Our impact as a WHO Collaborating Centre

NRL has been a WHO Prequalification Evaluation Laboratory since July 2017 and are authorised to evaluate IVDs for: 

  • HBV antigen/serology 
  • HBV NAT 
  • Syphilis serology 
  • HIV serology 
  • HCV serology
  • HCV NAT 

In 2024, NRL added SAR-CoV-2 antigen and NAT to the analytes tested.  Over the past decade, NRL has contributed to the assessment of numbers of IVD on behalf of WHO Prequalification group including rapid test devices /lateral flow devices through to automated serology and molecular tests.  NRL staff have also been involved in the drafting and review of evaluations protocols and the assessment of technical dossiers. 

Many countries, particularly those with low- and middle-income economies, often lack a robust regulatory framework and a dedicated authority to oversee the administration of diagnostic tests for infectious and other high-priority diseases. The World Health Organization (WHO) provides an independent and comprehensive evaluation of test kits for key diseases, including HIV, malaria, hepatitis B and C, as well as syphilis, HPV, and CD4 counts. National Ministries of Health and funding bodies such as the Global Fund rely on the WHO’s prequalification list to identify test kits that have undergone rigorous validation through the prequalification process. This approach facilitates more informed selection of diagnostic tools, ultimately leading to improved health outcomes.

 

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Training: Our Scientific Consulting & Training projects

  • Overview

    The scientific consulting staff at NRL have provided invaluable support for laboratory capacity assessment and enhancement programs for several decades. Collaborating closely with the World Health Organization’s Regional Offices in Southeast Asia (SEARO) and the Western Pacific (WPRO), NRL has assisted national public health laboratories in developing robust quality management systems, implementing external quality assessment schemes, and delivering training in various technical, quality, and safety domains. NRL-supported WHO training initiatives have been conducted in Mongolia, the Philippines, Indonesia, Sri Lanka, and India, further contributing to the strengthening of public health infrastructure in these regions.

    Impact
    The activities of the NRL Scientific Consulting and Training Team are focused on enhancing the quality of testing for infectious diseases, in alignment with the NRL mission statement. These initiatives are tailored to the local infrastructure and resources, ensuring they are culturally sensitive and sustainable. Whenever feasible, NRL establishes mentoring relationships with trainees to support their ongoing quality improvement efforts. This approach enables laboratories and their personnel to continuously refine their processes, ultimately resulting in more accurate test results and improved health outcomes for patients.

Prequalification: Our Evaluation's Projects

  • Overview
    Impact

List of PQx test kits

List of PQx test kits
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Page last updated: 11 October 2024