Rapid Diagnostic Tests for Neglected Infectious Diseases: Case Study Highlights Need for Customer Awareness and Postmarket Surveillance

Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development

“…62 EID public health and countermeasure programs have unique challenges for diagnostic and vaccine clinical assay development purposes. 2,39,41,[63][64][65][66][67][68][69][70][71] There may be an incomplete understanding of the biology or epidemiology of a new pathogen, which can delay or confound the selection of a relevant vaccine target and the subsequent assay development to be used to evaluate the candidates. The field may suffer from a lack of available reagent sources or with inconsistency in quantity and quality of those available, especially early in the discovery and development process.…”

Point-of-care and point-of-‘can’: leveraging reference-laboratory capacity for integrated diagnosis of fever syndromes in the tropics

“…However, this column does not represent the actual situation in all such settings, where theoretical availability frequently does not coincide with implementation or practical access. b Many validated RDTs described in this table face unstable production and quality management, as well as a lack of regulatory and financial conditions that could facilitate or incentivize stable production by quality manufacturers [92].…”

Clinical Research on Neglected Tropical Diseases: Challenges and Solutions

“…Other SOPs are disease- and syndrome-specific, which is to be expected, as the diagnosis, management, and treatment are idiosyncratic. We believe that sharing these SOPs on an open-access platform and providing additional specific information in a set of symposia articles in the current issue of PLoS Neglected Tropical Diseases [4–8] will contribute to facilitate and further strengthen GCP/GCLP-compliant clinical research by colleagues working in this field. Here, we share experiences and lessons from the NIDIAG consortium that range from designing, setting up, implementing, and evaluating multiple GCP/GCLP-compliant clinical studies in low- and middle-income countries in Africa and Asia.…”

“…In the current issue of PLoS Neglected Tropical Diseases , a collection of articles [4–8, 39]—mainly prepared in the style of symposia—is published, in which we would like to share experiences and lessons from the NIDIAG consortium that range from designing, setting up, implementing, and evaluating multiple clinical studies in partner countries in the global South. In this editorial, we provide an umbrella, discuss perceived challenges in the field of NTD research, and propose solutions on how these issues were overcome during the conduct of the NIDIAG studies.…”