2nd Meeting of the Strategic Advisory Group of Experts on IVDs

18 – 22 March 2019
Geneva, Switzerland

 

The 2nd meeting of the Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) was held at WHO Headquarters, Geneva, from 18 to 22 March 2019. The objectives of the meeting were:

  • To review suggested changes to the existing EDL entries based on requests made by WHO disease programmes, external stakeholders and SAGE IVD members;
  • To discuss the reviews of and public comments to new submissions to the EDL;
  • To discuss the EDL country implementation plan and determine the way forward;
  • To provide recommendations on considerations for future EDL editions; and
  • To review the results of the WHO Prequalification consultation on addition of new IVDs to its scope of work and to make a recommendation on prioritization and timeline for new additions

The application period for inclusion of in vitro diagnostics in the second edition of the EDL was opened in July 2018 and closed in December 2018. All submissions to the EDL, suggested changes to the existing EDL entries, expert reviews and public comments will be published here.

 

2019 SAGE IVD panel

  1. Dr. Rashad Abdul-Ghani
  2. Dr. Susan Best
  3. Dr Catharina Boehme
  4. Dr. Jane Y. Carter
  5. Prof. Jon Deeks
  6. Prof. Anthony Ogbonna Emeribe
  7. Naofumi Hashimoto
  8. Dr. Sally A. Hojvat
  9. Prof. Hairong Huang
  10. Prof. Adrian Newland
  11. A/ Prof. Salwa Obeisat
  12. Prof. Madhukar Pai
  13. A/Prof. Olga Perovic
  14. Sadia Shakoor
  15. Dr Kamini Walia
  16. Valerie Wilson

 

Applications for new product categories

1. Qualitative test for the detection and differentiation of genomic DNA from Chlamydia trachomatis (CT) and Neisseria gonorrhoeae
2. Histoplasma antigen test
3. Vaccine response test (tetanus and pneumococcal)
4. Numeration of lymphocyte subtypes, namely CD4 (as in HIV), CD8, CD20, CD16/56 cells
5. Immunoglobulin plasma levels (IgG, IgA, IgM)
6. Plasma and urine protein electrophoresis and immunofixation
7. Kato-Katz
8. Guaiac fecal occult blood test (gFOBT)
9. Faecal immunochemical test
10. Alpha fetoprotein (AFP) immunoassay
11. Papanicolaou (Pap) smear
12. Prostate specific antigen
13. Basic panel with Immunohistochemical testing (IHC) for lymphoma
14. Detection of BCR-ABL1 and ABL1 transcripts (NAT)
15. Lactate dehydrogenase (LDH) activity
16. Immunohistochemical testing (IHC) for the evaluation of the over-expression of the Receptor tyrosine-protein kinase erbB-2 or human epidermal growth factor receptor 2 (HER2)
17. Immunohistochemical testing (IHC) for the detection of estrogen (ER) and progesterone (PgR) receptors
18. Quantitative determination of the sum of human chorionic gonadotropin (hCG) plus the beta-hCG (ECLIA)
19. Essential panel of antibodies for flow cytometry for leukemia
20. Basic panel with Immunohistochemical testing (IHC) for solid tumours
21. rK39 rapid diagnostic test – Leishmaniasis
22. Dengue virus antibody (IgM) EIA or RDT
23. Dengue virus antigen (NS1) EIA or RDT
24. Dengue virus nucleic acid test (NAT)
25. Rapid Plasma Reagin
26. Zika virus nucleic acid test (NAT)
27. Zika virus IgM Immunoassay
28. Procalcitonin (PCT) test (immunoassay)
29. Cholera Rapid Diagnostic Test
30. Influenza RIDTs
31. Influenza PCR

 

Suggested edits to previous EDL entries

4. Suggested approach to consider therapeutic drug monitoring tests

 

Public comments

 

Full submissions will be available soon, they are being migrated to the new WHO web platform. In the meantime submissions are available upon request at edlsecretariat@who.int