The clinical significance of borderline results of the Elia CTD Screen assay
-
Christoph Robier
and
Omid Amouzadeh-Ghadikolai
Abstract
Background
Data on the clinical relevance of borderline results of solid-phase assays in the screening for antinuclear antibodies (ANA) are sparse. This study aimed to determine the clinical significance of borderline results of the Elia CTD Screen (ECS; Phadia/Thermo Fisher Scientific, Freiburg, Germany), a fluoroenzymeimmunoassay incorporating 17 recombinant human nuclear antigens.
Methods
We retrospectively examined the medical records of 143 subjects with borderline ECS results for ANA-associated autoimmune disorders (AASARD) and the association with the results of indirect immunofluorescence (IIF) and confirmatory assays for ANA.
Results
AASARD were diagnosed in 10 patients (7%) with systemic lupus erythematosus (n=5; four patients were prediagnosed and in clinical remission), polymyositis overlap syndromes (n=2), scleroderma, Raynaud’s syndrome and undetermined connective tissue disease (each n=1). Most frequently, homogeneous and nucleolar IIF patterns were found. Positive ANA subsets were observed in three patients. Furthermore, four patients were diagnosed with autoimmune liver diseases and yielded positive IIF in three and positive confirmatory assays in all cases. Taken together, 129 subjects had no AASARD. Within this group, 43 patients were IIF positive and most frequently showed speckled, unspecific nucleolar and only rarely homogeneous patterns. Positive ANA subsets were found in low concentrations near to the upper reference range in 18 subjects.
Conclusions
AASARD were observed in 7% of the subjects with borderline ECS and showed homogeneous or nucleolar IIF patterns in the majority of these cases. Our findings suggest that borderline results of the ECS can be clinically relevant and support the concept of a parallel or sequential screening for ANA by both ECS and IIF.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: CR received travel grants from Phadia/Thermo Fisher Scientific. The company was not involved in the study design, in the collection, analysis and interpretation of data, in the writing process and the decision to submit the manuscript for publication.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
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©2018 Walter de Gruyter GmbH, Berlin/Boston
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- Frontmatter
- Editorial
- Observing an analyzer’s operational life cycle: a useful management tool for clinical laboratories
- Reviews
- Personalized laboratory medicine: a patient-centered future approach
- Circular RNAs: a new class of biomarkers as a rising interest in laboratory medicine
- Mini Review
- Impact of interactions between drugs and laboratory test results on diagnostic test interpretation – a systematic review
- Opinion Paper
- Uncertainty in measurement and total error: different roads to the same quality destination?
- Guidelines and Recommendations
- Joint EFLM-COLABIOCLI Recommendation for venous blood sampling
- General Clinical Chemistry and Laboratory Medicine
- Evidence for the positive impact of ISO 9001 and ISO 15189 quality systems on laboratory performance – evaluation of immunohaematology external quality assessment results during 19 years in Austria
- Effects of high-dose, intravenous lipid emulsion on laboratory tests in humans: a randomized, placebo-controlled, double-blind, clinical crossover trial
- Commutability of the certified reference materials for the standardization of β-amyloid 1-42 assay in human cerebrospinal fluid: lessons for tau and β-amyloid 1-40 measurements
- Failure rate prediction of equipment: can Weibull distribution be applied to automated hematology analyzers?
- Evaluation of serum alkaline phosphatase measurement through the 4-year trueness verification program in China
- Increased serum concentrations of soluble ST2 predict mortality after burn injury
- The clinical significance of borderline results of the Elia CTD Screen assay
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- Detection of Plasmodium falciparum using automated digital cell morphology analyzer Sysmex DI-60
- Serum ischemia-modified albumin concentration may reflect long-term hypoxia in chronic respiratory disease: a pilot study
- Wet absorptive microsampling at home for HbA1c monitoring in diabetic children
- Serum endocan levels in patients with chronic obstructive pulmonary disease: a potential role in the evaluation of susceptibility to exacerbation
- Analytical and clinical validation of the new Roche Elecsys Vitamin D Total II assay
- Analytical validation of two second generation thyroglobulin immunoassays (Roche and Thermo Fisher)
- Omission of preservatives during 24-h of urine collection for the analysis of fractionated metanephrines enhance patient convenience
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- Nephelometric assay of urine free light chains: an alternative and early clinical test for Bence-Jones protein quantification
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