Comparison of the clinical utility of the Elia CTD Screen to indirect immunofluorescence on Hep-2 cells
-
Christoph Robier
,
Omid Amouzadeh-Ghadikolai
Abstract
Background: We compared the Elia CTD Screen (ECS), a fluoroenzymeimmunoassay incorporating 17 human antinuclear antigens (ANA), with indirect immunofluorescence (IIF) on Hep-2 cells in order to determine the clinical utility of the ECS in additon to or without IIF.
Methods: We examined 1708 consecutive serum samples submitted for ANA testing using the ECS and IIF in parallel. Positive screen results were further examined by quantitative fluoroenzymeimmunoassays and/or immunoblots for antibody identification. The medical records were evaluated for systemic rheumatic disorders.
Results: Concordance between ECS and IIF was observed in 1344 (78.8%) samples. ECS had a better detection rate for anti-dsDNA, -SSA/Ro, -SSB/La, -U1RNP and -Jo-1 antibodies, whereas IIF was superior in the detection of anti-CENP-B antibodies as well as anti-histone, -nucleosome and -Pl-12 antibodies, which are not included in the ECS antigen panel. ECS had a 100% sensitivity for Sjögren’s syndrome, systemic sclerosis and Sharp syndrome. The sensitivity for Sjögren’s syndrome was slightly higher for ESC than for IIF (94%). IIF had a higher diagnostic sensitivity for systemic lupus erythematosus, indeterminated connective tissue disease, Raynaud’s syndrome and limited scleroderma, compared to ESC (100% vs. 80%, 100 vs. 75%, 89 vs. 57%, 100 vs. 88.9%).
Conclusions: Our results suggest that the ECS represents an appropriate diagnostic tool for ANA screening. However, since some antigens are not incorporated in the ECS panel, and some ANA can also be missed by IIF, sequential or parallel screening with ECS and IIF may be reasonable when the clinical suspicion for connective tissue disease is high.
Acknowledgments
We thank Hannelore Kronawetter, Margot Pfeiffer, Claudia Schoberer, Michaela Schoberl, Rita Stocker, Barbara Haindl-Suppan, Sabine Hell, Birgit Schröttner, Silvia Seyfried, Renate Jauk and Maria Hofbauer from the Central Laboratory of the Hospital of the Brothers of St. John of God Graz for their excellent technical support.
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 a travel grant from Thermo Fisher Scientific.
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.
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Articles in the same Issue
- Frontmatter
- Editorials
- Laboratory analytical quality – the process continues
- Measurement uncertainty – a revised understanding of its calculation and use
- Review
- Substrate-zymography: a still worthwhile method for gelatinases analysis in biological samples
- Opinion Papers
- Is the combination of trueness and precision in one expression meaningful? On the use of total error and uncertainty in clinical chemistry
- The problem with total error models in establishing performance specifications and a simple remedy
- Measurement uncertainty for clinical laboratories – a revision of the concept
- Uncertainty in measurement and total error – are they so incompatible?
- General Clinical Chemistry and Laboratory Medicine
- Using the hazard ratio to evaluate allowable total error in predictive measurands
- Performance of electrolyte measurements assessed by a trueness verification program
- Analytical interference by monoclonal immunoglobulins on the direct bilirubin AU Beckman Coulter assay: the benefit of unsuspected diagnosis from spurious results
- Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China
- Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients
- Patient-performed extraction of faecal calprotectin
- Comparison of the clinical utility of the Elia CTD Screen to indirect immunofluorescence on Hep-2 cells
- Reference Values and Biological Variations
- Sex-related differences in the association of ghrelin levels with obesity in adolescents
- Gestation specific reference intervals for thyroid function tests in pregnancy
- Cancer Diagnostics
- SOX17 promoter methylation in plasma circulating tumor DNA of patients with non-small cell lung cancer
- Dopamine concentration in blood platelets is elevated in patients with head and neck paragangliomas
- Letters to the Editor
- Cancer dynamics and the success of cancer screening programs
- Mother’s instinct – a rare case of multiple test interferences due to heterophile antibodies
- Sigma metric or defects per million opportunities (DPMO): the performance of clinical laboratories should be evaluated by the Sigma metrics at decimal level with DPMOs
- A national survey of preanalytical handling of oral glucose tolerance tests in pregnancy
- Updating pregnancy diabetes guidelines: is (y)our laboratory ready?
- Low serum bilirubin values are associated with pulmonary embolism in a case-control study
- Effect of Hb H on HbA1c measurements as measured by IFCC reference method and affinity HPLC
- Adipocytes in venipunctures cause falsely elevated S-100B serum values
- Earlier detection of sepsis by Candida parapsilosis using three-dimensional cytographic anomalies on the Mindray BC-6800 hematological analyzer
- Theranos phenomenon – part 4: Theranos at an International Conference
