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External quality assessment of trans-European multicentre antigen determinations (enzyme-linked immunosorbent assay) of urokinase-type plasminogen activator (uPA) and its type 1 inhibitor (PAI-1) in human breast cancer tissue extracts
High levels of urokinase-type plasminogen activator (uPA) and plasminogen activator inhibitor type 1 (PAI-1) in breast cancer tissue extracts have been associated with rapid disease progression. In these studies, different enzyme-linked immunosorbent assay (ELISA) kits have been applied for the quan...
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| Published in: | British journal of cancer 1998-12, Vol.78 (11), p.1434-1441 |
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| container_title | British journal of cancer |
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| creator | Sweep, CGJ Geurts-Moespot, J Grebenschikov, N de Witte, JH Heuvel, JJTM Schmitt, M Duffy, MJ Jänicke, F Kramer, MD Foekens, JA Brünner, N Brugal, G Pedersen, AN Benraad, ThJ |
| description | High levels of urokinase-type plasminogen activator (uPA) and plasminogen activator inhibitor type 1 (PAI-1) in breast cancer tissue extracts have been associated with rapid disease progression. In these studies, different enzyme-linked immunosorbent assay (ELISA) kits have been applied for the quantification, and consequently the ranges of uPA and PAI-1 levels reported differ considerably. Therefore, the Receptor and Biomarker Study Group (RBSG) of the European Organization for Research and Treatment of Cancer (EORTC) and a consortium of the BIOMED-1 project 'Clinical Relevance of Proteases in Tumor Invasion and Metastasis' initiated three collaborative between-laboratory assessment trials aimed at controlling uPA and PAI-1 antigen analyses. For this purpose, two control preparations were produced from different sources: pooled human breast cancer specimens (QC-240893) and human breast cancer xenografts raised in nude mice (QC-101094). The lyophilized preparations were stable for prolonged times (at least 3 and 27 months respectively) at 4 degrees C. Furthermore, a good parallelism following dilution was found for uPA and PAI-1. The data from QC trial no. 1 clearly indicated that acceptable between-laboratory coefficients of variation (CVs) for uPA ( |
| doi_str_mv | 10.1038/bjc.1998.704 |
| format | article |
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In these studies, different enzyme-linked immunosorbent assay (ELISA) kits have been applied for the quantification, and consequently the ranges of uPA and PAI-1 levels reported differ considerably. Therefore, the Receptor and Biomarker Study Group (RBSG) of the European Organization for Research and Treatment of Cancer (EORTC) and a consortium of the BIOMED-1 project 'Clinical Relevance of Proteases in Tumor Invasion and Metastasis' initiated three collaborative between-laboratory assessment trials aimed at controlling uPA and PAI-1 antigen analyses. For this purpose, two control preparations were produced from different sources: pooled human breast cancer specimens (QC-240893) and human breast cancer xenografts raised in nude mice (QC-101094). The lyophilized preparations were stable for prolonged times (at least 3 and 27 months respectively) at 4 degrees C. Furthermore, a good parallelism following dilution was found for uPA and PAI-1. The data from QC trial no. 1 clearly indicated that acceptable between-laboratory coefficients of variation (CVs) for uPA (<8.2%) and PAI-1 (<16.6%) in QC-240893 could be achieved when the same type of ELISA kit (American Diagnostica) was used. From the second trial, in which ten EORTC laboratories each received five identical lyophilized QC-101094 samples, it appeared that the within-laboratory variations for uPA and PAI-1 determinations obtained by 'experienced' laboratories were lower (<12.9%) than those from non-experienced laboratories (<36.4%). In a third QC trial, five BIOMED-1 laboratories, all of which employed ELISA procedures for uPA and PAI-1, participated in six subsequent quality assessment rounds receiving five samples of QC-101094. Although for each laboratory the within-run CVs for uPA as well as for PAI-1 were low (<7.8%), the between-run CVs were found to be considerably higher (up to 56.2% for uPA and to 27.6% for PAI-1). Consequently, because of the different ELISA formats used, the absolute analyte values measured in the different laboratories varied substantially. The use of 'common external standards' in the different ELISAs resulted in a significant reduction of the between-laboratory CVs from 61.3% to 15.7% (uPA) and from 42.1% to 19.1% (PAI-1). The present data demonstrate that in multicentre studies the same ELISA kit should be used, and that external quality assurance (QA) is mandatory. Furthermore, it appears from the present study that standardization of the protein assay as a tissular parameter is imperative.</description><identifier>ISSN: 0007-0920</identifier><identifier>EISSN: 1532-1827</identifier><identifier>DOI: 10.1038/bjc.1998.704</identifier><identifier>PMID: 9836475</identifier><identifier>CODEN: BJCAAI</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>Animals ; Biological and medical sciences ; Biomedical and Life Sciences ; Biomedicine ; Breast Neoplasms - chemistry ; Cancer Research ; Drug Resistance ; Enzyme-Linked Immunosorbent Assay - methods ; Enzyme-Linked Immunosorbent Assay - standards ; Epidemiology ; Europe ; experimental-oncology ; Female ; Genital system. Mammary gland ; Humans ; Investigative techniques, diagnostic techniques (general aspects) ; Medical sciences ; Mice ; Mice, Nude ; Molecular Medicine ; Neoplasm Proteins - analysis ; Oncology ; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques ; Plasminogen Activator Inhibitor 1 - analysis ; Quality Control ; Reagent Kits, Diagnostic - standards ; Reference Values ; Urokinase-Type Plasminogen Activator - analysis</subject><ispartof>British journal of cancer, 1998-12, Vol.78 (11), p.1434-1441</ispartof><rights>Cancer Research Campaign 1998</rights><rights>1999 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c446t-28add90464b56af3f278bb191396e09f3fa7fc37e491f838f3d30fed573b1cbd3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2063209/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2063209/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,724,777,781,882,27905,27906,53772,53774</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1582958$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9836475$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sweep, CGJ</creatorcontrib><creatorcontrib>Geurts-Moespot, J</creatorcontrib><creatorcontrib>Grebenschikov, N</creatorcontrib><creatorcontrib>de Witte, JH</creatorcontrib><creatorcontrib>Heuvel, JJTM</creatorcontrib><creatorcontrib>Schmitt, M</creatorcontrib><creatorcontrib>Duffy, MJ</creatorcontrib><creatorcontrib>Jänicke, F</creatorcontrib><creatorcontrib>Kramer, MD</creatorcontrib><creatorcontrib>Foekens, JA</creatorcontrib><creatorcontrib>Brünner, N</creatorcontrib><creatorcontrib>Brugal, G</creatorcontrib><creatorcontrib>Pedersen, AN</creatorcontrib><creatorcontrib>Benraad, ThJ</creatorcontrib><title>External quality assessment of trans-European multicentre antigen determinations (enzyme-linked immunosorbent assay) of urokinase-type plasminogen activator (uPA) and its type 1 inhibitor (PAI-1) in human breast cancer tissue extracts</title><title>British journal of cancer</title><addtitle>Br J Cancer</addtitle><addtitle>Br J Cancer</addtitle><description>High levels of urokinase-type plasminogen activator (uPA) and plasminogen activator inhibitor type 1 (PAI-1) in breast cancer tissue extracts have been associated with rapid disease progression. In these studies, different enzyme-linked immunosorbent assay (ELISA) kits have been applied for the quantification, and consequently the ranges of uPA and PAI-1 levels reported differ considerably. Therefore, the Receptor and Biomarker Study Group (RBSG) of the European Organization for Research and Treatment of Cancer (EORTC) and a consortium of the BIOMED-1 project 'Clinical Relevance of Proteases in Tumor Invasion and Metastasis' initiated three collaborative between-laboratory assessment trials aimed at controlling uPA and PAI-1 antigen analyses. For this purpose, two control preparations were produced from different sources: pooled human breast cancer specimens (QC-240893) and human breast cancer xenografts raised in nude mice (QC-101094). The lyophilized preparations were stable for prolonged times (at least 3 and 27 months respectively) at 4 degrees C. Furthermore, a good parallelism following dilution was found for uPA and PAI-1. The data from QC trial no. 1 clearly indicated that acceptable between-laboratory coefficients of variation (CVs) for uPA (<8.2%) and PAI-1 (<16.6%) in QC-240893 could be achieved when the same type of ELISA kit (American Diagnostica) was used. From the second trial, in which ten EORTC laboratories each received five identical lyophilized QC-101094 samples, it appeared that the within-laboratory variations for uPA and PAI-1 determinations obtained by 'experienced' laboratories were lower (<12.9%) than those from non-experienced laboratories (<36.4%). In a third QC trial, five BIOMED-1 laboratories, all of which employed ELISA procedures for uPA and PAI-1, participated in six subsequent quality assessment rounds receiving five samples of QC-101094. Although for each laboratory the within-run CVs for uPA as well as for PAI-1 were low (<7.8%), the between-run CVs were found to be considerably higher (up to 56.2% for uPA and to 27.6% for PAI-1). Consequently, because of the different ELISA formats used, the absolute analyte values measured in the different laboratories varied substantially. The use of 'common external standards' in the different ELISAs resulted in a significant reduction of the between-laboratory CVs from 61.3% to 15.7% (uPA) and from 42.1% to 19.1% (PAI-1). The present data demonstrate that in multicentre studies the same ELISA kit should be used, and that external quality assurance (QA) is mandatory. Furthermore, it appears from the present study that standardization of the protein assay as a tissular parameter is imperative.</description><subject>Animals</subject><subject>Biological and medical sciences</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Breast Neoplasms - chemistry</subject><subject>Cancer Research</subject><subject>Drug Resistance</subject><subject>Enzyme-Linked Immunosorbent Assay - methods</subject><subject>Enzyme-Linked Immunosorbent Assay - standards</subject><subject>Epidemiology</subject><subject>Europe</subject><subject>experimental-oncology</subject><subject>Female</subject><subject>Genital system. Mammary gland</subject><subject>Humans</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Medical sciences</subject><subject>Mice</subject><subject>Mice, Nude</subject><subject>Molecular Medicine</subject><subject>Neoplasm Proteins - analysis</subject><subject>Oncology</subject><subject>Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques</subject><subject>Plasminogen Activator Inhibitor 1 - analysis</subject><subject>Quality Control</subject><subject>Reagent Kits, Diagnostic - standards</subject><subject>Reference Values</subject><subject>Urokinase-Type Plasminogen Activator - analysis</subject><issn>0007-0920</issn><issn>1532-1827</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1998</creationdate><recordtype>article</recordtype><recordid>eNptkk9vEzEQxVcIVELhxhXJB4QaiQ32ev_Yl0pRFaBSJXqA88rrnU2c7tqpx1s1fGQ-Bd4kKiBxsuz35jdj-yXJW0YXjHLxqdnqBZNSLCqaP0tmrOBZykRWPU9mlNIqpTKjL5NXiNu4lVRUZ8mZFLzMq2KW_Fo9BvBW9eR-VL0Je6IQAXEAG4jrSPDKYroavduBsmQY-2B01DwQZYNZgyUtRMJgrArGWSQXYH_uB0h7Y--gJWYYRuvQ-WYiRrjazydwJN7FGoQ07HdAdr3CyHATUOlgHlRwnlyMt8t5bBQxAcnByIixG9OYg3y7vE7ZPJ6QzTjE8RoPCgPRymrwJBjEEQg8xkvogK-TF53qEd6c1vPkx-fV96uv6c23L9dXy5tU53kZ0kyotpU0L_OmKFXHu6wSTcMk47IEKuOBqjrNK8gl6wQXHW857aAtKt4w3bT8PLk8cndjM0B7eC3V1ztvBuX3tVOm_lexZlOv3UOd0ZJnVEbAhxPAu_sRMNSDQQ19ryy4EeuKUlHQikbjx6NRe4fooXtqwmg9ZaOO2ainbMSaPNrf_T3Yk_kUhqi_P-kKteq7-PXa4B9mITJZiGhLjzaMil2Dr7dunCKE_2_7G6TH2Og</recordid><startdate>19981201</startdate><enddate>19981201</enddate><creator>Sweep, CGJ</creator><creator>Geurts-Moespot, J</creator><creator>Grebenschikov, N</creator><creator>de Witte, JH</creator><creator>Heuvel, JJTM</creator><creator>Schmitt, M</creator><creator>Duffy, MJ</creator><creator>Jänicke, F</creator><creator>Kramer, MD</creator><creator>Foekens, JA</creator><creator>Brünner, N</creator><creator>Brugal, G</creator><creator>Pedersen, AN</creator><creator>Benraad, ThJ</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</general><general>Nature Publishing Group|1</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>7X8</scope><scope>5PM</scope></search><sort><creationdate>19981201</creationdate><title>External quality assessment of trans-European multicentre antigen determinations (enzyme-linked immunosorbent assay) of urokinase-type plasminogen activator (uPA) and its type 1 inhibitor (PAI-1) in human breast cancer tissue extracts</title><author>Sweep, CGJ ; Geurts-Moespot, J ; Grebenschikov, N ; de Witte, JH ; Heuvel, JJTM ; Schmitt, M ; Duffy, MJ ; Jänicke, F ; Kramer, MD ; Foekens, JA ; Brünner, N ; Brugal, G ; Pedersen, AN ; Benraad, ThJ</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c446t-28add90464b56af3f278bb191396e09f3fa7fc37e491f838f3d30fed573b1cbd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1998</creationdate><topic>Animals</topic><topic>Biological and medical sciences</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Breast Neoplasms - chemistry</topic><topic>Cancer Research</topic><topic>Drug Resistance</topic><topic>Enzyme-Linked Immunosorbent Assay - methods</topic><topic>Enzyme-Linked Immunosorbent Assay - standards</topic><topic>Epidemiology</topic><topic>Europe</topic><topic>experimental-oncology</topic><topic>Female</topic><topic>Genital system. Mammary gland</topic><topic>Humans</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Medical sciences</topic><topic>Mice</topic><topic>Mice, Nude</topic><topic>Molecular Medicine</topic><topic>Neoplasm Proteins - analysis</topic><topic>Oncology</topic><topic>Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques</topic><topic>Plasminogen Activator Inhibitor 1 - analysis</topic><topic>Quality Control</topic><topic>Reagent Kits, Diagnostic - standards</topic><topic>Reference Values</topic><topic>Urokinase-Type Plasminogen Activator - analysis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sweep, CGJ</creatorcontrib><creatorcontrib>Geurts-Moespot, J</creatorcontrib><creatorcontrib>Grebenschikov, N</creatorcontrib><creatorcontrib>de Witte, JH</creatorcontrib><creatorcontrib>Heuvel, JJTM</creatorcontrib><creatorcontrib>Schmitt, M</creatorcontrib><creatorcontrib>Duffy, MJ</creatorcontrib><creatorcontrib>Jänicke, F</creatorcontrib><creatorcontrib>Kramer, MD</creatorcontrib><creatorcontrib>Foekens, JA</creatorcontrib><creatorcontrib>Brünner, N</creatorcontrib><creatorcontrib>Brugal, G</creatorcontrib><creatorcontrib>Pedersen, AN</creatorcontrib><creatorcontrib>Benraad, ThJ</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>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sweep, CGJ</au><au>Geurts-Moespot, J</au><au>Grebenschikov, N</au><au>de Witte, JH</au><au>Heuvel, JJTM</au><au>Schmitt, M</au><au>Duffy, MJ</au><au>Jänicke, F</au><au>Kramer, MD</au><au>Foekens, JA</au><au>Brünner, N</au><au>Brugal, G</au><au>Pedersen, AN</au><au>Benraad, ThJ</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>External quality assessment of trans-European multicentre antigen determinations (enzyme-linked immunosorbent assay) of urokinase-type plasminogen activator (uPA) and its type 1 inhibitor (PAI-1) in human breast cancer tissue extracts</atitle><jtitle>British journal of cancer</jtitle><stitle>Br J Cancer</stitle><addtitle>Br J Cancer</addtitle><date>1998-12-01</date><risdate>1998</risdate><volume>78</volume><issue>11</issue><spage>1434</spage><epage>1441</epage><pages>1434-1441</pages><issn>0007-0920</issn><eissn>1532-1827</eissn><coden>BJCAAI</coden><abstract>High levels of urokinase-type plasminogen activator (uPA) and plasminogen activator inhibitor type 1 (PAI-1) in breast cancer tissue extracts have been associated with rapid disease progression. In these studies, different enzyme-linked immunosorbent assay (ELISA) kits have been applied for the quantification, and consequently the ranges of uPA and PAI-1 levels reported differ considerably. Therefore, the Receptor and Biomarker Study Group (RBSG) of the European Organization for Research and Treatment of Cancer (EORTC) and a consortium of the BIOMED-1 project 'Clinical Relevance of Proteases in Tumor Invasion and Metastasis' initiated three collaborative between-laboratory assessment trials aimed at controlling uPA and PAI-1 antigen analyses. For this purpose, two control preparations were produced from different sources: pooled human breast cancer specimens (QC-240893) and human breast cancer xenografts raised in nude mice (QC-101094). The lyophilized preparations were stable for prolonged times (at least 3 and 27 months respectively) at 4 degrees C. Furthermore, a good parallelism following dilution was found for uPA and PAI-1. The data from QC trial no. 1 clearly indicated that acceptable between-laboratory coefficients of variation (CVs) for uPA (<8.2%) and PAI-1 (<16.6%) in QC-240893 could be achieved when the same type of ELISA kit (American Diagnostica) was used. From the second trial, in which ten EORTC laboratories each received five identical lyophilized QC-101094 samples, it appeared that the within-laboratory variations for uPA and PAI-1 determinations obtained by 'experienced' laboratories were lower (<12.9%) than those from non-experienced laboratories (<36.4%). In a third QC trial, five BIOMED-1 laboratories, all of which employed ELISA procedures for uPA and PAI-1, participated in six subsequent quality assessment rounds receiving five samples of QC-101094. Although for each laboratory the within-run CVs for uPA as well as for PAI-1 were low (<7.8%), the between-run CVs were found to be considerably higher (up to 56.2% for uPA and to 27.6% for PAI-1). Consequently, because of the different ELISA formats used, the absolute analyte values measured in the different laboratories varied substantially. The use of 'common external standards' in the different ELISAs resulted in a significant reduction of the between-laboratory CVs from 61.3% to 15.7% (uPA) and from 42.1% to 19.1% (PAI-1). The present data demonstrate that in multicentre studies the same ELISA kit should be used, and that external quality assurance (QA) is mandatory. Furthermore, it appears from the present study that standardization of the protein assay as a tissular parameter is imperative.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>9836475</pmid><doi>10.1038/bjc.1998.704</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | British journal of cancer, 1998-12, Vol.78 (11), p.1434-1441 |
| issn | 0007-0920 1532-1827 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2063209 |
| source | PubMed Central |
| subjects | Animals Biological and medical sciences Biomedical and Life Sciences Biomedicine Breast Neoplasms - chemistry Cancer Research Drug Resistance Enzyme-Linked Immunosorbent Assay - methods Enzyme-Linked Immunosorbent Assay - standards Epidemiology Europe experimental-oncology Female Genital system. Mammary gland Humans Investigative techniques, diagnostic techniques (general aspects) Medical sciences Mice Mice, Nude Molecular Medicine Neoplasm Proteins - analysis Oncology Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques Plasminogen Activator Inhibitor 1 - analysis Quality Control Reagent Kits, Diagnostic - standards Reference Values Urokinase-Type Plasminogen Activator - analysis |
| title | External quality assessment of trans-European multicentre antigen determinations (enzyme-linked immunosorbent assay) of urokinase-type plasminogen activator (uPA) and its type 1 inhibitor (PAI-1) in human breast cancer tissue extracts |
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