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dc.contributor.authorLiu, Jiakai
dc.contributor.authorTan, Chin Hon
dc.contributor.authorBadrick, Tony
dc.contributor.authorLoh, Tze Ping
dc.description.abstractBackground: Recently, the total prostate-specific antigen (PSA) assay used in a laboratory had a positive bias of 0.03 μg/L, which went undetected. Consequently, a number of post-prostatectomy patients with previously undetectable PSA concentrations (defined as <0.03 μg/L in that laboratory) were being reported as having detectable PSA, which suggested poorer prognosis according to clinical guidelines. Methods: Through numerical simulations, we explored (1) how a small bias may evade the detection of routine quality control (QC) procedures with specific reference to the concentration of the QC material, (2) whether the use of 'average of normals' approach may detect such a small bias, and (3) describe the use of moving sum of number of patient results with detectable PSA as an adjunct QC procedure. Results: The lowest QC level (0.86 μg/L) available from a commercial kit had poor probability (<10%) of a bias of 0.03 μg/L regardless of QC rule (i.e. 1:2S, 2:2S, 1:3S, 4:1S) used. The average number of patient results affected before error detection (ANPed) was high when using the average of normals approach due to the relatively wide control limits. By contrast, the ANPed was significantly lower for the moving sum of number of patient results with a detectable PSA approach. Conclusions: Laboratory practitioners should ensure their QC strategy can detect small but critical bias, and may require supplementation of ultra-low QC levels that are not covered by commercial kits with in-house preparations. The use of moving sum of number of patient results with a detectable result is a helpful adjunct QC tool.en_US
dc.publisherDe Gruyteren_US
dc.relation.ispartofjournalClinical Chemistry and Laboratory Medicineen_US
dc.subject.keywordsScience & Technologyen_US
dc.subject.keywordsLife Sciences & Biomedicineen_US
dc.subject.keywordsMedical Laboratory Technologyen_US
dc.subject.keywordsanalytical erroren_US
dc.subject.keywordsaverage of normalen_US
dc.titleMoving sum of number of positive patient results as a quality control toolen_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Articlesen_US
dcterms.bibliographicCitationLiu, J; Tan, CH; Badrick, T; Loh, TP, Moving sum of number of positive patient results as a quality control tool, Clinical Chemistry and Laboratory Medicine, 2017, 55 (11), pp. 1709-1714en_US
gro.hasfulltextNo Full Text
gro.griffith.authorBadrick, Tony C.

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