• Background on NRL Evaluations

    Pre-market evaluations of new IVD’s (In Vitro Diagnostic devices) are vital in ensuring new diagnostic products are accurate and fit for use. Quite literally, patient’s lives depend on the accuracy of the results derived from these IVD’s.

    NRL is a World Health Organisation (WHO) Prequalification Evaluating Laboratory. 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. As one of fourteen WHO Pre-qualification Evaluating Laboratories, NRL is one of only two laboratories authorised to perform pre-qualification assessment of IVDs that detect bloodborne infections. WHO Pre-qualification aims to ensure IVDs for supply to high and low-income countries are quality-assured, safe, effective and accessible.

    Impact of NRL Evaluations

    The impact of such activities has never been so apparent as NRL conducted multiple programs of evaluations for COVID-19 serology and Rapid Antigen test kits. These extensive tests were performed on behalf of stakeholders such as WHO, Australian Therapeutic Goods Administration and various commercial COVID-19 serology kits manufacturers globally.

    What does our Evaluations team do?

    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 Program 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.

COVID-19 Evaluations at NRL

Medical laboratory science has been central to the response to COVID-19, working tirelessly in the background. NRL is no exception. As an organisation focused on supporting quality testing for infectious diseases, NRL’s experience and knowledge supported the understanding of how the rapid influx of test kits performed.

NRL was contracted by the World Health Organization and the Australian Therapeutic Goods Administration to conduct large scale, comprehensive evaluations of SARS-CoV-2 serology assays, the results which can be found on our website here.

We have also been working closely with the TGA and the Peter Doherty Institute to conduct post-market evaluations of COVID-19 rapid antigen tests. In addition, NRL conducted evaluations on behalf of test kit manufacturers. NRL staff delivered several international conference presentations supporting the quality of testing for COVID-19.