Table 2.

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

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)