20-25% lower concentrations of total and free prostate-specific antigen (PSA) after calibration of PSA assays to the WHO reference materials - analysis of 1098 patients in four centers
Identifieur interne : 000058 ( PascalFrancis/Corpus ); précédent : 000057; suivant : 00005920-25% lower concentrations of total and free prostate-specific antigen (PSA) after calibration of PSA assays to the WHO reference materials - analysis of 1098 patients in four centers
Auteurs : Carsten Stephan ; Chris Bangma ; Giulio Vignati ; Georg Bartsch ; Michael Lein ; Klaus Jung ; Marianne Philippe ; Axel Semjonow ; William J. CatalonaSource :
- The International journal of biological markers [ 0393-6155 ] ; 2009.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Aim: To examine the potential clinical implications of the recalibration of total prostate-specific antigen (PSA) and free PSA (fPSA) assays to the World Health Organization (WHO) standard materials. Material and methods: Data from 1098 patients with or without clinically detected prostate cancer (PCa) from four independent cohort studies were compared using commercial assays calibrated to the traditional Hybritech® PSA (PSA-Hyb) and fPSA (fPSA-Hyb) standards and to the WHO 96/670 (PSA-WHO) and 96/668 (fPSA-WHO) standards. The Access® Immunoassay System (Beckman Coulter, Inc.) was used in all studies. Results: All studies showed 20% to 25% lower PSA and fPSA test results with the WHO-standardized assays. No significant change in %fPSA (fPSA/PSA x 100) was observed. Continuing to use the traditional clinical PSA cutoffs obtained with the Hybritech standard after changing to the PSA-WHO standard could result in up to one-third of prostate cancer cases being missed. Conclusions: Manufacturers should fully inform laboratories about a calibration change and its clinical impact. Laboratory reports for PSA measurements should indicate the assay's manufacturer and which calibration standard was used to avoid misleading information concerning PCa risk.
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NO : | PASCAL 09-0458278 INIST |
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ET : | 20-25% lower concentrations of total and free prostate-specific antigen (PSA) after calibration of PSA assays to the WHO reference materials - analysis of 1098 patients in four centers |
AU : | STEPHAN (Carsten); BANGMA (Chris); VIGNATI (Giulio); BARTSCH (Georg); LEIN (Michael); JUNG (Klaus); PHILIPPE (Marianne); SEMJONOW (Axel); CATALONA (William J.) |
AF : | Department of Urology, Charité - Universitätsmedizin Berlin/Berlin/Allemagne (1 aut., 5 aut., 6 aut.); Department of Urology, Erasmus Medical Center and University/Rotterdam/Pays-Bas (2 aut.); Center of Endocrine and Metabolic Diseases, G. Fornaroli Hospital/Magenta/Italie (3 aut.); Department of Urology, Medical University Innsbruck/Innsbruck/Autriche (4 aut.); Berlin Institute for Urologic Research/Berlin/Allemagne (5 aut., 6 aut.); Department of Clinical Biochemistry, Cliniques Universitaires Saint-Luc/Brussels/Belgique (7 aut.); Prostate Center, University Clinic Münster/Allemagne (8 aut.); Department of Urology, Northwestern Feinberg School of Medicine/Chicago, IL/Etats-Unis (9 aut.) |
DT : | Publication en série; Niveau analytique |
SO : | The International journal of biological markers; ISSN 0393-6155; Italie; Da. 2009; Vol. 24; No. 2; Pp. 65-69; Bibl. 27 ref. |
LA : | Anglais |
EA : | Aim: To examine the potential clinical implications of the recalibration of total prostate-specific antigen (PSA) and free PSA (fPSA) assays to the World Health Organization (WHO) standard materials. Material and methods: Data from 1098 patients with or without clinically detected prostate cancer (PCa) from four independent cohort studies were compared using commercial assays calibrated to the traditional Hybritech® PSA (PSA-Hyb) and fPSA (fPSA-Hyb) standards and to the WHO 96/670 (PSA-WHO) and 96/668 (fPSA-WHO) standards. The Access® Immunoassay System (Beckman Coulter, Inc.) was used in all studies. Results: All studies showed 20% to 25% lower PSA and fPSA test results with the WHO-standardized assays. No significant change in %fPSA (fPSA/PSA x 100) was observed. Continuing to use the traditional clinical PSA cutoffs obtained with the Hybritech standard after changing to the PSA-WHO standard could result in up to one-third of prostate cancer cases being missed. Conclusions: Manufacturers should fully inform laboratories about a calibration change and its clinical impact. Laboratory reports for PSA measurements should indicate the assay's manufacturer and which calibration standard was used to avoid misleading information concerning PCa risk. |
CC : | 002B24O11; 002B20B02 |
FD : | Biologie clinique; Analyse quantitative; Forme libre; Cancer de la prostate; Antigène spécifique prostate; Marqueur tumoral; Méthode immunologique; Etalonnage; Urologie; OMS; Matériau référence; Homme; Biochimie; Biologie moléculaire; Diagnostic; Total; Cancérologie |
FG : | Tumeur maligne; Cancer; Pathologie de la prostate; Pathologie de l'appareil génital mâle; Pathologie de l'appareil urinaire |
ED : | Clinical biology; Quantitative analysis; Free form; Prostate cancer; Prostate specific antigen; Tumoral marker; Immunological method; Calibration; Urology; WHO; Reference material; Human; Biochemistry; Molecular biology; Diagnosis; Total; Cancerology |
EG : | Malignant tumor; Cancer; Prostate disease; Male genital diseases; Urinary system disease |
SD : | Biología clínica; Análisis cuantitativo; Forma libre; Cáncer de la próstata; Antigeno específico prostata; Marcador tumoral; Método inmunológico; Contraste; Urología; OMS; Material referencia; Hombre; Bioquímica; Biología molecular; Diagnóstico; Total; Cancerología |
LO : | INIST-21868.354000171178220010 |
ID : | 09-0458278 |
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Pascal:09-0458278Le document en format XML
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<term>Méthode immunologique</term>
<term>Etalonnage</term>
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<term>OMS</term>
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<front><div type="abstract" xml:lang="en">Aim: To examine the potential clinical implications of the recalibration of total prostate-specific antigen (PSA) and free PSA (fPSA) assays to the World Health Organization (WHO) standard materials. Material and methods: Data from 1098 patients with or without clinically detected prostate cancer (PCa) from four independent cohort studies were compared using commercial assays calibrated to the traditional Hybritech® PSA (PSA-Hyb) and fPSA (fPSA-Hyb) standards and to the WHO 96/670 (PSA-WHO) and 96/668 (fPSA-WHO) standards. The Access® Immunoassay System (Beckman Coulter, Inc.) was used in all studies. Results: All studies showed 20% to 25% lower PSA and fPSA test results with the WHO-standardized assays. No significant change in %fPSA (fPSA/PSA x 100) was observed. Continuing to use the traditional clinical PSA cutoffs obtained with the Hybritech standard after changing to the PSA-WHO standard could result in up to one-third of prostate cancer cases being missed. Conclusions: Manufacturers should fully inform laboratories about a calibration change and its clinical impact. Laboratory reports for PSA measurements should indicate the assay's manufacturer and which calibration standard was used to avoid misleading information concerning PCa risk.</div>
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<fA14 i1="03"><s1>Center of Endocrine and Metabolic Diseases, G. Fornaroli Hospital</s1>
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<fA14 i1="04"><s1>Department of Urology, Medical University Innsbruck</s1>
<s2>Innsbruck</s2>
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<fA14 i1="07"><s1>Prostate Center, University Clinic Münster</s1>
<s3>DEU</s3>
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<fA14 i1="08"><s1>Department of Urology, Northwestern Feinberg School of Medicine</s1>
<s2>Chicago, IL</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
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</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Forma libre</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Cancer de la prostate</s0>
<s2>NM</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Prostate cancer</s0>
<s2>NM</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Cáncer de la próstata</s0>
<s2>NM</s2>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Antigène spécifique prostate</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Prostate specific antigen</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Antigeno específico prostata</s0>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Marqueur tumoral</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Tumoral marker</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Marcador tumoral</s0>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Méthode immunologique</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Immunological method</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Método inmunológico</s0>
<s5>07</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Etalonnage</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Calibration</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Contraste</s0>
<s5>08</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Urologie</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Urology</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Urología</s0>
<s5>09</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>OMS</s0>
<s5>11</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>WHO</s0>
<s5>11</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>OMS</s0>
<s5>11</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Matériau référence</s0>
<s5>12</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Reference material</s0>
<s5>12</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Material referencia</s0>
<s5>12</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Homme</s0>
<s5>17</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Human</s0>
<s5>17</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Hombre</s0>
<s5>17</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE"><s0>Biochimie</s0>
<s5>18</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG"><s0>Biochemistry</s0>
<s5>18</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA"><s0>Bioquímica</s0>
<s5>18</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE"><s0>Biologie moléculaire</s0>
<s5>19</s5>
</fC03>
<fC03 i1="14" i2="X" l="ENG"><s0>Molecular biology</s0>
<s5>19</s5>
</fC03>
<fC03 i1="14" i2="X" l="SPA"><s0>Biología molecular</s0>
<s5>19</s5>
</fC03>
<fC03 i1="15" i2="X" l="FRE"><s0>Diagnostic</s0>
<s5>20</s5>
</fC03>
<fC03 i1="15" i2="X" l="ENG"><s0>Diagnosis</s0>
<s5>20</s5>
</fC03>
<fC03 i1="15" i2="X" l="SPA"><s0>Diagnóstico</s0>
<s5>20</s5>
</fC03>
<fC03 i1="16" i2="X" l="FRE"><s0>Total</s0>
<s5>21</s5>
</fC03>
<fC03 i1="16" i2="X" l="ENG"><s0>Total</s0>
<s5>21</s5>
</fC03>
<fC03 i1="16" i2="X" l="SPA"><s0>Total</s0>
<s5>21</s5>
</fC03>
<fC03 i1="17" i2="X" l="FRE"><s0>Cancérologie</s0>
<s5>22</s5>
</fC03>
<fC03 i1="17" i2="X" l="ENG"><s0>Cancerology</s0>
<s5>22</s5>
</fC03>
<fC03 i1="17" i2="X" l="SPA"><s0>Cancerología</s0>
<s5>22</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Tumeur maligne</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Malignant tumor</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Tumor maligno</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Pathologie de la prostate</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Prostate disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Prostata patología</s0>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Pathologie de l'appareil génital mâle</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Male genital diseases</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Aparato genital macho patología</s0>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Pathologie de l'appareil urinaire</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Urinary system disease</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Aparato urinario patología</s0>
<s5>40</s5>
</fC07>
<fN21><s1>334</s1>
</fN21>
</pA>
</standard>
<server><NO>PASCAL 09-0458278 INIST</NO>
<ET>20-25% lower concentrations of total and free prostate-specific antigen (PSA) after calibration of PSA assays to the WHO reference materials - analysis of 1098 patients in four centers</ET>
<AU>STEPHAN (Carsten); BANGMA (Chris); VIGNATI (Giulio); BARTSCH (Georg); LEIN (Michael); JUNG (Klaus); PHILIPPE (Marianne); SEMJONOW (Axel); CATALONA (William J.)</AU>
<AF>Department of Urology, Charité - Universitätsmedizin Berlin/Berlin/Allemagne (1 aut., 5 aut., 6 aut.); Department of Urology, Erasmus Medical Center and University/Rotterdam/Pays-Bas (2 aut.); Center of Endocrine and Metabolic Diseases, G. Fornaroli Hospital/Magenta/Italie (3 aut.); Department of Urology, Medical University Innsbruck/Innsbruck/Autriche (4 aut.); Berlin Institute for Urologic Research/Berlin/Allemagne (5 aut., 6 aut.); Department of Clinical Biochemistry, Cliniques Universitaires Saint-Luc/Brussels/Belgique (7 aut.); Prostate Center, University Clinic Münster/Allemagne (8 aut.); Department of Urology, Northwestern Feinberg School of Medicine/Chicago, IL/Etats-Unis (9 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>The International journal of biological markers; ISSN 0393-6155; Italie; Da. 2009; Vol. 24; No. 2; Pp. 65-69; Bibl. 27 ref.</SO>
<LA>Anglais</LA>
<EA>Aim: To examine the potential clinical implications of the recalibration of total prostate-specific antigen (PSA) and free PSA (fPSA) assays to the World Health Organization (WHO) standard materials. Material and methods: Data from 1098 patients with or without clinically detected prostate cancer (PCa) from four independent cohort studies were compared using commercial assays calibrated to the traditional Hybritech® PSA (PSA-Hyb) and fPSA (fPSA-Hyb) standards and to the WHO 96/670 (PSA-WHO) and 96/668 (fPSA-WHO) standards. The Access® Immunoassay System (Beckman Coulter, Inc.) was used in all studies. Results: All studies showed 20% to 25% lower PSA and fPSA test results with the WHO-standardized assays. No significant change in %fPSA (fPSA/PSA x 100) was observed. Continuing to use the traditional clinical PSA cutoffs obtained with the Hybritech standard after changing to the PSA-WHO standard could result in up to one-third of prostate cancer cases being missed. Conclusions: Manufacturers should fully inform laboratories about a calibration change and its clinical impact. Laboratory reports for PSA measurements should indicate the assay's manufacturer and which calibration standard was used to avoid misleading information concerning PCa risk.</EA>
<CC>002B24O11; 002B20B02</CC>
<FD>Biologie clinique; Analyse quantitative; Forme libre; Cancer de la prostate; Antigène spécifique prostate; Marqueur tumoral; Méthode immunologique; Etalonnage; Urologie; OMS; Matériau référence; Homme; Biochimie; Biologie moléculaire; Diagnostic; Total; Cancérologie</FD>
<FG>Tumeur maligne; Cancer; Pathologie de la prostate; Pathologie de l'appareil génital mâle; Pathologie de l'appareil urinaire</FG>
<ED>Clinical biology; Quantitative analysis; Free form; Prostate cancer; Prostate specific antigen; Tumoral marker; Immunological method; Calibration; Urology; WHO; Reference material; Human; Biochemistry; Molecular biology; Diagnosis; Total; Cancerology</ED>
<EG>Malignant tumor; Cancer; Prostate disease; Male genital diseases; Urinary system disease</EG>
<SD>Biología clínica; Análisis cuantitativo; Forma libre; Cáncer de la próstata; Antigeno específico prostata; Marcador tumoral; Método inmunológico; Contraste; Urología; OMS; Material referencia; Hombre; Bioquímica; Biología molecular; Diagnóstico; Total; Cancerología</SD>
<LO>INIST-21868.354000171178220010</LO>
<ID>09-0458278</ID>
</server>
</inist>
</record>
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