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Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay
Published on: September 16, 2012
A multicenter comparison of MOG-IgG cell-based assays
Patrick J Waters1, Lars Komorowski1, Mark Woodhall1
1From the Oxford Autoimmune Neurology Group (P.J.W., M.W., S.R.I.), Nuffield Department of Clinical Neurosciences, UK; Institute for Experimental Immunology (L.K., S.L.), Affiliated to Euroimmun AG, Luebeck, Germany; and Departments of Neurology (M.M., E.P.F., A.C.K., A.M., S.J.P.) and Laboratory Medicine and Pathology (J.F., J.M., E.P.F., A.C.K., A.M., S.J.P.), Mayo Clinic, College of Medicine, Rochester, MN.
Three myelin oligodendrocyte glycoprotein-immunoglobulin G (IgG) cell-based assays (CBAs) show high agreement. Live cell assays offer more reliable results for MOG autoimmune disorders.
Area of Science:
- Neuroimmunology
- Autoimmune Disorders
- Diagnostic Assays
Background:
- Myelin oligodendrocyte glycoprotein-immunoglobulin G (MOG-IgG) is a key biomarker for certain autoimmune neurological disorders.
- Standardization of MOG-IgG detection methods is crucial for accurate diagnosis and patient management.
- Existing cell-based assays (CBAs) for MOG-IgG vary across different international centers.
Purpose of the Study:
- To compare the performance of three distinct MOG-IgG CBAs from different international laboratories.
- To assess the concordance and diagnostic reliability of fixed and live cell-based assay methodologies.
- To evaluate the clinical specificity and predictive values of these MOG-IgG assays.
Main Methods:
- Serum samples from 394 patients, including those with MOG-IgG-associated disorders and controls, were analyzed.
- Three CBAs were employed: Euroimmun fixed CBA, Oxford live cell CBA, and Mayo live cell fluorescence-activated cell sorting (FACS) assay.
- Seropositivity was determined by visual microscopy or flow cytometry.
Main Results:
- A high overall agreement was observed among the three MOG-IgG CBAs.
- Live cell-based assays demonstrated superior positive predictive values (PPVs) compared to the fixed cell assay.
- Clinical specificities ranged from 98.1% to 100%, and PPVs ranged from 82.1% to 100%.
Conclusions:
- The study confirms a high degree of concordance across different MOG-IgG CBAs.
- Live cell-based MOG-IgG assays are more reliable indicators of MOG autoimmune spectrum disorders due to their higher PPVs.
- These findings support the use of standardized live cell assays for improved diagnosis of MOG-IgG-associated conditions.
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