Evaluation of an immunoassay of whole blood sirolimus in pediatric transplant patients in comparison with high-performance liquid chromatography/tandem mass spectrometry
: Sirolimus is widely used as an immunosuppressant, along with calcineurin inhibitors. Because of its variable pharmacokinetics and narrow therapeutic range, therapeutic drug monitoring of sirolimus is critical to optimize its therapeutic effect and to minimize toxicity. Although liquid chromatograp...
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| Veröffentlicht in: | Clinical chemistry and laboratory medicine 2006-04, Vol.44 (4), p.497-499 |
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| creator | Vicente, Faye B. Smith, Frederick A. Peng, Yu Wang, Sihe |
| description | : Sirolimus is widely used as an immunosuppressant, along with calcineurin inhibitors. Because of its variable pharmacokinetics and narrow therapeutic range, therapeutic drug monitoring of sirolimus is critical to optimize its therapeutic effect and to minimize toxicity. Although liquid chromatography/tandem mass spectrometry is considered the method of choice, the technical and financial challenges of this method are obstacles to its use. A microparticle enzyme immunoassay on the Abbott IMx has recently been reintroduced to the clinical diagnostic market.
: We evaluated this immunoassay using high-performance liquid chromatography/tandem mass spectrometry as the reference method. Precision and carryover were evaluated using an expanded CLSI EP10-A2 protocol. Linearity was studied by serial dilution of high-level whole blood samples, and clinical utility was demonstrated by correlation with the reference method using 56 de-identified pediatric patient samples.
: The total imprecision was less than 12% across the concentrations tested. The method was linear from 2.6 to 31nM. The immunoassay showed a mean positive bias of 11.5% in patient specimens relative to high-performance liquid chromatography/mass spectrometry (p |
| doi_str_mv | 10.1515/CCLM.2006.080 |
| format | Article |
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: We evaluated this immunoassay using high-performance liquid chromatography/tandem mass spectrometry as the reference method. Precision and carryover were evaluated using an expanded CLSI EP10-A2 protocol. Linearity was studied by serial dilution of high-level whole blood samples, and clinical utility was demonstrated by correlation with the reference method using 56 de-identified pediatric patient samples.
: The total imprecision was less than 12% across the concentrations tested. The method was linear from 2.6 to 31nM. The immunoassay showed a mean positive bias of 11.5% in patient specimens relative to high-performance liquid chromatography/mass spectrometry (p<0.001), with a correlation coefficient (R) of 0.953.
: We conclude that the reintroduced immunoassay is useful for therapeutic drug monitoring of sirolimus.</description><identifier>ISSN: 1434-6621</identifier><identifier>EISSN: 1437-4331</identifier><identifier>DOI: 10.1515/CCLM.2006.080</identifier><identifier>PMID: 16599847</identifier><language>eng</language><publisher>Berlin: De Gruyter</publisher><subject>Biological and medical sciences ; Child ; Chromatography, High Pressure Liquid ; Drug Monitoring - methods ; Drug Monitoring - standards ; General aspects ; Hematopoietic Stem Cell Transplantation ; Humans ; immunoassay ; Immunoassay - methods ; Immunoassay - standards ; Investigative techniques, diagnostic techniques (general aspects) ; Mass Spectrometry ; Medical sciences ; microparticle enzyme immunoassay ; Reproducibility of Results ; sirolimus ; Sirolimus - blood</subject><ispartof>Clinical chemistry and laboratory medicine, 2006-04, Vol.44 (4), p.497-499</ispartof><rights>2006 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c373t-fac08bf29c8d535ac3ac57b38f6d998fafdea2a259f84e6a4824ef6c47de2c1c3</citedby><cites>FETCH-LOGICAL-c373t-fac08bf29c8d535ac3ac57b38f6d998fafdea2a259f84e6a4824ef6c47de2c1c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.degruyter.com/document/doi/10.1515/CCLM.2006.080/pdf$$EPDF$$P50$$Gwalterdegruyter$$H</linktopdf><linktohtml>$$Uhttps://www.degruyter.com/document/doi/10.1515/CCLM.2006.080/html$$EHTML$$P50$$Gwalterdegruyter$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,66497,68281</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17731788$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16599847$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vicente, Faye B.</creatorcontrib><creatorcontrib>Smith, Frederick A.</creatorcontrib><creatorcontrib>Peng, Yu</creatorcontrib><creatorcontrib>Wang, Sihe</creatorcontrib><title>Evaluation of an immunoassay of whole blood sirolimus in pediatric transplant patients in comparison with high-performance liquid chromatography/tandem mass spectrometry</title><title>Clinical chemistry and laboratory medicine</title><addtitle>Clin Chem Lab Med</addtitle><description>: Sirolimus is widely used as an immunosuppressant, along with calcineurin inhibitors. Because of its variable pharmacokinetics and narrow therapeutic range, therapeutic drug monitoring of sirolimus is critical to optimize its therapeutic effect and to minimize toxicity. Although liquid chromatography/tandem mass spectrometry is considered the method of choice, the technical and financial challenges of this method are obstacles to its use. A microparticle enzyme immunoassay on the Abbott IMx has recently been reintroduced to the clinical diagnostic market.
: We evaluated this immunoassay using high-performance liquid chromatography/tandem mass spectrometry as the reference method. Precision and carryover were evaluated using an expanded CLSI EP10-A2 protocol. Linearity was studied by serial dilution of high-level whole blood samples, and clinical utility was demonstrated by correlation with the reference method using 56 de-identified pediatric patient samples.
: The total imprecision was less than 12% across the concentrations tested. The method was linear from 2.6 to 31nM. The immunoassay showed a mean positive bias of 11.5% in patient specimens relative to high-performance liquid chromatography/mass spectrometry (p<0.001), with a correlation coefficient (R) of 0.953.
: We conclude that the reintroduced immunoassay is useful for therapeutic drug monitoring of sirolimus.</description><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Chromatography, High Pressure Liquid</subject><subject>Drug Monitoring - methods</subject><subject>Drug Monitoring - standards</subject><subject>General aspects</subject><subject>Hematopoietic Stem Cell Transplantation</subject><subject>Humans</subject><subject>immunoassay</subject><subject>Immunoassay - methods</subject><subject>Immunoassay - standards</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Mass Spectrometry</subject><subject>Medical sciences</subject><subject>microparticle enzyme immunoassay</subject><subject>Reproducibility of Results</subject><subject>sirolimus</subject><subject>Sirolimus - blood</subject><issn>1434-6621</issn><issn>1437-4331</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNptkE1v1DAQhiMEoqVw5Ip84ZitHTtxIk5oVaDSIi5wjmb9sXHlj2A7rPKT-Jf1dlfqpXOZkf3o1cxTVR8J3pCWtLfb7e7npsG42-Aev6quCaO8ZpSS108zq7uuIVfVu5QeMCZty_jb6op07TD0jF9X_-_-gV0gm-BR0Ag8Ms4tPkBKsJ5ejlOwCu1tCBIlE4M1bknIeDQraSBHI1CO4NNswWc0lyTl8xMggpshmlSSjyZPaDKHqZ5V1CE68EIha_4uRiIxxeAgh0OEeVpvM3ipHHJlA5RmJXL5VTmu76s3GmxSHy79pvrz7e739ke9-_X9fvt1VwvKaa41CNzvdTOIXra0BUFBtHxPe93JcrMGLRU00LSD7pnqgPUNU7oTjEvVCCLoTVWfc0UMKUWlxzkaB3EdCR5PyseT8vGkfCzKC__pzM_L3in5TF8cF-DzBYAkwOpiS5j0zHFOCe_7wn05c0ewWUWpDnFZyzA-hCX6cvLLC7BSA6eP3e-jmA</recordid><startdate>20060401</startdate><enddate>20060401</enddate><creator>Vicente, Faye B.</creator><creator>Smith, Frederick A.</creator><creator>Peng, Yu</creator><creator>Wang, Sihe</creator><general>De Gruyter</general><general>Walter de Gruyter</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></search><sort><creationdate>20060401</creationdate><title>Evaluation of an immunoassay of whole blood sirolimus in pediatric transplant patients in comparison with high-performance liquid chromatography/tandem mass spectrometry</title><author>Vicente, Faye B. ; Smith, Frederick A. ; Peng, Yu ; Wang, Sihe</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c373t-fac08bf29c8d535ac3ac57b38f6d998fafdea2a259f84e6a4824ef6c47de2c1c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Chromatography, High Pressure Liquid</topic><topic>Drug Monitoring - methods</topic><topic>Drug Monitoring - standards</topic><topic>General aspects</topic><topic>Hematopoietic Stem Cell Transplantation</topic><topic>Humans</topic><topic>immunoassay</topic><topic>Immunoassay - methods</topic><topic>Immunoassay - standards</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Mass Spectrometry</topic><topic>Medical sciences</topic><topic>microparticle enzyme immunoassay</topic><topic>Reproducibility of Results</topic><topic>sirolimus</topic><topic>Sirolimus - blood</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vicente, Faye B.</creatorcontrib><creatorcontrib>Smith, Frederick A.</creatorcontrib><creatorcontrib>Peng, Yu</creatorcontrib><creatorcontrib>Wang, Sihe</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><jtitle>Clinical chemistry and laboratory medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vicente, Faye B.</au><au>Smith, Frederick A.</au><au>Peng, Yu</au><au>Wang, Sihe</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of an immunoassay of whole blood sirolimus in pediatric transplant patients in comparison with high-performance liquid chromatography/tandem mass spectrometry</atitle><jtitle>Clinical chemistry and laboratory medicine</jtitle><addtitle>Clin Chem Lab Med</addtitle><date>2006-04-01</date><risdate>2006</risdate><volume>44</volume><issue>4</issue><spage>497</spage><epage>499</epage><pages>497-499</pages><issn>1434-6621</issn><eissn>1437-4331</eissn><abstract>: Sirolimus is widely used as an immunosuppressant, along with calcineurin inhibitors. Because of its variable pharmacokinetics and narrow therapeutic range, therapeutic drug monitoring of sirolimus is critical to optimize its therapeutic effect and to minimize toxicity. Although liquid chromatography/tandem mass spectrometry is considered the method of choice, the technical and financial challenges of this method are obstacles to its use. A microparticle enzyme immunoassay on the Abbott IMx has recently been reintroduced to the clinical diagnostic market.
: We evaluated this immunoassay using high-performance liquid chromatography/tandem mass spectrometry as the reference method. Precision and carryover were evaluated using an expanded CLSI EP10-A2 protocol. Linearity was studied by serial dilution of high-level whole blood samples, and clinical utility was demonstrated by correlation with the reference method using 56 de-identified pediatric patient samples.
: The total imprecision was less than 12% across the concentrations tested. The method was linear from 2.6 to 31nM. The immunoassay showed a mean positive bias of 11.5% in patient specimens relative to high-performance liquid chromatography/mass spectrometry (p<0.001), with a correlation coefficient (R) of 0.953.
: We conclude that the reintroduced immunoassay is useful for therapeutic drug monitoring of sirolimus.</abstract><cop>Berlin</cop><cop>New York, NY</cop><pub>De Gruyter</pub><pmid>16599847</pmid><doi>10.1515/CCLM.2006.080</doi><tpages>3</tpages></addata></record> |
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| source | MEDLINE; De Gruyter journals |
| subjects | Biological and medical sciences Child Chromatography, High Pressure Liquid Drug Monitoring - methods Drug Monitoring - standards General aspects Hematopoietic Stem Cell Transplantation Humans immunoassay Immunoassay - methods Immunoassay - standards Investigative techniques, diagnostic techniques (general aspects) Mass Spectrometry Medical sciences microparticle enzyme immunoassay Reproducibility of Results sirolimus Sirolimus - blood |
| title | Evaluation of an immunoassay of whole blood sirolimus in pediatric transplant patients in comparison with high-performance liquid chromatography/tandem mass spectrometry |
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