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dc.contributor.authorLopez, Joseph A
dc.contributor.authorHouston, Samuel D
dc.contributor.authorTea, Fiona
dc.contributor.authorMerheb, Vera
dc.contributor.authorLee, Fiona XZ
dc.contributor.authorSmith, Sandy
dc.contributor.authorMcDonald, David
dc.contributor.authorZou, Alicia
dc.contributor.authorLiyanage, Ganesha
dc.contributor.authorPilli, Deepti
dc.contributor.authorDenkova, Martina
dc.contributor.authorLechner-Scott, Jeannette
dc.contributor.authorvan der Walt, Anneke
dc.contributor.authorBarnett, Michael H
dc.contributor.authorBroadley, Simon
dc.contributor.authoret al.
dc.date.accessioned2021-11-04T01:32:51Z
dc.date.available2021-11-04T01:32:51Z
dc.date.issued2021
dc.identifier.issn2576-9456
dc.identifier.doi10.1093/jalm/jfab101
dc.identifier.urihttp://hdl.handle.net/10072/409771
dc.description.abstractBACKGROUND: Myelin oligodendrocyte glycoprotein antibodies (MOG Ab) are essential in the diagnosis of MOG Ab-associated disease (MOGAD). Live cell-based assays (CBAs) are the gold standard for MOG Ab detection with improved sensitivity and specificity over fixed CBAs. A number of testing centers have used flow cytometry for its high throughput and quantitative utility. Presently, there is increasing demand to translate these research-based methods into an accredited routine diagnostic setting. METHODS: A flow cytometry live CBA was used to detect MOG Ab in patients with demyelination. Serostatuses were compared between a research-based assay and a streamlined diagnostic assay. Inter-laboratory validation of the streamlined assay was performed in an accredited diagnostic laboratory. Further streamlining was performed by introducing a borderline serostatus range and reducing the number of controls used to determine the positivity threshold. RESULTS: High serostatus agreement (98%-100%) was observed between streamlined and research-based assays. Intra- and inter-assay imprecision was improved in the streamlined assay (mean intra- and inter-assay CV = 7.3% and 27.8%, respectively) compared to the research-based assay (mean intra- and inter-assay CV = 11.8% and 33.6%, respectively). Borderline positive and clear positive serostatuses were associated with confirmed phenotypes typical of MOGAD. Compared to using 24 controls, robust serostatus classification was observed when using 13 controls without compromising analytical performance (93%-98.5% agreement). CONCLUSIONS: Flow cytometry live CBAs show robust utility in determining MOG Ab serostatus. Streamlining and standardizing use of this assay for diagnostics would improve the accuracy and reliability of routine testing to aid diagnosis and treatment of patients with demyelination.
dc.description.peerreviewedYes
dc.languageeng
dc.publisherOxford University Press (OUP)
dc.relation.ispartofjournalThe Journal of Applied Laboratory Medicine
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchNeurosciences
dc.subject.fieldofresearchcode3202
dc.subject.fieldofresearchcode3209
dc.subject.keywordsMOG antibody
dc.subject.keywordsdemyelinating disorders
dc.subject.keywordsdiagnostic validation
dc.subject.keywordsflow cytometry
dc.titleValidation of a Flow Cytometry Live Cell-Based Assay to Detect Myelin Oligodendrocyte Glycoprotein Antibodies for Clinical Diagnostics
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationLopez, JA; Houston, SD; Tea, F; Merheb, V; Lee, FXZ; Smith, S; McDonald, D; Zou, A; Liyanage, G; Pilli, D; Denkova, M; Lechner-Scott, J; van der Walt, A; Barnett, MH; Broadley, S;et al., Brilot, F, Validation of a Flow Cytometry Live Cell-Based Assay to Detect Myelin Oligodendrocyte Glycoprotein Antibodies for Clinical Diagnostics., The Journal of Applied Laboratory Medicine, 2021
dcterms.dateAccepted2021-07-29
dcterms.licensehttp://creativecommons.org/licenses/by-nc/4.0/
dc.date.updated2021-11-03T21:51:42Z
dc.description.versionVersion of Record (VoR)
gro.description.notepublicThis publication has been entered as an advanced online version in Griffith Research Online.
gro.rights.copyright© American Association for Clinical Chemistry 2021. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
gro.hasfulltextFull Text
gro.griffith.authorBroadley, Simon
dc.subject.socioeconomiccode2001 Clinical health


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