Calculation of the decision limit (CCα) and the detection capability (CCβ) for banned substances: The imperfect marriage between the quantitative and the qualitative criteria
Initially in the Decision 2002/657/EC the criteria for the calculation of the decision limit (CCα) and the detection capability (CCβ) have been estimated as purely quantitative (α-error is 1% and β-error is 5%). In 2004, the European Commission has issued a document to provide guidance for the inter...
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| Veröffentlicht in: | Analytica chimica acta 2007-03, Vol.586 (1-2), p.8-12 |
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| creator | Van Loco, J. Jànosi, A. Impens, S. Fraselle, S. Cornet, V. Degroodt, J.M. |
| description | Initially in the Decision 2002/657/EC the criteria for the calculation of the decision limit (CCα) and the detection capability (CCβ) have been estimated as purely quantitative (α-error is 1% and β-error is 5%). In 2004, the European Commission has issued a document to provide guidance for the interpretation of the 2002/657/EC. In this document it is mentioned that also qualitative criteria should be fulfilled. Therefore, the calculated CCα and CCβ must be verified by using fortified samples. The method should be able to detect/identify the target component in 50% of the cases at CCα and in 95% of the cases at CCβ.
Analytical methods for the analysis of nitroimidazoles, nitrofurans and corticosteroids with LC–MS/MS have been validated by fortifying blank samples below and above the MRPL. CCα and CCβ were calculated using the ISO 11843 approach. In addition, the frequency of methodical compliance for the qualitative criteria was determined at each concentration level. It was observed that at the calculated CCα and CCβ levels the qualitative criteria were not fulfilled. It was concluded that the detection capability of the analytical method should be calculated by using decreasing fortification levels at and below the MRPL.
A protocol validating methods for banned substances by limiting the number of samples is presented and the qualitative criteria for the assessment of CCα and CCβ were verified based on the same set of data without the need of performing additional validation experiments. |
| doi_str_mv | 10.1016/j.aca.2006.11.058 |
| format | Article |
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Analytical methods for the analysis of nitroimidazoles, nitrofurans and corticosteroids with LC–MS/MS have been validated by fortifying blank samples below and above the MRPL. CCα and CCβ were calculated using the ISO 11843 approach. In addition, the frequency of methodical compliance for the qualitative criteria was determined at each concentration level. It was observed that at the calculated CCα and CCβ levels the qualitative criteria were not fulfilled. It was concluded that the detection capability of the analytical method should be calculated by using decreasing fortification levels at and below the MRPL.
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Analytical methods for the analysis of nitroimidazoles, nitrofurans and corticosteroids with LC–MS/MS have been validated by fortifying blank samples below and above the MRPL. CCα and CCβ were calculated using the ISO 11843 approach. In addition, the frequency of methodical compliance for the qualitative criteria was determined at each concentration level. It was observed that at the calculated CCα and CCβ levels the qualitative criteria were not fulfilled. It was concluded that the detection capability of the analytical method should be calculated by using decreasing fortification levels at and below the MRPL.
A protocol validating methods for banned substances by limiting the number of samples is presented and the qualitative criteria for the assessment of CCα and CCβ were verified based on the same set of data without the need of performing additional validation experiments.</description><subject>Adrenal Cortex Hormones - analysis</subject><subject>Adrenal Cortex Hormones - metabolism</subject><subject>Analytical chemistry</subject><subject>Banned substances</subject><subject>Chemistry</subject><subject>Chemistry Techniques, Analytical - methods</subject><subject>Chromatographic methods and physical methods associated with chromatography</subject><subject>Chromatography, Liquid</subject><subject>Commission decision 2002/657/EC</subject><subject>Detection capability</subject><subject>Doping in Sports</subject><subject>Drug Residues - analysis</subject><subject>Exact sciences and technology</subject><subject>Humans</subject><subject>ISO 11843</subject><subject>Linear Models</subject><subject>Liver - metabolism</subject><subject>Mass Spectrometry</subject><subject>Method validation</subject><subject>Models, Statistical</subject><subject>Nitrofurans - analysis</subject><subject>Nitroimidazoles - analysis</subject><subject>Other chromatographic methods</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><subject>Spectrometric and optical methods</subject><issn>0003-2670</issn><issn>1873-4324</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kcuO1DAQRSMEYpqBD2CDvAExiwQ7D8cNKxTxkkZiM6ytSrkMbuXRYzuD5q-AD-GbcHcHZsfKqvK55fK9WfZU8EJwIV_tCkAoSs5lIUTBG3Uv2wjVVnldlfX9bMM5r_JStvwsexTCLpWl4PXD7Ey0lZJyyzfZjw4GXAaIbp7YbFn8RswQunCoBze6yF523e-fFwwms95GwiOOsIfeDS7eHplfF8zOnvUwTWRYWPoQYUIKr9lVkrlxT94mJRvBewdfifUUvxNNx6nXC0zRxbTHDf17KjWHvz30LlLSPc4eWBgCPVnP8-zL-3dX3cf88vOHT93byxxrUcZcEVa2tyREj7beIqgGlYHayKYF1cqqMYANlo1VbY0GWymBkl0tIEfB--o8e3Gau_fz9UIh6tEFpGGAieYlaFErIaWqEihOIPo5BE9W771Lf7zVgutDTHqnU0z6EJMWQqeYkubZOnzpRzJ3ijWXBDxfAQgIg_XJSRfuONUosVXbxL05cZSsuHHkdUBHyXXjfPJam9n9Z40_eIm0zw</recordid><startdate>20070314</startdate><enddate>20070314</enddate><creator>Van Loco, J.</creator><creator>Jànosi, A.</creator><creator>Impens, S.</creator><creator>Fraselle, S.</creator><creator>Cornet, V.</creator><creator>Degroodt, J.M.</creator><general>Elsevier B.V</general><general>Elsevier</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>7ST</scope><scope>C1K</scope><scope>SOI</scope></search><sort><creationdate>20070314</creationdate><title>Calculation of the decision limit (CCα) and the detection capability (CCβ) for banned substances: The imperfect marriage between the quantitative and the qualitative criteria</title><author>Van Loco, J. ; Jànosi, A. ; Impens, S. ; Fraselle, S. ; Cornet, V. ; Degroodt, J.M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c412t-8ec3fbfe11bcf49ca85c8da4d657a87635dac5c25f874cdc766ae0037ac0c10b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Adrenal Cortex Hormones - analysis</topic><topic>Adrenal Cortex Hormones - metabolism</topic><topic>Analytical chemistry</topic><topic>Banned substances</topic><topic>Chemistry</topic><topic>Chemistry Techniques, Analytical - methods</topic><topic>Chromatographic methods and physical methods associated with chromatography</topic><topic>Chromatography, Liquid</topic><topic>Commission decision 2002/657/EC</topic><topic>Detection capability</topic><topic>Doping in Sports</topic><topic>Drug Residues - analysis</topic><topic>Exact sciences and technology</topic><topic>Humans</topic><topic>ISO 11843</topic><topic>Linear Models</topic><topic>Liver - metabolism</topic><topic>Mass Spectrometry</topic><topic>Method validation</topic><topic>Models, Statistical</topic><topic>Nitrofurans - analysis</topic><topic>Nitroimidazoles - analysis</topic><topic>Other chromatographic methods</topic><topic>Reproducibility of Results</topic><topic>Sensitivity and Specificity</topic><topic>Spectrometric and optical methods</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Van Loco, J.</creatorcontrib><creatorcontrib>Jànosi, A.</creatorcontrib><creatorcontrib>Impens, S.</creatorcontrib><creatorcontrib>Fraselle, S.</creatorcontrib><creatorcontrib>Cornet, V.</creatorcontrib><creatorcontrib>Degroodt, J.M.</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>Environment Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Environment Abstracts</collection><jtitle>Analytica chimica acta</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Van Loco, J.</au><au>Jànosi, A.</au><au>Impens, S.</au><au>Fraselle, S.</au><au>Cornet, V.</au><au>Degroodt, J.M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Calculation of the decision limit (CCα) and the detection capability (CCβ) for banned substances: The imperfect marriage between the quantitative and the qualitative criteria</atitle><jtitle>Analytica chimica acta</jtitle><addtitle>Anal Chim Acta</addtitle><date>2007-03-14</date><risdate>2007</risdate><volume>586</volume><issue>1-2</issue><spage>8</spage><epage>12</epage><pages>8-12</pages><issn>0003-2670</issn><eissn>1873-4324</eissn><coden>ACACAM</coden><abstract>Initially in the Decision 2002/657/EC the criteria for the calculation of the decision limit (CCα) and the detection capability (CCβ) have been estimated as purely quantitative (α-error is 1% and β-error is 5%). In 2004, the European Commission has issued a document to provide guidance for the interpretation of the 2002/657/EC. In this document it is mentioned that also qualitative criteria should be fulfilled. Therefore, the calculated CCα and CCβ must be verified by using fortified samples. The method should be able to detect/identify the target component in 50% of the cases at CCα and in 95% of the cases at CCβ.
Analytical methods for the analysis of nitroimidazoles, nitrofurans and corticosteroids with LC–MS/MS have been validated by fortifying blank samples below and above the MRPL. CCα and CCβ were calculated using the ISO 11843 approach. In addition, the frequency of methodical compliance for the qualitative criteria was determined at each concentration level. It was observed that at the calculated CCα and CCβ levels the qualitative criteria were not fulfilled. It was concluded that the detection capability of the analytical method should be calculated by using decreasing fortification levels at and below the MRPL.
A protocol validating methods for banned substances by limiting the number of samples is presented and the qualitative criteria for the assessment of CCα and CCβ were verified based on the same set of data without the need of performing additional validation experiments.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>17386690</pmid><doi>10.1016/j.aca.2006.11.058</doi><tpages>5</tpages></addata></record> |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adrenal Cortex Hormones - analysis Adrenal Cortex Hormones - metabolism Analytical chemistry Banned substances Chemistry Chemistry Techniques, Analytical - methods Chromatographic methods and physical methods associated with chromatography Chromatography, Liquid Commission decision 2002/657/EC Detection capability Doping in Sports Drug Residues - analysis Exact sciences and technology Humans ISO 11843 Linear Models Liver - metabolism Mass Spectrometry Method validation Models, Statistical Nitrofurans - analysis Nitroimidazoles - analysis Other chromatographic methods Reproducibility of Results Sensitivity and Specificity Spectrometric and optical methods |
| title | Calculation of the decision limit (CCα) and the detection capability (CCβ) for banned substances: The imperfect marriage between the quantitative and the qualitative criteria |
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