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

doi:10.1016/j.jcv.2015.05.022

. 2015 Aug:69:81-5.

doi: 10.1016/j.jcv.2015.05.022. Epub 2015 May 30.

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

Affiliations

¹ Department of Viroscience, Erasmus MC, Rotterdam, The Netherlands.
² Center for Biological Threats and Special Pathogens, Robert Koch Institute, Berlin, Germany.
³ Institute for virology, University of Bonn, Bonn, Germany; German Center for Infection Research (DZIF), Partner Site Bonn-Cologne, Bonn, Germany.
⁴ Federal Institute of Virology and Immunology, Berne and Mittelhäusern, Switzerland; Vetsuisse Faculty, University of Berne, Switzerland.
⁵ Department of Microbiology and Immunology, College of Medicine and Health Sciences, Sultan Qaboos University, Muscat, Oman; Institute of Virology, University of Veterinary Medicine Vienna, Vienna, Austria.
⁶ Center for Biological Threats and Special Pathogens, Robert Koch Institute, Berlin, Germany. Electronic address: niedrigm@rki.de.

PMID: 26209385
PMCID: PMC7106520
DOI: 10.1016/j.jcv.2015.05.022

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

Suzan D Pas et al. J Clin Virol. 2015 Aug.

. 2015 Aug:69:81-5.

doi: 10.1016/j.jcv.2015.05.022. Epub 2015 May 30.

Authors

Affiliations

¹ Department of Viroscience, Erasmus MC, Rotterdam, The Netherlands.
² Center for Biological Threats and Special Pathogens, Robert Koch Institute, Berlin, Germany.
³ Institute for virology, University of Bonn, Bonn, Germany; German Center for Infection Research (DZIF), Partner Site Bonn-Cologne, Bonn, Germany.
⁴ Federal Institute of Virology and Immunology, Berne and Mittelhäusern, Switzerland; Vetsuisse Faculty, University of Berne, Switzerland.
⁵ Department of Microbiology and Immunology, College of Medicine and Health Sciences, Sultan Qaboos University, Muscat, Oman; Institute of Virology, University of Veterinary Medicine Vienna, Vienna, Austria.
⁶ Center for Biological Threats and Special Pathogens, Robert Koch Institute, Berlin, Germany. Electronic address: niedrigm@rki.de.

PMID: 26209385
PMCID: PMC7106520
DOI: 10.1016/j.jcv.2015.05.022

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.

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

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Figures

**Fig. 1**
World map of MERS-CoV EQA participants per country. n = 1; n = 2; n = 3; n = 5; n = 12.

formula image — **Fig. 1**
World map of MERS-CoV EQA participants per country. n = 1; n = 2; n = 3; n = 5; n = 12.

See this image and copyright information in PMC

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References

1. van Boheemen S. Genomic characterization of a newly discovered coronavirus associated with acute respiratory distress syndrome in humans. mBio. 2012;3(6) e00473-12. - PMC - PubMed
1. Zaki A.M. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N. Engl. J. Med. 2012;367(19):1814–1820. - PubMed
1. Corman V.M. Detection of a novel human coronavirus by real-time reverse-transcription polymerase chain reaction. Eurosurveillance. 2012;17(39) pii=20285. - PubMed
1. Corman V.M. Assays for laboratory confirmation of novel human coronavirus (hCoV-EMC) infections. Eurosurveillance. 2012;17(49) pii=20334. - PubMed
1. Haagmans B.L. Middle East respiratory syndrome coronavirus in dromedary camels: an outbreak investigation. Lancet Infect. Dis. 2014;14(2):140–145. - PMC - PubMed

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[1] van Boheemen S. Genomic characterization of a newly discovered coronavirus associated with acute respiratory distress syndrome in humans. mBio. 2012;3(6) e00473-12. - PMC - PubMed

[2] van Boheemen S. Genomic characterization of a newly discovered coronavirus associated with acute respiratory distress syndrome in humans. mBio. 2012;3(6) e00473-12. - PMC - PubMed

[3] Zaki A.M. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N. Engl. J. Med. 2012;367(19):1814–1820. - PubMed

[4] Zaki A.M. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N. Engl. J. Med. 2012;367(19):1814–1820. - PubMed

[5] Corman V.M. Detection of a novel human coronavirus by real-time reverse-transcription polymerase chain reaction. Eurosurveillance. 2012;17(39) pii=20285. - PubMed

[6] Corman V.M. Detection of a novel human coronavirus by real-time reverse-transcription polymerase chain reaction. Eurosurveillance. 2012;17(39) pii=20285. - PubMed

[7] Corman V.M. Assays for laboratory confirmation of novel human coronavirus (hCoV-EMC) infections. Eurosurveillance. 2012;17(49) pii=20334. - PubMed

[8] Corman V.M. Assays for laboratory confirmation of novel human coronavirus (hCoV-EMC) infections. Eurosurveillance. 2012;17(49) pii=20334. - PubMed

[9] Haagmans B.L. Middle East respiratory syndrome coronavirus in dromedary camels: an outbreak investigation. Lancet Infect. Dis. 2014;14(2):140–145. - PMC - PubMed

[10] Haagmans B.L. Middle East respiratory syndrome coronavirus in dromedary camels: an outbreak investigation. Lancet Infect. Dis. 2014;14(2):140–145. - PMC - PubMed

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

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