Background In 2012, the World Health Organization (WHO) estimated 78 million cases of Neisseria gonorrhoea (NG) worldwide and recent reports indicate an increase in NG resistance to current antibiotic therapies globally. Chlamydia trachomatis (CT) infection is more prevalent than NG and current syndromic management guidelines are designed to simultaneously treat both bacteria with a combination of antibiotics to avoid missing treatment. In resource constrained settings many patients with urethral or vaginal discharge presenting at primary healthcare settings (PHC) are overtreated due to syndromic management, which lacks appropriate diagnostic tools for CT and NG differentiation in these settings.
Methods To address this gap, the Foundation for Innovative New Diagnostics (FIND) and WHO collaborated on the development of Target Product Profiles (TPPs) to guide the development of appropriate diagnostics tools for improved clinical management of NG and CT infections. Using a Delphi-like process involving two serial surveys to solicit input from over 52 experts.
Results Two TPPs for the appropriate identification of NG (and NG/CT) and its susceptibility/resistance profile to antibiotics were developed and will be publicly available on the WHO and FIND websites. A request for proposals is in process to stimulate the development of diagnostic tools that meet the technical characteristics of these TPPs.
Conclusion TPPs for rapid identification of NG-positive patients at PHC and for identification of NG susceptibility/resistance to antibiotics are urgently needed. Technology advancements over the past years may enable development of improved tests to support uptake and wide scale use in PHC. A reflex antibiotic susceptibility test would be useful to further guide prescription of current therapies. Results of this work will guide the development of new and appropriate diagnostics in the next 3–5 years, to enable improved patient management and conservation of new antibiotics that will become available.
Disclosure No significant relationships.
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