COVID-19 – News brought to you by EFLM

From WHO an interim guidance to laboratories and stakeholders involved in laboratory testing of patients with COVID-19

Recognizing that the global spread of COVID-19 has dramatically increased the number of suspected cases and the geographic area where laboratory testing needed to be implemented, intensified COVID-19 molecular testing has led to shortages of molecular testing reagents globally for COVID-19 and for other molecular diagnostics. Beyond supply issues, there are significant limitations of absorption capacity in many regions, especially in low- and middle-income countries.

As a reply, WHO has published the laboratory testing guidance for COVID-19 in suspected human cases with the aim to prioritize who gets tested according to health objectives.

EC postpones application of the Medical Devices Regulation to prioritise the fight against coronavirus

With patient health and safety as a guiding principle, the European Commission adopted a proposal on 3 April 2020 to postpone the application date of the Medical Devices Regulation (MDR) for one year. The goal is to have the Parliament and Council adopt the proposal by the end of May. This postponement will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.

From IFCC an Information Guide on COVID-19 and a new Task Force

The IFCC prepared an Information Guide on COVID-19. with the aim to organize relevant available information on laboratory screening, testing protocols, diagnosis, and other general information on COVID-19 for laboratory professionals, including links to helpful resources and interim guidelines. The guide will be continually updated as new guidelines and literature become available.

To highlight also the new IFCC Task Force on COVID-19.  The leading objectives of the Task Force encompass the provision of regular updates on epidemiology, pathogenesis and laboratory diagnostics of COVID-19, the development of practical recommendations for harmonizing the use of diagnostic tests for COVID-19 and biosafety measures for managing the specimens, as well as the organization of international studies to improve the knowledge on pathogenesis, diagnostics and therapeutic management of COVID-19. The Task Force will see also the representation of IFCC Regional Federations among its members.