Establishment of the first WHO International Standard and Reference Panel for anti-Lassa Fever virus antibody - 2021 Draft

Oct 2, 2026

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A WHO draft prepared for the Expert Committee on Biological Standardization (ECBS) invites comments on proposals establishing the first WHO International Standard and Reference Panel for anti–Lassa Fever virus antibody. It describes the scientific rationale for standardizing LASV serological assays to support vaccine and therapeutic development and improved understanding of viral epidemiology. A candidate plasma pool was assessed in a multi-laboratory, blinded study using neutralisation and binding assay formats, including various target antigens and virus systems. Evaluation outcomes informed suitability for international standardization.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages78

Reading Time3 h 17 min

AccessFree to download

Summary

Scientific rationale for LASV antibody standards

Multi-method evaluation and study design

WHO/BS/2021.2406 ENGLISH ONLY EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION Geneva, 18 October to 21 October 2021 Establishment of the first WHO International Standard and Reference Panel for anti-Lassa Fever virus antibody Giada Mattiuzzo 1\# , Emma M. Bentley 1, Samuel Richardson 1, Valentina Bernasconi2, Marian Killip3, Robert F. Garry4 , Luis Branco5 , Stephan Günther6, Ndapewa Ithete6, Ephraim OgbainiEmovon7, Eleanor Atkinson8, Peter Rigsby8, Johan Holst2, Paul Kristiansen2, Mark Page 1, and the collaborative study participants* 1Division of Virology, National Institute for Biological Standards and Control, UK;2Coalition for Epidemic Preparedness Innovations, Norway; 3High Containment Microbiology, National Infection Service, Public Health England, UK;4 4Department of Microbiology and Immunology, Tulane University School of Medicine, New Orleans, USA; 5Zalgen Laboratories, LLC, Maryland, USA, 6 Virology Department, Bernhard-Nocht Institute for Tropical Medicine, Germany; 7Institute of Lassa Fever Research and Control, Irrua Specialist Teaching Hospital, Nigeria;8Statistics group, National Institute for Biological Standards and Control, UK \#Study coordinator: TEL:+44 1707641283, E-mail: [Giada.Mattiuzzo@nibsc.org](Giada.Mattiuzzo@nibsc.org) *listed in Annex 1 NOTE: This document has been prepared for the purpose of inviting comments and suggestions on the proposals contained therein, which will then be considered by the Expert Committee on Biological Standardization (ECBS) . Comments MUST be received by 17 September 2021 and should be addressed to the World Health Organization, 1211 Geneva 27, Switzerland, attention: Technical Standards and Specifications (TSS) . Comments may also be submitted electronically to the Responsible Officer: Dr Ivana Knezevic at [email:](email: knezevici@who.int)[ ](email: knezevici@who.int)[knezevici@who.int](email: knezevici@who.int). © World Health Organization 2021 All rights reserved. This draft is intended for a restricted audience only, i.e. the individuals and organizations having received this draft. The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means outside these individuals and organizations (including the organizations' concerned staff and member organizations) without the permission of the World Health Organization. The draft should not be displayed on any website. Please send any request for permission to: Dr Ivana Knezevic, Technical Standards and Specifications, Department of Health Products Policy and Standards, World Health Organization, CH-1211 Geneva 27, [Switzerland. Email:](Switzerland. Email: knezevici@who.int)[ ](Switzerland. Email: knezevici@who.int)[knezevici@who.int](Switzerland. Email: knezevici@who.int). The designations employed and the presentation of the material in this draft do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or ofits authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others ofa similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this draft. However, the printed material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization

FAQs

What is the purpose of this WHO draft document?

To invite comments on proposals establishing the first WHO International Standard and Reference Panel for anti–Lassa Fever virus antibody.

Why is an International Standard for anti-LASV antibody needed?

It supports standardisation of LASV serological assays and helps enable vaccine and therapeutic development, while improving understanding of viral epidemiology.

How was the candidate antibody material evaluated?

A pool of plasma from recovered Lassa fever patients was tested in 36 methods across 17 laboratories using neutralisation assays and binding assays targeting LASV antigens, within a blinded panel study.

Oct 2, 2026

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