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The Empower project – a new way of assessing and monitoring test comparability and stability

  • Linde A.C. De Grande , Kenneth Goossens , Katleen Van Uytfanghe , Dietmar Stöckl and Linda M. Thienpont EMAIL logo
Published/Copyright: January 15, 2015
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 53 Issue 8

Abstract

Background: Manufacturers and laboratories might benefit from using a modern integrated tool for quality management/assurance. The tool should not be confounded by commutability issues and focus on the intrinsic analytical quality and comparability of assays as performed in routine laboratories. In addition, it should enable monitoring of long-term stability of performance, with the possibility to quasi “real-time” remedial action. Therefore, we developed the “Empower” project.

Methods: The project comprises four pillars: (i) master comparisons with panels of frozen single-donation samples, (ii) monitoring of patient percentiles and (iii) internal quality control data, and (iv) conceptual and statistical education about analytical quality. In the pillars described here (i and ii), state-of-the-art as well as biologically derived specifications are used.

Results: In the 2014 master comparisons survey, 125 laboratories forming 8 peer groups participated. It showed not only good intrinsic analytical quality of assays but also assay biases/non-comparability. Although laboratory performance was mostly satisfactory, sometimes huge between-laboratory differences were observed. In patient percentile monitoring, currently, 100 laboratories participate with 182 devices. Particularly, laboratories with a high daily throughput and low patient population variation show a stable moving median in time with good between-instrument concordance. Shifts/drifts due to lot changes are sometimes revealed. There is evidence that outpatient medians mirror the calibration set-points shown in the master comparisons.

Conclusions: The Empower project gives manufacturers and laboratories a realistic view on assay quality/comparability as well as stability of performance and/or the reasons for increased variation. Therefore, it is a modern tool for quality management/assurance toward improved patient care.

Keywords: analytical/population variation; bias; drift; median; moving median; outpatients; quality indicators; shift
Corresponding author: Linda M. Thienpont, Laboratory for Analytical Chemistry, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium, Phone: +32-9-264-8104, Fax: +32-9-264-8198, E-mail:

Acknowledgments

The authors are indebted to the laboratories and diagnostic manufacturers who showed their interest for the Empower project, either by participating in one or more surveys of the master comparisons and/or joining the patient percentile monitoring initiative.

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

Financial support: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

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.

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Supplemental Material

The online version of this article (DOI: 10.1515/cclm-2014-0959) offers supplementary material, available to authorized users.

Received: 2014-9-29
Accepted: 2014-12-15
Published Online: 2015-1-15
Published in Print: 2015-7-1

©2015 by De Gruyter

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https://doi.org/10.1515/cclm-2014-0959
Keywords for this article
analytical/population variation; bias; drift; median; moving median; outpatients; quality indicators; shift

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Once upon a time: a tale of ISO 15189 accreditation
  4. A new integrated tool for assessing and monitoring test comparability and stability
  5. Liver-FibroSTARD checklist and glossary: tools for standardized design and reporting of diagnostic accuracy studies of liver fibrosis tests
  6. Reviews
  7. Thromboembolic risk in hematological malignancies
  8. A review of the cut-off points for the diagnosis of vitamin B12 deficiency in the general population
  9. Opinion Paper
  10. Permissible limits for uncertainty of measurement in laboratory medicine
  11. EFLM Position Paper
  12. Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO)
  13. Genetics and Molecular Diagnostics
  14. Evaluation of a low-cost procedure for sampling, long-term storage, and extraction of RNA from blood for qPCR analyses
  15. Application of real-time PCR of sex-independent insertion-deletion polymorphisms to determine fetal sex using cell-free fetal DNA from maternal plasma
  16. General Clinical Chemistry and Laboratory Medicine
  17. The Empower project – a new way of assessing and monitoring test comparability and stability
  18. Comparison of four automated serum vitamin B12 assays
  19. Combined indicator of vitamin B12 status: modification for missing biomarkers and folate status and recommendations for revised cut-points
  20. INR vs. thrombin generation assays for guiding VKA reversal: a retrospective comparison
  21. Determination of dabigatran in plasma, serum, and urine samples: comparison of six methods
  22. Simple high-throughput analytical method using ultra-performance liquid chromatography coupled with tandem mass spectrometry to quantify total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol in urine
  23. Revival of physostigmine – a novel HPLC assay for simultaneous determination of physostigmine and its metabolite eseroline designed for a pharmacokinetic study of septic patients
  24. Relationship between antiphosphatidylserine/prothrombin and conventional antiphospholipid antibodies in primary antiphospholipid syndrome
  25. Reference Values and Biological Variations
  26. Relevance of EDTA carryover during blood collection
  27. Reference intervals for renal injury biomarkers neutrophil gelatinase-associated lipocalin and kidney injury molecule-1 in young infants
  28. Cardiovascular Diseases
  29. NT-proBNP levels and their relationship with systemic ventricular impairment in adult patients with transposition of the great arteries long after Mustard or Senning procedure
  30. Letters to the Editors
  31. Troponin T measured with highly sensitive assay (hsTnT) on admission does not reflect infarct size in ST-elevation myocardial infarction patients receiving primary percutaneous coronary intervention
  32. Analytical challenges related to the use of biomarker ratios for the biological diagnosis of Alzheimer’s disease
  33. Serum brain injury biomarkers as predictors of mortality after severe aneurysmal subarachnoid hemorrhage: preliminary results
  34. Tumor markers assay by the Lumipulse G
  35. Real-world costs of laboratory tests for non-small cell lung cancer
  36. Impact of stopping vitamin K antagonist therapy on concentrations of dephospho-uncarboxylated Matrix Gla protein
  37. Practicability of fetal scalp blood sampling during labor using microtubes and a point-of-care (POC) lactate testing device: difficulty assessment, sampling time and failure rates
  38. Establishing objective analytical quality requirements in the IgE specific assay: a message in a bottle
  39. Bacteria on a peripheral blood smear as presenting sign of overwhelming post-splenectomy infection in a patient with secondary acute myeloid leukemia
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