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Accuracy assessment of consecutive test strip lots for whole blood INR point-of-care instruments: clarifying the role of frozen plasma pools

  • Antonius M.H.P. van den Besselaar EMAIL logo , Charmane F. Abdoel , Claudia J.J. van Rijn , Felix J.M. van der Meer and Christa M. Cobbaert
Published/Copyright: February 14, 2019
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 57 Issue 9

Abstract

Background

In the Netherlands, each new lot of test strips for the CoaguChek XS is validated by a group of collaborating centers. The purpose of this study was to assess the accuracy of the international normalized ratio (INR) measured with consecutive test strip lots and the suitability of frozen plasma pools for accuracy evaluation.

Methods

Each year, a particular lot of CoaguChek XS test strips is used as reference lot. The reference lots have been validated with the International Standard for thromboplastin rTF/09, yielding a mathematical relationship (R1) between reference lot INR and International Standard INR. New lots are compared to the reference lot using patients’ capillary blood samples, yielding a relationship (R2) between the new lot INR and the reference lot INR. INRs of the blood samples were within the 1.5–4.5 interval. In parallel, three frozen plasmas pools are analyzed with the test strips. The distance of each plasma point to the line of relationship R2 was assessed.

Results

Fifty-four test strip lots have been evaluated during 3 years (2014–2016). Mean INR differences between test strip lot and International Standard rTF/09 varied between −0.14 and +0.20 (−4% and +8%, respectively). A positive trend with strip lot sequence number was observed (p<0.001). In several cases, the distance of the frozen plasmas to the whole blood relationship (R2) was greater than the critical value for commutability.

Conclusions

Using whole blood, all evaluated test strip lots met the analytical bias criterion of ±10%. Frozen plasma pools behave differently compared to whole blood and are not suitable for assessing absolute accuracy of new CoaguChek XS test strips.

Keywords: commutability; international normalized ratio; point-of-care testing; prothrombin time; thromboplastin; validation

Acknowledgments

The following Dutch Thrombosis Centers participated in the lot-to-lot evaluation of CoaguChek XS test strips: Jeroen Bosch Hospital (‘s-Hertogenbosch, The Netherlands), Thrombosis Service Saltro (Utrecht, The Netherlands), Thrombosis Service Leiden (Leiden, The Netherlands), INR Thrombosis Service (Nijmegen, The Netherlands), Thrombosis Service Friesland Noord (Leeuwarden, The Netherlands), ASCON (Enschede, The Netherlands), Star-SHL (Rotterdam, the Netherlands), Lab-West (Den Haag, The Netherlands).

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

  2. Research funding: This work was supported in part by Roche Diagnostics Nederland BV and in part by the Federation of Netherlands Thrombosis Services.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization 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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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2018-1054).

Received: 2018-09-25
Accepted: 2019-01-15
Published Online: 2019-02-14
Published in Print: 2019-08-27

©2019 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2018-1054
Keywords for this article
commutability; international normalized ratio; point-of-care testing; prothrombin time; thromboplastin; validation

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Sepsis biomarkers: past, present and future
  4. Reviews
  5. Making new biomarkers a reality: the case of serum human epididymis protein 4
  6. Faecal calprotectin in inflammatory bowel diseases: a review focused on meta-analyses and routine usage limitations
  7. Opinion Paper
  8. Procalcitonin (PCT)-guided antibiotic stewardship: an international experts consensus on optimized clinical use
  9. EFLM Paper
  10. Practice in financial support of third party organised conferences and courses at a national level for health care professionals in Europe
  11. General Clinical Chemistry and Laboratory Medicine
  12. Design and implementation of quality control plans that integrate moving average and internal quality control: incorporating the best of both worlds
  13. Elecsys® and Kryptor immunoassays for the measurement of sFlt-1 and PlGF to aid preeclampsia diagnosis: are they comparable?
  14. Accuracy assessment of consecutive test strip lots for whole blood INR point-of-care instruments: clarifying the role of frozen plasma pools
  15. Subcutaneous adipose tissue distribution and telomere length
  16. Hematology and Coagulation
  17. Automated measurement of the erythrocyte sedimentation rate: method validation and comparison
  18. The effect of DOAC-Stop on lupus anticoagulant testing in plasma samples of venous thromboembolism patients receiving direct oral anticoagulants
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  28. Biomarker-assisted identification of sepsis-related acute liver impairment: a frequent and deadly condition in critically ill patients
  29. Letters to the Editor
  30. Differences in procalcitonin measurements between three BRAHMS-partnered immunoassays (Liaison, Elecsys and Architect)
  31. The short story of the long-term Sigma metric: shift cannot be treated as a linear parameter
  32. Analytical and diagnostic performance evaluation of five creatinine POCT devices in the identification of patients at risk for post-contrast acute kidney injury (PCAKI)
  33. Lesson from inappropriate TSH-receptor antibody measurement in hypothyroidism: case series and literature review
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