During outbreaks of emerging viruses, such as the Zika outbreak in 2015–2016, speed and accuracy in detection of infection are critical factors to control the spread of the disease; often serological and diagnostic methods for emerging viruses are not well developed and validated. Thus, vaccines and treatments are difficult to evaluate due to the lack of comparable methods. In this study, we show how the 1st WHO International Standard for anti-Zika antibody was able to harmonize the neutralization titres of a panel of serological Zika-positive samples from laboratories worldwide. Expression of the titres in International Unit per millilitre reduced the inter-laboratory variance, allowing for greater comparability between laboratories. We advocate the use of the International Standard for anti-Zika virus antibodies for the calibration of neutralization assays to create a common language, which will permit a clear evaluation of the results of different clinical trials and expedite the vaccine/treatment development.
Bibliographical noteFunding Information:
4BlueSense Diagnostics ApS, Copenhagen, Denmark. 5Paul-Ehrlich-Institut, Langen, Germany. 6International Vaccine Institute, Seoul, Korea. 7Caribbean Public Health Agency, St. Clair-Port of Spain, Trinidad and Tobago. 8Virus Reference Department, Public Health England, London, UK. 9Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD, USA. 10Sanofi Pasteur, Swiftwater, PA, USA. 11Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. 12Takeda Vaccines Inc., Deerfield, IL, USA. 13Q2 Solutions-Vaccines, Focus Diagnostics Inc., San Juan Capistrano, CA, USA.14Vanderbilt University Medical Center, Nashville, TN, USA. 15University of North Carolina, Chapel Hill, NC, USA. 16National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. 17Chembio Diagnostic Systems Inc., Medford, NY, USA. 18DiaSorin Inc., Stillwater, MN, USA. 19Walter Reed Army Institute of Research, Silver Spring, MD, USA and funded by the NIHR Policy Research Programme (NIBSC Regulatory Science Research Unit). The views expressed in the publication are those of the author(s) and not necessarily those of the NHS, the NIHR, the Department of Health, ‘arms’ length bodies or other government departments.
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