Molecular chlamydia and gonorrhoea point of care tests implemented into routine practice: systematic review and value proposition development.

BackgroundIncreased access to point-of-care-tests (POCTs) to detect Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infection could reduce transmission and development of reproductive sequelae. Yet diagnostics with good clinical effectiveness evidence can fail to be implemented into care. Here we assess values beyond clinical effectiveness for molecular CT/NG POCTs. MethodsWe conducted a systematic review of peer-reviewed publications in Medline and Embase reporting on molecular CT/NG POCT implementation in routine clinical practice until 16th February 2021. Article titles, abstracts and full-texts were screened according to inclusion and exclusion criteria. Results were synthesised to assess the tests against guidance criteria and develop a CT/NG POCT value proposition. FindingsThe systematic review search returned 440 articles; 28 were included. The Cepheid CT/NG GeneXpert was the only molecular CT/NG POCT implemented and evaluated in routine practice. It did not fulfil all guidance criteria, however, studies of test implementation showed multiple values across various healthcare settings and locations. Our value proposition highlights that the majority of values are setting-specific. InterpretationThose 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.