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Table 3 Recommendations of the Clinical and Laboratory Standards Institute’s document I/LA2-A2 for Intralaboratory Quality Control on IIF-ANA and ELISA-ANA

From: Missing links in high quality diagnostics of inflammatory systemic rheumatic diseases

• Use in-house negative and positive controls with each assay
• Positive control should be chosen at a level that is important for clinical decision making
• Put in the analytical series a number of previously tested negative and positive sera for the purpose of making lot-to-lot comparisons of test reagents
• Definition of acceptable variability defined by the laboratory
• In terms of overall (qualitative) concordance/discordance with previous results or additional quantitative criteria, e.g., at least 85 % of results giving numerically equivalent results with both lots
• Monitor the frequencies of test results that fall in different reference range categories, e.g., negative, borderline (equivocal), or positive