The selection and use of essential in vitro diagnostics

29 Jan 2021

The Cochrane Review ‘Rapid, point‐of‐care antigen and molecular‐based tests for diagnosis of SARS‐CoV‐2 infection’ informed the WHO global guidelines on ‘The selection and use of essential in vitro diagnostics’.

Introduction to the Guidelines

SAGE IVD advises the Director-General of WHO in the area of in vitro diagnostics (IVDs). With members appointed from a roster of experts, the group provides WHO with technical advice on global policies and strategies related to priority, essential and neglected IVDs.

The group also oversees maintenance of the WHO Model List of Essential In Vitro Diagnostics (EDL), which serves as an evidence-based reference point for countries to develop their own national lists to guide how they choose and use IVDs. The EDL recognizes that IVDs are essential for advancing universal health coverage (UHC), addressing health emergencies and promoting healthier populations, which are the three strategic priorities of WHO’s thirteenth general programme of work covering 2019–2023 (GPW13).

The EDL is updated every year through a broad consensus-building process, including expert review and public consultation. As part of that process, SAGE IVD members usually meet face to face to jointly assess individual applications to update the EDL. This annual meeting is also used as a platform for exchanging experience and expertise: key stakeholders attend open sessions to share their views and concerns about the EDL; WHO technical staff update SAGE IVD on related areas of ongoing work; and SAGE IVD members debate key issues in IVD policy and EDL strategy.

In March 2020, the group’s annual face-to-face meeting was cancelled due to the global pandemic of coronavirus disease (COVID-19). Instead, SAGE IVD established a remote process to update the EDL and provide WHO with IVD-related advice. Through successive rounds of remote voting and online deliberations from April to July 2020, and two extraordinary sessions in October and November, SAGE IVD managed to consider and make recommendations on every application made to update the EDL, including late-breaker submissions of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests, as well as to share progress updates and discuss strategic topics. This report provides a summary of the group’s deliberations, decisions and recommendations achieved through this process.