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Integrating quality assurance in autoimmunity: the changing face of the automated ANA IIF test

  • Lieve Van Hoovels EMAIL logo , Xavier Bossuyt , Mariangela Manfredi , Valentina Grossi , Maurizio Benucci , Stefanie Van Den Bremt , Heidi De Baere , Daria Franceschi , Emiliano Tosi , Marco Meoni , Nicola Bizzaro and Maria Infantino
Published/Copyright: February 17, 2021
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 59 Issue 7

Abstract

Objectives

Currently available computer-aided diagnosis (CAD) systems for the detection of anti-nuclear antibodies (ANA) by indirect immunofluorescence (IIF) assay enable a standardized measurement of system-specific fluorescent intensity (FI) measures. We aimed to evaluate an internal quality control (iQC) program that controls the total ANA IIF process in routine practice.

Methods

In addition to the kit iQC materials, supplemental quality indicators were integrated in a total quality assurance (QA) program: patient-derived iQC’s samples (negative, 1/160 fine speckled and 1/160 homogeneous), median sample FI per run and percentage of ANA IIF positive samples per run. Analytical rejection criteria were based on the imprecision of the positivity index (PI) measure of the Zenit PRO system (Menarini). Clinical rejection criteria were based on changes in FI that correspond to a change in ANA IIF titer of ≥2. To evaluate the QA program, different artificial errors were introduced during the ANA IIF process. After every run, quality indicators were evaluated and compared to the pre-set target values.

Results

Rescanning the ANA IIF slides five times, using an old conjugate and a needle obstruction resulted in analytically and even clinically relevant errors in ANA IIF results. All errors were correctly detected by the different defined quality indicators. Traditional Westgard rules, including analytically (and clinically) defined rejection limits were useful in monitoring quality indicators.

Conclusions

The integration of a total process iQC program in CAD systems, based on the specific FI measurands and performance criteria of the system, adds value to QA.

Keywords: antinuclear antibodies; harmonization; indirect immunofluorescence; quality assurance
Corresponding author: Lieve Van Hoovels, Department of Laboratory Medicine, OLV Hospital, Aalst, Belgium; and Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium, E-mail:

Acknowledgments

We gratefully acknowledge lab technicians of OLV Hospital Aalst for their practical support and the colleagues of ASZ Aalst for the preliminary testing of the ANA IIF samples on their Zenit PRO instrument.

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Heidi de Baere, Daria Franceschi and Emiliano Tosi are employees of A. Menarini Diagnostics; Marco Meoni is an employee of Visia Lab Srl. All other authors state no conflict of interest.

  4. Ethical approval: The study was performed according to the Declaration of Helsinki and approved by the local ethical committee of OLV Hospital Aalst (study registration number B126201942365).

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2020-1669).

Received: 2020-11-06
Accepted: 2021-02-05
Published Online: 2021-02-17
Published in Print: 2021-06-25

© 2021 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2020-1669
Keywords for this article
antinuclear antibodies; harmonization; indirect immunofluorescence; quality assurance

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Machine learning and coagulation testing: the next big thing in hemostasis investigations?
  4. Reviews
  5. Updates on liquid biopsy: current trends and future perspectives for clinical application in solid tumors
  6. The underestimated issue of non-reproducible cardiac troponin I and T results: case series and systematic review of the literature
  7. Opinion Paper
  8. Benefits, limitations and controversies on patient-based real-time quality control (PBRTQC) and the evidence behind the practice
  9. Genetics and Molecular Diagnostics
  10. ctDNA from body fluids is an adequate source for EGFR biomarker testing in advanced lung adenocarcinoma
  11. General Clinical Chemistry and Laboratory Medicine
  12. Incidence, characteristics and outcomes among inpatient, outpatient and emergency department with reported high critical serum potassium values
  13. Clinical usefulness of drug-laboratory test interaction alerts: a multicentre survey
  14. Integrating quality assurance in autoimmunity: the changing face of the automated ANA IIF test
  15. Plasma thiol/disulphide homeostasis changes in patients with restless legs syndrome
  16. Reference Values and Biological Variations
  17. High-resolution pediatric reference intervals for 15 biochemical analytes described using fractional polynomials
  18. Continuous reference intervals for leukocyte telomere length in children: the method matters
  19. Hematology and Coagulation
  20. Using machine learning to identify clotted specimens in coagulation testing
  21. Cardiovascular Diseases
  22. Long term pronostic value of suPAR in chronic heart failure: reclassification of patients with low MAGGIC score
  23. Infectious Diseases
  24. Monocyte distribution width (MDW) parameter as a sepsis indicator in intensive care units
  25. A low level of CD16pos monocytes in SARS-CoV-2 infected patients is a marker of severity
  26. Thrombin generation in patients with COVID-19 with and without thromboprophylaxis
  27. Corrigendum
  28. Applying the concept of uncertainty to the sFlt-1/PlGF cut-offs for diagnosis and prognosis of preeclampsia
  29. Letters to the Editors
  30. Additional approaches for identifying non-reproducible cardiac troponin results
  31. Paediatric reference intervals for ionised calcium – a data mining approach
  32. A case of interference in testosterone, DHEA-S and progesterone measurements by second generation immunoassays
  33. Lack of cross-reactivity between anti-A IgG isoagglutinins and anti-SARS-CoV-2 IgG antibodies
  34. Artefactual bands on urine protein immunofixation gels
  35. A case of methaemoglobinaemia interference on the WDF channel on Sysmex XN-Series analysers
  36. Soluble fms-like tyrosine kinase-1: a potential early predictor of respiratory failure in COVID-19 patients
  37. Serendipitous detection of α1-antitrypsin deficiency: a single institution’s experience over a 32 month period
  38. The activated partial thromboplastin time may not reveal even severe fibrinogen deficiency
  39. Influence of C-reactive protein on thrombin generation assay
  40. Inappropriate extrapolations abound in fecal microbiota research
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