Application of statistical process control to qualitative molecular diagnostic assays

Hdl Handle:
http://hdl.handle.net/10147/337121
Title:
Application of statistical process control to qualitative molecular diagnostic assays
Authors:
O'Brien, Cathal P.; Finn, Stephen P.
Affiliation:
St. James's Hospital
Citation:
Front. Mol. Biosci., 05 November 2014 | doi: 10.3389/fmolb.2014.00018
Journal:
Front. Mol. Biosci.
Issue Date:
Nov-2014
URI:
http://hdl.handle.net/10147/337121
Abstract:
Modern pathology laboratories and in particular high throughput laboratories such as clinical chemistry have developed a reliable system for statistical process control (SPC). Such a system is absent from the majority of molecular laboratories and where present is confined to quantitative assays. As the inability to apply SPC to an assay is an obvious disadvantage this study aimed to solve this problem by using a frequency estimate coupled with a confidence interval calculation to detect deviations from an expected mutation frequency. The results of this study demonstrate the strengths and weaknesses of this approach and highlight minimum sample number requirements. Notably, assays with low mutation frequencies and detection of small deviations from an expected value require greater sample numbers to mitigate a protracted time to detection. Modeled laboratory data was also used to highlight how this approach might be applied in a routine molecular laboratory. This article is the first to describe the application of SPC to qualitative laboratory data.
Item Type:
Article
Language:
en
Keywords:
PATHOLOGY; LABORATORIES
Local subject classification:
STATISTICAL PROCESS CONTROL

Full metadata record

DC FieldValue Language
dc.contributor.authorO'Brien, Cathal P.en_GB
dc.contributor.authorFinn, Stephen P.en_GB
dc.date.accessioned2014-12-12T15:32:25Z-
dc.date.available2014-12-12T15:32:25Z-
dc.date.issued2014-11-
dc.identifier.citationFront. Mol. Biosci., 05 November 2014 | doi: 10.3389/fmolb.2014.00018en_GB
dc.identifier.urihttp://hdl.handle.net/10147/337121-
dc.description.abstractModern pathology laboratories and in particular high throughput laboratories such as clinical chemistry have developed a reliable system for statistical process control (SPC). Such a system is absent from the majority of molecular laboratories and where present is confined to quantitative assays. As the inability to apply SPC to an assay is an obvious disadvantage this study aimed to solve this problem by using a frequency estimate coupled with a confidence interval calculation to detect deviations from an expected mutation frequency. The results of this study demonstrate the strengths and weaknesses of this approach and highlight minimum sample number requirements. Notably, assays with low mutation frequencies and detection of small deviations from an expected value require greater sample numbers to mitigate a protracted time to detection. Modeled laboratory data was also used to highlight how this approach might be applied in a routine molecular laboratory. This article is the first to describe the application of SPC to qualitative laboratory data.en_GB
dc.language.isoenen
dc.subjectPATHOLOGYen_GB
dc.subjectLABORATORIESen_GB
dc.subject.otherSTATISTICAL PROCESS CONTROLen_GB
dc.titleApplication of statistical process control to qualitative molecular diagnostic assaysen_GB
dc.typeArticleen
dc.contributor.departmentSt. James's Hospitalen_GB
dc.identifier.journalFront. Mol. Biosci.en_GB
dc.description.fundingNo fundingen
dc.description.provinceLeinsteren
dc.description.peer-reviewpeer-reviewen
dc.description.notesThis paper won a HSE Open Access Research Award 2014 in the category of National Cancer Control Programmes.-
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