{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T22:39:43Z","timestamp":1782167983199,"version":"3.54.5"},"reference-count":38,"publisher":"Walter de Gruyter GmbH","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,10,25]]},"abstract":"<jats:title>Abstract<\/jats:title>\n<jats:sec id=\"j_cclm-2018-0351_s_999\">\n<jats:title id=\"d745630e71269\">Background:<\/jats:title>\n<jats:p>A general trend towards conducting infectious disease serology testing in centralized laboratories means that quality control (QC) principles used for clinical chemistry testing are applied to infectious disease testing. However, no systematic assessment of methods used to establish QC limits has been applied to infectious disease serology testing.<\/jats:p><\/jats:sec>\n<jats:sec id=\"j_cclm-2018-0351_s_998\">\n<jats:title id=\"d745630e71277\">Methods:<\/jats:title>\n<jats:p>A total of 103 QC data sets, obtained from six different infectious disease serology analytes, were parsed through standard methods for establishing statistical control limits, including guidelines from Public Health England, USA Clinical and Laboratory Standards Institute (CLSI), German Richtlinien der Bundes\u00e4rztekammer (RiliB\u00c4K) and Australian QConnect. The percentage of QC results failing each method was compared.<\/jats:p><\/jats:sec>\n<jats:sec id=\"j_cclm-2018-0351_s_997\">\n<jats:title id=\"d745630e71285\">Results:<\/jats:title>\n<jats:p>The percentage of data sets having more than 20% of QC results failing Westgard rules when the first 20 results were used to calculate the mean\u00b12 standard deviation (SD) ranged from 3 (2.9%) for R<jats:sub>4S<\/jats:sub> to 66 (64.1%) for 10<jats:sub>X<\/jats:sub> rule, whereas the percentage ranged from 0 (0%) for R<jats:sub>4S<\/jats:sub> to 32 (40.5%) for 10<jats:sub>X<\/jats:sub> when the first 100 results were used to calculate the mean\u00b12 SD. By contrast, the percentage of data sets with &gt;20% failing the RiliB\u00c4K control limits was 25 (24.3%). Only two data sets (1.9%) had more than 20% of results outside the QConnect Limits.<\/jats:p><\/jats:sec>\n<jats:sec id=\"j_cclm-2018-0351_s_996\">\n<jats:title id=\"d745630e71305\">Conclusions:<\/jats:title>\n<jats:p>The rate of failure of QCs using QConnect Limits was more applicable for monitoring infectious disease serology testing compared with UK Public Health, CLSI and RiliB\u00c4K, as the alternatives to QConnect Limits reported an unacceptably high percentage of failures across the 103 data sets.<\/jats:p><\/jats:sec>","DOI":"10.1515\/cclm-2018-0351","type":"journal-article","created":{"date-parts":[[2018,5,30]],"date-time":"2018-05-30T22:16:16Z","timestamp":1527718576000},"page":"1970-1978","source":"Crossref","is-referenced-by-count":20,"title":["Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing"],"prefix":"10.1515","volume":"56","author":[{"given":"Wayne","family":"Dimech","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marina","family":"Karakaltsas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe A.","family":"Vincini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","reference":[{"key":"ref41","doi-asserted-by":"crossref","first-page":"602","DOI":"10.1093\/clinchem\/43.4.602","article-title":"Quality-control (QC) performance measures and the QC planning process","volume":"43","year":"1997","journal-title":"Clin Chem"},{"key":"ref291","doi-asserted-by":"crossref","first-page":"1027","DOI":"10.1136\/jclinpath-2013-201661","article-title":"Internal quality control: best practice","volume":"66","year":"2013","journal-title":"J Clin Pathol"},{"key":"ref461","doi-asserted-by":"crossref","first-page":"1624","DOI":"10.1128\/CVI.00294-12","article-title":"Results of continuous monitoring of the performance of rubella virus IgG and hepatitis B virus surface antibody assays using trueness controls in a multicenter trial","volume":"19","year":"2012","journal-title":"Clin Vaccine Immunol"},{"key":"ref51","doi-asserted-by":"crossref","first-page":"1027","DOI":"10.1136\/jclinpath-2013-201661","article-title":"Internal quality control: best practice","volume":"66","year":"2013","journal-title":"J Clin Pathol"},{"key":"ref161","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1016\/j.cll.2012.10.004","article-title":"Statistical quality control procedures","volume":"33","year":"2013","journal-title":"Clin Lab Med"},{"key":"ref171","doi-asserted-by":"crossref","first-page":"32","DOI":"10.1177\/0004563215597248","article-title":"Quality control review: implementing a scientifically based quality control system","volume":"53","year":"2016","journal-title":"Ann Clin Biochem"},{"key":"ref151","first-page":"18","article-title":"QC design: it\u2019s easier than you think","volume":"45","year":"2013","journal-title":"MLO Med Lab Obs"},{"key":"ref231","doi-asserted-by":"crossref","first-page":"163","DOI":"10.1016\/S0009-8981(96)06494-7","article-title":"Clinical laboratory quality control: a costly process now out of control","volume":"260","year":"1997","journal-title":"Clin Chim Acta"},{"key":"ref121","first-page":"329","article-title":"Determination of quality control limits for serological infectious disease testing using historical data","volume":"53","year":"2015","journal-title":"Clin Chem Lab Med"},{"key":"ref31","volume-title":"Quality assurance in the diagnostic virology and serology laboratory","year":"2015"},{"key":"ref351","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1111\/j.1423-0410.2009.01218.x","article-title":"An international quality control programme for prism chemiluminescent immunoassays in blood service and blood product laboratories","volume":"97","year":"2009","journal-title":"Vox Sang"},{"key":"ref391","first-page":"18","article-title":"QC design: it\u2019s easier than you think","volume":"45","year":"2013","journal-title":"MLO Med Lab Obs"},{"key":"ref401","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1016\/j.cll.2012.10.004","article-title":"Statistical quality control procedures","volume":"33","year":"2013","journal-title":"Clin Lab Med"},{"key":"ref111","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1111\/j.1423-0410.2009.01218.x","article-title":"An international quality control programme for prism chemiluminescent immunoassays in blood service and blood product laboratories","volume":"97","year":"2009","journal-title":"Vox Sang"},{"key":"ref71","doi-asserted-by":"crossref","first-page":"499","DOI":"10.1093\/clinchem\/40.3.499","article-title":"Selecting appropriate quality-control rules","volume":"40","year":"1994","journal-title":"Clin Chem"},{"key":"ref81","doi-asserted-by":"crossref","first-page":"493","DOI":"10.1093\/clinchem\/27.3.493","article-title":"A multi-rule Shewhart chart for quality control in clinical chemistry","volume":"27","year":"1981","journal-title":"Clin Chem"},{"key":"ref421","doi-asserted-by":"crossref","first-page":"1187","DOI":"10.1373\/clinchem.2013.205070","article-title":"Failure of current laboratory protocols to detect lot-to-lot reagent differences: findings and possible solutions","volume":"59","year":"2013","journal-title":"Clin Chem"},{"key":"ref381","first-page":"S67","article-title":"The quality control system","volume":"29","year":"2008","journal-title":"Clin Biochem Rev"},{"key":"ref451","doi-asserted-by":"crossref","first-page":"3114","DOI":"10.1128\/JCM.00892-09","article-title":"Identification of performance problems in a commercial human immunodeficiency virus type 1 enzyme immunoassay by multiuser external quality control monitoring and real-time data analysis","volume":"47","year":"2009","journal-title":"J Clin Microbiol"},{"key":"ref101","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1007\/s00769-003-0734-5","article-title":"Comprehensive quality control programme for serology and nucleic acid testing using an internet-based application","volume":"9","year":"2004","journal-title":"Accred Qual Assur"},{"key":"ref141","first-page":"S67","article-title":"The quality control system","volume":"29","year":"2008","journal-title":"Clin Biochem Rev"},{"key":"ref191","doi-asserted-by":"crossref","first-page":"198","DOI":"10.1136\/jcp.48.3.198","article-title":"Internal quality assurance in a clinical virology laboratory. II. Internal quality control","volume":"48","year":"1995","journal-title":"J Clin Pathol"},{"key":"ref131","doi-asserted-by":"crossref","first-page":"593","DOI":"10.1258\/000456303770367199","article-title":"Internal quality control: planning and implementation strategies","volume":"40","year":"2003","journal-title":"Ann Clin Biochem"},{"key":"ref411","doi-asserted-by":"crossref","first-page":"32","DOI":"10.1177\/0004563215597248","article-title":"Quality control review: implementing a scientifically based quality control system","volume":"53","year":"2016","journal-title":"Ann Clin Biochem"},{"key":"ref361","first-page":"329","article-title":"Determination of quality control limits for serological infectious disease testing using historical data","volume":"53","year":"2015","journal-title":"Clin Chem Lab Med"},{"key":"ref201","doi-asserted-by":"crossref","first-page":"1618","DOI":"10.1093\/clinchem\/43.9.1618","article-title":"Quality control for qualitative assays: quantitative QC procedure designed to assure analytical quality required for an ELISA of hepatitis B surface antigen","volume":"43","year":"1997","journal-title":"Clin Chem"},{"key":"ref431","doi-asserted-by":"crossref","first-page":"198","DOI":"10.1136\/jcp.48.3.198","article-title":"Internal quality assurance in a clinical virology laboratory. II. Internal quality control","volume":"48","year":"1995","journal-title":"J Clin Pathol"},{"key":"ref341","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1007\/s00769-003-0734-5","article-title":"Comprehensive quality control programme for serology and nucleic acid testing using an internet-based application","volume":"9","year":"2004","journal-title":"Accred Qual Assur"},{"key":"ref221","doi-asserted-by":"crossref","first-page":"1624","DOI":"10.1128\/CVI.00294-12","article-title":"Results of continuous monitoring of the performance of rubella virus IgG and hepatitis B virus surface antibody assays using trueness controls in a multicenter trial","volume":"19","year":"2012","journal-title":"Clin Vaccine Immunol"},{"key":"ref281","doi-asserted-by":"crossref","first-page":"602","DOI":"10.1093\/clinchem\/43.4.602","article-title":"Quality-control (QC) performance measures and the QC planning process","volume":"43","year":"1997","journal-title":"Clin Chem"},{"key":"ref181","doi-asserted-by":"crossref","first-page":"1187","DOI":"10.1373\/clinchem.2013.205070","article-title":"Failure of current laboratory protocols to detect lot-to-lot reagent differences: findings and possible solutions","volume":"59","year":"2013","journal-title":"Clin Chem"},{"key":"ref311","doi-asserted-by":"crossref","first-page":"499","DOI":"10.1093\/clinchem\/40.3.499","article-title":"Selecting appropriate quality-control rules","volume":"40","year":"1994","journal-title":"Clin Chem"},{"key":"ref441","doi-asserted-by":"crossref","first-page":"1618","DOI":"10.1093\/clinchem\/43.9.1618","article-title":"Quality control for qualitative assays: quantitative QC procedure designed to assure analytical quality required for an ELISA of hepatitis B surface antigen","volume":"43","year":"1997","journal-title":"Clin Chem"},{"key":"ref471","doi-asserted-by":"crossref","first-page":"163","DOI":"10.1016\/S0009-8981(96)06494-7","article-title":"Clinical laboratory quality control: a costly process now out of control","volume":"260","year":"1997","journal-title":"Clin Chim Acta"},{"key":"ref211","doi-asserted-by":"crossref","first-page":"3114","DOI":"10.1128\/JCM.00892-09","article-title":"Identification of performance problems in a commercial human immunodeficiency virus type 1 enzyme immunoassay by multiuser external quality control monitoring and real-time data analysis","volume":"47","year":"2009","journal-title":"J Clin Microbiol"},{"key":"ref321","doi-asserted-by":"crossref","first-page":"493","DOI":"10.1093\/clinchem\/27.3.493","article-title":"A multi-rule Shewhart chart for quality control in clinical chemistry","volume":"27","year":"1981","journal-title":"Clin Chem"},{"key":"ref271","volume-title":"Quality assurance in the diagnostic virology and serology laboratory","year":"2015"},{"key":"ref371","doi-asserted-by":"crossref","first-page":"593","DOI":"10.1258\/000456303770367199","article-title":"Internal quality control: planning and implementation strategies","volume":"40","year":"2003","journal-title":"Ann Clin Biochem"}],"container-title":["Clinical Chemistry and Laboratory Medicine (CCLM)"],"original-title":[],"link":[{"URL":"http:\/\/www.degruyter.com\/view\/j\/cclm.2018.56.issue-11\/cclm-2018-0351\/cclm-2018-0351.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2018-0351\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,4,21]],"date-time":"2021-04-21T22:40:32Z","timestamp":1619044832000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2018-0351\/html"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,10,25]]},"references-count":38,"journal-issue":{"issue":"11"},"URL":"https:\/\/doi.org\/10.1515\/cclm-2018-0351","relation":{},"ISSN":["1437-4331","1434-6621"],"issn-type":[{"value":"1437-4331","type":"electronic"},{"value":"1434-6621","type":"print"}],"subject":[],"published":{"date-parts":[[2018,10,25]]}}}