ANA IIF Automation: Moving towards Harmonization? Results of a Multicenter Study.
Background. Our study aimed to investigate whether the introduction of automated anti-nuclear antibody (ANA) indirect immunofluorescence (IIF) analysis decreases the interlaboratory variability of ANA titer results.Method. Three serum samples were sent to 10 laboratories using the QUANTA-Lyser® in combination with the NOVA View®. Each laboratory performed the ANA IIF analysis 10x in 1 run and 1x in 10 different runs and determined the endpoint titer by dilution. One of the three samples had been sent in 2012, before the era of ANA IIF automation, by the Belgian National External Quality Assessment (EQA) Scheme. Harmonization was evaluated in terms of variability in fluorescence intensity (LIU) and ANA IIF titer.Results. The evaluation of the intra- and interrun LIU variability revealed a larger variability for 2 laboratories, due to preanalytical and analytical problems. Reanalysis of the EQA sample resulted in a lower titer variability. Diluted endpoint titers were similar to the estimated single well titer and the overall median titer as reported by the EQA in 2012.Conclusion.The introduction of automated microscopic analysis allows more harmonized ANA IIF reporting, provided that this totally automated process is controlled by a thorough quality assurance program, covering the total ANA IIF process.
Department of Laboratory Medicine, OLV Hospital, Aalst, Belgium.
Stefanie
0000-0002-4352-5208
S
Van den Bremt
Department of Laboratory Medicine, GZA Hospitals, Antwerp, Belgium.
Sofie
S
Schouwers
Scientific Institute of Public Health (WIV-ISP), Brussels, Belgium.
Marjan
M
Van Blerk
Department of Laboratory Medicine, OLV Hospital, Aalst, Belgium.
Lieve
0000-0002-3462-7288
L
Van Hoovels
D000974:Antibodies, Antinuclear / Q000097:blood*; D057205:Automation, Laboratory; D001530:Belgium; D003424:Crohn Disease / Q000175:diagnosis* / Q000453:epidemiology; D019084:Fluorescent Antibody Technique, Indirect / Q000295:instrumentation / Q000379:methods; D006801:Humans; D008856:Microscopy, Fluorescence; D015588:Observer Variation; D011785:Quality Assurance, Health Care; D015203:Reproducibility of Results; D012859:Sjogren's Syndrome / Q000175:diagnosis* / Q000453:epidemiology; D013673:Technology Assessment, Biomedical
D000974:Antibodies, Antinuclear