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 Earl; Nowotny, Norbert; Koopmans, Marion P.G.; Niedrig, Matthias (2015). First international external quality assessment of molecular diagnostics for Mers-CoV. Journal of clinical virology, 69, pp. 81-85. Elsevier 10.1016/j.jcv.2015.05.022

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

05 Veterinary Medicine > Department of Infectious Diseases and Pathobiology (DIP) > Institute of Virology and Immunology
05 Veterinary Medicine > Research Foci > Host-Pathogen Interaction
05 Veterinary Medicine > Department of Infectious Diseases and Pathobiology (DIP)

UniBE Contributor:

Dijkman, Ronald and Thiel, Volker Earl

Subjects:

600 Technology > 630 Agriculture

ISSN:

1386-6532

Publisher:

Elsevier

Language:

English

Submitter:

Barbara Gautschi-Steffen

Date Deposited:

29 Feb 2016 16:39

Last Modified:

06 Jul 2016 20:59

Publisher DOI:

10.1016/j.jcv.2015.05.022

PubMed ID:

26209385

Uncontrolled Keywords:

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

BORIS DOI:

10.7892/boris.76078

URI:

https://boris.unibe.ch/id/eprint/76078

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