The 4th SAGE IVD meeting was held on 14–18 November 2022 in a virtual format. On the first day of the meeting, the WHO EDL Secretariat organized an open webinar session with the participation of worldwide laboratory medicine professionals and nongovernmental organizations (NGOs), and representatives of WHO regional offices, country offices, and headquarters.
In the subsequent days, the 2021 panel of SAGE IVD members held closed discussions on the applications received for the fourth WHO model list of essential in vitro diagnostics (EDL 4) as well as on the way forward for the EDL and its role in increasing availability, access and proper use of IVDs. Dario Trapani (SAGE IVD member) chaired the closed sessions of the meeting.
EDL 4 applications
In total, the WHO EDL Secretariat received 12 applications: nine applications were to add new IVD test categories, two proposed edits of IVDs listed in EDL 3, and one application involved including a Do Not Do recommendation. The original applications and the reviews are available in full here.
- 17-Hydroxyprogesterone
- A, B, and O blood groups and Rhesus (Rh) factor POC dry format card
- High-sensitivity troponin I point-of-care test
- Hepatitis E virus nucleic acid test
- Immunoglobulin M antibodies to hepatitis E virus
- Immunoglobulin M antibodies to hepatitis E virus rapid diagnostic test
- Kleihauer-Betke acid-elution test
- Meningitis/encephalitis multiplex polymerase chain reaction panel
- Parathyroid hormone
- Glucose
- Mycobacterium tuberculosis DNA
- Serological tests for detection of typhoid antigen and immunoglobulin M/immunoglobulin G antibodies
Disclaimer
WHO publishes the applications as submitted by the applicants. The submitted applications may include references to specific companies or certain manufacturers’ products and/or contain package inserts. This does not mean in any way that they are endorsed or recommended by WHO in preference to others of a similar nature or that WHO provides any representation or warranty of any kind in relation thereof. WHO disclaims any and all liability whatsoever that may arise as a result of, or in connection with, the procurement, distribution, and use of any product referred to in the applications.