Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 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

Suzan D Pas  1 , Pranav Patel  2 , Chantal Reusken  1 , Cristina Domingo  2 , Victor M Corman  3 , Christian Drosten  3 , Ronald Dijkman  4 , Volker Thiel  4 , Norbert Nowotny  5 , Marion P G Koopmans  1 , Matthias Niedrig  6
Affiliations

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

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

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.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
World map of MERS-CoV EQA participants per country. formula imagen = 1; formula imagen = 2; formula imagen = 3; formula imagen = 5; formula imagen = 12.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

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

Publication types

MeSH terms