Duplex molecular assay intended for point-of-care diagnosis of influenza A/B virus infection.
Identifieur interne : 000043 ( Main/Corpus ); précédent : 000042; suivant : 000044Duplex molecular assay intended for point-of-care diagnosis of influenza A/B virus infection.
Auteurs : Liang-Ta Wu ; Isabelle Thomas ; Martin D. Curran ; Joanna S. Ellis ; Surendra Parmar ; Neha Goel ; Pia I. Sharma ; Jean-Pierre Allain ; Helen H. LeeSource :
- Journal of clinical microbiology [ 1098-660X ] ; 2013.
English descriptors
- KwdEn :
- Belgium, Humans, Influenza A virus (isolation & purification), Influenza B virus (isolation & purification), Influenza, Human (diagnosis), Influenza, Human (virology), Molecular Diagnostic Techniques (methods), Nasal Mucosa (virology), Nasopharynx (virology), Pharynx (virology), Point-of-Care Systems, Sensitivity and Specificity, United Kingdom, Virology (methods).
- MESH :
- geographic : Belgium, United Kingdom.
- diagnosis : Influenza, Human.
- isolation & purification : Influenza A virus, Influenza B virus.
- methods : Molecular Diagnostic Techniques, Virology.
- virology : Influenza, Human, Nasal Mucosa, Nasopharynx, Pharynx.
- Humans, Point-of-Care Systems, Sensitivity and Specificity.
Abstract
Early diagnosis and management of influenza virus infection directly correlates with the effectiveness in disease control. Current molecular influenza virus tests were designed for use in diagnostic testing facilities, where sophisticated equipment and highly trained technicians are available. A longer turnaround time for the centralized testing than when testing near the sample source could delay the initiation of medical intervention, thereby reducing the efficacy of antiviral treatment. The new assay, the SAMBA (simple amplification-based assay) Flu duplex test, is a dipstick-based molecular assay developed to provide a simple, accurate, and cost-effective solution for the diagnosis of influenza A/B viruses intended for near-patient testing. The test presents an alternative format of influenza virus molecular testing that utilizes isothermal amplification and visual detection of nucleic acid on a test strip. The entire test procedure (extraction, amplification, and detection) is integrated into an enclosed semiautomated system. Analytically, the SAMBA Flu duplex test detects 95 and 85 copies of viral genomes for influenza A and B viruses, respectively, with no cross-reactivity observed against other common respiratory pathogens. The clinical performance was established by blind testing of 328 nasal/throat and nasopharyngeal swab specimens from the United Kingdom and Belgium and comparing the results with the quantitative reverse transcription-PCR method routinely used in two public health laboratories. The SAMBA Flu duplex test showed a clinical sensitivity and specificity of 100% and 97.9% for influenza virus A and 100% and 100% for influenza virus B. The test provides a new technology that could facilitate simple and timely identification of influenza virus infection, potentially resulting in more efficient control measures.
DOI: 10.1128/JCM.00740-13
PubMed: 23850955
Links to Exploration step
pubmed:23850955Le document en format XML
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Ellis</name></author><author><name sortKey="Parmar, Surendra" sort="Parmar, Surendra" uniqKey="Parmar S" first="Surendra" last="Parmar">Surendra Parmar</name></author><author><name sortKey="Goel, Neha" sort="Goel, Neha" uniqKey="Goel N" first="Neha" last="Goel">Neha Goel</name></author><author><name sortKey="Sharma, Pia I" sort="Sharma, Pia I" uniqKey="Sharma P" first="Pia I" last="Sharma">Pia I. Sharma</name></author><author><name sortKey="Allain, Jean Pierre" sort="Allain, Jean Pierre" uniqKey="Allain J" first="Jean-Pierre" last="Allain">Jean-Pierre Allain</name></author><author><name sortKey="Lee, Helen H" sort="Lee, Helen H" uniqKey="Lee H" first="Helen H" last="Lee">Helen H. Lee</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2013">2013</date><idno type="RBID">pubmed:23850955</idno><idno type="pmid">23850955</idno><idno type="doi">10.1128/JCM.00740-13</idno><idno type="wicri:Area/Main/Corpus">000043</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000043</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Duplex molecular assay intended for point-of-care diagnosis of influenza A/B virus infection.</title><author><name sortKey="Wu, Liang Ta" sort="Wu, Liang Ta" uniqKey="Wu L" first="Liang-Ta" last="Wu">Liang-Ta Wu</name><affiliation><nlm:affiliation>Diagnostics Development Unit, Department of Haematology, University of Cambridge, Cambridge, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Thomas, Isabelle" sort="Thomas, Isabelle" uniqKey="Thomas I" first="Isabelle" last="Thomas">Isabelle Thomas</name></author><author><name sortKey="Curran, Martin D" sort="Curran, Martin D" uniqKey="Curran M" first="Martin D" last="Curran">Martin D. Curran</name></author><author><name sortKey="Ellis, Joanna S" sort="Ellis, Joanna S" uniqKey="Ellis J" first="Joanna S" last="Ellis">Joanna S. Ellis</name></author><author><name sortKey="Parmar, Surendra" sort="Parmar, Surendra" uniqKey="Parmar S" first="Surendra" last="Parmar">Surendra Parmar</name></author><author><name sortKey="Goel, Neha" sort="Goel, Neha" uniqKey="Goel N" first="Neha" last="Goel">Neha Goel</name></author><author><name sortKey="Sharma, Pia I" sort="Sharma, Pia I" uniqKey="Sharma P" first="Pia I" last="Sharma">Pia I. Sharma</name></author><author><name sortKey="Allain, Jean Pierre" sort="Allain, Jean Pierre" uniqKey="Allain J" first="Jean-Pierre" last="Allain">Jean-Pierre Allain</name></author><author><name sortKey="Lee, Helen H" sort="Lee, Helen H" uniqKey="Lee H" first="Helen H" last="Lee">Helen H. Lee</name></author></analytic><series><title level="j">Journal of clinical microbiology</title><idno type="eISSN">1098-660X</idno><imprint><date when="2013" type="published">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Belgium</term><term>Humans</term><term>Influenza A virus (isolation & purification)</term><term>Influenza B virus (isolation & purification)</term><term>Influenza, Human (diagnosis)</term><term>Influenza, Human (virology)</term><term>Molecular Diagnostic Techniques (methods)</term><term>Nasal Mucosa (virology)</term><term>Nasopharynx (virology)</term><term>Pharynx (virology)</term><term>Point-of-Care Systems</term><term>Sensitivity and Specificity</term><term>United Kingdom</term><term>Virology (methods)</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Belgium</term><term>United Kingdom</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="isolation & purification" xml:lang="en"><term>Influenza A virus</term><term>Influenza B virus</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Molecular Diagnostic Techniques</term><term>Virology</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Influenza, Human</term><term>Nasal Mucosa</term><term>Nasopharynx</term><term>Pharynx</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term><term>Point-of-Care Systems</term><term>Sensitivity and Specificity</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Early diagnosis and management of influenza virus infection directly correlates with the effectiveness in disease control. Current molecular influenza virus tests were designed for use in diagnostic testing facilities, where sophisticated equipment and highly trained technicians are available. A longer turnaround time for the centralized testing than when testing near the sample source could delay the initiation of medical intervention, thereby reducing the efficacy of antiviral treatment. The new assay, the SAMBA (simple amplification-based assay) Flu duplex test, is a dipstick-based molecular assay developed to provide a simple, accurate, and cost-effective solution for the diagnosis of influenza A/B viruses intended for near-patient testing. The test presents an alternative format of influenza virus molecular testing that utilizes isothermal amplification and visual detection of nucleic acid on a test strip. The entire test procedure (extraction, amplification, and detection) is integrated into an enclosed semiautomated system. Analytically, the SAMBA Flu duplex test detects 95 and 85 copies of viral genomes for influenza A and B viruses, respectively, with no cross-reactivity observed against other common respiratory pathogens. The clinical performance was established by blind testing of 328 nasal/throat and nasopharyngeal swab specimens from the United Kingdom and Belgium and comparing the results with the quantitative reverse transcription-PCR method routinely used in two public health laboratories. The SAMBA Flu duplex test showed a clinical sensitivity and specificity of 100% and 97.9% for influenza virus A and 100% and 100% for influenza virus B. The test provides a new technology that could facilitate simple and timely identification of influenza virus infection, potentially resulting in more efficient control measures. </div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">23850955</PMID><DateCompleted><Year>2014</Year><Month>03</Month><Day>10</Day></DateCompleted><DateRevised><Year>2020</Year><Month>04</Month><Day>30</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1098-660X</ISSN><JournalIssue CitedMedium="Internet"><Volume>51</Volume><Issue>9</Issue><PubDate><Year>2013</Year><Month>Sep</Month></PubDate></JournalIssue><Title>Journal of clinical microbiology</Title><ISOAbbreviation>J. Clin. Microbiol.</ISOAbbreviation></Journal><ArticleTitle>Duplex molecular assay intended for point-of-care diagnosis of influenza A/B virus infection.</ArticleTitle><Pagination><MedlinePgn>3031-8</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1128/JCM.00740-13</ELocationID><Abstract><AbstractText>Early diagnosis and management of influenza virus infection directly correlates with the effectiveness in disease control. Current molecular influenza virus tests were designed for use in diagnostic testing facilities, where sophisticated equipment and highly trained technicians are available. A longer turnaround time for the centralized testing than when testing near the sample source could delay the initiation of medical intervention, thereby reducing the efficacy of antiviral treatment. The new assay, the SAMBA (simple amplification-based assay) Flu duplex test, is a dipstick-based molecular assay developed to provide a simple, accurate, and cost-effective solution for the diagnosis of influenza A/B viruses intended for near-patient testing. The test presents an alternative format of influenza virus molecular testing that utilizes isothermal amplification and visual detection of nucleic acid on a test strip. The entire test procedure (extraction, amplification, and detection) is integrated into an enclosed semiautomated system. Analytically, the SAMBA Flu duplex test detects 95 and 85 copies of viral genomes for influenza A and B viruses, respectively, with no cross-reactivity observed against other common respiratory pathogens. The clinical performance was established by blind testing of 328 nasal/throat and nasopharyngeal swab specimens from the United Kingdom and Belgium and comparing the results with the quantitative reverse transcription-PCR method routinely used in two public health laboratories. The SAMBA Flu duplex test showed a clinical sensitivity and specificity of 100% and 97.9% for influenza virus A and 100% and 100% for influenza virus B. The test provides a new technology that could facilitate simple and timely identification of influenza virus infection, potentially resulting in more efficient control measures. </AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Wu</LastName><ForeName>Liang-Ta</ForeName><Initials>LT</Initials><AffiliationInfo><Affiliation>Diagnostics Development Unit, Department of Haematology, University of Cambridge, Cambridge, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thomas</LastName><ForeName>Isabelle</ForeName><Initials>I</Initials></Author><Author ValidYN="Y"><LastName>Curran</LastName><ForeName>Martin D</ForeName><Initials>MD</Initials></Author><Author ValidYN="Y"><LastName>Ellis</LastName><ForeName>Joanna S</ForeName><Initials>JS</Initials></Author><Author ValidYN="Y"><LastName>Parmar</LastName><ForeName>Surendra</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Goel</LastName><ForeName>Neha</ForeName><Initials>N</Initials></Author><Author ValidYN="Y"><LastName>Sharma</LastName><ForeName>Pia I</ForeName><Initials>PI</Initials></Author><Author ValidYN="Y"><LastName>Allain</LastName><ForeName>Jean-Pierre</ForeName><Initials>JP</Initials></Author><Author ValidYN="Y"><LastName>Lee</LastName><ForeName>Helen H</ForeName><Initials>HH</Initials></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><Acronym>WT_</Acronym><Agency>Wellcome Trust</Agency><Country>United Kingdom</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D023362">Evaluation Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2013</Year><Month>07</Month><Day>12</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Clin Microbiol</MedlineTA><NlmUniqueID>7505564</NlmUniqueID><ISSNLinking>0095-1137</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D001530" MajorTopicYN="N" Type="Geographic">Belgium</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009980" MajorTopicYN="N">Influenza A virus</DescriptorName><QualifierName UI="Q000302" MajorTopicYN="Y">isolation & purification</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D009981" MajorTopicYN="N">Influenza B virus</DescriptorName><QualifierName UI="Q000302" MajorTopicYN="Y">isolation & purification</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, 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