Evaluation and Clinical Validation of Two Field–Deployable Reverse Transcription-Insulated Isothermal PCR Assays for the Detection of the Middle East Respiratory Syndrome–Coronavirus
Identifieur interne : 000D94 ( Main/Exploration ); précédent : 000D93; suivant : 000D95Evaluation and Clinical Validation of Two Field–Deployable Reverse Transcription-Insulated Isothermal PCR Assays for the Detection of the Middle East Respiratory Syndrome–Coronavirus
Auteurs : Yun Young Go [Corée du Sud] ; Yeon-Sook Kim [Corée du Sud] ; Shinhye Cheon [Corée du Sud] ; Sangwoo Nam [Corée du Sud] ; Keun Bon Ku [Corée du Sud] ; Meehyein Kim [Corée du Sud] ; Nam Hyuk Cho [Corée du Sud] ; Hyun Park [Corée du Sud] ; Pei-Yu Alison Lee [États-Unis] ; Yu-Chun Lin [États-Unis] ; Yun-Long Tsai [États-Unis] ; Hwa-Tang Thomas Wang [États-Unis] ; Udeni B. R. Balasuriya [États-Unis]Source :
- The Journal of Molecular Diagnostics : JMD [ 1525-1578 ] ; 2017.
Descripteurs français
- KwdFr :
- ARN viral (génétique), ARN viral (isolement et purification), Coronavirus du syndrome respiratoire du Moyen-Orient (génétique), Coronavirus du syndrome respiratoire du Moyen-Orient (isolement et purification), Coronavirus du syndrome respiratoire du Moyen-Orient (pathogénicité), Humains, Infections à coronavirus (diagnostic), Infections à coronavirus (génétique), Infections à coronavirus (virologie), Réaction de polymérisation en chaine en temps réel (), République de Corée (épidémiologie), Transcription inverse (génétique).
- MESH :
- diagnostic : Infections à coronavirus.
- génétique : ARN viral, Coronavirus du syndrome respiratoire du Moyen-Orient, Infections à coronavirus, Transcription inverse.
- isolement et purification : ARN viral, Coronavirus du syndrome respiratoire du Moyen-Orient.
- pathogénicité : Coronavirus du syndrome respiratoire du Moyen-Orient.
- virologie : Infections à coronavirus.
- épidémiologie : République de Corée.
- Humains, Réaction de polymérisation en chaine en temps réel.
English descriptors
- KwdEn :
- Coronavirus Infections (diagnosis), Coronavirus Infections (genetics), Coronavirus Infections (virology), Humans, Middle East Respiratory Syndrome Coronavirus (genetics), Middle East Respiratory Syndrome Coronavirus (isolation & purification), Middle East Respiratory Syndrome Coronavirus (pathogenicity), RNA, Viral (genetics), RNA, Viral (isolation & purification), Real-Time Polymerase Chain Reaction (methods), Republic of Korea (epidemiology), Reverse Transcription (genetics).
- MESH :
- chemical , genetics : RNA, Viral.
- diagnosis : Coronavirus Infections.
- epidemiology : Republic of Korea.
- genetics : Coronavirus Infections, Middle East Respiratory Syndrome Coronavirus, Reverse Transcription.
- isolation & purification : Middle East Respiratory Syndrome Coronavirus, RNA, Viral.
- methods : Real-Time Polymerase Chain Reaction.
- pathogenicity : Middle East Respiratory Syndrome Coronavirus.
- virology : Coronavirus Infections.
- Humans.
Abstract
Middle East respiratory syndrome (MERS) is an emerging zoonotic viral respiratory disease that was first identified in Saudi Arabia in 2012. In 2015, the largest MERS outbreak outside of the Middle East region occurred in the Republic of Korea. The rapid nosocomial transmission of MERS-coronavirus (MERS-CoV) in Korean health care settings highlighted the importance and urgent need for a rapid and reliable on-site diagnostic assay to implement effective control and preventive measures. Here, the evaluation and validation of two newly developed reverse transcription–insulated isothermal PCR (RT-iiPCR) methods targeting the
Url:
DOI: 10.1016/j.jmoldx.2017.06.007
PubMed: 28807812
PubMed Central: 7106309
Affiliations:
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xml:lang="en" level="a" type="main">Evaluation and Clinical Validation of Two Field–Deployable Reverse Transcription-Insulated Isothermal PCR Assays for the Detection of the Middle East Respiratory Syndrome–Coronavirus</title><author><name sortKey="Go, Yun Young" sort="Go, Yun Young" uniqKey="Go Y" first="Yun Young" last="Go">Yun Young Go</name><affiliation wicri:level="1"><nlm:aff id="aff1">Center for Virus Research and Testing, Korea Research Institute of Chemical Technology, Daejeon, Republic of Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Center for Virus Research and Testing, Korea Research Institute of Chemical Technology, Daejeon</wicri:regionArea><wicri:noRegion>Daejeon</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2">Department of Medicinal Chemistry and Pharmacology, University of Science and Technology, Daejeon, Republic of Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Department of Medicinal Chemistry and Pharmacology, University of Science and Technology, Daejeon</wicri:regionArea><wicri:noRegion>Daejeon</wicri:noRegion></affiliation></author><author><name sortKey="Kim, Yeon Sook" sort="Kim, Yeon Sook" uniqKey="Kim Y" first="Yeon-Sook" last="Kim">Yeon-Sook Kim</name><affiliation wicri:level="1"><nlm:aff id="aff3">Department of Medicine, Chungnam National University School of Medicine, Daejeon, Republic of Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Department of Medicine, Chungnam National University School of Medicine, Daejeon</wicri:regionArea><wicri:noRegion>Daejeon</wicri:noRegion></affiliation></author><author><name sortKey="Cheon, Shinhye" sort="Cheon, Shinhye" uniqKey="Cheon S" first="Shinhye" last="Cheon">Shinhye Cheon</name><affiliation wicri:level="1"><nlm:aff id="aff3">Department of Medicine, Chungnam National University School of Medicine, Daejeon, Republic of Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Department of Medicine, Chungnam National University School of Medicine, Daejeon</wicri:regionArea><wicri:noRegion>Daejeon</wicri:noRegion></affiliation></author><author><name sortKey="Nam, Sangwoo" sort="Nam, Sangwoo" uniqKey="Nam S" first="Sangwoo" last="Nam">Sangwoo Nam</name><affiliation wicri:level="1"><nlm:aff id="aff1">Center for Virus Research and Testing, Korea Research Institute of Chemical Technology, Daejeon, Republic of Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Center for Virus Research and Testing, Korea Research Institute of Chemical Technology, Daejeon</wicri:regionArea><wicri:noRegion>Daejeon</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2">Department of Medicinal Chemistry and Pharmacology, University of Science and Technology, Daejeon, Republic of Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Department of Medicinal Chemistry and Pharmacology, University of Science and Technology, Daejeon</wicri:regionArea><wicri:noRegion>Daejeon</wicri:noRegion></affiliation></author><author><name sortKey="Ku, Keun Bon" sort="Ku, Keun Bon" uniqKey="Ku K" first="Keun Bon" last="Ku">Keun Bon Ku</name><affiliation wicri:level="1"><nlm:aff id="aff1">Center for Virus Research and Testing, Korea Research Institute of Chemical Technology, Daejeon, Republic of Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Center for Virus Research and Testing, Korea Research Institute of Chemical Technology, Daejeon</wicri:regionArea><wicri:noRegion>Daejeon</wicri:noRegion></affiliation></author><author><name sortKey="Kim, Meehyein" sort="Kim, Meehyein" uniqKey="Kim M" first="Meehyein" last="Kim">Meehyein Kim</name><affiliation wicri:level="1"><nlm:aff id="aff1">Center for Virus Research and Testing, Korea Research Institute of Chemical Technology, Daejeon, Republic of Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Center for Virus Research and Testing, Korea Research Institute of Chemical Technology, Daejeon</wicri:regionArea><wicri:noRegion>Daejeon</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2">Department of Medicinal Chemistry and Pharmacology, University of Science and Technology, Daejeon, Republic of Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Department of Medicinal Chemistry and Pharmacology, University of Science and Technology, Daejeon</wicri:regionArea><wicri:noRegion>Daejeon</wicri:noRegion></affiliation></author><author><name sortKey="Cho, Nam Hyuk" sort="Cho, Nam Hyuk" uniqKey="Cho N" first="Nam Hyuk" last="Cho">Nam Hyuk Cho</name><affiliation wicri:level="3"><nlm:aff id="aff4">Department of Microbiology and Immunology, and Department of Biomedical Science, Seoul National University College of Medicine and Bundang Hospital, Seoul, Republic of Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Department of Microbiology and Immunology, and Department of Biomedical Science, Seoul National University College of Medicine and Bundang Hospital, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Park, Hyun" sort="Park, Hyun" uniqKey="Park H" first="Hyun" last="Park">Hyun Park</name><affiliation wicri:level="1"><nlm:aff id="aff5">Department of Infection Biology, School of Medicine, Wonkwang University, Iksan, Republic of Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Department of Infection Biology, School of Medicine, Wonkwang University, Iksan</wicri:regionArea><wicri:noRegion>Iksan</wicri:noRegion></affiliation></author><author><name sortKey="Alison Lee, Pei Yu" sort="Alison Lee, Pei Yu" uniqKey="Alison Lee P" first="Pei-Yu" last="Alison Lee">Pei-Yu Alison Lee</name><affiliation wicri:level="2"><nlm:aff id="aff6">GeneReach USA, Lexington, Massachusetts</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>GeneReach USA, Lexington</wicri:cityArea></affiliation></author><author><name sortKey="Lin, Yu Chun" sort="Lin, Yu Chun" uniqKey="Lin Y" first="Yu-Chun" last="Lin">Yu-Chun Lin</name><affiliation wicri:level="2"><nlm:aff id="aff6">GeneReach USA, Lexington, Massachusetts</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>GeneReach USA, Lexington</wicri:cityArea></affiliation></author><author><name sortKey="Tsai, Yun Long" sort="Tsai, Yun Long" uniqKey="Tsai Y" first="Yun-Long" last="Tsai">Yun-Long Tsai</name><affiliation wicri:level="2"><nlm:aff id="aff6">GeneReach USA, Lexington, Massachusetts</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>GeneReach USA, Lexington</wicri:cityArea></affiliation></author><author><name sortKey="Thomas Wang, Hwa Tang" sort="Thomas Wang, Hwa Tang" uniqKey="Thomas Wang H" first="Hwa-Tang" last="Thomas Wang">Hwa-Tang Thomas Wang</name><affiliation wicri:level="2"><nlm:aff id="aff6">GeneReach USA, Lexington, Massachusetts</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>GeneReach USA, Lexington</wicri:cityArea></affiliation></author><author><name sortKey="Balasuriya, Udeni B R" sort="Balasuriya, Udeni B R" uniqKey="Balasuriya U" first="Udeni B. R." last="Balasuriya">Udeni B. R. Balasuriya</name><affiliation wicri:level="2"><nlm:aff id="aff7">Maxwell H. Gluck Equine Research Center, Department of Veterinary Science, College of Agriculture, Food and Environment and Department of Microbiology, Immunology and Molecular Genetics, College of Medicine, University of Kentucky, Lexington, Kentucky</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Kentucky</region></placeName><wicri:cityArea>Maxwell H. Gluck Equine Research Center, Department of Veterinary Science, College of Agriculture, Food and Environment and Department of Microbiology, Immunology and Molecular Genetics, College of Medicine, University of Kentucky, Lexington</wicri:cityArea></affiliation></author></analytic><series><title level="j">The Journal of Molecular Diagnostics : JMD</title><idno type="ISSN">1525-1578</idno><idno type="eISSN">1943-7811</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Coronavirus Infections (diagnosis)</term><term>Coronavirus Infections (genetics)</term><term>Coronavirus Infections (virology)</term><term>Humans</term><term>Middle East Respiratory Syndrome Coronavirus (genetics)</term><term>Middle East Respiratory Syndrome Coronavirus (isolation & purification)</term><term>Middle East Respiratory Syndrome Coronavirus (pathogenicity)</term><term>RNA, Viral (genetics)</term><term>RNA, Viral (isolation & purification)</term><term>Real-Time Polymerase Chain Reaction (methods)</term><term>Republic of Korea (epidemiology)</term><term>Reverse Transcription (genetics)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>ARN viral (génétique)</term><term>ARN viral (isolement et purification)</term><term>Coronavirus du syndrome respiratoire du Moyen-Orient (génétique)</term><term>Coronavirus du syndrome respiratoire du Moyen-Orient (isolement et purification)</term><term>Coronavirus du syndrome respiratoire du Moyen-Orient (pathogénicité)</term><term>Humains</term><term>Infections à coronavirus (diagnostic)</term><term>Infections à coronavirus (génétique)</term><term>Infections à coronavirus (virologie)</term><term>Réaction de polymérisation en chaine en temps réel ()</term><term>République de Corée (épidémiologie)</term><term>Transcription inverse (génétique)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en"><term>RNA, Viral</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Coronavirus Infections</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Infections à coronavirus</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Republic of Korea</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Coronavirus Infections</term><term>Middle East Respiratory Syndrome Coronavirus</term><term>Reverse Transcription</term></keywords><keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>ARN viral</term><term>Coronavirus du syndrome respiratoire du Moyen-Orient</term><term>Infections à coronavirus</term><term>Transcription inverse</term></keywords><keywords scheme="MESH" qualifier="isolation & purification" xml:lang="en"><term>Middle East Respiratory Syndrome Coronavirus</term><term>RNA, Viral</term></keywords><keywords scheme="MESH" qualifier="isolement et purification" xml:lang="fr"><term>ARN viral</term><term>Coronavirus du syndrome respiratoire du Moyen-Orient</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Real-Time Polymerase Chain Reaction</term></keywords><keywords scheme="MESH" qualifier="pathogenicity" xml:lang="en"><term>Middle East Respiratory Syndrome Coronavirus</term></keywords><keywords scheme="MESH" qualifier="pathogénicité" xml:lang="fr"><term>Coronavirus du syndrome respiratoire du Moyen-Orient</term></keywords><keywords scheme="MESH" qualifier="virologie" xml:lang="fr"><term>Infections à coronavirus</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Coronavirus Infections</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>République de Corée</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Humains</term><term>Réaction de polymérisation en chaine en temps réel</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Middle East respiratory syndrome (MERS) is an emerging zoonotic viral respiratory disease that was first identified in Saudi Arabia in 2012. In 2015, the largest MERS outbreak outside of the Middle East region occurred in the Republic of Korea. The rapid nosocomial transmission of MERS-coronavirus (MERS-CoV) in Korean health care settings highlighted the importance and urgent need for a rapid and reliable on-site diagnostic assay to implement effective control and preventive measures. Here, the evaluation and validation of two newly developed reverse transcription–insulated isothermal PCR (RT-iiPCR) methods targeting the <italic>ORF1a</italic> and <italic>upE</italic> genes of MERS-CoV are described. Compared with World Health Organization-recommended singleplex real-time quantitative RT-PCR (RT-qPCR) assays, both RT-iiPCR assays had comparable analytical sensitivity for the detection of MERS-CoV RNA in tissue culture fluid and in sputum samples spiked with infectious virus. Furthermore, clinical evaluation was performed with sputum samples collected from subjects with acute and chronic respiratory illnesses, including patients infected with MERS-CoV. The overall agreement values between the two RT-iiPCR assays and the reference RT-qPCR assays were 98.06% (95% CI, 94.43%–100%; κ = 0.96) and 99.03% (95% CI, 95.88%–100%; κ = 0.99) for <italic>ORF1a</italic> and <italic>upE</italic> assays, respectively. The <italic>ORF1a</italic> and <italic>upE</italic> MERS-CoV RT-iiPCR assays coupled with a field-deployable system provide a platform for a highly sensitive and specific on-site tool for diagnosis of MERS-CoV infections.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Chan, J F" uniqKey="Chan J">J.F. Chan</name></author><author><name sortKey="Lau, S K" uniqKey="Lau S">S.K. Lau</name></author><author><name sortKey="To, K K" uniqKey="To K">K.K. 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Memish</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Corée du Sud</li><li>États-Unis</li></country><region><li>Kentucky</li><li>Massachusetts</li><li>Région capitale de Séoul</li></region><settlement><li>Séoul</li></settlement></list><tree><country name="Corée du Sud"><noRegion><name sortKey="Go, Yun Young" sort="Go, Yun Young" uniqKey="Go Y" first="Yun Young" last="Go">Yun Young Go</name></noRegion><name sortKey="Cheon, Shinhye" sort="Cheon, Shinhye" uniqKey="Cheon S" first="Shinhye" last="Cheon">Shinhye Cheon</name><name sortKey="Cho, Nam Hyuk" sort="Cho, Nam Hyuk" uniqKey="Cho N" first="Nam Hyuk" last="Cho">Nam Hyuk Cho</name><name sortKey="Go, Yun Young" sort="Go, Yun Young" uniqKey="Go Y" first="Yun Young" last="Go">Yun Young Go</name><name sortKey="Kim, Meehyein" sort="Kim, Meehyein" uniqKey="Kim M" first="Meehyein" last="Kim">Meehyein Kim</name><name sortKey="Kim, Meehyein" sort="Kim, Meehyein" uniqKey="Kim M" first="Meehyein" last="Kim">Meehyein Kim</name><name sortKey="Kim, Yeon Sook" sort="Kim, Yeon Sook" uniqKey="Kim Y" first="Yeon-Sook" last="Kim">Yeon-Sook Kim</name><name sortKey="Ku, Keun Bon" sort="Ku, Keun Bon" uniqKey="Ku K" first="Keun Bon" last="Ku">Keun Bon Ku</name><name sortKey="Nam, Sangwoo" sort="Nam, Sangwoo" uniqKey="Nam S" first="Sangwoo" last="Nam">Sangwoo Nam</name><name sortKey="Nam, Sangwoo" sort="Nam, Sangwoo" uniqKey="Nam S" first="Sangwoo" last="Nam">Sangwoo Nam</name><name sortKey="Park, Hyun" sort="Park, Hyun" uniqKey="Park H" first="Hyun" last="Park">Hyun Park</name></country><country name="États-Unis"><region name="Massachusetts"><name sortKey="Alison Lee, Pei Yu" sort="Alison Lee, Pei Yu" uniqKey="Alison Lee P" first="Pei-Yu" last="Alison Lee">Pei-Yu Alison Lee</name></region><name sortKey="Balasuriya, Udeni B R" sort="Balasuriya, Udeni B R" uniqKey="Balasuriya U" first="Udeni B. R." last="Balasuriya">Udeni B. R. Balasuriya</name><name sortKey="Lin, Yu Chun" sort="Lin, Yu Chun" uniqKey="Lin Y" first="Yu-Chun" last="Lin">Yu-Chun Lin</name><name sortKey="Thomas Wang, Hwa Tang" sort="Thomas Wang, Hwa Tang" uniqKey="Thomas Wang H" first="Hwa-Tang" last="Thomas Wang">Hwa-Tang Thomas Wang</name><name sortKey="Tsai, Yun Long" sort="Tsai, Yun Long" uniqKey="Tsai Y" first="Yun-Long" last="Tsai">Yun-Long Tsai</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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