First international external quality assessment of molecular diagnostics for Mers-CoV

Suzan D. Pas, Pranav Patel, Chantal Reusken, Cristina Domingo, Victor M. Corman, Christian Drosten, Ronald Dijkman, Volker Thiel, Norbert Nowotny, Marion P G Koopmans, Matthias Niedrig

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background: Since the discovery of Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012, diagnostic protocols were quickly published and deployed globally. Objectives: We set out to assess the quality of MERS-CoV molecular diagnostics worldwide. Study design: Both sensitivity and specificity were assessed using 12 samples containing different viral loads of MERS-CoV or common coronaviruses (OC43, 229E, NL63, HKU1). Results: The 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. Conclusions: The 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.

Original languageEnglish
Pages (from-to)81-85
Number of pages5
JournalJournal of Clinical Virology
Volume69
DOIs
Publication statusPublished - Aug 1 2015

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Keywords

  • Diagnosis
  • EQA
  • MERS-CoV
  • Molecular
  • QPCR
  • Quality control
  • Real-time RT-PCR
  • Viral load

ASJC Scopus subject areas

  • Virology
  • Infectious Diseases

Cite this

Pas, S. D., Patel, P., Reusken, C., Domingo, C., Corman, V. M., Drosten, C., Dijkman, R., Thiel, V., Nowotny, N., Koopmans, M. P. G., & Niedrig, M. (2015). First international external quality assessment of molecular diagnostics for Mers-CoV. Journal of Clinical Virology, 69, 81-85. https://doi.org/10.1016/j.jcv.2015.05.022