@article {Naidesjrheum.190933, author = {Stanley J. Naides and Jonathan R. Genzen and Gyorgy Abel and Christine Bashleben and M. Qasim Ansari}, title = {Antinuclear Antibodies (ANA) Testing Method Variability: A Survey of Participants in the College of American Pathologists{\textquoteright} (CAP) Proficiency Testing Program}, elocation-id = {jrheum.190933}, year = {2020}, doi = {10.3899/jrheum.190933}, publisher = {The Journal of Rheumatology}, abstract = {Objective This study was conducted to determine the spectrum of laboratory practices in ANA test target, performance and result reporting. Methods A questionnaire on ANA testing was distributed by the Diagnostic Immunology and Flow Cytometry Committee (DIFCC) of the College of American Pathologists (CAP) to laboratories participating in the 2016 CAP ANA proficiency survey. Results Of 5847 survey kits distributed, 1206 (21\%) responded. ANA screening method varied: 55\% indirect immunofluorescence assay (IFA), 21\% enzyme linked immunosorbent assay (ELISA), 12\% multi-bead immunoassay, and 18\% {\textquotedblleft}other{\textquotedblright} methods. Ordering test name indicated method used in only 32\% of laboratories; only 39\% stated method used on the report. Of 644 laboratories, 80\% used HEp-2 cell substrate, 18\% HEp-2000 (HEp-2 cell line engineered to overexpress SSA antigen, Ro60), and 2\% {\textquotedblleft}other.{\textquotedblright} Slides were prepared manually (67\%) or on an automated platform (33\%), and examined by direct microscopy (84\%) or images captured by an automated platform (16\%). Only 50\% reported a positive result at the customary 1:40 dilution. Titre was reported to endpoint routinely by 43\%, only upon request by 23\%, or never by 35\%. 8\% of laboratories did not report dual patterns. Of those reporting multiple patterns, 23\% did not report a titre with each pattern. Conclusion ANA methodology and practice and test naming and reporting varies significantly between laboratories. Lack of uniformity in testing and reporting practice and lack of transparency in communicating the testing method may misdirect clinicians in their management of patients.}, issn = {0315-162X}, URL = {https://www.jrheum.org/content/early/2020/03/09/jrheum.190933}, eprint = {https://www.jrheum.org/content/early/2020/03/09/jrheum.190933.full.pdf}, journal = {The Journal of Rheumatology} }