diagnosis of sexually transmitted infections including human immunodeficiency virus“ and “WHO Enhanced Gonorrhoeae Surveillance Programme” (EGASP) protocol.