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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Tate, Jillian R. / Tsongalis, Gregory J.

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Screening of antinuclear antibodies: comparison between enzyme immunoassay based on nuclear homogenates, purified or recombinant antigens and immunofluorescence assay

Sergio Bernardini1 / Maria Infantino2 / Lorenza Bellincampi3 / Marzia Nuccetelli4 / Antonella Afeltra5 / Roberta Iori6 / Antonino Biroccio7 / Andrea Urbani8 / Giorgio Federici9










Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 42, Issue 10, Pages 1155–1160, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2004.235, October 2004

Publication History

July 9, 2004
July 12, 2004


Current clinical practice considers antinuclear antibody (ANA) testing as a screening test; this has a major impact on laboratory work with a growing volume of analyses that need to be performed rapidly, to maintain good specificity and sensitivity. Ongoing discussions have been raised in order to identify the best technology to use in ANA screening, taking into account both clinical and economical implications. The aim of our study was to compare three different enzyme immunoassays (EIA) with immunofluorescence (IF) assay in order to identify which test is better for use as a screening test. The study was performed on 473 sera and the three different EIA tests were based on nuclear homogenates from HeLa cells, purified antigens from HEp-2 cells and recombinant antigens, respectively. The concordance between EIA-ANA and IF-ANA techniques, determined by the κ statistic, was acceptable, but not complete, and discrepancies between both EIA-positive/IF-negative samples and IF-positive/EIA-negative were found. Both methods show interesting diagnostic abilities, however, the IF-ANA assay seems to be the first choice test in a well-standardized immunofluorescence laboratory with experienced microscopists, whereas the EIA test might be useful especially in large-scale ANA screening.

Keywords: antinuclear antibody; immunofluorescence; enzyme immunoassay

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