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Research ArticleArticle

Antinuclear Antibodies Testing Method Variability: A Survey of Participants in the College of American Pathologists’ Proficiency Testing Program

Stanley J. Naides, Jonathan R. Genzen, Gyorgy Abel, Christine Bashleben and M. Qasim Ansari
The Journal of Rheumatology March 2020, jrheum.190933; DOI: https://doi.org/10.3899/jrheum.190933
Stanley J. Naides
S.J. Naides, MD, Scientific Affairs, Euroimmun US, a PerkinElmer company, Mountain Lakes, New Jersey, and Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois; J.R. Genzen, MD, PhD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Pathology, University of Utah / ARUP Laboratories, Salt Lake City, Utah; G. Abel, MD, PhD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Laboratory Medicine and Pathology, Lahey Hospital & Medical Center, Beth Israel Lahey Health, Burlington, Massachusetts; C. Bashleben, MT, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois; M.Q. Ansari, MD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Pathology and Laboratory Medicine, Louis Stokes VAMC, Cleveland, Ohio, USA. This work was supported by the College of American Pathologists Diagnostic Immunology and Flow Cytometry Committee. Dr. S.J. Naides is employed by Euroimmun US. Dr. J.R. Genzen is employed by University of Utah/ARUP Laboratories, and is the principal investigator and contract researcher at ARUP Laboratories, Fujirebio Diagnostics. Address correspondence to Dr. S.J. Naides, Euroimmun US, 1 Bloomfield Avenue, Mountain Lakes, NJ 07046, USA. Email: stanley.naides@euroimmun.us. Accepted for publication February 28, 2020.
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Jonathan R. Genzen
S.J. Naides, MD, Scientific Affairs, Euroimmun US, a PerkinElmer company, Mountain Lakes, New Jersey, and Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois; J.R. Genzen, MD, PhD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Pathology, University of Utah / ARUP Laboratories, Salt Lake City, Utah; G. Abel, MD, PhD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Laboratory Medicine and Pathology, Lahey Hospital & Medical Center, Beth Israel Lahey Health, Burlington, Massachusetts; C. Bashleben, MT, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois; M.Q. Ansari, MD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Pathology and Laboratory Medicine, Louis Stokes VAMC, Cleveland, Ohio, USA. This work was supported by the College of American Pathologists Diagnostic Immunology and Flow Cytometry Committee. Dr. S.J. Naides is employed by Euroimmun US. Dr. J.R. Genzen is employed by University of Utah/ARUP Laboratories, and is the principal investigator and contract researcher at ARUP Laboratories, Fujirebio Diagnostics. Address correspondence to Dr. S.J. Naides, Euroimmun US, 1 Bloomfield Avenue, Mountain Lakes, NJ 07046, USA. Email: stanley.naides@euroimmun.us. Accepted for publication February 28, 2020.
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Gyorgy Abel
S.J. Naides, MD, Scientific Affairs, Euroimmun US, a PerkinElmer company, Mountain Lakes, New Jersey, and Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois; J.R. Genzen, MD, PhD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Pathology, University of Utah / ARUP Laboratories, Salt Lake City, Utah; G. Abel, MD, PhD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Laboratory Medicine and Pathology, Lahey Hospital & Medical Center, Beth Israel Lahey Health, Burlington, Massachusetts; C. Bashleben, MT, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois; M.Q. Ansari, MD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Pathology and Laboratory Medicine, Louis Stokes VAMC, Cleveland, Ohio, USA. This work was supported by the College of American Pathologists Diagnostic Immunology and Flow Cytometry Committee. Dr. S.J. Naides is employed by Euroimmun US. Dr. J.R. Genzen is employed by University of Utah/ARUP Laboratories, and is the principal investigator and contract researcher at ARUP Laboratories, Fujirebio Diagnostics. Address correspondence to Dr. S.J. Naides, Euroimmun US, 1 Bloomfield Avenue, Mountain Lakes, NJ 07046, USA. Email: stanley.naides@euroimmun.us. Accepted for publication February 28, 2020.
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Christine Bashleben
S.J. Naides, MD, Scientific Affairs, Euroimmun US, a PerkinElmer company, Mountain Lakes, New Jersey, and Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois; J.R. Genzen, MD, PhD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Pathology, University of Utah / ARUP Laboratories, Salt Lake City, Utah; G. Abel, MD, PhD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Laboratory Medicine and Pathology, Lahey Hospital & Medical Center, Beth Israel Lahey Health, Burlington, Massachusetts; C. Bashleben, MT, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois; M.Q. Ansari, MD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Pathology and Laboratory Medicine, Louis Stokes VAMC, Cleveland, Ohio, USA. This work was supported by the College of American Pathologists Diagnostic Immunology and Flow Cytometry Committee. Dr. S.J. Naides is employed by Euroimmun US. Dr. J.R. Genzen is employed by University of Utah/ARUP Laboratories, and is the principal investigator and contract researcher at ARUP Laboratories, Fujirebio Diagnostics. Address correspondence to Dr. S.J. Naides, Euroimmun US, 1 Bloomfield Avenue, Mountain Lakes, NJ 07046, USA. Email: stanley.naides@euroimmun.us. Accepted for publication February 28, 2020.
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M. Qasim Ansari
S.J. Naides, MD, Scientific Affairs, Euroimmun US, a PerkinElmer company, Mountain Lakes, New Jersey, and Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois; J.R. Genzen, MD, PhD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Pathology, University of Utah / ARUP Laboratories, Salt Lake City, Utah; G. Abel, MD, PhD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Laboratory Medicine and Pathology, Lahey Hospital & Medical Center, Beth Israel Lahey Health, Burlington, Massachusetts; C. Bashleben, MT, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois; M.Q. Ansari, MD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Pathology and Laboratory Medicine, Louis Stokes VAMC, Cleveland, Ohio, USA. This work was supported by the College of American Pathologists Diagnostic Immunology and Flow Cytometry Committee. Dr. S.J. Naides is employed by Euroimmun US. Dr. J.R. Genzen is employed by University of Utah/ARUP Laboratories, and is the principal investigator and contract researcher at ARUP Laboratories, Fujirebio Diagnostics. Address correspondence to Dr. S.J. Naides, Euroimmun US, 1 Bloomfield Avenue, Mountain Lakes, NJ 07046, USA. Email: stanley.naides@euroimmun.us. Accepted for publication February 28, 2020.
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Abstract

Objective This study was conducted to determine the spectrum of laboratory practices in antinuclear antibody (ANA) test target, performance, and result reporting.

Methods A questionnaire on ANA testing was distributed by the Diagnostic Immunology and Flow Cytometry Committee 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, 21% ELISA, 12% multibead immunoassay, and 18% other methods. The name of the test indicated the method used in only 32% of laboratories; only 39% stated the 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% other. 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. Titer was reported to endpoint routinely by 43%, only upon request by 23%, or never by 35%. Of the laboratories, 8% did not report dual patterns. Of those reporting multiple patterns, 23% did not report a titer 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.

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The Journal of Rheumatology
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1 Jan 2021
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Antinuclear Antibodies Testing Method Variability: A Survey of Participants in the College of American Pathologists’ Proficiency Testing Program
Stanley J. Naides, Jonathan R. Genzen, Gyorgy Abel, Christine Bashleben, M. Qasim Ansari
The Journal of Rheumatology Mar 2020, jrheum.190933; DOI: 10.3899/jrheum.190933

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Antinuclear Antibodies Testing Method Variability: A Survey of Participants in the College of American Pathologists’ Proficiency Testing Program
Stanley J. Naides, Jonathan R. Genzen, Gyorgy Abel, Christine Bashleben, M. Qasim Ansari
The Journal of Rheumatology Mar 2020, jrheum.190933; DOI: 10.3899/jrheum.190933
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