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

10 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

Fingerprint

Molecular Pathology
Molecular Diagnostic Techniques
Coronavirus
Middle East Respiratory Syndrome Coronavirus
Viral Load
Real-Time Polymerase Chain Reaction
RNA
Sensitivity and Specificity
Polymerase Chain Reaction

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., ... 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

First international external quality assessment of molecular diagnostics for Mers-CoV. / Pas, Suzan D.; Patel, Pranav; Reusken, Chantal; Domingo, Cristina; Corman, Victor M.; Drosten, Christian; Dijkman, Ronald; Thiel, Volker; Nowotny, Norbert; Koopmans, Marion P G; Niedrig, Matthias.

In: Journal of Clinical Virology, Vol. 69, 01.08.2015, p. 81-85.

Research output: Contribution to journalArticle

Pas, SD, Patel, P, Reusken, C, Domingo, C, Corman, VM, Drosten, C, Dijkman, R, Thiel, V, Nowotny, N, Koopmans, MPG & Niedrig, M 2015, 'First international external quality assessment of molecular diagnostics for Mers-CoV', Journal of Clinical Virology, vol. 69, pp. 81-85. https://doi.org/10.1016/j.jcv.2015.05.022
Pas, Suzan D. ; Patel, Pranav ; Reusken, Chantal ; Domingo, Cristina ; Corman, Victor M. ; Drosten, Christian ; Dijkman, Ronald ; Thiel, Volker ; Nowotny, Norbert ; Koopmans, Marion P G ; Niedrig, Matthias. / First international external quality assessment of molecular diagnostics for Mers-CoV. In: Journal of Clinical Virology. 2015 ; Vol. 69. pp. 81-85.
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