Differences in Recognition of the 1st WHO International Reference Reagents for hCG-Related Isoforms by Diagnostic Immunoassays for Human Chorionic Gonadotropin
Identifieur interne : 008392 ( Main/Exploration ); précédent : 008391; suivant : 008393Differences in Recognition of the 1st WHO International Reference Reagents for hCG-Related Isoforms by Diagnostic Immunoassays for Human Chorionic Gonadotropin
Auteurs : Catharine M. Sturgeon [Royaume-Uni] ; Peter Berger [Autriche] ; Jean-Michel Bidart [France] ; Steven Birken [États-Unis] ; Chris Burns [Royaume-Uni] ; Robert J. Norman [Australie] ; Ulf-Hakan Stenman [Finlande]Source :
- Clinical chemistry : (Baltimore, Md.) [ 0009-9147 ] ; 2009.
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- Pascal (Inist)
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Abstract
BACKGROUND: The 1st WHO International Reference Reagents (IRRs) for 6 human chorionic gonadotropin (hCG)-related molecular variants, highly purified and calibrated in substance concentrations by the IFCC Working Group for hCG, permit experimental elucidation of what commercially available hCG methods measure in molar terms and enable assessment of their fitness for clinical purposes. METHODS: Pools containing known amounts of the IRRs spiked into normal human serum were issued to participants through the UK National External Quality Assessment Service for hCG for a period of 7 years. Among 16 assays used, 4 recognized only hCG, whereas 6 recognized hCG and its free β-subunit (hCGβ), and 6 recognized hCG, hCGβ, and the beta core fragment. RESULTS: Differences in calibration of current hCG assays are moderate. Mean recovery of the current International Standard (IS), hCG IS 75/589, was 107% (range 93% to 126%), whereas that of the IRR 99/688 for hCG was 139% (range 109%-164%). Between-method variation for the latter (CV 12.3%) was also greater than for IS 75/589 (CV 8.8%). Recognition of hCGβ varied markedly (CV 37%). Most assays overestimated it, but 2 RIAs produced results that were slight underestimations. Recognition of the beta core fragment was even more variable (CV 57%) and was closest to equimolarity for the RIAs. CONCLUSIONS: Assays for hCG show considerable variation in their recognition of various forms of hCG, and this variablility is the most important cause of method-related differences in hCG results in serum and an even more important cause of method-related differences in urine measurements. Equimolar recognition of the major hCG isoforms is essential if between-method comparability for hCG is to be improved.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Differences in Recognition of the 1st WHO International Reference Reagents for hCG-Related Isoforms by Diagnostic Immunoassays for Human Chorionic Gonadotropin</title><author><name sortKey="Sturgeon, Catharine M" sort="Sturgeon, Catharine M" uniqKey="Sturgeon C" first="Catharine M." last="Sturgeon">Catharine M. Sturgeon</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Department of Clinical Biochemistry, Royal Infirmary</s1><s2>Edinburgh</s2><s3>GBR</s3><sZ>1 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Édimbourg</settlement><region type="country">Écosse</region></placeName></affiliation></author><author><name sortKey="Berger, Peter" sort="Berger, Peter" uniqKey="Berger P" first="Peter" last="Berger">Peter Berger</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Institute for Biomedical Aging Research, Austrian Academy of Sciences</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>2 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion></affiliation></author><author><name sortKey="Bidart, Jean Michel" sort="Bidart, Jean Michel" uniqKey="Bidart J" first="Jean-Michel" last="Bidart">Jean-Michel Bidart</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Clinical Biology, Institut Gustave-Roussy</s1><s2>Villejuif</s2><s3>FRA</s3><sZ>3 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Institut Gustave-Roussy</wicri:noRegion><wicri:noRegion>Villejuif</wicri:noRegion></affiliation></author><author><name sortKey="Birken, Steven" sort="Birken, Steven" uniqKey="Birken S" first="Steven" last="Birken">Steven Birken</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Obstetrics and Gynecology, College of Physicians and Surgeons of Columbia University</s1><s2>NY, NY</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>NY, NY</wicri:noRegion></affiliation></author><author><name sortKey="Burns, Chris" sort="Burns, Chris" uniqKey="Burns C" first="Chris" last="Burns">Chris Burns</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>National Institute of Biological Standards and Control</s1><s2>Potters Bar</s2><s3>GBR</s3><sZ>5 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>National Institute of Biological Standards and Control</wicri:noRegion></affiliation></author><author><name sortKey="Norman, Robert J" sort="Norman, Robert J" uniqKey="Norman R" first="Robert J." last="Norman">Robert J. 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Sturgeon</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Department of Clinical Biochemistry, Royal Infirmary</s1><s2>Edinburgh</s2><s3>GBR</s3><sZ>1 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Édimbourg</settlement><region type="country">Écosse</region></placeName></affiliation></author><author><name sortKey="Berger, Peter" sort="Berger, Peter" uniqKey="Berger P" first="Peter" last="Berger">Peter Berger</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Institute for Biomedical Aging Research, Austrian Academy of Sciences</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>2 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion></affiliation></author><author><name sortKey="Bidart, Jean Michel" sort="Bidart, Jean Michel" uniqKey="Bidart J" first="Jean-Michel" last="Bidart">Jean-Michel Bidart</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Clinical Biology, Institut Gustave-Roussy</s1><s2>Villejuif</s2><s3>FRA</s3><sZ>3 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Institut Gustave-Roussy</wicri:noRegion><wicri:noRegion>Villejuif</wicri:noRegion></affiliation></author><author><name sortKey="Birken, Steven" sort="Birken, Steven" uniqKey="Birken S" first="Steven" last="Birken">Steven Birken</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Obstetrics and Gynecology, College of Physicians and Surgeons of Columbia University</s1><s2>NY, NY</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>NY, NY</wicri:noRegion></affiliation></author><author><name sortKey="Burns, Chris" sort="Burns, Chris" uniqKey="Burns C" first="Chris" last="Burns">Chris Burns</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>National Institute of Biological Standards and Control</s1><s2>Potters Bar</s2><s3>GBR</s3><sZ>5 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>National Institute of Biological Standards and Control</wicri:noRegion></affiliation></author><author><name sortKey="Norman, Robert J" sort="Norman, Robert J" uniqKey="Norman R" first="Robert J." last="Norman">Robert J. Norman</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Research Centre for Reproductive Health, Department of Obstetrics and Gynaecology, University of Adelaide, The Queen Elizabeth Hospital</s1><s2>Woodville</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Woodville</wicri:noRegion></affiliation></author><author><name sortKey="Stenman, Ulf Hakan" sort="Stenman, Ulf Hakan" uniqKey="Stenman U" first="Ulf-Hakan" last="Stenman">Ulf-Hakan Stenman</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Clinical Chemistry, Helsinki University Central Hospital</s1><s3>FIN</s3><sZ>7 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Department of Clinical Chemistry, Helsinki University Central Hospital</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Clinical chemistry : (Baltimore, Md.)</title><title level="j" type="abbreviated">Clin. chem. : (Baltim. Md.)</title><idno type="ISSN">0009-9147</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Clinical chemistry : (Baltimore, Md.)</title><title level="j" type="abbreviated">Clin. chem. : (Baltim. Md.)</title><idno type="ISSN">0009-9147</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Analytical reagent</term><term>Biochemistry</term><term>Chorionic gonadotrophin</term><term>Clinical biology</term><term>Diagnosis</term><term>Human</term><term>Human chorionic gonadotrophin</term><term>Immunological method</term><term>International</term><term>Molecular biology</term><term>Molecular form</term><term>Recognition</term><term>Reference</term><term>WHO</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Méthode immunologique</term><term>OMS</term><term>Reconnaissance</term><term>Gonadotrophine chorionique</term><term>International</term><term>Référence</term><term>Réactif analytique</term><term>HCG</term><term>Forme moléculaire</term><term>Diagnostic</term><term>Homme</term><term>Biochimie</term><term>Biologie clinique</term><term>Biologie moléculaire</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term><term>Biochimie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND: The 1st WHO International Reference Reagents (IRRs) for 6 human chorionic gonadotropin (hCG)-related molecular variants, highly purified and calibrated in substance concentrations by the IFCC Working Group for hCG, permit experimental elucidation of what commercially available hCG methods measure in molar terms and enable assessment of their fitness for clinical purposes. METHODS: Pools containing known amounts of the IRRs spiked into normal human serum were issued to participants through the UK National External Quality Assessment Service for hCG for a period of 7 years. Among 16 assays used, 4 recognized only hCG, whereas 6 recognized hCG and its free β-subunit (hCGβ), and 6 recognized hCG, hCGβ, and the beta core fragment. RESULTS: Differences in calibration of current hCG assays are moderate. Mean recovery of the current International Standard (IS), hCG IS 75/589, was 107% (range 93% to 126%), whereas that of the IRR 99/688 for hCG was 139% (range 109%-164%). Between-method variation for the latter (CV 12.3%) was also greater than for IS 75/589 (CV 8.8%). Recognition of hCGβ varied markedly (CV 37%). Most assays overestimated it, but 2 RIAs produced results that were slight underestimations. Recognition of the beta core fragment was even more variable (CV 57%) and was closest to equimolarity for the RIAs. CONCLUSIONS: Assays for hCG show considerable variation in their recognition of various forms of hCG, and this variablility is the most important cause of method-related differences in hCG results in serum and an even more important cause of method-related differences in urine measurements. Equimolar recognition of the major hCG isoforms is essential if between-method comparability for hCG is to be improved.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Autriche</li><li>Finlande</li><li>France</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Écosse</li></region><settlement><li>Édimbourg</li></settlement></list><tree><country name="Royaume-Uni"><region name="Écosse"><name sortKey="Sturgeon, Catharine M" sort="Sturgeon, Catharine M" uniqKey="Sturgeon C" first="Catharine M." last="Sturgeon">Catharine M. Sturgeon</name></region><name sortKey="Burns, Chris" sort="Burns, Chris" uniqKey="Burns C" first="Chris" last="Burns">Chris Burns</name></country><country name="Autriche"><noRegion><name sortKey="Berger, Peter" sort="Berger, Peter" uniqKey="Berger P" first="Peter" last="Berger">Peter Berger</name></noRegion></country><country name="France"><noRegion><name sortKey="Bidart, Jean Michel" sort="Bidart, Jean Michel" uniqKey="Bidart J" first="Jean-Michel" last="Bidart">Jean-Michel Bidart</name></noRegion></country><country name="États-Unis"><noRegion><name sortKey="Birken, Steven" sort="Birken, Steven" uniqKey="Birken S" first="Steven" last="Birken">Steven Birken</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Norman, Robert J" sort="Norman, Robert J" uniqKey="Norman R" first="Robert J." last="Norman">Robert J. Norman</name></noRegion></country><country name="Finlande"><noRegion><name sortKey="Stenman, Ulf Hakan" sort="Stenman, Ulf Hakan" uniqKey="Stenman U" first="Ulf-Hakan" last="Stenman">Ulf-Hakan Stenman</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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