'There Is No Magic Bullet.' Considerations For Adoption Of Molecular Chlamydia And Gonorrhoea Point Of Care Tests Into Routine Care

Background Sexually Transmitted Infections (STIs), including Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), continue to be a global health problem, with the majority of disease burden in Low-and-Middle-Income Countries. This could in part be addressed through increased access to point-of-care-tests (POCTs) to detect infection and appropriately manage cases and contacts. Criteria for the development of STI POCTs have been established, and several CT and NG POCTs have been brought to market. Yet even those diagnostics with good evidence of clinical effectiveness often fail to be implemented and adopted into routine care. Methods We first reviewed whether the Cepheid CT/NG GeneXpert POCT fulfils published international guidance for STI POCT development: the (RE)ASSURED and Target Product Profile (TPP) criteria. Then, through a systematic review of Medline and Embase of published literature that reported on the test’s implementation, demonstrated its values in different settings and to a variety of stakeholders. This information was then applied to form the basis of a value proposition for an ‘ideal’ CT/NG POCT. Results The Cepheid CT/NG GeneXpert did not fulfill all (RE)ASSURED or TPP criteria, however, studies of test implementation showed multiple stakeholder values for use of the test across various healthcare settings and locations. The majority of values identified were setting-specific. Sexual health services and outreach services had the least overlap in values, whereas General Practice and other non-sexual health specialist services served as a ‘bridge’ between the two. Conclusion We recommend that those wishing to improve CT/NG diagnosis be supported to identify the values most relevant to their settings and context, and prioritise implementation of those tests most closely aligned with those values.