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Table 2 Items in the clinical and laboratory standards institute’s document I/LA2-A2 on the quality in the autoimmunology laboratory

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

Part I. Indirect immunofluorescence test for antinuclear antibodies (IF-ANA)
Principles of the IF-ANA test
Patient specimen and collection procedure
Substrate and fixative variations
Fixation of substrate tissues
SS-A/Ro antigen
Fluorochrome-labeled conjugates
Working dilution
Polyvalent and IgG-specific conjugates
Reference preparation of fluorochrome-labeled conjugates
Microscope optics
Part II. The enzyme immunoassay test (ELISA-ANA)
Assay requirements
Solid phase with adsorbed nuclear antigens
Enzyme-labeled (second stage) detection antibody (conjugate)
Standards, calibrators, and controls
Wash solutions and other reagents
Assay validation
Assay validation from the manufacturer’s perspective
Assay validation from the user’s perspective
ELISA enzyme-labeled conjugates
ELISA detection methods
Technical considerations
Alternative, emerging solid-phase technologies
Part III. Quantitation of antibodies, reference intervals and reporting of test results, and intralaboratory quality control
Quantitation of antibodies
Reference intervals and reporting of results
Intralaboratory quality control
Reference preparations for ANA tests
Definitions and nomenclature
WHO/IUIS reference preparations
AF/CDC reference sera for autoantibodies to nuclear and intracellular antigens
College of American pathologists reference serum for anti-SS-A/Ro antibodies
ANA reference preparations of association of medical laboratory immunologists (AMLI)