Barriers to Access to New Gonorrhea Point-of-Care Diagnostic Tests in Low- and Middle-Income Countries and Potential Solutions: A Qualitative Interview-Based Study.

Background To assess the potential market for 2 hypothetical diagnostic tests, one forNeisseria gonorrhoeae/Chlamydia trachomatis(NG/CT) detection and one for NG antimicrobial resistance (AMR) marker identification. Methods This is a qualitative interview-based study. Semistructured interviews with global- and country-level experts were performed. Interviewees were provided with simplified versions of Foundation for Innovative New Diagnostics/World Health Organization-developed target product profiles for each test. Interviewees were asked to comment on use cases, test characteristics, and factors that may influence test adoption. Results Twenty-one experts were interviewed, including 15 country-level experts (from South Africa, India, Zimbabwe, Ghana, China, Peru, Kenya, and Cambodia). Interviewees welcomed an NG/CT point-of-care test, with near-universal preference for a test that could detect symptomatic and asymptomatic infections. Interviewees also saw value in a test that could be used to screen high-risk populations. Factors that may drive adoption of the NG/CT test identified by interviewees included price, cost-effectiveness, evidence of public health benefit, and World Health Organization guidance. Interviewees felt that AMR test use would likely be limited to patients failing first-line treatment. Conclusions Although the potential target population for an NG/CT diagnostic test in low- and middle-income countries is sizeable, there are areas of uncertainty relating to the price of the test and its intended use, warranting further research to determine the most effective positioning. An NG AMR test would likely be used very selectively.