First international external quality assessment of molecular diagnostics for Mers-CoV
Identifieur interne : 000D96 ( Pmc/Curation ); précédent : 000D95; suivant : 000D97First international external quality assessment of molecular diagnostics for Mers-CoV
Auteurs : Suzan D. Pas [Pays-Bas] ; Pranav Patel [Allemagne] ; Chantal Reusken [Pays-Bas] ; Cristina Domingo [Allemagne] ; Victor M. Corman [Allemagne] ; Christian Drosten [Allemagne] ; Ronald Dijkman [Suisse] ; Volker Thiel [Suisse] ; Norbert Nowotny [Oman, Autriche] ; Marion P. G. Koopmans [Pays-Bas] ; Matthias Niedrig [Allemagne]Source :
- Journal of Clinical Virology [ 1386-6532 ] ; 2015.
Abstract
We describe results of the first HCoV-MERS external quality control panel. 85% of the 189 returned results had a 100% score. 8.1% of laboratories produced false positive results. ORF1b target is not recommended for screenings PCR.
Url:
DOI: 10.1016/j.jcv.2015.05.022
PubMed: 26209385
PubMed Central: 7106520
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<front><div type="abstract" xml:lang="en"><title>Highlights</title>
<p><list list-type="simple" id="lis0005"><list-item id="lsti0005"><label>•</label>
<p id="par0005">We describe results of the first HCoV-MERS external quality control panel.</p>
</list-item>
<list-item id="lsti0010"><label>•</label>
<p id="par0010">85% of the 189 returned results had a 100% score.</p>
</list-item>
<list-item id="lsti0015"><label>•</label>
<p id="par0015">8.1% of laboratories produced false positive results.</p>
</list-item>
<list-item id="lsti0020"><label>•</label>
<p id="par0020">ORF1b target is not recommended for screenings PCR.</p>
</list-item>
</list>
</p>
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<front><journal-meta><journal-id journal-id-type="nlm-ta">J Clin Virol</journal-id>
<journal-id journal-id-type="iso-abbrev">J. Clin. Virol</journal-id>
<journal-title-group><journal-title>Journal of Clinical Virology</journal-title>
</journal-title-group>
<issn pub-type="ppub">1386-6532</issn>
<issn pub-type="epub">1873-5967</issn>
<publisher><publisher-name>The Authors. Published by Elsevier B.V.</publisher-name>
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<article-meta><article-id pub-id-type="pmid">26209385</article-id>
<article-id pub-id-type="pmc">7106520</article-id>
<article-id pub-id-type="publisher-id">S1386-6532(15)00167-5</article-id>
<article-id pub-id-type="doi">10.1016/j.jcv.2015.05.022</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>First international external quality assessment of molecular diagnostics for Mers-CoV</article-title>
</title-group>
<contrib-group><contrib contrib-type="author" id="aut0005"><name><surname>Pas</surname>
<given-names>Suzan D.</given-names>
</name>
<xref rid="aff0005" ref-type="aff">a</xref>
<xref rid="cor0010" ref-type="corresp">⁎⁎</xref>
</contrib>
<contrib contrib-type="author" id="aut0010"><name><surname>Patel</surname>
<given-names>Pranav</given-names>
</name>
<xref rid="aff0010" ref-type="aff">b</xref>
</contrib>
<contrib contrib-type="author" id="aut0015"><name><surname>Reusken</surname>
<given-names>Chantal</given-names>
</name>
<xref rid="aff0005" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author" id="aut0020"><name><surname>Domingo</surname>
<given-names>Cristina</given-names>
</name>
<xref rid="aff0010" ref-type="aff">b</xref>
</contrib>
<contrib contrib-type="author" id="aut0025"><name><surname>Corman</surname>
<given-names>Victor M.</given-names>
</name>
<xref rid="aff0015" ref-type="aff">c</xref>
<xref rid="aff0020" ref-type="aff">d</xref>
</contrib>
<contrib contrib-type="author" id="aut0030"><name><surname>Drosten</surname>
<given-names>Christian</given-names>
</name>
<xref rid="aff0015" ref-type="aff">c</xref>
<xref rid="aff0020" ref-type="aff">d</xref>
</contrib>
<contrib contrib-type="author" id="aut0035"><name><surname>Dijkman</surname>
<given-names>Ronald</given-names>
</name>
<xref rid="aff0025" ref-type="aff">e</xref>
<xref rid="aff0030" ref-type="aff">f</xref>
</contrib>
<contrib contrib-type="author" id="aut0040"><name><surname>Thiel</surname>
<given-names>Volker</given-names>
</name>
<xref rid="aff0025" ref-type="aff">e</xref>
<xref rid="aff0030" ref-type="aff">f</xref>
</contrib>
<contrib contrib-type="author" id="aut0045"><name><surname>Nowotny</surname>
<given-names>Norbert</given-names>
</name>
<xref rid="aff0035" ref-type="aff">g</xref>
<xref rid="aff0040" ref-type="aff">h</xref>
</contrib>
<contrib contrib-type="author" id="aut0050"><name><surname>Koopmans</surname>
<given-names>Marion P.G.</given-names>
</name>
<xref rid="aff0005" ref-type="aff">a</xref>
</contrib>
<contrib contrib-type="author" id="aut0055"><name><surname>Niedrig</surname>
<given-names>Matthias</given-names>
</name>
<email>niedrigm@rki.de</email>
<xref rid="aff0010" ref-type="aff">b</xref>
<xref rid="cor0005" ref-type="corresp">⁎</xref>
</contrib>
</contrib-group>
<aff id="aff0005"><label>a</label>
Department of Viroscience, Erasmus MC, Rotterdam, The Netherlands</aff>
<aff id="aff0010"><label>b</label>
Center for Biological Threats and Special Pathogens, Robert Koch Institute, Berlin, Germany</aff>
<aff id="aff0015"><label>c</label>
Institute for virology, University of Bonn, Bonn, Germany</aff>
<aff id="aff0020"><label>d</label>
German Center for Infection Research (DZIF), Partner Site Bonn-Cologne, Bonn, Germany</aff>
<aff id="aff0025"><label>e</label>
Federal Institute of Virology and Immunology, Berne and Mittelhäusern, Switzerland</aff>
<aff id="aff0030"><label>f</label>
Vetsuisse Faculty, University of Berne, Switzerland</aff>
<aff id="aff0035"><label>g</label>
Department of Microbiology and Immunology, College of Medicine and Health Sciences, Sultan Qaboos University, Muscat, Oman</aff>
<aff id="aff0040"><label>h</label>
Institute of Virology, University of Veterinary Medicine Vienna, Vienna, Austria</aff>
<author-notes><corresp id="cor0005"><label>⁎</label>
Corresponding author at: Robert Koch – Institute, Nordufer 20, 13353 Berlin, Germany. Tel.: +49 30 18754 2370; fax: +49 30 18754 2625. <email>niedrigm@rki.de</email>
</corresp>
<corresp id="cor0010"><label>⁎⁎</label>
Corresponding author at: Department of Viroscience, Erasmus MC, Room Na1017, Wytemaweg 80, 3015CN Rotterdam, The Netherlands.</corresp>
</author-notes>
<pub-date pub-type="pmc-release"><day>30</day>
<month>5</month>
<year>2015</year>
</pub-date>
<pmc-comment> PMC Release delay is 0 months and 0 days and was based on .</pmc-comment>
<pub-date pub-type="ppub"><month>8</month>
<year>2015</year>
</pub-date>
<pub-date pub-type="epub"><day>30</day>
<month>5</month>
<year>2015</year>
</pub-date>
<volume>69</volume>
<fpage>81</fpage>
<lpage>85</lpage>
<history><date date-type="received"><day>4</day>
<month>3</month>
<year>2015</year>
</date>
<date date-type="rev-recd"><day>26</day>
<month>5</month>
<year>2015</year>
</date>
<date date-type="accepted"><day>28</day>
<month>5</month>
<year>2015</year>
</date>
</history>
<permissions><copyright-statement>© 2015 The Authors</copyright-statement>
<copyright-year>2015</copyright-year>
<license><license-p>Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.</license-p>
</license>
</permissions>
<abstract abstract-type="author-highlights" id="abs0005"><title>Highlights</title>
<p><list list-type="simple" id="lis0005"><list-item id="lsti0005"><label>•</label>
<p id="par0005">We describe results of the first HCoV-MERS external quality control panel.</p>
</list-item>
<list-item id="lsti0010"><label>•</label>
<p id="par0010">85% of the 189 returned results had a 100% score.</p>
</list-item>
<list-item id="lsti0015"><label>•</label>
<p id="par0015">8.1% of laboratories produced false positive results.</p>
</list-item>
<list-item id="lsti0020"><label>•</label>
<p id="par0020">ORF1b target is not recommended for screenings PCR.</p>
</list-item>
</list>
</p>
</abstract>
<abstract id="abs0010"><sec><title>Background</title>
<p>Since the discovery of Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012, diagnostic protocols were quickly published and deployed globally.</p>
</sec>
<sec><title>Objectives</title>
<p>We set out to assess the quality of MERS-CoV molecular diagnostics worldwide.</p>
</sec>
<sec><title>Study design</title>
<p>Both sensitivity and specificity were assessed using 12 samples containing different viral loads of MERS-CoV or common coronaviruses (OC43, 229E, NL63, HKU1).</p>
</sec>
<sec><title>Results</title>
<p>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.</p>
</sec>
<sec><title>Conclusions</title>
<p>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.</p>
</sec>
</abstract>
<kwd-group id="kwd0005"><title>Keywords</title>
<kwd>MERS-CoV</kwd>
<kwd>Real-time RT-PCR</kwd>
<kwd>EQA</kwd>
<kwd>QPCR</kwd>
<kwd>Molecular</kwd>
<kwd>Diagnosis</kwd>
<kwd>Viral load</kwd>
<kwd>Quality control</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
</record>
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