Abstract
Sexually Transmitted Infections, including Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), continue to be a global health problem. Increased access to point-of-care-tests (POCTs) could help detect infection and lead to appropriate management of cases and contacts, reducing transmission and development of reproductive health sequelae. Yet diagnostics with good clinical effectiveness evidence can fail to be implemented into routine care. Here we assess values beyond clinical effectiveness for molecular CT/NG POCTs implemented across diverse routine practice settings. We conducted a systematic review of peer-reviewed primary research and conference abstract publications in Medline and Embase reporting on molecular CT/NG POCT implementation in routine clinical practice until 16th February 2021. Results were extracted into EndNote software and initially screened by title and abstract by one author according to the inclusion and exclusion criteria. Articles that met the criteria, or were unclear, were included for full-text assessment by all authors. Results were synthesised to assess the tests against guidance criteria and develop a CT/NG POCT value proposition for multiple stakeholders and settings. The systematic review search returned 440 articles; 28 were included overall. The Cepheid CT/NG GeneXpert was the only molecular CT/NG POCT implemented and evaluated in routine practice. It did not fulfil all test guidance criteria, however, studies of test implementation showed multiple values for test use across various healthcare settings and locations. Our value proposition highlights that the majority of values are setting-specific. Sexual health services and outreach services have the least overlap, with General Practice and other non-sexual health specialist services serving as a "bridge" between the two. Those wishing to improve CT/NG diagnosis should be supported to identify the values most relevant to their settings and context, and prioritise implementation of tests that are most closely aligned with those values.
Highlights
It is estimated that there are over 1 million new curable sexually transmitted infections (STI) cases every day; in 2016 there were approximately 376 million new cases of the most common curable STIs: Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) Trichomonas vaginalis (TV), and syphilis [1]
Sexual health services and outreach services have the least overlap, with General Practice and other non-sexual health specialist services serving as a “bridge” between the two. Those wishing to improve CT/NG diagnosis should be supported to identify the values most relevant to their settings and context, and prioritise implementation of tests that are most closely aligned with those values
The overall research question was: “What are the outcomes of molecular CT/NG POCTs implementation for patients being tested for CT/NG in different routine practice settings?” To answer this question, we developed three specific objectives: i.) What values are placed on CT/ NG POCTs implemented in routine practice in the published literature? ii.) Do molecular CT/ NG POCTs implemented in routine practice fulfil the (RE)ASSURED and Target Product Profile (TPP) criteria? iii.) What is the value proposition for molecular CT/NG POCTs by setting, based on the value proposition for laboratory medicine [35]?
Summary
It is estimated that there are over 1 million new curable sexually transmitted infections (STI) cases every day; in 2016 there were approximately 376 million new cases of the most common curable STIs: Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) Trichomonas vaginalis (TV), and syphilis [1] If left untreated, these infections can result in serious reproductive health sequelae, such as infertility, chronic pelvic pain, ectopic pregnancy, and pelvic inflammatory disease. Syndromic management (diagnosis and treatment of STIs based on patients’ clinical history and reported and observed symptoms) has been shown to be both poorly sensitive and specific for STI diagnosis [4]. It can result in asymptomatic but infected individuals not being treated, resulting in continued transmission and development of reproductive health sequelae. We assess values beyond clinical effectiveness for molecular CT/NG POCTs implemented across diverse routine practice settings
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
