We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Rapid Diagnostic Tests for Neglected Infectious Diseases: Case Study Highlights Need for Customer Awareness and Postmarket Surveillance.
- Authors
Barbé, Barbara; Verdonck, Kristien; El-Safi, Sayda; Khanal, Basudha; Teav, Syna; Lilo Kalo, Jean-Roger; Ravinetto, Raffaella; Chappuis, François; Boelaert, Marleen; Jacobs, Jan
- Abstract
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.
- Subjects
COMMUNICABLE disease diagnosis; DIAGNOSTIC microbiology; DIAGNOSTIC examinations; DIAGNOSIS of fever; MEDICAL technology
- Publication
PLoS Neglected Tropical Diseases, 2016, Vol 10, Issue 11, p1
- ISSN
1935-2727
- Publication type
Case Study
- DOI
10.1371/journal.pntd.0004655