Autoimmune rheumatologic diseases

Oral

Variability in Method of Testing for Antinuclear Antibodies (ana): A Survey of Participants in the College of American Pathologist’s (cap) Proficiency Testing Program

Wednesday, June 14
6:15 PM - 7:45 PM

A 2010 American College of Rheumatology position paper designated indirect immunofluorescence assay (IFA) on HEp-2 cells the "gold standard" for ANA testing and that laboratories performing other methods should state the method used and describe its performance parameters. Laboratories participating in CAP proficiency testing for ANA answered supplemental questions in 2016. Of 5847 kits distributed, 1206 (21%) participants responded (942 in the US and 264 international). ANA screening method varied: 56% IFA, 21% ELISA, 12% multi-bead immunoassay, and 18% "other" methods. Ordering test name indicated method used in only 32%; only 39% stated method used on the report. Of 644 laboratories, 80% used HEp-2 substrate, 18% HEp-2000 (HEp-2 cell line engineered to overexpress SSA), 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%). IFA patterns were interpreted by personnel in 95% of laboratories; < 1% used automated image capture and analysis solely; 4% interpreted images both by personnel and an automated platform. 97% of 641 laboratories reporting ANA by IFA provided a titer. Only 51% reported a positive result at the traditional 1:40 dilution. Titer was reported to endpoint routinely by 43%, only upon request by 23%, or never by 35%. 8% did not report dual patterns. Of those reporting multiple patterns, 24% did not report a titer with each pattern. In conclusion, only slightly more than half of testing laboratories utilize the ACR "gold standard" IFA method using HEp-2 cells.

Stanley J. Naides

Medical Director, Immunology
Quest Diagnostics Nichols Institute

Presentation(s):

    Send Email for Stanley Naides

    Jonathan R. Genzen

    Assistant Professor / Medical Director of Automated Core Laboratory
    University of Utah / ARUP

    Presentation(s):

      Send Email for Jonathan Genzen

      Gyorgy Abel

      Director of Clinical Chemistry, Molecular Diagnostics, and Immunology
      Lahey Clinic Burlington

      Presentation(s):

        Send Email for Gyorgy Abel

        Mu Shan

        Biostatistician
        College of American Pathologists

        Presentation(s):

          Send Email for Mu Shan

          Christine Bashleben

          Senior Technical Specialist, Surveys
          College of American Pathologists

          Presentation(s):

            Send Email for Christine Bashleben

            Mohammad Qasim Ansari

            Professor of Pathology, Medical Director, Immunopathology Laboratory
            Cleveland Clinic Lerner College of Medicine

            Presentation(s):

              Send Email for Mohammad Qasim Ansari


              Assets

              Variability in Method of Testing for Antinuclear Antibodies (ana): A Survey of Participants in the College of American Pathologist’s (cap) Proficiency Testing Program



              Attendees who have favorited this

              Send Email for Variability in Method of Testing for Antinuclear Antibodies (ana): A Survey of Participants in the College of American Pathologist’s (cap) Proficiency Testing Program