Background: Several automated systems had been developed in order to reduce inter-observer variability in
indirect immunofluorescence (IIF) interpretation. We aimed to evaluate the performance of a processing system in
antinuclear antibodies (ANA) screening on HEp-2 cells.
Patients and Methods: This study included 64 ANA-positive sera and 107 ANA-negative sera that underwent IIF on two
commercial kits of HEp-2 cells (BioSystems® and Euroimmun®). IIF results were compared with a novel automated
interpretation system, the “CyclopusCADImmuno®” (CAD).
Results: All ANA-positive sera images were recognized as positive by CAD (sensitivity = 100%), while 17 (15.9%) of the
ANA-negative sera images were interpreted as positive (specificity = 84.1%), =0.799 (SD=0.045). Comparison of IIF
pattern determination between human and CAD system revealed on HEp-2 (BioSystems®), a complete concordance in
6 (9.37%) sera, a partial concordance (sharing of at least 1 pattern) in 42 (65.6%) cases and in 16 (25%) sera the
pattern interpretation was discordant. Similarly, on HEp-2 (Euroimmun®) the concordance in pattern interpretation was
total in 5 (7.8%) sera, partial in 39 (60.9%) and absent in 20 (31.25%). For both tested HEp-2 cells kits agreement was
enhanced for the most common patterns, homogenous, fine speckled and coarse speckled. While there was an issue in
identification of nucleolar, dots and nuclear membranous patterns by CAD.
Conclusion: Assessment of ANA by IIF on HEp-2 cells using the automated interpretation system, the
“CyclopusCADImmuno®” is a reliable method for positive/negative differentiation. Continuous integration of IIF images
would improve the pattern identification by the CAD