- Keywords > good quality in vitro diagnostics (IVDs)
- Keywords > post-emergency-use-listing safety monitoring - medicines, IVDs, vaccines granted EUAL
- Keywords > selection process
- Keywords > in vitro Diagnostic (IVD)
- Keywords > in vitro diagnostic medical devices
- Keywords > WHO Model List of Essential In Vitro Diagnostics (EDL)
(2018; 35 pages)
Access to good quality, affordable, and appropriate health products is indispensable to advance universal health coverage, address health emergencies, and promote healthier populations – the three strategic priorities of the World Health Organization (WHO) Thirteenth General Programme of Work 2019–2023. Without access to In vitro diagnostics (IVDs), health providers cannot diagnose patients effectively and promptly or provide appropriate treatments.
In March 2017, the WHO Expert Committee on Selection and Use of Essential Medicines recommended the development of a Model List of Essential In Vitro Diagnostics (EDL), to complement the WHO Model List of Essential Medicines (EML). To support the EDL and to advise on other in vitro diagnostic initiatives, WHO created a Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE-IVD). The SAGE-IVD, which includes 19 multidisciplinary members with global representation, held its first meeting from 16–20 April 2018 at WHO headquarters, Geneva. The SAGE IVD made recommendations for the content, format and implementation of the first edition of the EDL.
It is foreseen that EDL will be an important tool in increasing access to appropriate, affordable and quality-assured IVDs, particularly where they are most needed to address health priorities. The first edition of the EDL consists of:
- 58 general laboratory tests that can be used for routine patient care and for the detection and diagnosis of a wide array of diseases communicable and noncommunicable, in the disciplines of clinical chemistry, blood transfusion, serology, microbiology, mycology, parasitology and haematology. These tests support routine diagnosis and monitoring of many conditions such as diabetes, cardiovascular, anaemia, liver function.
- 55 types of laboratory tests needed for the detection, diagnosis and monitoring of HIV, tuberculosis, malaria, hepatitis B and C, syphilis and human papilloma virus. For each category of test, the EDL specifies: test category and purpose; assay format; specimen type; and, health care facility level for most appropriate use (e.g. primary care with no or minimal laboratories versus facilities with laboratories). Links to WHO guidelines or publications and, when available, to prequalification or endorsed products. The EDL refers to tests according to their biological targets and does not use brand names.