Migrating a lab-developed MERS-CoV real-time PCR to 3 “Sample to Result” systems: experiences on optimization and validation
Identifieur interne : 000230 ( Pmc/Checkpoint ); précédent : 000229; suivant : 000231Migrating a lab-developed MERS-CoV real-time PCR to 3 “Sample to Result” systems: experiences on optimization and validation
Auteurs : Glynis Frans ; Kurt Beuselinck ; Bart Peeters ; Marc Van Ranst ; Veroniek Saegeman ; Stefanie Desmet ; Katrien LagrouSource :
- Diagnostic Microbiology and Infectious Disease [ 0732-8893 ] ; 2019.
Abstract
The goal of the study was to adapt our Middle East respiratory syndrome coronavirus (MERS-CoV) lab-developed test (LDT) to 3 “Sample to Result” (S2R) systems: BD MAX (BD), ELITe InGenius (ELITechGroup), and ARIES (Luminex).
The BD MAX and InGenius system allowed use of lab-developed primers and TaqMan probes, while ARIES required conversion to MultiCode primers for melting curve analysis. Each device required ≤1 day of training and assay optimization. No discordant results were noted after analysis of 32 External Quality Control (EQC) samples. On a 10-fold dilution series of a MERS-CoV–positive EQC sample, InGenius obtained the highest detection rate. Laboratory technicians rated the ARIES as the user-friendliest. It also required the least hands-on time. BD MAX had the lowest turnaround time and highest throughput.
While each device had distinguishing system properties with associated (dis)advantages, the 3 S2R systems were comparable in terms of assay development and validation.
Url:
DOI: 10.1016/j.diagmicrobio.2019.02.006
PubMed: 30929995
PubMed Central: 7127711
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Migrating a lab-developed MERS-CoV real-time PCR to 3 “Sample to Result” systems: experiences on optimization and validation</title><author><name sortKey="Frans, Glynis" sort="Frans, Glynis" uniqKey="Frans G" first="Glynis" last="Frans">Glynis Frans</name></author><author><name sortKey="Beuselinck, Kurt" sort="Beuselinck, Kurt" uniqKey="Beuselinck K" first="Kurt" last="Beuselinck">Kurt Beuselinck</name></author><author><name sortKey="Peeters, Bart" sort="Peeters, Bart" uniqKey="Peeters B" first="Bart" last="Peeters">Bart Peeters</name></author><author><name sortKey="Van Ranst, Marc" sort="Van Ranst, Marc" uniqKey="Van Ranst M" first="Marc" last="Van Ranst">Marc Van Ranst</name></author><author><name sortKey="Saegeman, Veroniek" sort="Saegeman, Veroniek" uniqKey="Saegeman V" first="Veroniek" last="Saegeman">Veroniek Saegeman</name></author><author><name sortKey="Desmet, Stefanie" sort="Desmet, Stefanie" uniqKey="Desmet S" first="Stefanie" last="Desmet">Stefanie Desmet</name></author><author><name sortKey="Lagrou, Katrien" sort="Lagrou, Katrien" uniqKey="Lagrou K" first="Katrien" last="Lagrou">Katrien Lagrou</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">30929995</idno><idno type="pmc">7127711</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7127711</idno><idno type="RBID">PMC:7127711</idno><idno type="doi">10.1016/j.diagmicrobio.2019.02.006</idno><date when="2019">2019</date><idno type="wicri:Area/Pmc/Corpus">000C05</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000C05</idno><idno type="wicri:Area/Pmc/Curation">000C05</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000C05</idno><idno type="wicri:Area/Pmc/Checkpoint">000230</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000230</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Migrating a lab-developed MERS-CoV real-time PCR to 3 “Sample to Result” systems: experiences on optimization and validation</title><author><name sortKey="Frans, Glynis" sort="Frans, Glynis" uniqKey="Frans G" first="Glynis" last="Frans">Glynis Frans</name></author><author><name sortKey="Beuselinck, Kurt" sort="Beuselinck, Kurt" uniqKey="Beuselinck K" first="Kurt" last="Beuselinck">Kurt Beuselinck</name></author><author><name sortKey="Peeters, Bart" sort="Peeters, Bart" uniqKey="Peeters B" first="Bart" last="Peeters">Bart Peeters</name></author><author><name sortKey="Van Ranst, Marc" sort="Van Ranst, Marc" uniqKey="Van Ranst M" first="Marc" last="Van Ranst">Marc Van Ranst</name></author><author><name sortKey="Saegeman, Veroniek" sort="Saegeman, Veroniek" uniqKey="Saegeman V" first="Veroniek" last="Saegeman">Veroniek Saegeman</name></author><author><name sortKey="Desmet, Stefanie" sort="Desmet, Stefanie" uniqKey="Desmet S" first="Stefanie" last="Desmet">Stefanie Desmet</name></author><author><name sortKey="Lagrou, Katrien" sort="Lagrou, Katrien" uniqKey="Lagrou K" first="Katrien" last="Lagrou">Katrien Lagrou</name></author></analytic><series><title level="j">Diagnostic Microbiology and Infectious Disease</title><idno type="ISSN">0732-8893</idno><idno type="eISSN">1879-0070</idno><imprint><date when="2019">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>The goal of the study was to adapt our Middle East respiratory syndrome coronavirus (MERS-CoV) lab-developed test (LDT) to 3 “Sample to Result” (S2R) systems: BD MAX (BD), ELITe InGenius (ELITechGroup), and ARIES (Luminex).</p><p>The BD MAX and InGenius system allowed use of lab-developed primers and TaqMan probes, while ARIES required conversion to MultiCode primers for melting curve analysis. Each device required ≤1 day of training and assay optimization. No discordant results were noted after analysis of 32 External Quality Control (EQC) samples. On a 10-fold dilution series of a MERS-CoV–positive EQC sample, InGenius obtained the highest detection rate. Laboratory technicians rated the ARIES as the user-friendliest. It also required the least hands-on time. BD MAX had the lowest turnaround time and highest throughput.</p><p>While each device had distinguishing system properties with associated (dis)advantages, the 3 S2R systems were comparable in terms of assay development and validation.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Azhar, E I" uniqKey="Azhar E">E.I. Azhar</name></author><author><name sortKey="El Kafrawy, S A" uniqKey="El Kafrawy S">S.A. El-Kafrawy</name></author><author><name sortKey="Farraj, S A" uniqKey="Farraj S">S.A. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Diagn Microbiol Infect Dis</journal-id><journal-id journal-id-type="iso-abbrev">Diagn. Microbiol. Infect. Dis</journal-id><journal-title-group><journal-title>Diagnostic Microbiology and Infectious Disease</journal-title></journal-title-group><issn pub-type="ppub">0732-8893</issn><issn pub-type="epub">1879-0070</issn><publisher><publisher-name>Elsevier Inc.</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">30929995</article-id><article-id pub-id-type="pmc">7127711</article-id><article-id pub-id-type="publisher-id">S0732-8893(18)30503-0</article-id><article-id pub-id-type="doi">10.1016/j.diagmicrobio.2019.02.006</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Migrating a lab-developed MERS-CoV real-time PCR to 3 “Sample to Result” systems: experiences on optimization and validation</article-title></title-group><contrib-group><contrib contrib-type="author" id="au0005"><name><surname>Frans</surname><given-names>Glynis</given-names></name><email>glynis.frans@uzleuven.be</email></contrib><contrib contrib-type="author" id="au0010"><name><surname>Beuselinck</surname><given-names>Kurt</given-names></name><email>kurt.beuselinck@uzleuven.be</email><xref rid="cr0005" ref-type="corresp">⁎</xref></contrib><contrib contrib-type="author" id="au0015"><name><surname>Peeters</surname><given-names>Bart</given-names></name><email>bart.peeters@uza.be</email><xref rid="fn0005" ref-type="fn">1</xref></contrib><contrib contrib-type="author" id="au0020"><name><surname>Van Ranst</surname><given-names>Marc</given-names></name><email>marc.vanranst@uzleuven.be</email></contrib><contrib contrib-type="author" id="au0025"><name><surname>Saegeman</surname><given-names>Veroniek</given-names></name><email>veroniek.saegeman@uzleuven.be</email></contrib><contrib contrib-type="author" id="au0030"><name><surname>Desmet</surname><given-names>Stefanie</given-names></name><email>stefanie.desmet@uzleuven.be</email></contrib><contrib contrib-type="author" id="au0035"><name><surname>Lagrou</surname><given-names>Katrien</given-names></name><email>katrien.lagrou@uzleuven.be</email></contrib></contrib-group><aff id="af0005">Department of Laboratory Medicine, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium</aff><author-notes><corresp id="cr0005"><label>⁎</label>Corresponding author. Tel.: +32-16-34-79-31. <email>kurt.beuselinck@uzleuven.be</email></corresp><fn id="fn0005"><label>1</label><p id="np0050">Present address: Department of Laboratory Medicine, University Hospital Antwerp, Wilrijkstraat 10, 2650 Edegem, Belgium.</p></fn></author-notes><pub-date pub-type="pmc-release"><day>10</day><month>2</month><year>2019</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>2019</year></pub-date><pub-date pub-type="epub"><day>10</day><month>2</month><year>2019</year></pub-date><volume>94</volume><issue>4</issue><fpage>349</fpage><lpage>354</lpage><history><date date-type="received"><day>16</day><month>10</month><year>2018</year></date><date date-type="rev-recd"><day>1</day><month>2</month><year>2019</year></date><date date-type="accepted"><day>4</day><month>2</month><year>2019</year></date></history><permissions><copyright-statement>© 2019 Elsevier Inc. All rights reserved.</copyright-statement><copyright-year>2019</copyright-year><copyright-holder>Elsevier Inc.</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><abstract id="ab0005"><p>The goal of the study was to adapt our Middle East respiratory syndrome coronavirus (MERS-CoV) lab-developed test (LDT) to 3 “Sample to Result” (S2R) systems: BD MAX (BD), ELITe InGenius (ELITechGroup), and ARIES (Luminex).</p><p>The BD MAX and InGenius system allowed use of lab-developed primers and TaqMan probes, while ARIES required conversion to MultiCode primers for melting curve analysis. Each device required ≤1 day of training and assay optimization. No discordant results were noted after analysis of 32 External Quality Control (EQC) samples. On a 10-fold dilution series of a MERS-CoV–positive EQC sample, InGenius obtained the highest detection rate. Laboratory technicians rated the ARIES as the user-friendliest. It also required the least hands-on time. BD MAX had the lowest turnaround time and highest throughput.</p><p>While each device had distinguishing system properties with associated (dis)advantages, the 3 S2R systems were comparable in terms of assay development and validation.</p></abstract><kwd-group id="ks0005"><title>Abbreviations</title><kwd>CoV, Coronaviruses</kwd><kwd>EQC, External Quality Control</kwd><kwd>LDT, Lab-developed test</kwd><kwd>MERS, Middle East respiratory syndrome</kwd><kwd>MERS-CoV, Middle East respiratory syndrome coronavirus</kwd><kwd>PDV, Phocine Distemper Virus</kwd><kwd>RT-PCR, Real-time reverse-transcription polymerase chain reaction</kwd><kwd>S2R, Sample to Result</kwd><kwd>SPC, Specimen Processing Control</kwd><kwd>UTM, Universal Transport Medium</kwd></kwd-group><kwd-group id="ks0010"><title>Keywords</title><kwd>Sample to result systems</kwd><kwd>Middle East respiratory syndrome coronavirus</kwd><kwd>BD MAX</kwd><kwd>ELITe InGenius</kwd><kwd>ARIES</kwd></kwd-group></article-meta></front></pmc><affiliations><list></list><tree><noCountry><name sortKey="Beuselinck, Kurt" sort="Beuselinck, Kurt" uniqKey="Beuselinck K" first="Kurt" last="Beuselinck">Kurt Beuselinck</name><name sortKey="Desmet, Stefanie" sort="Desmet, Stefanie" uniqKey="Desmet S" first="Stefanie" last="Desmet">Stefanie Desmet</name><name sortKey="Frans, Glynis" sort="Frans, Glynis" uniqKey="Frans G" first="Glynis" last="Frans">Glynis Frans</name><name sortKey="Lagrou, Katrien" sort="Lagrou, Katrien" uniqKey="Lagrou K" first="Katrien" last="Lagrou">Katrien Lagrou</name><name sortKey="Peeters, Bart" sort="Peeters, Bart" uniqKey="Peeters B" first="Bart" last="Peeters">Bart Peeters</name><name sortKey="Saegeman, Veroniek" sort="Saegeman, Veroniek" uniqKey="Saegeman V" first="Veroniek" last="Saegeman">Veroniek Saegeman</name><name sortKey="Van Ranst, Marc" sort="Van Ranst, Marc" uniqKey="Van Ranst M" first="Marc" last="Van Ranst">Marc Van Ranst</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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