Article
Licensed
Unlicensed Requires Authentication

Evaluation of Two Automated Enzyme Immunoassays for Detection of Antinuclear Antibodies

Published/Copyright: June 1, 2005
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Volume 38 Issue 10

Abstract

We evaluated two enzyme immunoassays (EIA) for detection of antinuclear antibodies (ANA) which became recently available and which were designed for application on a fully automated system; (i) the EIA-ANA screen kit from Sigma Diagnostics (St. Louis, MO, USA) applied on APTUS™, an automated EIA analyser from Sigma Diagnostics and (ii) the Cobas® Core Hep-2 EIA-ANA assay applied on the fully automated Cobas Core immunochemistry analyzer from Roche Diagnostics (Basel, Switzerland). The evaluation was done by an analytic comparison of the automated systems to an established indirect immunofluorescence (IF) method performed on SSA transfected human epitheloid cell substrate slides. Three hundred and thirty six samples were tested with the Sigma EIA-ANA assay and 603 samples with the Cobas® Core Hep-2 EIA-ANA assay. For both EIA systems, there was a trend of generally increasing signal from the assay system with increasing IF-ANA titers. With an IF-ANA reference range of < 1:160, concordance between Sigma® EIA-ANA and IFANA was 86% and concordance between Roche® EIA-ANA and IF-ANA was 85%. When compared to IF-ANA with a reference range of < 1:160, sensitivity and specificity of the EIA-ANA screen was 0.65 and 0.92, respectively, for Sigma® EIA-ANA and 0.61 and 0.91, respectively, for the Cobas® Core assay. The low sensitivity observed with both methods is a major concern. Sigma EIA-ANA screen revealed the presence of autoantibodies in 23 of the 29 samples containing antibodies to extractable nuclear antigens (ENA) and/or double stranded DNA and the Cobas® Core Hep-2 EIA-ANA assay revealed the presence of autoantibodies in 40 of the 43 samples containing antibodies to ENA and/or double stranded DNA.

:
Published Online: 2005-06-01
Published in Print: 2000-10-16

Copyright © 2000 by Walter de Gruyter GmbH & Co. KG

Articles in the same Issue

  1. Genetic Polymorphisms and Activity of Cholesterol Ester Transfer Protein (CETP): Should We Be Measuring Them?
  2. Detection of Haemoglobins with Abnormal Oxygen Affinity by Single Blood Gas Analysis and 2,3-Diphosphoglycerate Measurement
  3. Effect of Acute Phase Response on Cumulative Troponin T Release
  4. Measurement of Water Turnover Using Deuterium Dilution: Impact of Periodically Varying Turnover Rates on Precision and Accuracy
  5. Personal Experience with the Application of Carbohydrate-Deficient Transferrin (CDT) Assays to the Detection of Congenital Disorders of Glycosylation
  6. The Efficacy of Hormone Assays in the Differential Diagnosis of Amenorrhea and Menopause
  7. Screening for Proteinuria in Japanese Schoolchildren: a New Approach
  8. Determination of a Redox Compensation Index and Its Relationships to Glycaemic Control in Type 2 Diabetes Mellitus
  9. Clinical Experiences with a New Semi-Quantitative Solid Phase Immunoassay for Rapid Measurement of Procalcitonin
  10. Inter-Method Differences and Commutability of Control Materials for HbA2 Measurement
  11. High Sensitivity C-Reactive Protein: Biological Variations and Reference Limits
  12. A Model for a Multicentre Approach to the Derivation of Reference Intervals for Thyroid Hormones and Testosterone for Laboratories Using Identical Analysers
  13. Evaluating Agreement between Two Analytical Methods in Clinical Chemistry
  14. Comparison of Two Methods for the Detection of Urinary Iodine Used in Epidemiological Studies
  15. Evaluation of Two Automated Enzyme Immunoassays for Detection of Antinuclear Antibodies
  16. Performance Evaluation of Nine Hormone Assays on the Immulite 2000®Immunoassay System
  17. Evaluation of the Clinical Chemistry Analyser Olympus AU400
  18. Effects of Vitamin E and Selenium on Lipid Peroxidation and Antioxidant Enzymes in Colon of Methylazoxymethanol Treated Rats
  19. C-Reactive Protein as Cardiovascular Risk Factor A Discovery by ECAT
  20. Usefulness of EC4 Essential Criteria for Quality Systems of Medical Laboratories as Guideline to the ISO 15189 and ISO 17025 Documents
  21. Recommendations for Measurement of and Conventions for Reporting Sodium and Potassium by Ion-Selective Electrodes in Undiluted Serum, Plasma or Whole Blood
  22. IFCC News
  23. Atlas of Clinical Haematology, by H. Löffler and J. Rastetter
  24. Introduction to Clinical Nutrition, by Vishwanath M. Sardesai
  25. Biochemical Composition and Electrolyte Balance of Unstimulated Whole Human Saliva
https://doi.org/10.1515/CCLM.2000.153

Articles in the same Issue

  1. Genetic Polymorphisms and Activity of Cholesterol Ester Transfer Protein (CETP): Should We Be Measuring Them?
  2. Detection of Haemoglobins with Abnormal Oxygen Affinity by Single Blood Gas Analysis and 2,3-Diphosphoglycerate Measurement
  3. Effect of Acute Phase Response on Cumulative Troponin T Release
  4. Measurement of Water Turnover Using Deuterium Dilution: Impact of Periodically Varying Turnover Rates on Precision and Accuracy
  5. Personal Experience with the Application of Carbohydrate-Deficient Transferrin (CDT) Assays to the Detection of Congenital Disorders of Glycosylation
  6. The Efficacy of Hormone Assays in the Differential Diagnosis of Amenorrhea and Menopause
  7. Screening for Proteinuria in Japanese Schoolchildren: a New Approach
  8. Determination of a Redox Compensation Index and Its Relationships to Glycaemic Control in Type 2 Diabetes Mellitus
  9. Clinical Experiences with a New Semi-Quantitative Solid Phase Immunoassay for Rapid Measurement of Procalcitonin
  10. Inter-Method Differences and Commutability of Control Materials for HbA2 Measurement
  11. High Sensitivity C-Reactive Protein: Biological Variations and Reference Limits
  12. A Model for a Multicentre Approach to the Derivation of Reference Intervals for Thyroid Hormones and Testosterone for Laboratories Using Identical Analysers
  13. Evaluating Agreement between Two Analytical Methods in Clinical Chemistry
  14. Comparison of Two Methods for the Detection of Urinary Iodine Used in Epidemiological Studies
  15. Evaluation of Two Automated Enzyme Immunoassays for Detection of Antinuclear Antibodies
  16. Performance Evaluation of Nine Hormone Assays on the Immulite 2000®Immunoassay System
  17. Evaluation of the Clinical Chemistry Analyser Olympus AU400
  18. Effects of Vitamin E and Selenium on Lipid Peroxidation and Antioxidant Enzymes in Colon of Methylazoxymethanol Treated Rats
  19. C-Reactive Protein as Cardiovascular Risk Factor A Discovery by ECAT
  20. Usefulness of EC4 Essential Criteria for Quality Systems of Medical Laboratories as Guideline to the ISO 15189 and ISO 17025 Documents
  21. Recommendations for Measurement of and Conventions for Reporting Sodium and Potassium by Ion-Selective Electrodes in Undiluted Serum, Plasma or Whole Blood
  22. IFCC News
  23. Atlas of Clinical Haematology, by H. Löffler and J. Rastetter
  24. Introduction to Clinical Nutrition, by Vishwanath M. Sardesai
  25. Biochemical Composition and Electrolyte Balance of Unstimulated Whole Human Saliva
Downloaded on 5.4.2026 from https://www.degruyterbrill.com/document/doi/10.1515/CCLM.2000.153/html
Scroll to top button