Anne E Tebo1,2, Robert L Schmidt3,4, Kamran Kadkhoda5, Lisa K Peterson3,4, Edward K L Chan6, Marvin J Fritzler7, Mark H Wener8. 1. Department of Pathology, University of Utah, Salt Lake City, UT, USA. anne.tebo@hsc.utah.edu. 2. ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, USA. anne.tebo@hsc.utah.edu. 3. Department of Pathology, University of Utah, Salt Lake City, UT, USA. 4. ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, USA. 5. Immunopathology Laboratory, Robert J. Tomsich Pathology & Laboratory Medicine Institute, Cleveland Clinic, Cleveland, OH, USA. 6. Department of Oral Biology, University of Florida, Gainesville, FL, USA. 7. Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. 8. Department of Laboratory Medicine and Pathology & Department of Medicine, University of Washington, Seattle, WA, USA.
Abstract
BACKGROUND: To evaluate the interpretation and reporting of antinuclear antibodies (ANA) by indirect immunofluorescence assay (IFA) using HEp-2 substrates based on common practice and guidance by the International Consensus on ANA patterns (ICAP). METHOD: Participants included two groups [16 clinical laboratories (CL) and 8 in vitro diagnostic manufacturers (IVD)] recruited via an email sent to the Association of Medical Laboratory Immunologists (AMLI) membership. Twelve (n = 12) pre-qualified specimens were distributed to participants for testing, interpretation and reporting HEp-2 IFA. Results obtained were analyzed for accuracy with the intended and consensus response for three main categorical patterns (nuclear, cytoplasmic and mitotic), common patterns and ICAP report nomenclatures. The distributions of antibody titers of specimens were also compared. RESULTS: Laboratories differed in the categorical patterns reported; 8 reporting all patterns, 3 reporting only nuclear patterns and 5 reporting nuclear patterns with various combinations of other patterns. For all participants, accuracy with the intended response for the categorical nuclear pattern was excellent at 99% [95% confidence interval (CI): 97-100%] compared to 78% [95% CI 67-88%] for the cytoplasmic, and 93% [95% CI 86%-100%] for mitotic patterns. The accuracy was 13% greater for the common nomenclature [87%, 95% CI 82-90%] compared to the ICAP nomenclature [74%, 95% CI 68-79%] for all participants. Participants reporting all three main categories demonstrated better performances compared to those reporting 2 or less categorical patterns. The average accuracies varied between participant groups, however, with the lowest and most variable performances for cytoplasmic pattern specimens. The reported titers for all specimens varied, with the least variability for nuclear patterns and most titer variability associated with cytoplasmic patterns. CONCLUSIONS: Our study demonstrated significant accuracy for all participants in identifying the categorical nuclear staining as well as traditional pattern assignments for nuclear patterns. However, there was less consistency in reporting cytoplasmic and mitotic patterns, with implications for assigning competencies and training for clinical laboratory personnel.
BACKGROUND: To evaluate the interpretation and reporting of antinuclear antibodies (ANA) by indirect immunofluorescence assay (IFA) using HEp-2 substrates based on common practice and guidance by the International Consensus on ANA patterns (ICAP). METHOD:Participants included two groups [16 clinical laboratories (CL) and 8 in vitro diagnostic manufacturers (IVD)] recruited via an email sent to the Association of Medical Laboratory Immunologists (AMLI) membership. Twelve (n = 12) pre-qualified specimens were distributed to participants for testing, interpretation and reporting HEp-2 IFA. Results obtained were analyzed for accuracy with the intended and consensus response for three main categorical patterns (nuclear, cytoplasmic and mitotic), common patterns and ICAP report nomenclatures. The distributions of antibody titers of specimens were also compared. RESULTS: Laboratories differed in the categorical patterns reported; 8 reporting all patterns, 3 reporting only nuclear patterns and 5 reporting nuclear patterns with various combinations of other patterns. For all participants, accuracy with the intended response for the categorical nuclear pattern was excellent at 99% [95% confidence interval (CI): 97-100%] compared to 78% [95% CI 67-88%] for the cytoplasmic, and 93% [95% CI 86%-100%] for mitotic patterns. The accuracy was 13% greater for the common nomenclature [87%, 95% CI 82-90%] compared to the ICAP nomenclature [74%, 95% CI 68-79%] for all participants. Participants reporting all three main categories demonstrated better performances compared to those reporting 2 or less categorical patterns. The average accuracies varied between participant groups, however, with the lowest and most variable performances for cytoplasmic pattern specimens. The reported titers for all specimens varied, with the least variability for nuclear patterns and most titer variability associated with cytoplasmic patterns. CONCLUSIONS: Our study demonstrated significant accuracy for all participants in identifying the categorical nuclear staining as well as traditional pattern assignments for nuclear patterns. However, there was less consistency in reporting cytoplasmic and mitotic patterns, with implications for assigning competencies and training for clinical laboratory personnel.
Authors: Carlos Alberto von Mühlen; Ignacio Garcia-De La Torre; Maria Infantino; Jan Damoiseaux; Luis E C Andrade; Orlando Gabriel Carballo; Karsten Conrad; Paulo Luiz Carvalho Francescantonio; Marvin J Fritzler; Manfred Herold; Werner Klotz; Wilson de Melo Cruvinel; Tsuneyo Mimori; Minoru Satoh; Lucile Musset; Edward K L Chan Journal: Immunol Res Date: 2021-10-09 Impact factor: 2.829