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Differences in Recognition of the 1st WHO International Reference Reagents for hCG-Related Isoforms by Diagnostic Immunoassays for Human Chorionic Gonadotropin

Identifieur interne : 003391 ( PascalFrancis/Curation ); précédent : 003390; suivant : 003392

Differences 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 :

RBID : Pascal:09-0358356

Descripteurs français

English descriptors

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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A08 01  1  ENG  @1 Differences in Recognition of the 1st WHO International Reference Reagents for hCG-Related Isoforms by Diagnostic Immunoassays for Human Chorionic Gonadotropin
A11 01  1    @1 STURGEON (Catharine M.)
A11 02  1    @1 BERGER (Peter)
A11 03  1    @1 BIDART (Jean-Michel)
A11 04  1    @1 BIRKEN (Steven)
A11 05  1    @1 BURNS (Chris)
A11 06  1    @1 NORMAN (Robert J.)
A11 07  1    @1 STENMAN (Ulf-Hakan)
A14 01      @1 Department of Clinical Biochemistry, Royal Infirmary @2 Edinburgh @3 GBR @Z 1 aut.
A14 02      @1 Institute for Biomedical Aging Research, Austrian Academy of Sciences @2 Innsbruck @3 AUT @Z 2 aut.
A14 03      @1 Department of Clinical Biology, Institut Gustave-Roussy @2 Villejuif @3 FRA @Z 3 aut.
A14 04      @1 Department of Obstetrics and Gynecology, College of Physicians and Surgeons of Columbia University @2 NY, NY @3 USA @Z 4 aut.
A14 05      @1 National Institute of Biological Standards and Control @2 Potters Bar @3 GBR @Z 5 aut.
A14 06      @1 Research Centre for Reproductive Health, Department of Obstetrics and Gynaecology, University of Adelaide, The Queen Elizabeth Hospital @2 Woodville @3 AUS @Z 6 aut.
A14 07      @1 Department of Clinical Chemistry, Helsinki University Central Hospital @3 FIN @Z 7 aut.
A17 01  1    @1 IFCC Working Group on hCG @3 INC
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C01 01    ENG  @0 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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C03 01  X  FRE  @0 Méthode immunologique @5 01
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C03 04  X  FRE  @0 Gonadotrophine chorionique @2 NK @2 FR @5 04
C03 04  X  ENG  @0 Chorionic gonadotrophin @2 NK @2 FR @5 04
C03 04  X  SPA  @0 Gonadotrofina coriónica @2 NK @2 FR @5 04
C03 05  X  FRE  @0 International @5 05
C03 05  X  ENG  @0 International @5 05
C03 05  X  SPA  @0 Internacional @5 05
C03 06  X  FRE  @0 Référence @5 06
C03 06  X  ENG  @0 Reference @5 06
C03 06  X  SPA  @0 Referencia @5 06
C03 07  X  FRE  @0 Réactif analytique @5 08
C03 07  X  ENG  @0 Analytical reagent @5 08
C03 07  X  SPA  @0 Reactivo analítico @5 08
C03 08  X  FRE  @0 HCG @5 09
C03 08  X  ENG  @0 Human chorionic gonadotrophin @5 09
C03 08  X  SPA  @0 HCG @5 09
C03 09  X  FRE  @0 Forme moléculaire @5 11
C03 09  X  ENG  @0 Molecular form @5 11
C03 09  X  SPA  @0 Forma molecular @5 11
C03 10  X  FRE  @0 Diagnostic @5 12
C03 10  X  ENG  @0 Diagnosis @5 12
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C03 14  X  ENG  @0 Molecular biology @5 20
C03 14  X  SPA  @0 Biología molecular @5 20
C07 01  X  FRE  @0 Hormone placentaire @5 37
C07 01  X  ENG  @0 Placental hormone @5 37
C07 01  X  SPA  @0 Hormona placentaria @5 37
C07 02  X  FRE  @0 Hormone protéine @5 38
C07 02  X  ENG  @0 Protein hormone @5 38
C07 02  X  SPA  @0 Hormona proteina @5 38
N21       @1 257
N44 01      @1 OTO
N82       @1 OTO

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<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>
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<term>Biologie clinique</term>
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<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>
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<fA44>
<s0>0000</s0>
<s1>© 2009 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45>
<s0>26 ref.</s0>
</fA45>
<fA47 i1="01" i2="1">
<s0>09-0358356</s0>
</fA47>
<fA60>
<s1>P</s1>
</fA60>
<fA61>
<s0>A</s0>
</fA61>
<fA64 i1="01" i2="1">
<s0>Clinical chemistry : (Baltimore, Md.)</s0>
</fA64>
<fA66 i1="01">
<s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG">
<s0>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.</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002B24</s0>
</fC02>
<fC02 i1="02" i2="X">
<s0>002A02</s0>
</fC02>
<fC02 i1="03" i2="X">
<s0>002A03</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<s0>Méthode immunologique</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Immunological method</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Método inmunológico</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE">
<s0>OMS</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>WHO</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>OMS</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Reconnaissance</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Recognition</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Reconocimiento</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Gonadotrophine chorionique</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Chorionic gonadotrophin</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Gonadotrofina coriónica</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>International</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>International</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Internacional</s0>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Référence</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Reference</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Referencia</s0>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Réactif analytique</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Analytical reagent</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Reactivo analítico</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>HCG</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Human chorionic gonadotrophin</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>HCG</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Forme moléculaire</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Molecular form</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Forma molecular</s0>
<s5>11</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Diagnostic</s0>
<s5>12</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Diagnosis</s0>
<s5>12</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Diagnóstico</s0>
<s5>12</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE">
<s0>Homme</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG">
<s0>Human</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA">
<s0>Hombre</s0>
<s5>17</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE">
<s0>Biochimie</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG">
<s0>Biochemistry</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA">
<s0>Bioquímica</s0>
<s5>18</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE">
<s0>Biologie clinique</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG">
<s0>Clinical biology</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA">
<s0>Biología clínica</s0>
<s5>19</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE">
<s0>Biologie moléculaire</s0>
<s5>20</s5>
</fC03>
<fC03 i1="14" i2="X" l="ENG">
<s0>Molecular biology</s0>
<s5>20</s5>
</fC03>
<fC03 i1="14" i2="X" l="SPA">
<s0>Biología molecular</s0>
<s5>20</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Hormone placentaire</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Placental hormone</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Hormona placentaria</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Hormone protéine</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Protein hormone</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Hormona proteina</s0>
<s5>38</s5>
</fC07>
<fN21>
<s1>257</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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