The antinuclear antibody HEp-2 indirect immunofluorescence assay: a survey of laboratory performance, pattern recognition and interpretation

被引:10
|
作者
Tebo, Anne E. [1 ,2 ]
Schmidt, Robert L. [1 ,2 ]
Kadkhoda, Kamran [3 ]
Peterson, Lisa K. [1 ,2 ]
Chan, Edward K. L. [4 ]
Fritzler, Marvin J. [5 ]
Wener, Mark H. [6 ,7 ]
机构
[1] Univ Utah, Dept Pathol, Salt Lake City, UT 84112 USA
[2] ARUP Inst Clin & Expt Pathol, Salt Lake City, UT USA
[3] Cleveland Clin, Robert J Tomsich Pathol & Lab Med Inst, Immunopathol Lab, Cleveland, OH 44106 USA
[4] Univ Florida, Dept Oral Biol, Gainesville, FL 32610 USA
[5] Univ Calgary, Cumming Sch Med, Dept Med, Calgary, AB, Canada
[6] Univ Washington, Dept Lab Med & Pathol, Seattle, WA 98195 USA
[7] Univ Washington, Dept Med, Seattle, WA USA
关键词
Anti-nuclear antibodies; Cytoplasmic patterns; Performance survey; Indirect immunofluorescence; Mitotic patterns; Nuclear patterns;
D O I
10.1186/s13317-020-00146-w
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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.
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页数:10
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