Quality Assurance & Policy

ACT-A Dx Knowledge Hub

The Diagnostic Journey

Ensuring that the developed in-vitro diagnostic (IVDs) tools and technologies emerging from the R&D phase are safe and accurate is critical to ensuring their effective use to achieve public health objectives. Consumers, whether patients or health professionals are not in a position to assess the quality and safety or set policies for the appropriate use of diagnostic tools and technologies. Instead, regulatory authorities and recognized agencies are responsible for this oversight.

Challenge

During the initial stages of the pandemic, there was a vacuum in knowledge as SARS-CoV-2 was a new pathogen with unknown pathogenesis (development of disease) and risk. Additionally, access to specimens was limited, making it difficult for IVD manufacturers to develop and validate tests according to established principles. As a result, markets were flooded with tests (e.g., SARS-CoV-2 molecular and antigen-detection rapid tests – AgRDTs) of varying quality. Without sufficient capacity and capability, delays in access to SARS-CoV-2 IVDs can occur and, on a larger scale, can threaten global public health security. Many countries felt this challenge acutely, particularly those in low- and middle-income settings with a weaker capacity to provide regulatory oversight and appropriate assessment of products.

Furthermore, there was an urgent need for testing guidance and policy to inform use cases for testing, prioritization for populations and settings, and considerations for implementation. Moreover, given the dynamic nature of SARS-CoV-2 transmission and varying resource availability, it is critical that these policies and strategies remain agile and adaptive.

Approach

Since 2014, WHO has had an Emergency Use procedure in place which can be activated in response to a Public Health Emergency of International Concern (PHEIC). To quickly respond to the rapidly evolving environment, WHO initiated the Emergency Use Listing (EUL) procedure for IVDs to detect SARS-CoV-2 during the very early stages of the COVID-19 pandemic. WHO’s EUL procedure is a risk-based approach to assess and list commercially available in-vitro diagnostics, unlicensed vaccines and therapeutics with the aim to speed up the availability of these products for emergency use. In addition, WHO and other national, regional and local public health agencies also developed technical specification guidance, testing guidelines, guidiance on specimen collection and transport, as well as other critical normative products to promote the safe, appropriate development, production, regulation, implementation and use of SARS-CoV-2 tests.

With the support of partners, the following key activities were prioritized to support quality assurance and policy efforts:

Implementation of the WHO EUL procedure to assess the safety, performance, and quality of IVDs to detect SARS-CoV-2. Outcomes (positive and negative) of assessments are published and are recognized and leveraged by other regulatory authorities and procurement agencies
Development of the WHO EUL – Facilitated Procedure to facilitate national regulatory decisions of SARS-CoV-2 in-vitro diagnostics
Performance of in-country evaluation studies on usability and clinical performance of SARS-CoV-2 IVDs to generate independent performance data for interested parties. Study findings may be used by manufacturers to complement their technical file for regulatory purposes and by procurers as part of their product selection process
Development and issuance of COVID-19 testing guidelines and policies by WHO, with partner and expert involvement, for diagnosis and screening of SARS-CoV-2 (e.g. use of molecular tests, AgRDTs (professional use tests and self-tests)) particularly to address the needs low- and middle-income settings

Making an impact

Investments in quality assurance activities and policies for COVID-19 IVD tools and technologies enabled countries to access and usage of safe and effective products for the diagnosis and screening of SARS-CoV-2. Notable regulation achievements are highlighted below. To learn more about quality assurance and policy achievements and work, refer to the key learnings and resource section below.

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expressions of interest for COVID-19 EUL received by WHO

antigen RDTs approved by WHO for EUL

molecular tests approved by WHO for EUL

member states have access to WHO COVID-19 testing guidelines

Key Learnings & Featured Work

Reflections on Quality Assurance & Policy

Leveraging the ACT-Accelerator experience, there are key lessons to expand the use of diagnostic tools and technologies for COVID-19 as well as other diseases of endemic and pandemic potential.