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Automated indirect immunofluorescence microscopy enables the implementation of a quantitative internal quality control system for anti-nuclear antibody (ANA) analysis

  • Thomas M. Maenhout EMAIL logo , Carolien Bonroy , Charlotte Verfaillie , Veronique Stove and Katrien Devreese
Published/Copyright: March 6, 2014
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 52 Issue 7

Abstract

Background: Screening for anti-nuclear antibodies by indirect immunofluorescence (ANA-IIF) remains mandatory in the serological work-up of connective tissue diseases. Recently, automated approaches were introduced that may improve harmonization. Here, we investigated whether the introduction of automated ANA-IIF and more specifically the use of its quantitative measure, could improve ANA-IIF internal quality control (IQC) management.

Methods: We retrospectively reviewed results of two cohorts of routine samples and parallel IQC data collected from January 2010 to February 2013 and from February to mid October 2013. For the first cohort, data were collected using conventional microscopy. The second cohort was analyzed by an automated ANA-IIF microscope (Zenit G sight, A. Menarini). Retrospectively, we evaluated the applicability of the probability index (PI) of control material measurements and patient results for IQC management based on Westgard multirules. This approach was also compared with monthly monitoring of the %ANA-IIF positive samples.

Results: In our historical data set, we showed that monitoring of %ANA positives identified systematic errors that were not detected by monitoring control material results. Data resulting from automated microscopy showed that PI measurements on control material remained stable within the observed period and that Westgard multirules can be used for IQC follow-up. Parallel monitoring of the daily median patient PI and the monthly %ANA positives, showed that the daily median was a sensitive and fast tool for detecting systematic errors.

Conclusions: The introduction of the automated ANA-IIF microscope could enable objective IQC procedures and should be considered an important step forward in ANA-IIF harmonization.

Keywords: anti-nuclear antibodies; automation; laboratory management; quality control
Corresponding author: Thomas M. Maenhout, Ghent University Hospital (2P8), De Pintelaan 185, 9000, Ghent, Belgium, Phone: +32 9 3323631, Fax: +32 9 3324985, E-mail:
aThomas M. Maenhout and Carolien Bonroy contributed equally to this work.

Acknowledgments

The technical assistance of Ms Virgie Baert, Ms Annette Heirwegh, Ms Vicky Mortier and Ms Sylvia Van Haelst is greatly acknowledged.

Conflict of interest statement

Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Funding played no role in thestudy design; in the collection, analysis, and interpretationof data; in the writing of the report; or in the decision tosubmit the report for publication.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Funding: Carolien Bonroy is granted by the Fund for Scientific Research, Flanders.

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Received: 2013-10-23
Accepted: 2014-2-5
Published Online: 2014-3-6
Published in Print: 2014-7-1

©2014 by Walter de Gruyter Berlin/Boston

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https://doi.org/10.1515/cclm-2013-0912
Keywords for this article
anti-nuclear antibodies; automation; laboratory management; quality control

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Diagnosis of diabetes mellitus: reiterated responsibilities for the clinical laboratory
  4. Review
  5. The association between plasminogen activator inhibitor type 1 (PAI-1) levels, PAI-1 4G/5G polymorphism, and myocardial infarction: a Mendelian randomization meta-analysis
  6. Opinion Papers
  7. Harmonization of quality indicators in laboratory medicine. A preliminary consensus
  8. Cardiac biomarkers and risk assessment in patients undergoing major non-cardiac surgery: time to revise the guidelines?
  9. General Clinical Chemistry and Laboratory Medicine
  10. A statistical basis for harmonization of thyroid stimulating hormone immunoassays using a robust factor analysis model
  11. Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target
  12. Combined light chain immunofixation to detect monoclonal gammopathy: a comparison to standard electrophoresis in serum and urine
  13. Automated indirect immunofluorescence microscopy enables the implementation of a quantitative internal quality control system for anti-nuclear antibody (ANA) analysis
  14. Peripheral blood lymphocytes from patients with bipolar disorder demonstrate apoptosis and differential regulation of advanced glycation end products and S100B
  15. Coefficient of energy balance, a new parameter for basic investigation of the cerebrospinal fluid
  16. Interconversion of stone composition profiles from two recurrent stone episodes in stone formers
  17. Reference Values
  18. Complete blood count reference intervals and age- and sex-related trends of North China Han population
  19. Cancer Diagnostics
  20. The quantification of HER2 and MYC gene fragments in cell-free plasma as putative biomarkers for gastric cancer diagnosis
  21. Cardiovascular Diseases
  22. Novel sensitive cardiac troponin I immunoassay free from troponin I-specific autoantibody interference
  23. Interleukin-6 receptor Asp358Ala gene polymorphism is associated with plasma C-reactive protein levels and severity of aortic valve stenosis
  24. Diabetes
  25. Stability of glucose in plasma with different anticoagulants
  26. Plasma glucose measurement in diabetes: impact and implications of variations in sample collection procedures with a focus on the first hour after sample collection
  27. Changing from glucose to HbA1c for diabetes diagnosis: predictive values of one test and importance of analytical bias and imprecision
  28. System accuracy evaluation of systems for point-of-care testing of blood glucose: a comparison of a patient-use system with six professional-use systems
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  30. Reply to the article entitled “Identification of an 18 bp deletion in the TWIST1 gene by CO-amplification at lower denaturation temperature-PCR (COLD-PCR) for non-invasive prenatal diagnosis of craniosynostosis: first case report” by Galbiati et al., Clin Chem Lab Med 2014;52(4):505–9
  31. Further considerations concerning non-invasive prenatal diagnosis of craniosynostosis based on the identification of an 18 bp deletion in the TWIST1 gene by COLD-PCR
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