Fully automated diagnosis of MERS-CoV infection in respiratory specimen on the IdyllaTM MDx Platform
Identifieur interne : 000596 ( Pmc/Corpus ); précédent : 000595; suivant : 000597Fully automated diagnosis of MERS-CoV infection in respiratory specimen on the IdyllaTM MDx Platform
Auteurs : N. Trost ; A. Gilles ; I. Erquiaga ; H. Kenes ; D. Nauwelaers ; M. Steimer ; W. Carman ; E. SablonSource :
- Journal of Clinical Virology [ 1386-6532 ] ; 2016.
Url:
DOI: 10.1016/j.jcv.2016.08.067
PubMed: NONE
PubMed Central: 7128325
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PMC:7128325Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Fully automated diagnosis of MERS-CoV infection in respiratory specimen on the IdyllaTM MDx Platform</title><author><name sortKey="Trost, N" sort="Trost, N" uniqKey="Trost N" first="N." last="Trost">N. Trost</name><affiliation><nlm:aff id="aff0005">Fast-track Diagnostics, Esch-sur-Alzette, Luxembourg</nlm:aff></affiliation></author><author><name sortKey="Gilles, A" sort="Gilles, A" uniqKey="Gilles A" first="A." last="Gilles">A. Gilles</name><affiliation><nlm:aff id="aff0005">Fast-track Diagnostics, Esch-sur-Alzette, Luxembourg</nlm:aff></affiliation></author><author><name sortKey="Erquiaga, I" sort="Erquiaga, I" uniqKey="Erquiaga I" first="I." last="Erquiaga">I. Erquiaga</name><affiliation><nlm:aff id="aff0005">Fast-track Diagnostics, Esch-sur-Alzette, Luxembourg</nlm:aff></affiliation></author><author><name sortKey="Kenes, H" sort="Kenes, H" uniqKey="Kenes H" first="H." last="Kenes">H. Kenes</name><affiliation><nlm:aff id="aff0010">Biocartis NV, Mechelen, Belgium</nlm:aff></affiliation></author><author><name sortKey="Nauwelaers, D" sort="Nauwelaers, D" uniqKey="Nauwelaers D" first="D." last="Nauwelaers">D. Nauwelaers</name><affiliation><nlm:aff id="aff0010">Biocartis NV, Mechelen, Belgium</nlm:aff></affiliation></author><author><name sortKey="Steimer, M" sort="Steimer, M" uniqKey="Steimer M" first="M." last="Steimer">M. Steimer</name><affiliation><nlm:aff id="aff0005">Fast-track Diagnostics, Esch-sur-Alzette, Luxembourg</nlm:aff></affiliation></author><author><name sortKey="Carman, W" sort="Carman, W" uniqKey="Carman W" first="W." last="Carman">W. Carman</name><affiliation><nlm:aff id="aff0005">Fast-track Diagnostics, Esch-sur-Alzette, Luxembourg</nlm:aff></affiliation></author><author><name sortKey="Sablon, E" sort="Sablon, E" uniqKey="Sablon E" first="E." last="Sablon">E. Sablon</name><affiliation><nlm:aff id="aff0010">Biocartis NV, Mechelen, Belgium</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmc">7128325</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7128325</idno><idno type="RBID">PMC:7128325</idno><idno type="doi">10.1016/j.jcv.2016.08.067</idno><idno type="pmid">NONE</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000596</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000596</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Fully automated diagnosis of MERS-CoV infection in respiratory specimen on the IdyllaTM MDx Platform</title><author><name sortKey="Trost, N" sort="Trost, N" uniqKey="Trost N" first="N." last="Trost">N. Trost</name><affiliation><nlm:aff id="aff0005">Fast-track Diagnostics, Esch-sur-Alzette, Luxembourg</nlm:aff></affiliation></author><author><name sortKey="Gilles, A" sort="Gilles, A" uniqKey="Gilles A" first="A." last="Gilles">A. Gilles</name><affiliation><nlm:aff id="aff0005">Fast-track Diagnostics, Esch-sur-Alzette, Luxembourg</nlm:aff></affiliation></author><author><name sortKey="Erquiaga, I" sort="Erquiaga, I" uniqKey="Erquiaga I" first="I." last="Erquiaga">I. Erquiaga</name><affiliation><nlm:aff id="aff0005">Fast-track Diagnostics, Esch-sur-Alzette, Luxembourg</nlm:aff></affiliation></author><author><name sortKey="Kenes, H" sort="Kenes, H" uniqKey="Kenes H" first="H." last="Kenes">H. Kenes</name><affiliation><nlm:aff id="aff0010">Biocartis NV, Mechelen, Belgium</nlm:aff></affiliation></author><author><name sortKey="Nauwelaers, D" sort="Nauwelaers, D" uniqKey="Nauwelaers D" first="D." last="Nauwelaers">D. Nauwelaers</name><affiliation><nlm:aff id="aff0010">Biocartis NV, Mechelen, Belgium</nlm:aff></affiliation></author><author><name sortKey="Steimer, M" sort="Steimer, M" uniqKey="Steimer M" first="M." last="Steimer">M. Steimer</name><affiliation><nlm:aff id="aff0005">Fast-track Diagnostics, Esch-sur-Alzette, Luxembourg</nlm:aff></affiliation></author><author><name sortKey="Carman, W" sort="Carman, W" uniqKey="Carman W" first="W." last="Carman">W. Carman</name><affiliation><nlm:aff id="aff0005">Fast-track Diagnostics, Esch-sur-Alzette, Luxembourg</nlm:aff></affiliation></author><author><name sortKey="Sablon, E" sort="Sablon, E" uniqKey="Sablon E" first="E." last="Sablon">E. Sablon</name><affiliation><nlm:aff id="aff0010">Biocartis NV, Mechelen, Belgium</nlm:aff></affiliation></author></analytic><series><title level="j">Journal of Clinical Virology</title><idno type="ISSN">1386-6532</idno><idno type="eISSN">1873-5967</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader></TEI><pmc article-type="abstract"><pmc-dir>properties open_access</pmc-dir>
<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>Published by Elsevier B.V.</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmc">7128325</article-id><article-id pub-id-type="publisher-id">S1386-6532(16)30259-1</article-id><article-id pub-id-type="doi">10.1016/j.jcv.2016.08.067</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Fully automated diagnosis of MERS-CoV infection in respiratory specimen on the IdyllaTM MDx Platform</article-title></title-group><contrib-group><contrib contrib-type="author" id="aut0005"><name><surname>Trost</surname><given-names>N.</given-names></name><xref rid="aff0005" ref-type="aff">1</xref><xref rid="cor0005" ref-type="corresp">⁎</xref></contrib><contrib contrib-type="author" id="aut0010"><name><surname>Gilles</surname><given-names>A.</given-names></name><xref rid="aff0005" ref-type="aff">1</xref></contrib><contrib contrib-type="author" id="aut0015"><name><surname>Erquiaga</surname><given-names>I.</given-names></name><xref rid="aff0005" ref-type="aff">1</xref></contrib><contrib contrib-type="author" id="aut0020"><name><surname>Kenes</surname><given-names>H.</given-names></name><xref rid="aff0010" ref-type="aff">2</xref></contrib><contrib contrib-type="author" id="aut0025"><name><surname>Nauwelaers</surname><given-names>D.</given-names></name><xref rid="aff0010" ref-type="aff">2</xref></contrib><contrib contrib-type="author" id="aut0030"><name><surname>Steimer</surname><given-names>M.</given-names></name><xref rid="aff0005" ref-type="aff">1</xref></contrib><contrib contrib-type="author" id="aut0035"><name><surname>Carman</surname><given-names>W.</given-names></name><xref rid="aff0005" ref-type="aff">1</xref></contrib><contrib contrib-type="author" id="aut0040"><name><surname>Sablon</surname><given-names>E.</given-names></name><xref rid="aff0010" ref-type="aff">2</xref></contrib></contrib-group><aff id="aff0005"><label>1</label>Fast-track Diagnostics, Esch-sur-Alzette, Luxembourg</aff><aff id="aff0010"><label>2</label>Biocartis NV, Mechelen, Belgium</aff><author-notes><corresp id="cor0005"><label>⁎</label>Corresponding author.</corresp></author-notes><pub-date pub-type="pmc-release"><day>12</day><month>9</month><year>2016</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>9</month><year>2016</year></pub-date><pub-date pub-type="epub"><day>12</day><month>9</month><year>2016</year></pub-date><volume>82</volume><fpage>S34</fpage><lpage>S35</lpage><permissions><copyright-statement>Copyright © 2016 Published by Elsevier B.V.</copyright-statement><copyright-year>2016</copyright-year><copyright-holder></copyright-holder><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></article-meta></front><body><p id="par0005"><bold>Background:</bold> Rapid diagnosis of MERS-CoV infection is essential for the successful clinical management and isolation of MERS patients. The prototype Idylla™ MERS assay is a RT-PCR based assay which generates highly sensitive, specific results with a minimal turn-around time. Two independent PCR assays, targeting different regions in the MERS-CoV genome, are combined to detect and at the same time confirm infection with MERS-CoV. The prototype Idylla™ MERS assay is a single-use cartridge that will be run in the fully automated Idylla™ MDx Platform. The cartridge contains all reagents and is capable of processing samples without any user manipulation, minimizing the possibility of errors in setup and decreasing the risk of infection or contamination. The aim of this work was to demonstrate the performance of the prototype Idylla™ MERS assay on the Idylla™ Platform.</p><p id="par0010"><bold>Methods:</bold> Performance of the prototype Idylla™ MERS assay was assessed using serial dilutions of viral culture spiked in MERS-CoV negative clinical material. The performance of the prototype Idylla™ MERS assay was compared to a conventional RT-PCR kit in combination with extraction by the NucliSENS<sup>®</sup> easyMag<sup>®</sup>. In vitro transcribed MERS-CoV RNA was used to determine the LoD of the assay and to show reproducibility. Cross-reactivity was analysed using culture and clinical specimen positive of other respiratory pathogens. Additionally, an <italic>in-silico</italic> analysis was performed to prove the reactivity with all available MERS-CoV sequences and to exclude any cross-reactivity with organisms present in respiratory specimen or with the human genome.</p><p id="par0015"><bold>Results:</bold> The prototype Idylla™ MERS assay demonstrated high sensitivity and specificity. The analysis of MERS-CoV viral culture showed the same sensitivity with the Idylla™ MERS assay as a conventional MERS RT-PCR kit in combination with NucliSENS<sup>®</sup> easyMag<sup>®</sup> extraction. No cross-reactivity with other pathogens or the human genome was observed <italic>in-vitro</italic> or <italic>in-silico</italic>. The <italic>in-silico</italic> reactivity analysis showed 100% identity in 98.31% of the available sequences for the MERS screening assay and 97.07% for the confirmatory assay. The remaining sequences only showed minor mismatches and we confirmed the binding capability of our assay by using plasmids containing the mismatches.</p><p id="par0020"><bold>Conclusions:</bold> The fully automated prototype Idylla™ MERS assay requires less than 2 min of hands-on time for sample handling and provides results in less than 90 min without need for experienced staff or extensive training. Due to the integrated sample preparation the handling of the infectious material is reduced to an absolute minimum. The automated sample processing and RT-PCR and data analysis will lead to a sensitive and accurate calling of any MERS-CoV positive sample. The sample-to-result format of the prototype Idylla™ MERS assay offers the possibility for point-of care or centralized laboratory testing.</p></body></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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