• Suzan D Pas, Pranav Patel, Chantal Reusken, Cristina Domingo, Victor M Corman, Christian Drosten, Ronald Dijkman, Volker Thiel, Norbert Nowotny, Marion P G Koopmans, and Matthias Niedrig.
• Department of Viroscience, Erasmus MC, Rotterdam, The Netherlands.
• J. Clin. Virol. 2015 Aug 1; 69: 81-5.

BackgroundSince the discovery of Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012, diagnostic protocols were quickly published and deployed globally.ObjectivesWe set out to assess the quality of MERS-CoV molecular diagnostics worldwide.Study DesignBoth sensitivity and specificity were assessed using 12 samples containing different viral loads of MERS-CoV or common coronaviruses (OC43, 229E, NL63, HKU1).ResultsThe panel was sent to more than 106 participants, of which 99 laboratories from 6 continents returned 189 panel results.Scores ranged from 100% (84 laboratories) to 33% (1 laboratory). 15% of respondents reported quantitative results, 61% semi-quantitative (Ct-values or time to positivity) and 24% reported qualitative results. The major specific technique used was real-time RT-PCR using the WHO recommended targets upE, ORF1a and ORF1b. The evaluation confirmed that RT-PCRs targeting the ORF1b are less sensitive, and therefore not advised for primary diagnostics.ConclusionsThe first external quality assessment MERS-CoV panel gives a good insight in molecular diagnostic techniques and their performances for sensitive and specific detection of MERS-CoV RNA globally. Overall, all laboratories were capable of detecting MERS-CoV with some differences in sensitivity. The observation that 8% of laboratories reported false MERS-CoV positive single assay results shows room for improvement, and the importance of using confirmatory targets.Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

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