External Quality Assessment of MERS-CoV Molecular Diagnostics During the 2015 Korean Outbreak
Identifieur interne : 001795 ( Main/Exploration ); précédent : 001794; suivant : 001796External Quality Assessment of MERS-CoV Molecular Diagnostics During the 2015 Korean Outbreak
Auteurs : Moon-Woo Seong [Corée du Sud] ; Seung Jun Lee [Corée du Sud] ; Sung Im Cho [Corée du Sud] ; Kyungphil Ko [Corée du Sud] ; Mi-Na Kim [Corée du Sud] ; Heungsub Sung [Corée du Sud] ; Jae-Seok Kim [Corée du Sud] ; Ji Soo Ahn [Corée du Sud] ; Byung Su Yu [Corée du Sud] ; Taek Soo Kim [Corée du Sud] ; Eui Chong Kim [Corée du Sud] ; Sung Sup Park [Corée du Sud]Source :
- Annals of Laboratory Medicine [ 2234-3806 ] ; 2015.
Descripteurs français
- KwdFr :
- ARN viral (analyse), Assurance de la qualité des soins de santé, Coronavirus du syndrome respiratoire du Moyen-Orient (génétique), Coronavirus du syndrome respiratoire du Moyen-Orient (isolement et purification), Enquêtes et questionnaires, Flambées de maladies, Humains, Infections à coronavirus (diagnostic), Infections à coronavirus (virologie), Infections à coronavirus (épidémiologie), Réaction de polymérisation en chaine en temps réel, République de Corée (épidémiologie), Techniques de diagnostic moléculaire (normes).
- MESH :
- analyse : ARN viral.
- diagnostic : Infections à coronavirus.
- génétique : Coronavirus du syndrome respiratoire du Moyen-Orient.
- isolement et purification : Coronavirus du syndrome respiratoire du Moyen-Orient.
- normes : Techniques de diagnostic moléculaire.
- virologie : Infections à coronavirus.
- épidémiologie : Infections à coronavirus, République de Corée.
- Assurance de la qualité des soins de santé, Enquêtes et questionnaires, Flambées de maladies, Humains, Réaction de polymérisation en chaine en temps réel.
English descriptors
- KwdEn :
- Coronavirus Infections (diagnosis), Coronavirus Infections (epidemiology), Coronavirus Infections (virology), Disease Outbreaks, Humans, Middle East Respiratory Syndrome Coronavirus (genetics), Middle East Respiratory Syndrome Coronavirus (isolation & purification), Molecular Diagnostic Techniques (standards), Quality Assurance, Health Care, RNA, Viral (analysis), Real-Time Polymerase Chain Reaction, Republic of Korea (epidemiology), Surveys and Questionnaires.
- MESH :
- chemical , analysis : RNA, Viral.
- diagnosis : Coronavirus Infections.
- epidemiology : Coronavirus Infections, Republic of Korea.
- genetics : Middle East Respiratory Syndrome Coronavirus.
- isolation & purification : Middle East Respiratory Syndrome Coronavirus.
- standards : Molecular Diagnostic Techniques.
- virology : Coronavirus Infections.
- Disease Outbreaks, Humans, Quality Assurance, Health Care, Real-Time Polymerase Chain Reaction, Surveys and Questionnaires.
Abstract
The largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infection outside Middle East Asia in 2015 has necessitated the rapid expansion of laboratories that conduct MERS-CoV molecular testing in Korea, together with external quality assessment (EQA) to evaluate the assays used.
The EQA program consisted of two phases; self-validation and blind assessment. For the first EQA phase,
The first EQA phase results for 46 participants showed a linear relationship between the threshold cycle (CT) values of RNA materials and the logarithmic concentrations for both upE and ORF1a gene targets (R2=0.73 and 0.75, respectively). The mean CT value for each concentration was different depending on which commercial kit was used for the assay. Among the three commonly used kits, PowerChek MERS Real-Time PCR kit (KogeneBiotech, Korea) showed the lowest CT values at all concentrations of upE and most concentrations of ORF1a. The second EQA phase results for 47 participants were 100% correct for all tested samples.
This EQA survey demonstrates that the MERS-CoV molecular testing performed in Korea during the 2015 outbreak is of robust capability. However, careful establishment and validation of a cut-off value are recommended to ensure good analytical sensitivity.
Url:
DOI: 10.3343/alm.2016.36.3.230
PubMed: 26915611
PubMed Central: 4773263
Affiliations:
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Le document en format XML
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<term>Coronavirus Infections (virology)</term>
<term>Disease Outbreaks</term>
<term>Humans</term>
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<term>Coronavirus du syndrome respiratoire du Moyen-Orient (isolement et purification)</term>
<term>Enquêtes et questionnaires</term>
<term>Flambées de maladies</term>
<term>Humains</term>
<term>Infections à coronavirus (diagnostic)</term>
<term>Infections à coronavirus (virologie)</term>
<term>Infections à coronavirus (épidémiologie)</term>
<term>Réaction de polymérisation en chaine en temps réel</term>
<term>République de Corée (épidémiologie)</term>
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<keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Coronavirus du syndrome respiratoire du Moyen-Orient</term>
</keywords>
<keywords scheme="MESH" qualifier="isolation & purification" xml:lang="en"><term>Middle East Respiratory Syndrome Coronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="isolement et purification" xml:lang="fr"><term>Coronavirus du syndrome respiratoire du Moyen-Orient</term>
</keywords>
<keywords scheme="MESH" qualifier="normes" xml:lang="fr"><term>Techniques de diagnostic moléculaire</term>
</keywords>
<keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Molecular Diagnostic Techniques</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>Infections à coronavirus</term>
<term>République de Corée</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Disease Outbreaks</term>
<term>Humans</term>
<term>Quality Assurance, Health Care</term>
<term>Real-Time Polymerase Chain Reaction</term>
<term>Surveys and Questionnaires</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Assurance de la qualité des soins de santé</term>
<term>Enquêtes et questionnaires</term>
<term>Flambées de maladies</term>
<term>Humains</term>
<term>Réaction de polymérisation en chaine en temps réel</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>The largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infection outside Middle East Asia in 2015 has necessitated the rapid expansion of laboratories that conduct MERS-CoV molecular testing in Korea, together with external quality assessment (EQA) to evaluate the assays used.</p>
</sec>
<sec><title>Methods</title>
<p>The EQA program consisted of two phases; self-validation and blind assessment. For the first EQA phase, <italic>in vitro</italic>
transcribed upstream region of the envelope gene (upE) and the open reading frame (ORF)1a RNAs were used at a concentration of 1,000 copies/µL. The test panel for the second EQA phase consisted of RNA extracts from three samples, which were obtained from two MERS-CoV positive patients and one MERS-CoV negative patient.</p>
</sec>
<sec><title>Results</title>
<p>The first EQA phase results for 46 participants showed a linear relationship between the threshold cycle (C<sub>T</sub>
) values of RNA materials and the logarithmic concentrations for both upE and ORF1a gene targets (R<sup>2</sup>
=0.73 and 0.75, respectively). The mean C<sub>T</sub>
value for each concentration was different depending on which commercial kit was used for the assay. Among the three commonly used kits, PowerChek MERS Real-Time PCR kit (KogeneBiotech, Korea) showed the lowest C<sub>T</sub>
values at all concentrations of upE and most concentrations of ORF1a. The second EQA phase results for 47 participants were 100% correct for all tested samples.</p>
</sec>
<sec><title>Conclusions</title>
<p>This EQA survey demonstrates that the MERS-CoV molecular testing performed in Korea during the 2015 outbreak is of robust capability. However, careful establishment and validation of a cut-off value are recommended to ensure good analytical sensitivity.</p>
</sec>
</div>
</front>
<back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Van Boheemen, S" uniqKey="Van Boheemen S">S van Boheemen</name>
</author>
<author><name sortKey="De Graaf, M" uniqKey="De Graaf M">M de Graaf</name>
</author>
<author><name sortKey="Lauber, C" uniqKey="Lauber C">C Lauber</name>
</author>
<author><name sortKey="Bestebroer, Tm" uniqKey="Bestebroer T">TM Bestebroer</name>
</author>
<author><name sortKey="Raj, Vs" uniqKey="Raj V">VS Raj</name>
</author>
<author><name sortKey="Zaki, Am" uniqKey="Zaki A">AM Zaki</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Zaki, Am" uniqKey="Zaki A">AM Zaki</name>
</author>
<author><name sortKey="Van Boheemen, S" uniqKey="Van Boheemen S">S van Boheemen</name>
</author>
<author><name sortKey="Bestebroer, Tm" uniqKey="Bestebroer T">TM Bestebroer</name>
</author>
<author><name sortKey="Osterhaus, Ad" uniqKey="Osterhaus A">AD Osterhaus</name>
</author>
<author><name sortKey="Fouchier, Ra" uniqKey="Fouchier R">RA Fouchier</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Corman, Vm" uniqKey="Corman V">VM Corman</name>
</author>
<author><name sortKey="Eckerle, I" uniqKey="Eckerle I">I Eckerle</name>
</author>
<author><name sortKey="Bleicker, T" uniqKey="Bleicker T">T Bleicker</name>
</author>
<author><name sortKey="Zaki, A" uniqKey="Zaki A">A Zaki</name>
</author>
<author><name sortKey="Landt, O" uniqKey="Landt O">O Landt</name>
</author>
<author><name sortKey="Eschbach Bludau, M" uniqKey="Eschbach Bludau M">M Eschbach-Bludau</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Corman, Vm" uniqKey="Corman V">VM Corman</name>
</author>
<author><name sortKey="Muller, Ma" uniqKey="Muller M">MA Muller</name>
</author>
<author><name sortKey="Costabel, U" uniqKey="Costabel U">U Costabel</name>
</author>
<author><name sortKey="Timm, J" uniqKey="Timm J">J Timm</name>
</author>
<author><name sortKey="Binger, T" uniqKey="Binger T">T Binger</name>
</author>
<author><name sortKey="Meyer, B" uniqKey="Meyer B">B Meyer</name>
</author>
</analytic>
</biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Pas, Sd" uniqKey="Pas S">SD Pas</name>
</author>
<author><name sortKey="Patel, P" uniqKey="Patel P">P Patel</name>
</author>
<author><name sortKey="Reusken, C" uniqKey="Reusken C">C Reusken</name>
</author>
<author><name sortKey="Domingo, C" uniqKey="Domingo C">C Domingo</name>
</author>
<author><name sortKey="Corman, Vm" uniqKey="Corman V">VM Corman</name>
</author>
<author><name sortKey="Drosten, C" uniqKey="Drosten C">C Drosten</name>
</author>
</analytic>
</biblStruct>
</listBibl>
</div1>
</back>
</TEI>
<affiliations><list><country><li>Corée du Sud</li>
</country>
<region><li>Région capitale de Séoul</li>
</region>
<settlement><li>Séoul</li>
</settlement>
</list>
<tree><country name="Corée du Sud"><region name="Région capitale de Séoul"><name sortKey="Seong, Moon Woo" sort="Seong, Moon Woo" uniqKey="Seong M" first="Moon-Woo" last="Seong">Moon-Woo Seong</name>
</region>
<name sortKey="Ahn, Ji Soo" sort="Ahn, Ji Soo" uniqKey="Ahn J" first="Ji Soo" last="Ahn">Ji Soo Ahn</name>
<name sortKey="Cho, Sung Im" sort="Cho, Sung Im" uniqKey="Cho S" first="Sung Im" last="Cho">Sung Im Cho</name>
<name sortKey="Kim, Eui Chong" sort="Kim, Eui Chong" uniqKey="Kim E" first="Eui Chong" last="Kim">Eui Chong Kim</name>
<name sortKey="Kim, Jae Seok" sort="Kim, Jae Seok" uniqKey="Kim J" first="Jae-Seok" last="Kim">Jae-Seok Kim</name>
<name sortKey="Kim, Mi Na" sort="Kim, Mi Na" uniqKey="Kim M" first="Mi-Na" last="Kim">Mi-Na Kim</name>
<name sortKey="Kim, Taek Soo" sort="Kim, Taek Soo" uniqKey="Kim T" first="Taek Soo" last="Kim">Taek Soo Kim</name>
<name sortKey="Ko, Kyungphil" sort="Ko, Kyungphil" uniqKey="Ko K" first="Kyungphil" last="Ko">Kyungphil Ko</name>
<name sortKey="Lee, Seung Jun" sort="Lee, Seung Jun" uniqKey="Lee S" first="Seung Jun" last="Lee">Seung Jun Lee</name>
<name sortKey="Park, Sung Sup" sort="Park, Sung Sup" uniqKey="Park S" first="Sung Sup" last="Park">Sung Sup Park</name>
<name sortKey="Sung, Heungsub" sort="Sung, Heungsub" uniqKey="Sung H" first="Heungsub" last="Sung">Heungsub Sung</name>
<name sortKey="Yu, Byung Su" sort="Yu, Byung Su" uniqKey="Yu B" first="Byung Su" last="Yu">Byung Su Yu</name>
</country>
</tree>
</affiliations>
</record>
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