Abstract
The recent availability of automated computer-assisted diagnosis (CAD) systems for the reading and interpretation of the anti-nuclear antibody (ANA) test performed with the indirect immunofluorescence (IIF) method on HEp-2 cells, has improved the reproducibility of the results and initiated a process of harmonization of this test. Furthermore, CAD systems provide quantitative expression of fluorescence intensity, allowing the introduction of objective quality control procedures to the monitoring of the entire process. The calibration of the reading systems and the automated image interpretation are essential prerequisites for obtaining reproducible and harmonized IIF test results and form the basis for standardization, regardless of the computer algorithms used in the different systems. The use of automated CAD systems, facilitating control procedures, represents a step forward for the quality certification of the laboratory.
Highlights
The indirect immunofluorescence (IIF) assay on HEp-2 cells is considered the reference method for the screening of anti-nuclear antibodies (ANA) and plays a central role in the diagnosis of autoimmune rheumatic diseases
The most important cause of variability in the detection of HEp-2 IIF anti-nuclear antibody (ANA) is represented by the subjectivity in titer and pattern interpretation, even when the reading is performed by expert personnel [10, 11]
The greater reproducibility of the results provided by the new automatic methods was demonstrated in a study that compared the analytical imprecision of six computer-assisted diagnosis (CAD) systems vs. the manual HEp-2 IIF method
Summary
The indirect immunofluorescence (IIF) assay on HEp-2 cells is considered the reference method for the screening of anti-nuclear antibodies (ANA) and plays a central role in the diagnosis of autoimmune rheumatic diseases. Its high diagnostic sensitivity allows the detection of over 30 different fluorescence patterns, corresponding to as many autoantibody specificities [1,2,3,4]. The HEp-2 IIF method is currently limited by a low level of harmonization. Major drawbacks are high intra and inter-laboratory variability, semiquantitative expression of results and lack of specificity. It was pointed out that the high variability of the method jeopardizes the selection of patients to be included in clinical trials for the evaluation of therapeutic protocols [9].
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