Independent assessment of in vitro diagnostic devices (IVDs) and provision of customised validation and verification panels, data analysis and reporting
NRL Evaluations conduct assessments of IVDs that test for infectious disease ensuring the associated evidence is scientifically sound and key performance, quality and safety criteria are met. NRL is a World Health Organisation (WHO) Prequalification Evaluating Laboratory.
Our team can:
Provide customised sample panels and associated services such as data analysis and report writing for assay validation, verification and evaluation in laboratories
Conduct independent performance evaluations for commercial manufacturers’ IVDs that test for infectious diseases
Perform validation of IVDs for testing institutions
Validate the use of alternate sample types such as cadaveric samples or dried blood spots for use in IVDs
Offer specialised advice on the development of evaluation and verification protocols
Aside from the services listed above, NRL conducts laboratory assessments of IVD performance on behalf of the WHO Prequalification of Diagnostics Programme whose aim is to increase the accessibility to affordable and high quality diagnostics technology for use in resource limited settings. This entails manufacturer site visits, independent assessment of IVDs based on manufacturer’s evidence (desktop evaluations) and/or laboratory assessment of IVD performance.
For more information on NRL Evaluations Services please phone: +61 3 9418 1132