Gonorrhoea is the second most common bacterial sexually transmitted infection (STI) and results in substantial morbidity and economic cost globally. WHO estimates that in 2016, 87 million new cases occurred among adolescents and adults aged 15–49 years worldwide with a global incidence rate of 20 per 1000 females and 26 per 1000 males, with the highest magnitude in the WHO Western Pacific and African Regions. Co-infection with chlamydia (CT) is detected in 10–40% of people with gonorrhoea.
WHO has identified Neisseria gonorrhoeae (NG) as a high-priority pathogen because of widespread antimicrobial resistance to penicillin, tetracyclines, macrolides (including azithromycin), sulphonamides, trimethoprims, and quinolones, including emergent resistance to the “last line” extended-spectrum cephalosporins cefixime and ceftriaxone. The emergence of decreased susceptibility of Neisseria gonorrhoeae to extended-spectrum cephalosporins together with already-existing resistance to other antibiotics, makes Neisseria gonorrhoeae a multidrug-resistant organism.
New therapies have been spearheaded by investments into the Global Antibiotic Research & Development Partnership (GARDP) and CARB-X. GARDP has prioritized the development of a new gonorrhoea antibiotic (Zoliflodacin) for the treatment of uncomplicated gonorrhoea, by 2023. As multiple organizations push to develop new drugs, and WHO simultaneously recommends the AWARE (Access, Watch, and Reserve) approach for antibiotic stewardship, countries will need diagnostic tools to guide treatment choices, ensure current therapies remain effective for as long as possible and preserve new drugs from rapid development of resistance by overuse.
Currently, there is no clinically validated rapid diagnostic test widely available for Neisseria gonorrhoeae identification. One FDA-approved molecular diagnostic test is available to distinguish between chlamydia trachomatis and Neisseria gonorrhoeae infections; however, turnaround time to results is too long for use in clinics, the cost remains prohibitive for use in primary health care settings, and uptake remains limited to reference-level laboratories. Recent technology advancements may facilitate development of rapid diagnostic tests for NG. A low cost rapid diagnostic test for Neisseria gonorrhoeae detection alone or combined NG/CT detection and differentiation would enable wide scale uptake at primary health care level in low- and middle-income countries.
New diagnostics are needed to help guide diagnosis and treatment decisions to foster antibiotic stewardship of existing and new antibiotics. If syndromic evaluation remains the primary approach to guide treatment of STIs, there is a significant risk of misdiagnosis and antibiotic overuse, which has been shown to lead to antimicrobial resistance. To prevent misuse of antibiotics, a diagnostic based stewardship strategy is urgently needed, particularly at primary health centres where patients present for treatment. The stewardship strategy must fit within a redefined, WHO supported clinical algorithm that includes the use of diagnostics for patients presenting to primary health care settings.