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.

Diagnosis, EQA, MERS-CoV, Molecular, QPCR, Quality control, Real-time RT-PCR, Viral load
dx.doi.org/10.1016/j.jcv.2015.05.022, hdl.handle.net/1765/85322
Journal of Clinical Virology
Department of Virology

Pas, S.D, Patel, P, Reusken, C.B.E.M, 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. doi:10.1016/j.jcv.2015.05.022