“There is no magic bullet.” Considerations for the adoption of molecular chlamydia and gonorrhoea point of care tests into routine care

Introduction Sexually Transmitted Infections (STIs), including Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), continue to be a global health problem, with the majority of the disease burden in Low and Middle Income Countries. This could in part be addressed through increased access to rapid point-of-care-tests (POCTs) for infection detection and appropriate clinical management. Guidelines and criteria for the development of STI POCTs have been established, and several POCTs for CT and NG 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. Here we review the current literature for test development and implementation alongside studies of how the Cepheid CT/NG GeneXpert POCT has been utilised in different healthcare settings, to develop a value proposition for CT/NG POCT adoption. Methods We review whether the Cepheid CT/NG GeneXpert fulfil the (RE)ASSURED and Target Product Profile (TPP) criteria, and present published literature reporting on the test’s implementation, to demonstrate its range of values in different settings and to a variety of stakeholders. This information is then applied to the value proposition for laboratory medicine, to form the basis of a value proposition for a CT/NG POCT. Results The Cepheid CT/NG GeneXpert did not fulfil all (RE)ASSURED or TPP criteria, however, studies of test implementation showed multiple stakeholder values for the use of the test across various healthcare settings and geographic 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.