Point-Of-Care Diagnostic Tests (POCTs) for Sexually Transmitted Infections (STIs)
Background and rationale
Over 90% of the global burden of STIs occurs in low- and middle-income countries where there is limited or no access to appropriate diagnostics.
A major barrier to sexually transmitted infections (STIs) control and prevention is the unavailability of reliable, low-cost, point-of-care tests (POCTs) which allow diagnosis and treatment in a single visit. POCTs can be used by professional and lay health workers. POCTs also offer the potential for improved STI surveillance.
Since the "Sexually Transmitted Diseases Diagnostics Initiative" was housed in WHO 15 years ago, some progress has been made towards developing rapid diagnostic tests (RDTs) for syphilis.
- Rapid diagnostic tests for STIs
- WHO information note on the use of dual HIV/Syphilis rapid diagnostic tests (RDT)
For chlamydial and gonococcal infections, and trichomoniasis, there are still no tests available that answer the main requirements for POCTs, i.e.
- rapid turnaround (up to 20 minutes);
- ease of use;
- Clinical Laboratory Improvement Amendments (CLIA)-waived;
- user-friendly (for both patients and staff);
- and sturdy (Yu-Hsiang Hsieh at al, PLOS ONE 2010).
The development of POCTs, prequalified according to WHO standards, could revolutionize STI control and prevention as well as facilitate integration of STIs within reproductive health, HIV/AIDS, and tuberculosis programmes.
Advances in STI diagnostics will require substantial efforts in terms of coordination among stakeholders, which include research institutions, donors, multi and bilateral technical partners. WHO is in a unique position to initiate and lead such a process because of its convening power and its recognised technical expertise.
WHO Technical Consultation
A technical consultation on POCTs was held in Annecy, France, from 6 to 8 May 2014. The outcomes of the consultation were:
All these achievements allowed RHR to initiate the development of a research protocol for an independent multi-country validation of promising tests and technologies. This validation is an essential step to advance our understanding of performance, feasibility, acceptability and utility of STI POCTs, as well as to develop an investment case for further implementation of STI POCT within national STI control and prevention programmes.
- A systematic review and landscape analysis of the promising STI POCT and diagnostic technologies;
- Target product profiles for POCTs to detect Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Human papillomavirus (HPV), and syphilis;
- A comprehensive set of research questions;
- Establishment of an International Advisory Group on STI POCT.
Building on the achievements of this Technical Consultation and a second one held in July 2015, WHO plans to conduct an independent multicountry validation study of promising (near) POCTs. The validation process of existing tests and the development of a roadmap are planned for 2016-17. At the 2015 Technical Consultation of the WHO Advisory Group on STI POCTs, key elements of the roadmap including identifying the processes and milestones to accelerate access to STI POCTs, were discussed and agreed. A landscape analysis of promising (near) STI POCTs, as well as those in the pipeline and at the prototype stage, has been completed.
Core protocols for an independent laboratory-based and field (clinic-based) validation of POCTs to detect Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), and HIV/syphilis have been finalized.
National and international research and innovation centers, international development foundations, industries.