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Performance characteristics of consensus approaches for small and minor paroxysmal nocturnal hemoglobinuria clone determination by flow cytometry

  • Iuri Marinov EMAIL logo , Martina Kohoutová , Vlasta Tkáčová , Adam Pešek , Jaroslav Čermák and Petr Cetkovský
Published/Copyright: June 26, 2013
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 51 Issue 11

Abstract

Background: Evaluation of paroxysmal nocturnal hemoglobinuria (PNH) clones by flow cytometry (FCM) is not standardized and is associated with consistent inter-laboratory variability.

Methods: In order to rule out the influence of particular approach in generating final results, we analyzed the performance characteristics of individual consensus strategies for small to intermediate (1%–20%) and minor (<1%) PNH clones within the white blood cell (WBC) and red blood cell (RBC) compartments with sensitivity up to 0.1%.

Results: Coefficient of variation (CV) for precision/reproducibility analysis ranged from 0.67%/1.49% to 2.56%/3.09% for granulocytes, from 0.93%/3.09% to 7.76%/12.06% for monocytes and from 0.41%/4.73% to 6.53%/5.1% for RBCs. Coefficient of determination (r2) for linear regression analysis ranged from 0.95 to 0.99, Wilcoxon ranks test showed no statistically significant differences (p>0.05), Bland-Altman analysis demonstrated performance agreement with mean bias ranging from −0.18 to 1.24.

Conclusions: Our results confirmed very good performance characteristics for precision and reproducibility analysis, excellent correlation and favorable agreement between strategies, suggesting that reported inter-laboratory variability is related mainly to incorrect performance and/or insufficient experience with PNH testing by flow cytometry, rather than to relevant limitations of any particular approach.

Keywords: consensus approaches; flow cytometry; paroxysmal nocturnal hemoglobinuria (PNH); performance characteristics
Corresponding author: Iuri Marinov, MD, PhD, Institute of Hematology and Blood Transfusion, U nemocnice 1, 128 20, Prague 2, Czech Republic, Phone: +420 602 775894, Fax: +420 221 977249, E-mail:

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Received: 2013-04-04
Accepted: 2013-06-02
Published Online: 2013-06-26
Published in Print: 2013-11-01

©2013 by Walter de Gruyter Berlin Boston

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https://doi.org/10.1515/cclm-2013-0251
Keywords for this article
consensus approaches; flow cytometry; paroxysmal nocturnal hemoglobinuria (PNH); performance characteristics

Articles in the same Issue

  1. Letter to the Editor
  2. Elevated level of cell-free plasma DNA is associated with advanced-stage breast cancer and metastasis
  3. Is procalcitonin a reliable marker of sepsis in critically ill septic patients undergoing continuous veno-venous hemodiafiltration with “high cut-off” membranes (HCO-CVVHDF)?
  4. Challenging our serological algorithm for celiac disease (CD) diagnosis by the ESPGHAN guidelines
  5. Preanalytical quality control in a university hospital in China
  6. Racial differences and relationships between gestational thyrotropin and free thyroxine in a multiracial Asian population
  7. Analytical performance and method comparison study of the total homocysteine immunoassay on the AIA 600II analyser
  8. Easy verification of clinical chemistry reference intervals
  9. The Elecsys® Vitamin B12 assay is not affected by anti-intrinsic factor antibodies
  10. Chemiluminescence-based cobalamin assay errors: background and perspectives
  11. Congress Abstracts
  12. Abstracts IV Italian Great Network Congress Rome, 14th–18th October 2013*)
  13. Masthead
  14. Masthead
  15. Editorial
  16. Making colorectal cancer screening FITTER for purpose with quantitative faecal immunochemical tests for haemoglobin (FIT)
  17. From “panic” to “critical” values: which path toward harmonization?
  18. Review
  19. Cerebrospinal fluid analyses for the diagnosis of subarachnoid haemorrhage and experience from a Swedish study. What method is preferable when diagnosing a subarachnoid haemorrhage?
  20. Opinion Paper
  21. False myths and legends in laboratory diagnostics
  22. General Clinical Chemistry and Laboratory Medicine
  23. National survey on critical values notification of 599 institutions in China
  24. Influence of physical properties of cuvette surface on measurement of serum lipase
  25. Red cell indices: differentiation between β-thalassemia trait and iron deficiency anemia and application to sickle-cell disease and sickle-cell thalassemia
  26. Measurement of immature platelets with Abbott CD-Sapphire and Sysmex XE-5000 in haematology and oncology patients
  27. Performance characteristics of consensus approaches for small and minor paroxysmal nocturnal hemoglobinuria clone determination by flow cytometry
  28. Comparison of PR3-ANCA specific assay performance for the diagnosis of granulomatosis with polyangiitis (Wegener’s)
  29. The integration of the detection of systemic sclerosis-associated antibodies in a routine laboratory setting: comparison of different strategies
  30. Reference Values and Biological Variations
  31. Reference interval studies: what is the maximum number of samples recommended?
  32. Short-term estimation and application of biological variation of small dense low-density lipoproteins in healthy individuals
  33. Cancer Diagnostics
  34. Diagnostic inconsistency of faecal immunochemical tests for haemoglobin in population screening of colorectal cancer
  35. Cardiovascular Diseases
  36. Comparison of the 99th percentiles of three troponin I assays in a large reference population
  37. Assessment of plasma aminothiol levels and the association with recurrent atherothrombotic events in patients hospitalized for an acute coronary syndrome: a prospective study
  38. Diabetes
  39. The relationship between estimated average glucose and fasting plasma glucose
  40. Evaluation of enzymatic BM Test HbA1c on the JCA-BM6010/C and comparison with Bio-Rad Variant II Turbo, Tosoh HLC 723 G8, and AutoLab immunoturbidimetry assay
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