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

The article presents a case study commissioned by the Neglected Infectious Disease dIAGnosis (NIDIAG) on rapid diagnostic tests (RDT) labeling and instructions for use in persistent fever, with emphasis on in vitro diagnostic tests (IVD). It highlights the need for proactive interest from IVD manufacturers in connection with ISO 13485 guidelines.