Evaluations

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 

Current IVD Evaluations Projects

Under contract with the Peter Doherty Institute, NRL assessed the performance of 12 rapid diagnostic tests listed in the Australian Registry of Therapeutic Goods (ARTG) by the Therapeutic Goods Administration of Australia. 

NRL also provided fee for service agreements with manufacturers for similar assessments of SARS-CoV-2 serology test kits using an established protocol.

Such studies again highlight the depth of expertise and knowledge NRL scientists bring to the scientific community, enhancing our reputation for competence in the field of infectious disease serology and IVD evaluations.

Further evaluations are being conducted. In collaboration with the World Health Organization Emergency Group, NRL is contacted to evaluate up to 40 more serology assays. This study represents the largest comprehensive head-to-head evaluation of SARS-CoV-2 serology assays undertaken. Further information will be added to this website over the coming weeks.