Abstract
Antinuclear antibodies (ANA) represent a family of autoantibodies targeting ubiquitous cellular constituents and are a hallmark of systemic inflammatory autoimmune rheumatic diseases named connective tissue diseases (CTD). The gold standard method for ANA determination is indirect immunofluorescence (IIF) on the human laryngeal epidermoid carcinoma cell line type 2 substrate (HEp-2), but with increasing demand for ANA testing, novel methods eased for automation emerged, which allows testing by staff less experienced in this specific field of laboratory diagnostic. In 2016 The working group (WG) for laboratory diagnostics of autoimmune diseases as part of the Committee for the Scientific Professional Development of the Croatian Society of Medical Biochemistry and Laboratory Medicine (CSMBLM) published the data of a survey regarding general practice in laboratory diagnostics of autoimmune diseases in Croatia. Results indicated high diversity in the performance of autoantibody testing as well as reporting of the results and indicated the need of creating recommendations for the assessment of ANA that would help harmonize diagnostics of systemic autoimmune rheumatic diseases in Croatia. This document encompasses twenty-seven recommendations for ANA testing created concerning indications for ANA testing, preanalytical, analytical, and postanalytical issues, including rational algorithm and quality control assurance. These recommendations are based on the relevant international recommendations and guidelines for the assessment of ANA testing and relevant literature search and should help to harmonize the approach in ANA testing and clarify differences in interpretation of the results obtained using different methods of determination.
Highlights
Autoantibodies are a hallmark of autoimmunity, of which antinuclear antibodies (ANA) have the historically central role [1,2]
It should be noted that the detectable differences of ANA indirect immunofluorescence (IIF) method are typical + or - 2 serial, twofold dilutions [24] and are recommended as criteria for acceptance of difference between two measurements of the control sample
The International consensus on antinuclear antibody pattern (ICAP) intention/recommendation for pattern recognition is to differentiate them on two levels: Competent-level: patterns that are recognizable and are strongly recommended for reporting
Summary
Autoantibodies are a hallmark of autoimmunity, of which antinuclear antibodies (ANA) have the historically central role [1,2]. The growing number of newly characterized target autoantigens and evidence of their role in certain autoimmune diseases resulted in the continuing broadening of test panels with concomitant evolution of methods and analytical systems in this specific field of laboratory diagnostics. ©Copyright by Croatian Society of Medical Biochemistry and Laboratory Medicine.
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