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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

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1437-4331
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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
  • Corresponding author
  • Coagulation Reference Laboratory, Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands
  • Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands, Phone: +31 71 5261888
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Charmane F. Abdoel
  • Coagulation Reference Laboratory, Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, The Netherlands
  • Other articles by this author:
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/ Claudia J.J. van Rijn
  • Coagulation Reference Laboratory, Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, The Netherlands
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/ Felix J.M. van der Meer
  • Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands
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/ Christa M. Cobbaert
  • Coagulation Reference Laboratory, Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, The Netherlands
  • Other articles by this author:
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Published Online: 2019-02-14 | DOI: https://doi.org/10.1515/cclm-2018-1054

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.

This article offers supplementary material which is provided at the end of the article.

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

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About the article

Received: 2018-09-25

Accepted: 2019-01-15

Published Online: 2019-02-14


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

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

Employment or leadership: None declared.

Honorarium: None declared.

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.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), 20181054, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2018-1054.

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