The clinical significance of borderline results of the Elia CTD Screen assay
-
Christoph Robier
und
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
1. Agmon-Levin N, Damoiseaux J, Kallenberg C, Sack U, Witte T, Herold M, et al. International recommendationds for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies. Ann Rheum Dis 2014;73:17–23.10.1136/annrheumdis-2013-203863Suche in Google Scholar
2. Willems P, De Langhe E, Claessens J, Westhovens R, Van Hoeyveld E, Poesen K, et al. Screening for connective-tissue disease-associated antibodies by automated immunoassay. Clin Chem Lab Med 2018;56:909–18.10.1515/cclm-2017-0905Suche in Google Scholar
3. Bernardini S, Infantino M, Bellincampi L, Nuccetelli M, Afeltra A, Iori R. Screening of antinuclear antibodies: comparison between enzyme immunoassay based on nuclear homogenates, purified or recombinant antigens and immunofluorescence assay. Clin Chem Lab Med 2004;42:1155–60.10.1515/CCLM.2004.235Suche in Google Scholar
4. Robier C, Amouzadeh-Ghadikolai O, Stettin M, Reicht G. Comparison of the clinical utility of the Elia CTD Screen to indirect immunofluorescence on Hep 2 cells. Clin Chem Lab Med 2016;54:1365–70.10.1515/cclm-2015-1051Suche in Google Scholar
5. Op De Beeck K, Vermeersch P, Verschueren P, Westhovens R, Marien G, Blockmans D, et al. Detection of antinuclear antibodies by indirect immunofluorescence and by solid phase assay. Autoimmune Rev 2011;10:801–8.10.1016/j.autrev.2011.06.005Suche in Google Scholar
6. Bossuyt X, Luyckx A. Antibodies to extractable nuclear antigens in antinuclear antibody-negative samples. Clin Chem 2005;51:2426–7.10.1373/clinchem.2005.058552Suche in Google Scholar
7. Hoffman IE, Peene I, Veys EM, De Keyser F. Detection of specific antinuclear reactivities in patients with negative anti-nuclear antibody immunofluorescence screening tests. Clin Chem 2002;48:2171–6.10.1093/clinchem/48.12.2171Suche in Google Scholar
8. Bossuyt X, Fieuws S. Detection of antinuclear antibodies: added value of solid phase assay? Ann Rheum Dis 2014;73:e10.10.1136/annrheumdis-2013-204793Suche in Google Scholar
9. Gonzalez C, Guevara P, Alarcon I, Hernando M, Navajo JA, Gonzalez-Buitrago JM. Antinuclear antibodies (ANA) screening by enzyme immunoassay with nuclear Hep-2 cell extract and recombinant antigens: analytical and clinical evaluation. Clin Biochem 2002;35:463–9.10.1016/S0009-9120(02)00342-9Suche in Google Scholar
10. Van der Pol P, Bakker-Jonges LE, Kuijpers JH, Schreurs MW. Analytical and clinical comparison oft wo fully automated immunoassay systems for the detection of autoantibodies to extractable nuclear antigens. Clin Chim Acta 2018;476: 154–9.10.1016/j.cca.2017.11.014Suche in Google Scholar PubMed
©2018 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- 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
- Reference Values and Biological Variations
- Reference intervals for 33 biochemical analytes in healthy Indian population: C-RIDL IFCC initiative
- Cancer Diagnostics
- BCL2L12 improves risk stratification and prediction of BFM-chemotherapy response in childhood acute lymphoblastic leukemia
- Cardiovascular Diseases
- The correlation between glucose fluctuation from self-monitored blood glucose and the major adverse cardiac events in diabetic patients with acute coronary syndrome during a 6-month follow-up by WeChat application
- Diabetes
- Impact of blood cell counts and volumes on glucose concentration in uncentrifuged serum and lithium-heparin blood tubes
- Letters to the Editor
- Standard process-oriented workflow introduces pre-analytical error when used in large study sample batches
- Comparison of three staining methods in the automated digital cell imaging analyzer Sysmex DI-60
- 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
- Transient monoclonal gammopathy in a 2-year-old child with combined viral and bacterial infection
- Nephelometric assay of urine free light chains: an alternative and early clinical test for Bence-Jones protein quantification
- Congress Abstracts
- Congress of Laboratory Medicine and Clinical Chemistry 7th Annual Meeting of the Austrian Society for Laboratory Medicine and Clinical Chemistry (ÖGLMKC)
- 50th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)
- Revolution drives Evolution – from measuring to understanding: Annual meeting of Swiss Society of Clinical Chemistry (SSCC) in Bern, November 15-16 2018
Artikel in diesem Heft
- 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
- Reference Values and Biological Variations
- Reference intervals for 33 biochemical analytes in healthy Indian population: C-RIDL IFCC initiative
- Cancer Diagnostics
- BCL2L12 improves risk stratification and prediction of BFM-chemotherapy response in childhood acute lymphoblastic leukemia
- Cardiovascular Diseases
- The correlation between glucose fluctuation from self-monitored blood glucose and the major adverse cardiac events in diabetic patients with acute coronary syndrome during a 6-month follow-up by WeChat application
- Diabetes
- Impact of blood cell counts and volumes on glucose concentration in uncentrifuged serum and lithium-heparin blood tubes
- Letters to the Editor
- Standard process-oriented workflow introduces pre-analytical error when used in large study sample batches
- Comparison of three staining methods in the automated digital cell imaging analyzer Sysmex DI-60
- 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
- Transient monoclonal gammopathy in a 2-year-old child with combined viral and bacterial infection
- Nephelometric assay of urine free light chains: an alternative and early clinical test for Bence-Jones protein quantification
- Congress Abstracts
- Congress of Laboratory Medicine and Clinical Chemistry 7th Annual Meeting of the Austrian Society for Laboratory Medicine and Clinical Chemistry (ÖGLMKC)
- 50th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)
- Revolution drives Evolution – from measuring to understanding: Annual meeting of Swiss Society of Clinical Chemistry (SSCC) in Bern, November 15-16 2018
