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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 : 000059

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

Auteurs : Carsten Stephan ; Chris Bangma ; Giulio Vignati ; Georg Bartsch ; Michael Lein ; Klaus Jung ; Marianne Philippe ; Axel Semjonow ; William J. Catalona

Source :

RBID : Pascal:09-0458278

Descripteurs français

English descriptors

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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A06       @2 2
A08 01  1  ENG  @1 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
A11 01  1    @1 STEPHAN (Carsten)
A11 02  1    @1 BANGMA (Chris)
A11 03  1    @1 VIGNATI (Giulio)
A11 04  1    @1 BARTSCH (Georg)
A11 05  1    @1 LEIN (Michael)
A11 06  1    @1 JUNG (Klaus)
A11 07  1    @1 PHILIPPE (Marianne)
A11 08  1    @1 SEMJONOW (Axel)
A11 09  1    @1 CATALONA (William J.)
A14 01      @1 Department of Urology, Charité - Universitätsmedizin Berlin @2 Berlin @3 DEU @Z 1 aut. @Z 5 aut. @Z 6 aut.
A14 02      @1 Department of Urology, Erasmus Medical Center and University @2 Rotterdam @3 NLD @Z 2 aut.
A14 03      @1 Center of Endocrine and Metabolic Diseases, G. Fornaroli Hospital @2 Magenta @3 ITA @Z 3 aut.
A14 04      @1 Department of Urology, Medical University Innsbruck @2 Innsbruck @3 AUT @Z 4 aut.
A14 05      @1 Berlin Institute for Urologic Research @2 Berlin @3 DEU @Z 5 aut. @Z 6 aut.
A14 06      @1 Department of Clinical Biochemistry, Cliniques Universitaires Saint-Luc @2 Brussels @3 BEL @Z 7 aut.
A14 07      @1 Prostate Center, University Clinic Münster @3 DEU @Z 8 aut.
A14 08      @1 Department of Urology, Northwestern Feinberg School of Medicine @2 Chicago, IL @3 USA @Z 9 aut.
A20       @1 65-69
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A60       @1 P
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C01 01    ENG  @0 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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Format Inist (serveur)

NO : PASCAL 09-0458278 INIST
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:09-0458278

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<term>Biologie clinique</term>
<term>Analyse quantitative</term>
<term>Forme libre</term>
<term>Cancer de la prostate</term>
<term>Antigène spécifique prostate</term>
<term>Marqueur tumoral</term>
<term>Méthode immunologique</term>
<term>Etalonnage</term>
<term>Urologie</term>
<term>OMS</term>
<term>Matériau référence</term>
<term>Homme</term>
<term>Biochimie</term>
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<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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<s0>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.</s0>
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<s5>02</s5>
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<s5>03</s5>
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<s5>03</s5>
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<fC03 i1="03" i2="X" l="SPA">
<s0>Forma libre</s0>
<s5>03</s5>
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<s0>Cancer de la prostate</s0>
<s2>NM</s2>
<s5>04</s5>
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<fC03 i1="04" i2="X" l="ENG">
<s0>Prostate cancer</s0>
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<s5>04</s5>
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<s5>11</s5>
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<s0>WHO</s0>
<s5>11</s5>
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<s0>OMS</s0>
<s5>11</s5>
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<s5>12</s5>
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<fC03 i1="11" i2="X" l="ENG">
<s0>Reference material</s0>
<s5>12</s5>
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<fC03 i1="11" i2="X" l="SPA">
<s0>Material referencia</s0>
<s5>12</s5>
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<s5>18</s5>
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<s5>19</s5>
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<s5>19</s5>
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<s0>Diagnostic</s0>
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<s5>21</s5>
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<s0>Prostate disease</s0>
<s5>38</s5>
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<s0>Prostata patología</s0>
<s5>38</s5>
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<fC07 i1="04" i2="X" l="FRE">
<s0>Pathologie de l'appareil génital mâle</s0>
<s5>39</s5>
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<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>
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<fC07 i1="05" i2="X" l="FRE">
<s0>Pathologie de l'appareil urinaire</s0>
<s5>40</s5>
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<s0>Urinary system disease</s0>
<s5>40</s5>
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<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>
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<ID>09-0458278</ID>
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