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Time for a conceptual shift in assessment of internal quality control for whole blood or cell-based testing systems? An evaluation using platelet function and the PFA-100 as a case example

  • Emmanuel J. Favaloro EMAIL logo
Published/Copyright: November 5, 2012
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 51 Issue 4

Abstract

Internal quality control (IQC) is essential to good laboratory practice. IQC for certain tests are, however, limited due to inherent problems in providing stabilized IQC material, as applicable to many whole-blood and cell-based systems. Paradigmatic in the hemostasis field is platelet function testing, where IQC processes remain at their infancy, despite such tests being undertaken for decades. One example is the PFA-100, a popular primary hemostasis screening system used to evaluate pre-surgical bleeding risk, screen for possible von Willebrand disease and/or platelet function disorders, and assess desmopressin and anti-platelet therapy; whatever application, laboratories are required to ensure instruments are in optimal working condition, but currently available IQC is limited. Accordingly, a novel test process for IQC of the PFA-100 is explored as an example of potential development. In brief, IQC test systems were prepared to yield prolonged PFA closure times (CTs) (‘pathological QC’) after the addition of normal whole blood (which provided ‘normal QC’). Inter-run test systems coefficients of variation (CVs; range 3.1%–26.2%) were typically similar or better than normal baseline CTs (16.1%–19.2%). There was no evidence of deterioration in CTs over time, indicating at least several years test system stability, and Levey-Jennings plots, typically applied to IQC monitoring, could also be devised. This provides the first evidence of feasibility, or proof of concept, for IQC testing for the PFA-100 incorporating pathological test findings and Levey-Jennings plots. Such a concept is also potentially more broadly applicable to other platelet function, or whole blood or cell-based test systems.

Keywords: internal quality control; PFA-100; platelet function; point of care; whole blood
Corresponding author: Emmanuel J. Favaloro, Department of Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), Westmead Hospital, Westmead, NSW, Australia, Phone: +61 2 9845 6618, Fax: +61 2 9689 2331

The author thanks Soma Mohammed, Jane McDonald and Ella Grezchnik for technical assistance in performance of PFA-100 testing.

Conflict of interest statement

Author’s conflict of interest disclosure: The author stated that there are no conflicts of interest regarding the publication of this article.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

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Received: 2012-09-17
Accepted: 2012-10-10
Published Online: 2012-11-05
Published in Print: 2013-04-01

©2013 by Walter de Gruyter Berlin Boston

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https://doi.org/10.1515/cclm-2012-0616
Keywords for this article
internal quality control; PFA-100; platelet function; point of care; whole blood

Articles in the same Issue

  1. Letters to the Editor
  2. Missing agreement between the two IMMULITE® PSA assays
  3. “Cerebrovascular stressing”: dipyridamole-induced S100B elevation predicts ischemic cerebrovascular events
  4. Discrepancy in lamellar body counts (LBCs) between the Sysmex XE-2100 and Sysmex XT-2000i instruments
  5. Interphase fluorescent in situ hybridization detection of the 7q11.23 chromosomal inversion in a clinical laboratory: automated versus manual scoring
  6. Adrenocorticotropic hormone stability in preanalytical phase depends on temperature and proteolytic enzyme inhibitor
  7. The impact on costs and efficiency of reducing the number of collected tubes
  8. Improved software on the Sysmex XE-5000 BF mode for counting leukocytes in cerebrospinal fluid
  9. First trimester placental growth factor and soluble fms-like tyrosine kinase 1 are significantly related to PAPP-A levels
  10. Preliminary evaluation of complete blood cell count on Mindray BC-6800
  11. Rational use of laboratory tests: albuminuria
  12. Masthead
  13. Masthead
  14. Editorials
  15. Fifty years of CCLM – invitation to join us for a reception in Milan
  16. Personalized (laboratory) medicine: a bridge to the future
  17. PSA, PCA3 and the phi losophy of prostate cancer management
  18. Reviews
  19. Gender medicine: a task for the third millennium
  20. Evaluation of [−2] proPSA and Prostate Health Index (phi) for the detection of prostate cancer: a systematic review and meta-analysis
  21. Harmonization in laboratory medicine: the complete picture
  22. Opinion Papers
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  25. Guidelines and Recommendations
  26. A position paper of the EFLM Committee on Education and Training and Working Group on Distance Education Programmes/E-Learning: developing an e-learning platform for the education of stakeholders in laboratory medicine
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