Call for submission - Submissions for the fifth WHO model list of essential in vitro diagnostics (EDL 5)

Closed call

 Deadline: 30 June 2024, 12PM CEST

The EDL Secretariat is pleased to announce the opening of the call for applications for the fifth edition of the WHO model list of essential in vitro diagnostics (EDL 5). We invite you to express your intention to apply for the EDL 5 by reaching the Secretariat at EDLSecretariat@who.int. You will then receive the submission form.

Background

The EDL is a health policy document, based on scientific evidence, consisting of a list of categories of IVD tests and recommendations for using those tests in relation to the assay format, test purpose, specimen type and health care setting.  The EDL aims to serve as a reference to guide development of or to update a national EDL (NEDL) at the country level within the framework of universal health coverage.  The EDL Secretariat oversees the application process and the Strategic Advisory Group of Experts on IVDs (SAGE IVD) is responsible for the review of applications and making recommendations.  

Process to submit applications to EDL 5

All submissions for the EDL 5 shall be made through email.  We invite you to express your intention to apply by reaching the Secretariat at EDLSecretariat@who.int, your email should describe the following:

• Type of application
• IVD category

The title of the email should be EDL 5 applications.  You will then receive the application form(s) and further instructions. 

 EDL type of applications

There are five different types of applications:

• Addition of a new IVD category   
• Edits to the current list
• Remove an IVD from the current list
• Submit additional evidence for IVDs conditionally listed
• Addition of do not do recommendations.

 High priority IVD categories for EDL 5

For the addition of new IVDs, we are specially inviting applications for the following IVD categories:

1. Therapeutic drug monitoring, Amikacin
2. Therapeutic drug monitoring, Gentamicin
3. Therapeutic drug monitoring, Phenytoin
4. Therapeutic drug monitoring, Lithium
5. Therapeutic drug monitoring, Methotrexate
6. Lead (blood lead concentration)
7. IVDs for Hepatitis Delta (RDT, EIA, PCR)
8. IVDs for Hepatitis A
9. Entamoeba antigen test
10. Free light-chain test (in serum)
11. Protein electrophoresis (in serum and urine)  
12. Immunofixation electrophoresis
13. IgM antibodies against scrub typhus
14. IgM antibodies against Leptospira
15. IVDs for Bordetella pertussis
16. NAT for diphtheria
17. Serology tests for yellow fever
18. NAT for Neisseria meningitidis - singleplex
19. Testosterone, total
20. IVDs for Poliovirus
21. IVDs for Rotavirus

The EDL Secretariat will also consider submissions for IVD categories not mentioned in the above list.