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dc.contributor.authorKoerbin, Gus
dc.contributor.authorLiu, Jiakai
dc.contributor.authorEigenstetter, Alex
dc.contributor.authorTan, Chin Hon
dc.contributor.authorBadrick, Tony
dc.contributor.authorLoh, Tze Ping
dc.date.accessioned2020-02-17T01:42:44Z
dc.date.available2020-02-17T01:42:44Z
dc.date.issued2018
dc.identifier.issn1330-0962
dc.identifier.doi10.11613/BM.2018.010705
dc.identifier.urihttp://hdl.handle.net/10072/391554
dc.description.abstractIntroduction: A product recall was issued for the Roche/Hitachi Cobas Gentamicin II assays on 25 th May 2016 in Australia, after a 15 - 20% positive analytical shift was discovered. Laboratories were advised to employ the Thermo Fisher Gentamicin assay as an alternative. Following the reintro-duction of the revised assay on 12 th September 2016, a second reagent recall was made on 20 th March 2017 after the discovery of a 20% negative analytical shift due to erroneous instrument adjustment factor. Materials and methods: The practices of an index laboratory were examined to determine how the analytical shifts evaded detection by routine internal quality control (IQC) and external quality assurance (EQA) systems. The ability of the patient result-based approaches, including moving average (MovAvg) and moving sum of outliers (MovSO) approaches in detecting these shifts were examined. Results: Internal quality control data of the index laboratory were acceptable prior to the product recall. The practice of adjusting IQC target following a change in assay method resulted in the missed negative shift when the revised Roche assay was reintroduced. While the EQA data of the Roche subgroup showed clear negative bias relative to other laboratory methods, the results were considered as possible ‘matrix effect’. The MovAvg method detected the positive shift before the product recall. The MovSO did not detect the negative shift in the index laboratory but did so in another laboratory 5 days before the second product recall. Conclusions: There are gaps in current laboratory quality practices that leave room for analytical errors to evade detection.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherCroatian Society of Medical Biochemistry
dc.relation.ispartofpagefrom1
dc.relation.ispartofpageto8
dc.relation.ispartofissue1
dc.relation.ispartofjournalBiochemia Medica
dc.relation.ispartofvolume28
dc.subject.fieldofresearchMedical Biochemistry and Metabolomics
dc.subject.fieldofresearchcode1101
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.subject.keywordsMedical Laboratory Technology
dc.subject.keywordserror
dc.subject.keywordsmoving average
dc.titleMissed detection of significant positive and negative shifts in gentamicin assay: implications for routine laboratory quality practices
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationKoerbin, G; Liu, J; Eigenstetter, A; Tan, CH; Badrick, T; Loh, TP, Missed detection of significant positive and negative shifts in gentamicin assay: implications for routine laboratory quality practices, Biochemia Medica, 2018, 28 (1), pp. 1-8
dcterms.dateAccepted2017-10-20
dcterms.licensehttp://creativecommons.org/licenses/by/4.0/
dc.date.updated2020-02-17T01:39:20Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© Copyright by Croatian Society of Medical Biochemistry and Laboratory Medicine. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) which permits users to read, download, copy, distribute, print, search, or link to the full texts of these articles in any medium or format and to remix, transform and build upon the material, provided the original work is properly cited and any changes properly indicated .
gro.hasfulltextFull Text
gro.griffith.authorBadrick, Tony C.


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