Call for submission - Submissions for the fourth WHO model list of essential in vitro diagnostics (EDL 4)

Closed call

The EDL Secretariat is pleased to announce the opening of the application period for the fourth edition of the WHO Model List of Essential In Vitro Diagnostics (EDL 4).  All submission for the EDL 4 shall be made using the submission portal https://submissions.who-healthtechnologies.org/ . You will require and Access key and a Secret to log in to the submission portal.  We invite you to express your intention to apply for the EDL 4 by reaching the Secretariat at EDLSecretariat@who.int. You will then receive your Access key and Secret to start your electronic submission.

The update of the EDL is a rigorous evidence-based process, the list is updated regularly with periodic calls for submission of applications.  There are different types of applications:

• Addition of a new In Vitro Diagnostic (IVD) category.  For pre-submissions the deadline is March 15, 2022; for full submission the deadline is July 31, 2022.
• Remove IVD from the current list (submit a request for removal of an existing IVD). Deadline is July 31, 2022.
• Edit IVD from the current list (submit a request for changing/editing an existing IVD). Deadline is July 31, 2022.
• Submit evidence in support of previous submission (submit evidence for existing IVD accepted conditionally for inclusion).  Deadline is July 31, 2022.

For the addition of new IVD categories the application process has two phases: pre-submission and full submission.  For the pre-submission phase, applicants will be required to submit basic information to allow the EDL Secretariat in collaboration with WHO disease programmes to determine suitability for full submission. Successful applicants will be invited to submit a full submission with more detailed information, including all the evidence necessary to support inclusion of the new test category.  The other types of applications consist of a single-phase submission process. 

For the addition of new IVD categories 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. nucleic acid testing, N. meningitidis
7. antigen, Entamoeba
8. Testosterone, total
9. Protein electrophoresis (in serum and urine)  
10. Immunofixation electrophoresis
11. Free light-chain test (in serum)
12. Antibodies against Scrub Typhus (IgM)
13. Antibodies against Leptospira (IgM)
14. serology, Yellow fever
15. nucleic acid testing, Diphtheria
16. IVDs for Bordetella pertussis
17. IVDs for Poliovirus
18. IVDs for Rotavirus
19. Lead
20. Hepatitis Delta (RDTs, EIA and RNA PCR)
21. Hepatitis E (RDTs, EIA and RNA PCR)
22. 17 hydroxyprogesterone
23. Parathyroid hormone

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

The WHO model list of essential in vitro diagnostics (EDL) is a policy document, based on scientific evidence, consisting of a list of categories of IVD tests for infectious diseases and non-communicable diseases and recommendations for its use at different levels of the health care system.  The EDL is intended to support IVD policy development to improve people access to IVD testing and clinical laboratory services. 

The EDL Secretariat oversees submissions, and the Strategic Advisory Group of Experts on IVDs (SAGE IVD) is responsible for reviewing applications and making final recommendations.