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Performance of an Automated Fluorescence Antinuclear Antibody Image Analyzer.

Abstract：

BACKGROUND:The gold standard for antinuclear antibody (ANA) screening is the indirect immunofluorescence (IIF) assay with human epithelial cells (HEp-2). However, a number of substantial disadvantages of manual IIF assays have highlighted the need for the automation and standardization of fluorescent ANA (FANA) testing. We evaluated the performance of EUROPattern Suite (Euroimmun AG, Germany), an automated FANA image analyzer, with regard to ANA detection and pattern recognition compared with conventional manual interpretation using the fluorescence microscopic IIF assay. METHODS:A total of 104 samples including 70 ANA-positive sera and 34 ANA-negative sera collected from September to October 2015 were included. The sensitivity, specificity, and pattern recognition function were evaluated to determine the performance of EUROPattern Suite compared with the manual IIF assay results. RESULTS:The sensitivity and specificity of EUROPattern Suite for ANA detection were 94.3% and 94.1%, respectively. The concordance rate between the two methods was 94.2%. For pattern recognition, 45.7% of the samples were assigned identical ANA patterns including simple and mixed. When major pattern matching was considered, 83.7% (41/49) and 95.2% (20/21) of the samples with simple and mixed patterns, respectively, showed concordant results between the two methods. CONCLUSIONS:EUROPattern Suite, an automated FANA image analyzer, provides a viable option for distinguishing between positive and negative results, although the ability to assign specific patterns is insufficient to replace manual microscopic interpretation. This automated system may increase efficiency in laboratories, in which a large number of samples need to be processed.

journal_name

Ann Lab Med

journal_title

Annals of laboratory medicine

authors

Yoo IY,Oh JW,Cha HS,Koh EM,Kang ES

doi

10.3343/alm.2017.37.3.240

subject

Has Abstract

pub_date

2017-05-01 00:00:00

pages

240-247

issue

3

eissn

2234-3806

issn

2234-3814

pii

37.240

journal_volume

37

pub_type

杂志文章

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