Biological Variation of Total Prostate-Specific Antigen: A Survey of Published Estimates and Consequences for Clinical Practice
The objectives of this study were to determine whether a single result for total prostate-specific antigen (tPSA) can be used confidently to guide the need for prostate biopsy and by how much serial tPSA measurements must differ to be significant. tPSA measurements include both analytical and biolog...
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| Veröffentlicht in: | Clinical chemistry (Baltimore, Md.) Md.), 2005-08, Vol.51 (8), p.1342-1351 |
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| creator | Soletormos, Gyorgy Semjonow, Axel Sibley, Paul E.C Lamerz, Rolf Petersen, Per Hyltoft Albrecht, Walter Bialk, Peter Gion, Massimo Junker, Frank Schmid, Hans-Peter Van Poppel, Hein on behalf of European Group on Tumor Markers |
| description | The objectives of this study were to determine whether a single result for total prostate-specific antigen (tPSA) can be used confidently to guide the need for prostate biopsy and by how much serial tPSA measurements must differ to be significant. tPSA measurements include both analytical and biological components of variation. The European Group on Tumor Markers conducted a literature survey to determine both the magnitude and impact of biological variation on single, the mean of replicate, and serial tPSA measurements.
The survey yielded 27 studies addressing the topic, and estimates for the biological variation of tPSA could be derived from 12 of these studies.
The mean biological variation was 20% in the concentration range 0.1-20 microg/L for men over 50 years. The biological variation means that the one-sided 95% confidence interval (CI) of the dispersion for a single tPSA result is approximately 33%. Three replicate samples with one analysis on each narrow the one-sided 95% CI for the mean concentration to approximately 20% and facilitate decisions on prostate biopsy. During monitoring of serial measurements, the change needed for significance is approximately 50% (P |
| doi_str_mv | 10.1373/clinchem.2004.046086 |
| format | Article |
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The survey yielded 27 studies addressing the topic, and estimates for the biological variation of tPSA could be derived from 12 of these studies.
The mean biological variation was 20% in the concentration range 0.1-20 microg/L for men over 50 years. The biological variation means that the one-sided 95% confidence interval (CI) of the dispersion for a single tPSA result is approximately 33%. Three replicate samples with one analysis on each narrow the one-sided 95% CI for the mean concentration to approximately 20% and facilitate decisions on prostate biopsy. During monitoring of serial measurements, the change needed for significance is approximately 50% (P <0.05).
The biological variation of tPSA has implications for screening, diagnosis, and monitoring. Single measurements may not be sufficiently precise for screening and diagnosis. Replicate samples and calculation of the mean concentration may improve precision by reducing the dispersion. Monitoring of tPSA requires an estimate of either the change needed for significance or, alternatively, of the significance of the change.</description><identifier>ISSN: 0009-9147</identifier><identifier>EISSN: 1530-8561</identifier><identifier>DOI: 10.1373/clinchem.2004.046086</identifier><identifier>PMID: 15961552</identifier><identifier>CODEN: CLCHAU</identifier><language>eng</language><publisher>Washington, DC: Am Assoc Clin Chem</publisher><subject>Analytical, structural and metabolic biochemistry ; Antigens ; Biological and medical sciences ; Biological variation ; Biomarkers ; Biopsy ; Circadian Rhythm ; Estimates ; Fundamental and applied biological sciences. Psychology ; Humans ; Investigative techniques, diagnostic techniques (general aspects) ; Literature reviews ; Male ; Mass Screening ; Medical sciences ; Physiology ; Prostate cancer ; Prostate-Specific Antigen - blood ; Prostatic Neoplasms - diagnosis ; Reproducibility of Results ; Sensitivity and Specificity</subject><ispartof>Clinical chemistry (Baltimore, Md.), 2005-08, Vol.51 (8), p.1342-1351</ispartof><rights>2005 INIST-CNRS</rights><rights>Copyright American Association for Clinical Chemistry Aug 2005</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c439t-5ea7130562c41985624dda6c76c462a0393a82ade95e3ab627ed4f0fd425f4303</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16989451$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15961552$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Soletormos, Gyorgy</creatorcontrib><creatorcontrib>Semjonow, Axel</creatorcontrib><creatorcontrib>Sibley, Paul E.C</creatorcontrib><creatorcontrib>Lamerz, Rolf</creatorcontrib><creatorcontrib>Petersen, Per Hyltoft</creatorcontrib><creatorcontrib>Albrecht, Walter</creatorcontrib><creatorcontrib>Bialk, Peter</creatorcontrib><creatorcontrib>Gion, Massimo</creatorcontrib><creatorcontrib>Junker, Frank</creatorcontrib><creatorcontrib>Schmid, Hans-Peter</creatorcontrib><creatorcontrib>Van Poppel, Hein</creatorcontrib><creatorcontrib>on behalf of European Group on Tumor Markers</creatorcontrib><title>Biological Variation of Total Prostate-Specific Antigen: A Survey of Published Estimates and Consequences for Clinical Practice</title><title>Clinical chemistry (Baltimore, Md.)</title><addtitle>Clin Chem</addtitle><description>The objectives of this study were to determine whether a single result for total prostate-specific antigen (tPSA) can be used confidently to guide the need for prostate biopsy and by how much serial tPSA measurements must differ to be significant. tPSA measurements include both analytical and biological components of variation. The European Group on Tumor Markers conducted a literature survey to determine both the magnitude and impact of biological variation on single, the mean of replicate, and serial tPSA measurements.
The survey yielded 27 studies addressing the topic, and estimates for the biological variation of tPSA could be derived from 12 of these studies.
The mean biological variation was 20% in the concentration range 0.1-20 microg/L for men over 50 years. The biological variation means that the one-sided 95% confidence interval (CI) of the dispersion for a single tPSA result is approximately 33%. Three replicate samples with one analysis on each narrow the one-sided 95% CI for the mean concentration to approximately 20% and facilitate decisions on prostate biopsy. During monitoring of serial measurements, the change needed for significance is approximately 50% (P <0.05).
The biological variation of tPSA has implications for screening, diagnosis, and monitoring. Single measurements may not be sufficiently precise for screening and diagnosis. Replicate samples and calculation of the mean concentration may improve precision by reducing the dispersion. Monitoring of tPSA requires an estimate of either the change needed for significance or, alternatively, of the significance of the change.</description><subject>Analytical, structural and metabolic biochemistry</subject><subject>Antigens</subject><subject>Biological and medical sciences</subject><subject>Biological variation</subject><subject>Biomarkers</subject><subject>Biopsy</subject><subject>Circadian Rhythm</subject><subject>Estimates</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Humans</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Literature reviews</subject><subject>Male</subject><subject>Mass Screening</subject><subject>Medical sciences</subject><subject>Physiology</subject><subject>Prostate cancer</subject><subject>Prostate-Specific Antigen - blood</subject><subject>Prostatic Neoplasms - diagnosis</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><issn>0009-9147</issn><issn>1530-8561</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNpdkV-LEzEUxYMobnf1G4gEQd-m5v9MfOuWXRUWLOzqa0gzd9osM0lNZiz75Fc3tZWCT-FefvfmnHsQekPJnPKaf3S9D24Lw5wRIuZEKNKoZ2hGJSdVIxV9jmaEEF1pKuoLdJnzYylF3aiX6IJKraiUbIZ-X_vYx413tsc_bPJ29DHg2OGHOJbWKsU82hGq-x0433mHF2H0Gwif8ALfT-kXPB3g1bTufd5Ci2_y6IcykLENLV7GkOHnBMGVRhcTXhbRf_9aJetG7-AVetHZPsPr03uFvt_ePCy_VHffPn9dLu4qJ7geKwm2ppxIxZyguthjom2tcrVyQjFLuOa2YbYFLYHbtWI1tKIjXSuY7AQn_Ap9OO7dpVgE5dEMPjvoexsgTtmohqiaNk0B3_0HPsYphaLNMMq1ZpSKAokj5Mp9coLO7FKxnZ4MJeaQjvmXjjmkY47plLG3p93TeoD2PHSKowDvT4DN5UpdssH5fOaUbrSQ9Oxm6zfbvU9g8mD7vqylZr_fS2qaIkMw_gedhqeX</recordid><startdate>20050801</startdate><enddate>20050801</enddate><creator>Soletormos, Gyorgy</creator><creator>Semjonow, Axel</creator><creator>Sibley, Paul E.C</creator><creator>Lamerz, Rolf</creator><creator>Petersen, Per Hyltoft</creator><creator>Albrecht, Walter</creator><creator>Bialk, Peter</creator><creator>Gion, Massimo</creator><creator>Junker, Frank</creator><creator>Schmid, Hans-Peter</creator><creator>Van Poppel, Hein</creator><creator>on behalf of European Group on Tumor Markers</creator><general>Am Assoc Clin Chem</general><general>American Association for Clinical Chemistry</general><general>Oxford University Press</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4U-</scope><scope>7QO</scope><scope>7RV</scope><scope>7TM</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>BKSAR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PCBAR</scope><scope>PDBOC</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>RC3</scope><scope>S0X</scope><scope>7X8</scope></search><sort><creationdate>20050801</creationdate><title>Biological Variation of Total Prostate-Specific Antigen: A Survey of Published Estimates and Consequences for Clinical Practice</title><author>Soletormos, Gyorgy ; Semjonow, Axel ; Sibley, Paul E.C ; Lamerz, Rolf ; Petersen, Per Hyltoft ; Albrecht, Walter ; Bialk, Peter ; Gion, Massimo ; Junker, Frank ; Schmid, Hans-Peter ; Van Poppel, Hein ; on behalf of European Group on Tumor Markers</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c439t-5ea7130562c41985624dda6c76c462a0393a82ade95e3ab627ed4f0fd425f4303</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Analytical, structural and metabolic biochemistry</topic><topic>Antigens</topic><topic>Biological and medical sciences</topic><topic>Biological variation</topic><topic>Biomarkers</topic><topic>Biopsy</topic><topic>Circadian Rhythm</topic><topic>Estimates</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Humans</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Literature reviews</topic><topic>Male</topic><topic>Mass Screening</topic><topic>Medical sciences</topic><topic>Physiology</topic><topic>Prostate cancer</topic><topic>Prostate-Specific Antigen - blood</topic><topic>Prostatic Neoplasms - diagnosis</topic><topic>Reproducibility of Results</topic><topic>Sensitivity and Specificity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Soletormos, Gyorgy</creatorcontrib><creatorcontrib>Semjonow, Axel</creatorcontrib><creatorcontrib>Sibley, Paul E.C</creatorcontrib><creatorcontrib>Lamerz, Rolf</creatorcontrib><creatorcontrib>Petersen, Per Hyltoft</creatorcontrib><creatorcontrib>Albrecht, Walter</creatorcontrib><creatorcontrib>Bialk, Peter</creatorcontrib><creatorcontrib>Gion, Massimo</creatorcontrib><creatorcontrib>Junker, Frank</creatorcontrib><creatorcontrib>Schmid, Hans-Peter</creatorcontrib><creatorcontrib>Van Poppel, Hein</creatorcontrib><creatorcontrib>on behalf of European Group on Tumor Markers</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>University Readers</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Nucleic Acids Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>Natural Science Collection</collection><collection>Earth, Atmospheric & Aquatic Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Earth, Atmospheric & Aquatic Science Database</collection><collection>Materials Science Collection</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>Genetics Abstracts</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical chemistry (Baltimore, Md.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Soletormos, Gyorgy</au><au>Semjonow, Axel</au><au>Sibley, Paul E.C</au><au>Lamerz, Rolf</au><au>Petersen, Per Hyltoft</au><au>Albrecht, Walter</au><au>Bialk, Peter</au><au>Gion, Massimo</au><au>Junker, Frank</au><au>Schmid, Hans-Peter</au><au>Van Poppel, Hein</au><au>on behalf of European Group on Tumor Markers</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Biological Variation of Total Prostate-Specific Antigen: A Survey of Published Estimates and Consequences for Clinical Practice</atitle><jtitle>Clinical chemistry (Baltimore, Md.)</jtitle><addtitle>Clin Chem</addtitle><date>2005-08-01</date><risdate>2005</risdate><volume>51</volume><issue>8</issue><spage>1342</spage><epage>1351</epage><pages>1342-1351</pages><issn>0009-9147</issn><eissn>1530-8561</eissn><coden>CLCHAU</coden><abstract>The objectives of this study were to determine whether a single result for total prostate-specific antigen (tPSA) can be used confidently to guide the need for prostate biopsy and by how much serial tPSA measurements must differ to be significant. tPSA measurements include both analytical and biological components of variation. The European Group on Tumor Markers conducted a literature survey to determine both the magnitude and impact of biological variation on single, the mean of replicate, and serial tPSA measurements.
The survey yielded 27 studies addressing the topic, and estimates for the biological variation of tPSA could be derived from 12 of these studies.
The mean biological variation was 20% in the concentration range 0.1-20 microg/L for men over 50 years. The biological variation means that the one-sided 95% confidence interval (CI) of the dispersion for a single tPSA result is approximately 33%. Three replicate samples with one analysis on each narrow the one-sided 95% CI for the mean concentration to approximately 20% and facilitate decisions on prostate biopsy. During monitoring of serial measurements, the change needed for significance is approximately 50% (P <0.05).
The biological variation of tPSA has implications for screening, diagnosis, and monitoring. Single measurements may not be sufficiently precise for screening and diagnosis. Replicate samples and calculation of the mean concentration may improve precision by reducing the dispersion. Monitoring of tPSA requires an estimate of either the change needed for significance or, alternatively, of the significance of the change.</abstract><cop>Washington, DC</cop><pub>Am Assoc Clin Chem</pub><pmid>15961552</pmid><doi>10.1373/clinchem.2004.046086</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Clinical chemistry (Baltimore, Md.), 2005-08, Vol.51 (8), p.1342-1351 |
| issn | 0009-9147 1530-8561 |
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| subjects | Analytical, structural and metabolic biochemistry Antigens Biological and medical sciences Biological variation Biomarkers Biopsy Circadian Rhythm Estimates Fundamental and applied biological sciences. Psychology Humans Investigative techniques, diagnostic techniques (general aspects) Literature reviews Male Mass Screening Medical sciences Physiology Prostate cancer Prostate-Specific Antigen - blood Prostatic Neoplasms - diagnosis Reproducibility of Results Sensitivity and Specificity |
| title | Biological Variation of Total Prostate-Specific Antigen: A Survey of Published Estimates and Consequences for Clinical Practice |
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