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La Rivista Italiana della Medicina di Laboratorio 2021 Feb 03

DOI: 10.23736/S1825-859X.21.00088-8

Copyright © 2021 EDIZIONI MINERVA MEDICA

language: Italian

Harmonization and reproducibility of ANA-IFI test results by automated computer-assisted diagnosis (CAD) systems

Luigi CINQUANTA 1 , Nicola BIZZARO 2

1 IRCCS S.D.N., Napoli, Italia; 2 Laboratorio di Patologia Clinica, Ospedale San Antonio, Tolmezzo, Azienda Sanitaria Universitaria Integrata di Udine, Tolmezzo, Udine, Italia


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The recent availability and increasingly diffusion of automated systems for the reading and interpretation of antibodies to cellular antigens (ANA) with the indirect immunofluorescence (IIF) method on HEp-2 cells has given new impetus to the process of harmonization and reproducibility of the results of the test. New computer-aided diagnosis (CAD) systems by virtue of the quantitative expression of fluorescence intensity, allow for the introduction of objective quality control procedures, essential for obtaining reproducible IIF test results and form the basis for harmonization of the results, regardless of the computer algorithms used in the different systems. Furthermore, the use of automated CAD systems, facilitating control procedures and ensuring full traceability of the sample during the analytical process, makes it possible to achieve ISO 15189 accreditation also for the autoimmunology laboratory. Finally, the possibility of obtaining continuous quantitative measurements of fluorescence intensity allows the expression of ANA test results in terms of likelihood ratio, with a further step towards the harmonization of HEp-2 IIF tests.


KEY WORDS: Harmonization; Standardization; Anti-nuclear antibodies; Computer-assisted diagnosis; Immunofluorescence; Quality assurance

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