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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Standardization of Assays That Detect Anti-Rubella Virus IgG Antibodies</title><author><name sortKey="Dimech, Wayne" sort="Dimech, Wayne" uniqKey="Dimech W" first="Wayne" last="Dimech">Wayne Dimech</name><affiliation><nlm:aff id="aff1">NRL, Fitzroy, Victoria, Australia</nlm:aff></affiliation></author><author><name sortKey="Grangeot Keros, Liliane" sort="Grangeot Keros, Liliane" uniqKey="Grangeot Keros L" first="Liliane" last="Grangeot-Keros">Liliane Grangeot-Keros</name><affiliation><nlm:aff id="aff2">Paris-Sud University, AP-HP, Hôpital Paul Brousse, Virologie, National Reference Laboratory for Maternofetal Rubella Infections, Villejuif, France</nlm:aff></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><nlm:aff id="aff2">Paris-Sud University, AP-HP, Hôpital Paul Brousse, Virologie, National Reference Laboratory for Maternofetal Rubella Infections, Villejuif, France</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26607813</idno><idno type="pmc">4771216</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4771216</idno><idno type="RBID">PMC:4771216</idno><idno type="doi">10.1128/CMR.00045-15</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000651</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000651</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Standardization of Assays That Detect Anti-Rubella Virus IgG Antibodies</title><author><name sortKey="Dimech, Wayne" sort="Dimech, Wayne" uniqKey="Dimech W" first="Wayne" last="Dimech">Wayne Dimech</name><affiliation><nlm:aff id="aff1">NRL, Fitzroy, Victoria, Australia</nlm:aff></affiliation></author><author><name sortKey="Grangeot Keros, Liliane" sort="Grangeot Keros, Liliane" uniqKey="Grangeot Keros L" first="Liliane" last="Grangeot-Keros">Liliane Grangeot-Keros</name><affiliation><nlm:aff id="aff2">Paris-Sud University, AP-HP, Hôpital Paul Brousse, Virologie, National Reference Laboratory for Maternofetal Rubella Infections, Villejuif, France</nlm:aff></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><nlm:aff id="aff2">Paris-Sud University, AP-HP, Hôpital Paul Brousse, Virologie, National Reference Laboratory for Maternofetal Rubella Infections, Villejuif, France</nlm:aff></affiliation></author></analytic><series><title level="j">Clinical Microbiology Reviews</title><idno type="ISSN">0893-8512</idno><idno type="eISSN">1098-6618</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>SUMMARY</title><p>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.</p></div></front></TEI><pmc article-type="review-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Clin Microbiol Rev</journal-id><journal-id journal-id-type="iso-abbrev">Clin. Microbiol. Rev</journal-id><journal-id journal-id-type="hwp">cmr</journal-id><journal-id journal-id-type="pmc">cmr</journal-id><journal-id journal-id-type="publisher-id">CMR</journal-id><journal-title-group><journal-title>Clinical Microbiology Reviews</journal-title></journal-title-group><issn pub-type="ppub">0893-8512</issn><issn pub-type="epub">1098-6618</issn><publisher><publisher-name>American Society for Microbiology</publisher-name><publisher-loc>1752 N St., N.W., Washington, DC</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26607813</article-id><article-id pub-id-type="pmc">4771216</article-id><article-id pub-id-type="publisher-id">00045-15</article-id><article-id pub-id-type="doi">10.1128/CMR.00045-15</article-id><article-categories><subj-group subj-group-type="heading"><subject>Reviews</subject></subj-group></article-categories><title-group><article-title>Standardization of Assays That Detect Anti-Rubella Virus IgG Antibodies</article-title><alt-title alt-title-type="running-head">Standardization of Anti-Rubella Virus IgG Assays</alt-title><alt-title alt-title-type="short-authors">Dimech et al.</alt-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Dimech</surname><given-names>Wayne</given-names></name><xref ref-type="aff" rid="aff1"><sup>a</sup></xref><xref ref-type="bio" rid="d36e50">*</xref></contrib><contrib contrib-type="author"><name><surname>Grangeot-Keros</surname><given-names>Liliane</given-names></name><xref ref-type="aff" rid="aff2"><sup>b</sup></xref><xref ref-type="bio" rid="d36e67">*</xref></contrib><contrib contrib-type="author"><name><surname>Vauloup-Fellous</surname><given-names>Christelle</given-names></name><xref ref-type="aff" rid="aff2"><sup>b</sup></xref><xref ref-type="bio" rid="d36e84">*</xref></contrib><aff id="aff1"><label>a</label>NRL, Fitzroy, Victoria, Australia</aff><aff id="aff2"><label>b</label>Paris-Sud University, AP-HP, Hôpital Paul Brousse, Virologie, National Reference Laboratory for Maternofetal Rubella Infections, Villejuif, France</aff></contrib-group><author-notes><corresp id="cor1">Address correspondence to Wayne Dimech, <email>wayne@nrl.gov.au</email>.</corresp><fn fn-type="other"><p><bold>Citation</bold> Dimech W, Grangeot-Keros L, Vauloup-Fellous C. 2016. Standardization of assays that detect anti-rubella virus IgG antibodies. Clin Microbiol Rev 29:163–174. doi:<ext-link ext-link-type="uri" xlink:href="http://dx.doi.org/10.1128/CMR.00045-15">10.1128/CMR.00045-15</ext-link>.</p></fn></author-notes><pub-date pub-type="epub"><day>25</day><month>11</month><year>2015</year></pub-date><pub-date pub-type="ppub"><month>1</month><year>2016</year></pub-date><volume>29</volume><issue>1</issue><fpage>163</fpage><lpage>174</lpage><permissions><copyright-statement>Copyright © 2015, American Society for Microbiology. All Rights Reserved.</copyright-statement><copyright-year>2015</copyright-year><copyright-holder>American Society for Microbiology</copyright-holder></permissions><self-uri content-type="pdf" xlink:href="zcm001162536163.pdf"></self-uri><abstract><title>SUMMARY</title><p>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.</p></abstract><counts><fig-count count="4"></fig-count><table-count count="1"></table-count><equation-count count="0"></equation-count><ref-count count="91"></ref-count><page-count count="12"></page-count><word-count count="11561"></word-count></counts></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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