Performance analysis of automated evaluation of antinuclear antibody indirect immunofluorescent tests in a routine setting

Abstract

PurposeIndirect immunofluorescence (IIF) on the human epithelial cell-line HEp-2 (or derivatives) serves as the gold standard in antinuclear antibody (ANA) screening. IIF, and its evaluation, is a labor-intensive method, making ANA testing a major challenge for present clinical laboratories. Nowadays, several automated ANA pattern recognition systems are on the market. In the current study, the EUROPattern Suite is evaluated for its use in daily practice in a routine setting.MethodsA total of 1033 consecutive routine samples was used to screen for ANA. Results (positive/negative ANA screening, pattern identification and titer) were compared between software-generated results (EUROPattern) and visual interpretation (observer) of automatically acquired digital images.ResultsConsidering the visual interpretation as reference, a relative sensitivity of 99.3% and a relative specificity of 88.9% were obtained for negative and positive discrimination by the software (EPa). A good agreement between visual and software-based interpretation was observed with respect to pattern recognition (mean kappa: for 7 patterns: 0.7). Interestingly, EPa software distinguished more patterns per positive sample than the observer (on average 1.5 and 1.2, respectively). Finally, a concordance of 99.3% was observed within the range of 1 titer step difference between EPa and observer.ConclusionsThe ANA IIF results reported by the EPa software are in very good agreement with the results reported by the observer with respect to being negative/positive, pattern recognition and titer, making automated ANA IIF evaluation an objective and time-efficient tool for routine testing.Electronic supplementary materialThe online version of this article (10.1007/s13317-018-0108-y) contains supplementary material, which is available to authorized users.

Clinical relevance of HEp-2 indirect immunofluorescent patterns: the International Consensus on ANA patterns (ICAP) perspective

“…This is exactly the reason why ICAP was initiated: the consensus on nomenclature and definitions of HEp-2 IIFA patterns allows to align pattern description across laboratories. Also, the integration of computer-aided immunofluorescence microscopy (CAIFM) may further improve the consistency in pattern assignments 126–131. As such, it is promising that several companies involved in CAIFM have declared their intention to accommodate to the ICAP classification.…”

The value of anti‐rods and rings antibodies in Western China population: A retrospective study

“…Antinuclear antibodies (ANAs), a series of autoantibodies, which target nuclear and cytoplasmic proteins as antigens, can be useful in the case of clinical diagnosis of suspected autoimmune diseases (AID), such as systemic lupus erythematosus (SLE), systemic sclerosis (SSc), dermatomyositis (DM), polymyositis (PM), Sjogren's syndrome (SS), and mixed connective tissue disorder (MCTD) . ANAs as a key indicator, detected by indirect immunofluorescence on HEp‐2 cells (IIF‐HEp‐2) in daily clinical work, have been used to screen and diagnose patients who suffer from AID . Anti‐rods and rings (anti‐RR) antibodies were first observed in the standard IIF‐HEp‐2 assay.…”

“…1,2 ANAs as a key indicator, detected by indirect immunofluorescence on HEp-2 cells (IIF-HEp-2) in daily clinical work, have been used to screen and diagnose patients who suffer from AID. 3 Anti-rods and rings (anti-RR) antibodies were first observed in the standard IIF-HEp-2 assay. Observing by fluorescence microscope, the anti-RR has a variety of structures, but there are two basic forms-rods 3-10μm length and rings 2-5μm diameter.…”

Current Laboratory and Clinical Practices in Reporting and Interpreting Anti-nuclear Antibody Indirect Immunofluorescence (ANA IIF) Patterns: Results of an International Survey

“…Overall, cytoplasmic and mitotic patterns are less reported by laboratories than nuclear patterns. The integration of computer-aided immuno uorescence microscopy could further improve the familiarity and consistency in pattern assignments (24,25), although currently the existing systems are able to recognize only a small fraction of patterns.…”