Authors: Raymond E Biagini Christine G Parks Jerome P Smith Deborah L Sammons Shirley A Robertson
Publish Date: 2007/04/03
Volume: 388, Issue: 3, Pages: 613-618
Abstract
The purpose of this study was to evaluate the precision and accuracy of a commercial multiplexed kit for the measurement of 9 antinuclear antibodies ANAs antiSS/A antiSS/B antiSm antiRNP antiJo1 antiScl70 antidsDNA antiCentromere B and antiHistone and to compare these results to a subset of ANAs measured by enzymelinked immunosorbent assays ELISA and immunodiffusion ID Sera were obtained from 22 systemic lupus erythematosus SLE patients twelve controls and five others commercial source with various autoimmune diseases ANA results from the AtheNA MultiLyte® ANA II Assay AtheNA were compared to ELISA results controls and patients ID The AtheNA interassay coefficients of variation CVs N = 39 performed in duplicate replicated 3× ranged from 62 to 167 mean = 98 while the intraassay CVs ranged from 58 to 143 mean = 108 Compared to results for SLE cases and controls the sensitivity of AtheNA ranged from 857 to 100 mean = 971 while diagnostic specificity ranged from 167 to 100 mean = 716 There was significant agreement P values ranging from 00001 to 003 when analytes coanalyzed by AtheNA and ELISA/ID were evaluated using Cohen’s kappa κ values ranging from 0376 to 1000 No false positive ANA results were observed for either the control or commercial source autoimmune disease sera These results indicate that the AtheNA assay is a precise and accurate alternative for performing multiple ELISAs or IDs in the diagnosis of autoimmune diseases especially when the number of sera to be tested is large such as in clinical screening or epidemiologic studies It also appears that the AtheNA assay identifies positive ANA specificities which are missed by ID techniques suggesting that it may have greater analytical sensitivity for some ANAsMention of a product or company name does not constitute endorsement by NIOSH This work was supported in part by an interagency agreement between NIOSH and NIEHS Y1ES0001Clinical Immunotoxicity The content and conclusions of this report are those of the authors and do not necessarily represent the views of the National Institute for Occupational Safety and Health
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