July 2017: NRL Accredited as a WHO Prequalification Evaluating Laboratory
On the 25 July 2017, NRL was accepted as a WHO Prequalification Evaluating Laboratory allowing NRL to independently evaluate in vitro diagnostic devices (IVDs) for HIV, HCV and HBV Nucleic Acid Testing and HIV, HCV, HBV and Syphilis serology. The aim of the WHO Prequalification of IVDs is to promote and facilitate access to safe, appropriate and affordable IVDs of acceptable quality. Products submitted for prequalification are subjected to a comprehensive, standardized assessment to determine if WHO prequalification requirements are met. The assessment comprises three components:
Review of a product dossier;
evaluation of performance and operational characteristics; and
manufacturing site(s) inspection.
As part of a small selection of laboratories qualified to undertake this work, NRL looks forward to offering this service.