Point-Of-Care Diagnostic Tests (POCTs) for Sexually Transmitted Infections (STIs)
Point-of-care tests for sexually transmitted infections:...
Background and rationale
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.
In 2006, WHO introduced the ASSURED criteria for POCTs for use at the level 1 health centre: Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free and Deliverable to end users. Although notable progress has been made in developing diagnostic tests for syphilis, chlamydial and gonococcal infections, and trichomoniasis, there are still no tests available that comply to all these criteria.
Accelerating advances
WHO's Global health sector strategy for the Control and Prevention of STIs recognises STI POCTs as an innovation that enables improvement in all steps of the STI services cascade. 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 Consultations and progress
Technical consultation on STI POCTs were held in 2014, 2015 and 2019. These expert meetings resulted in target product profiles (TPPs) for POCTs for these infections and standard protocols to independently validate the performance of STI POCTs in the laboratory and the clinic and to evaluate its utility in the field. Since 2015, WHO also facilitates regular landscape analyses of potential POC diagnostic technologies for dual HIV/syphilis tests, CT, NG, TV and HPV, available and in the pipeline.
All these achievements resulted in 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. Results are expected in the second half of 2023. A follow-up implementation study on the in-country introduction of STI POCTs is planned for 2024.
Products
Landscape analysis: The Point-of-Care Diagnostic Landscape for STIs, Updated October 2019
TPPs: Target product Profiles (updated version under review)
Core Protocols for STI POCT Evaluation
Laboratory-based
Clinic-based
Tests for the Screening of HIV and Syphilis in Pregnant Women
Tests for the Screening of HIV and Syphilis in Men Who Have Sex with Men and Sex Workers
Utility Evaluation
Special Supplement
Advancing point of care diagnostics for the control and prevention of sexually transmitted infections
BMJ Journals, December 2017
Peer reviewed articles
Point-of-care testing for sexually transmitted infections in low-resource settings. Clinical Microbiology and Infection. In press. Accepted: May 31, 2021
Standardised protocol for a prospective cross-sectional multicentre clinic-based evaluation of two dual point-of-care tests for the screening of HIV and syphilis in men who have sex with men, sex workers and pregnant women.
BMJ Open 2020;10:e044479. First published November 26, 2020.
Call to action for health systems integration of point-of-care testing to mitigate the transmission and burden of sexually transmitted infections. Sexually Transmitted Infections 2020;96:342-347.
WHO laboratory validation of Xpert® CT/NG and Xpert® TV on the GeneXpert system verifies high performances. APMIS 2018; 126: 907– 912. First published: 19 November 2018
Disclaimer Special issue and peer reviewed articles: The authors alone are responsible for the views expressed and they do not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
Collaborating partners
WHO Collaborating Centres, national and international research and innovation centers, international development foundations, industries.