Standardization of Assays That Detect Anti-Rubella Virus IgG Antibodies.
Identifieur interne : 001659 ( PubMed/Checkpoint ); précédent : 001658; suivant : 001660Standardization of Assays That Detect Anti-Rubella Virus IgG Antibodies.
Auteurs : Wayne Dimech [Australie] ; Liliane Grangeot-Keros [France] ; Christelle Vauloup-Fellous [France]Source :
- Clinical microbiology reviews [ 1098-6618 ] ; 2016.
Descripteurs français
- KwdFr :
- MESH :
- immunologie : Virus de la rubéole.
- normes : Test ELISA.
- sang : Anticorps antiviraux, Immunoglobuline G.
- Humains, Test ELISA.
English descriptors
- KwdEn :
- MESH :
- chemical , blood : Antibodies, Viral, Immunoglobulin G.
- immunology : Rubella virus.
- methods : Enzyme-Linked Immunosorbent Assay.
- standards : Enzyme-Linked Immunosorbent Assay.
- Humans.
Abstract
Rubella virus usually causes a mild infection in humans but can cause congenital rubella syndrome (CRS). Vaccination programs have significantly decreased primary rubella virus infection and CRS; however, vaccinated individuals usually have lower levels of rubella virus IgG than those with natural infections. Rubella virus IgG is quantified with enzyme immunoassays that have been calibrated against the World Health Organization (WHO) international standard and report results in international units per milliliter. It is recognized that the results reported by these assays are not standardized. This investigation into the reasons for the lack of standardization found that the current WHO international standard (RUB-1-94) fails by three key metrological principles. The standard is not a pure analyte but is composed of pooled human immunoglobulin. It was not calibrated by certified reference methods; rather, superseded tests were used. Finally, no measurement uncertainty estimations have been provided. There is an analytical and clinical consequence to the lack of standardization of rubella virus IgG assays, which leads to misinterpretation of results. The current approach to standardization of rubella virus IgG assays has not achieved the desired results. A new approach is required.
DOI: 10.1128/CMR.00045-15
PubMed: 26607813
Affiliations:
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pubmed:26607813Le document en format XML
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Villejuif</wicri:regionArea><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Villejuif</wicri:noRegion></affiliation></author><author><name sortKey="Vauloup Fellous, Christelle" sort="Vauloup Fellous, Christelle" uniqKey="Vauloup Fellous C" first="Christelle" last="Vauloup-Fellous">Christelle Vauloup-Fellous</name><affiliation wicri:level="1"><nlm:affiliation>Paris-Sud University, AP-HP, Hôpital Paul Brousse, Virologie, National Reference Laboratory for Maternofetal Rubella Infections, Villejuif, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Paris-Sud University, AP-HP, Hôpital Paul Brousse, Virologie, National Reference Laboratory for Maternofetal Rubella Infections, Villejuif</wicri:regionArea><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Villejuif</wicri:noRegion></affiliation></author></analytic><series><title level="j">Clinical microbiology reviews</title><idno type="eISSN">1098-6618</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antibodies, Viral (blood)</term><term>Enzyme-Linked Immunosorbent Assay (methods)</term><term>Enzyme-Linked Immunosorbent Assay (standards)</term><term>Humans</term><term>Immunoglobulin G (blood)</term><term>Rubella virus (immunology)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Anticorps antiviraux (sang)</term><term>Humains</term><term>Immunoglobuline G (sang)</term><term>Test ELISA ()</term><term>Test ELISA (normes)</term><term>Virus de la rubéole (immunologie)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Viral</term><term>Immunoglobulin G</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Virus de la rubéole</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Rubella virus</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Enzyme-Linked Immunosorbent Assay</term></keywords><keywords scheme="MESH" qualifier="normes" xml:lang="fr"><term>Test ELISA</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Anticorps antiviraux</term><term>Immunoglobuline G</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Enzyme-Linked Immunosorbent Assay</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Humains</term><term>Test ELISA</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Rubella virus usually causes a mild infection in humans but can cause congenital rubella syndrome (CRS). Vaccination programs have significantly decreased primary rubella virus infection and CRS; however, vaccinated individuals usually have lower levels of rubella virus IgG than those with natural infections. Rubella virus IgG is quantified with enzyme immunoassays that have been calibrated against the World Health Organization (WHO) international standard and report results in international units per milliliter. It is recognized that the results reported by these assays are not standardized. This investigation into the reasons for the lack of standardization found that the current WHO international standard (RUB-1-94) fails by three key metrological principles. The standard is not a pure analyte but is composed of pooled human immunoglobulin. It was not calibrated by certified reference methods; rather, superseded tests were used. Finally, no measurement uncertainty estimations have been provided. There is an analytical and clinical consequence to the lack of standardization of rubella virus IgG assays, which leads to misinterpretation of results. The current approach to standardization of rubella virus IgG assays has not achieved the desired results. A new approach is required.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26607813</PMID><DateCreated><Year>2015</Year><Month>11</Month><Day>26</Day></DateCreated><DateCompleted><Year>2016</Year><Month>08</Month><Day>02</Day></DateCompleted><DateRevised><Year>2017</Year><Month>02</Month><Day>20</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1098-6618</ISSN><JournalIssue CitedMedium="Internet"><Volume>29</Volume><Issue>1</Issue><PubDate><Year>2016</Year><Month>Jan</Month></PubDate></JournalIssue><Title>Clinical microbiology reviews</Title><ISOAbbreviation>Clin. Microbiol. Rev.</ISOAbbreviation></Journal><ArticleTitle>Standardization of Assays That Detect Anti-Rubella Virus IgG Antibodies.</ArticleTitle><Pagination><MedlinePgn>163-74</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1128/CMR.00045-15</ELocationID><Abstract><AbstractText>Rubella virus usually causes a mild infection in humans but can cause congenital rubella syndrome (CRS). Vaccination programs have significantly decreased primary rubella virus infection and CRS; however, vaccinated individuals usually have lower levels of rubella virus IgG than those with natural infections. Rubella virus IgG is quantified with enzyme immunoassays that have been calibrated against the World Health Organization (WHO) international standard and report results in international units per milliliter. It is recognized that the results reported by these assays are not standardized. This investigation into the reasons for the lack of standardization found that the current WHO international standard (RUB-1-94) fails by three key metrological principles. The standard is not a pure analyte but is composed of pooled human immunoglobulin. It was not calibrated by certified reference methods; rather, superseded tests were used. Finally, no measurement uncertainty estimations have been provided. There is an analytical and clinical consequence to the lack of standardization of rubella virus IgG assays, which leads to misinterpretation of results. The current approach to standardization of rubella virus IgG assays has not achieved the desired results. A new approach is required.</AbstractText><CopyrightInformation>Copyright © 2015, American Society for Microbiology. All Rights Reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Dimech</LastName><ForeName>Wayne</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>NRL, Fitzroy, Victoria, Australia wayne@nrl.gov.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grangeot-Keros</LastName><ForeName>Liliane</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Paris-Sud University, AP-HP, Hôpital Paul Brousse, Virologie, National Reference Laboratory for Maternofetal Rubella Infections, Villejuif, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vauloup-Fellous</LastName><ForeName>Christelle</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Paris-Sud University, AP-HP, Hôpital Paul Brousse, Virologie, National Reference Laboratory for Maternofetal Rubella Infections, Villejuif, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Microbiol Rev</MedlineTA><NlmUniqueID>8807282</NlmUniqueID><ISSNLinking>0893-8512</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007074">Immunoglobulin G</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Commun Dis Intell. 1999 Aug 5;23(8):209-14</RefSource><PMID Version="1">10497832</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Epidemiol Infect. 1988 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MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007074" MajorTopicYN="N">Immunoglobulin G</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012412" MajorTopicYN="N">Rubella virus</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC4771216 [Available on 01/01/17]</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>11</Month><Day>27</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>11</Month><Day>27</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>8</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26607813</ArticleId><ArticleId IdType="pii">29/1/163</ArticleId><ArticleId IdType="doi">10.1128/CMR.00045-15</ArticleId><ArticleId IdType="pmc">PMC4771216</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Australie</li><li>France</li></country></list><tree><country name="Australie"><noRegion><name sortKey="Dimech, Wayne" sort="Dimech, Wayne" uniqKey="Dimech W" first="Wayne" last="Dimech">Wayne Dimech</name></noRegion></country><country name="France"><noRegion><name sortKey="Grangeot Keros, Liliane" sort="Grangeot Keros, Liliane" uniqKey="Grangeot Keros L" first="Liliane" last="Grangeot-Keros">Liliane Grangeot-Keros</name></noRegion><name sortKey="Vauloup Fellous, Christelle" sort="Vauloup Fellous, Christelle" uniqKey="Vauloup Fellous C" first="Christelle" last="Vauloup-Fellous">Christelle Vauloup-Fellous</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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