Startseite Medizin Analytical performance and user-friendliness of four point-of-care measuring systems for monitoring prothrombin time international normalized ratio in the hands of the intended users
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Analytical performance and user-friendliness of four point-of-care measuring systems for monitoring prothrombin time international normalized ratio in the hands of the intended users

  • Dår Kristian Kur , Elisabet Eriksson Boija , Christine Morken , Sverre Sandberg und Anne Stavelin ORCID logo EMAIL logo
Veröffentlicht/Copyright: 23. Mai 2025
Diagnosis
Aus der Zeitschrift Diagnosis Band 12 Heft 3

Abstract

Objectives

Scandinavian evaluation of laboratory equipment for point of care testing (SKUP) provides objective and supplier-independent information about analytical quality and user-friendliness of point-of-care (POC) measuring systems. The evaluation reports are freely available online and are valuable tools when selecting fit-for-purpose POC equipment. In this study, we present an overview of the performance of four POC measuring systems for monitoring prothrombin time international normalized ratio (INR) assessed against updated analytical performance specifications (APSs).

Methods

Primary healthcare centres (PHCCs) in Sweden and Norway did the practical work under real-life conditions. In each evaluation, 2–4 PHCCs participated with at least 40 patients on Warfarin treatment per site. Capillary samples were measured on the POC INR systems (qLabs Q3 Plus PT-INR Owren, Xprecia Stride, microINR or ProTime InRhythm), with venous samples analysed at hospital laboratories for comparison (STA-R Evolution or Sysmex CS5100). In the current study, APSs from SKUP, ISO 17593:2022, and CLSI POCT14-Ed2 were used. User-friendliness was assessed by addressing operational facilities, user-manual, time factors, and quality control.

Results

Only microINR coagulometer met the APS for accuracy, while qLabs Q3 Plus PT-INR Owren and ProTime InRhythm met the repeatability criteria. Xprecia Stride scored highest on user-friendliness, whereas the other systems faced challenges with sample application and unclear error messages on the devices.

Conclusions

This study highlights the potential for improvements in POC INR measuring systems and underscores the importance of performing objective evaluations under real-life conditions.

Keywords: analytical performance; international normalized ratio; method evaluation; point-of-care testing; user-friendliness
Corresponding author: Anne Stavelin, The Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway, E-mail:

Acknowledgments

The authors acknowledge the evaluation sites and persons performing sample collection and measurements in the four SKUP evaluations.

  1. Research ethics: The local Institutional Review Board deemed the study exempt from review.

  2. Informed consent: Not applicable.

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

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: The authors elect to not share data.

  8. Role of sponsor: The four evaluations are in part financed by the manufacturers and/or suppliers of the POCT systems. The company requesting the evaluation paid the actual testing costs and received in return an impartial evaluation.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/dx-2025-0023).

Received: 2025-02-10
Accepted: 2025-04-12
Published Online: 2025-05-23

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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  24. Fetal hematological phenotypes of various hemoglobinopathies and demonstration of embryonic hemoglobins on capillary electrophoresis: a large cohort data from prenatal screening program
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  33. Immunoglobulin E in an inverted skin-prick test for rapid detection of cutaneous antigens
https://doi.org/10.1515/dx-2025-0023
Schlagwörter für diesen Artikel
analytical performance; international normalized ratio; method evaluation; point-of-care testing; user-friendliness

Artikel in diesem Heft

  1. Frontmatter
  2. Reviews
  3. Accuracy of pulse wave velocity for screening coronary artery disease: a systematic review and meta-analysis
  4. Prenatal screening for genetic disorders: updated guidelines, proposed counseling, a holistic approach for primary health care providers in developing countries
  5. A scoping review of fever of unknown origin with normal serum C-reactive protein
  6. Mini Review
  7. Overview of dengue diagnostic limitations and potential strategies for improvement
  8. Opinion Papers
  9. Demystifying cognitive bias in the diagnostic process for frontline clinicians and educators; new words for old ideas
  10. Physicians’ prism: illuminating history with structured expertise
  11. Original Articles
  12. Implementation of a curriculum on communicating diagnostic uncertainty for clerkship-level medical students: a pseudorandomized and controlled study
  13. A synthesized differential diagnosis is associated with fewer diagnostic errors compared to an inventorial list
  14. Equity-Driven Diagnostic Excellence framework: An upstream approach to minimize risk of diagnostic inequity
  15. Two decades of autopsy-detected diagnostic errors in Japan
  16. Does management reasoning display context specificity? An exploration of sleep loss and other distracting situational (contextual) factors in clinical reasoning
  17. Cognitive biases in osteopathic diagnosis: a mixed study among French osteopaths
  18. Racial and ethnic disparities in pediatric emergency department patients with missed opportunities for diagnostic excellence
  19. Diagnostic accuracy of non-mydriatic fundus photography as a triage and telemedicine tool for patients with vision loss
  20. “Innumerable” lesion burden on brain MRI ‒ a diagnostic approach
  21. Factors associated with positive findings of deep infection on computed tomography among patients with extremity cellulitis
  22. Exploring emergency department providers’ uncertainty in neurological clinical reasoning
  23. Analytical performance and user-friendliness of four point-of-care measuring systems for monitoring prothrombin time international normalized ratio in the hands of the intended users
  24. Fetal hematological phenotypes of various hemoglobinopathies and demonstration of embryonic hemoglobins on capillary electrophoresis: a large cohort data from prenatal screening program
  25. Development and assessment of autoverification system for routine coagulation assays in inpatient and outpatient settings of tertiary care hospital: algorithm performance and impact on laboratory efficiency
  26. Validation of new, circulating biomarkers for gliomas
  27. Short Communications
  28. Using language to evaluate curricular impact: a novel approach in assessing clinical reasoning curricula
  29. Comparative evaluation of routine coagulation testing on Stago sthemO 301 and Werfen ACL TOP 750
  30. Letters to the Editor
  31. Reversible systemic vasoconstriction syndrome: a new diagnostic family of generalized vasospasm in multiple organs
  32. The value of designating symptoms as “vague” in diagnosis
  33. Immunoglobulin E in an inverted skin-prick test for rapid detection of cutaneous antigens
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