Point-of-Care Sexually Transmitted Infection Diagnostics: Proceedings of the STAR Sexually Transmitted Infection—Clinical Trial Group Programmatic Meeting

Abstract

The goal of the Point-of-Care (POC) Sexually Transmitted Infection (STI) Diagnostics meeting was to review the state-of-the art research and develop recommendations for the use of POC STI diagnostics. Experts from academia, government, non-profit and industry discussed POC diagnostics for STIs such as Chlamydia trachomatis, Human Papillomavirus, Neisseria gonorrhoeae, Trichomonas vaginalis and Treponema pallidum. Key objectives included a review of current and emerging technologies, clinical and public health benefits, POC STI diagnostics in developing countries, regulatory considerations and future areas of development. Key points of the meeting are as follows: (i)while some rapid point-of-care tests are affordable, sensitive, specific, easy to perform, and deliverable to those who need them for select sexually transmitted infections, implementation barriers exist at the device, patient, provider and health system levels; (ii) further investment in research and development of point-of-care tests for sexually transmitted infections is needed and new technologies can be used to improve diagnostic testing, test uptake and treatment; (iii) efficient deployment of self-testing in supervised (i.e., pharmacies, clinics etc.) and/or unsupervised (i.e., home, offices etc.) settings could facilitate more screening and diagnosis that will reduce the burden of sexually transmitted infections; (iv) development of novel diagnostic technologies has outpaced the generation of guidance tools and documents issued by regulatory agencies and (v) questions regarding quality management are emerging including the mechanism by which poor performing diagnostics are removed from the market and quality assurance of self-testing is ensured.

A high burden of asymptomatic genital tract infections undermines the syndromic management approach among adolescents and young adults in South Africa: implications for HIV prevention efforts

“…Our findings suggest a need to evolve sexual health services to benefit youth. Although a test-and-treat approach to GTIs has historically posed financial and logistical challenges, recent innovations in affordable real-time STI testing, such as point-of-care (POC) diagnostics, warrant further investigation for wide-scale implementation [ 16 , 30 ]. By providing immediate testing results and facilitating treatment without delay, POC tests can help reduce secondary transmission and the consequences of infection progression [ 31 ].…”

Current and Future Trends in the Laboratory Diagnosis of Sexually Transmitted Infections

“…In particular, the CT/NG assay running on this platform showed excellent sensitivity (100%) and specificity (≥99.8%) in detecting these organisms in the urine of both men and women [77]. However, its high price and the need for electricity do not allow this platform to be considered as a fully realized POC test [26].…”

“…Point-of-care (POC) tests represent an answer to the problem of needing to reach a diagnosis quickly outside of a standard laboratory. By definition, a POC test can be performed at the patient's hospital bedside or own house, the physician's office, or in the field [26]. Ideally, a POC test should meet the WHO affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free and deliverable to end-users (ASSURED) criteria [27].…”

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

“…Therefore, in recent years, there has been considerable effort to develop new diagnostic tools including point-of-care tests (POCTs), which can be used outside of a typical clinical laboratory (eg, a physician’s office, hospital bedside, patient’s home, in the field/community based), by non-laboratory trained healthcare providers (HCPs). 2 Over the last decade, many POCTs for sexually transmitted infections (STIs) have been developed and are commercially available. 3 Guidance or recommendations regarding the placement of these new tests in the diagnostic pathway for STIs are limited, however, interim recommendations on the use of POCTs among pregnant women (PW) are available.…”