Reliability of CoaguChek Pro II Point of Care System in Outpatient Setting in Farwaniya Hospital, Kuwait

Aida Thabet; Danah Al-Shatti; Mohamed Elrahwan

doi:doi:10.11648/j.ajlm.20210603.11

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Reliability of CoaguChek Pro II Point of Care System in Outpatient Setting in Farwaniya Hospital, Kuwait

Aida Thabet, Danah Al-Shatti, Mohamed Elrahwan

Published in American Journal of Laboratory Medicine (Volume 6, Issue 3)

Received: 16 April 2021 Accepted: 5 May 2021 Published: 14 May 2021

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Abstract

Point of care testing (POCT) coagulometers are widely used for international normalized ratio (INR) monitoring for patients on vitamin K antagonists (VKA) therapy. In our study, we investigated the accuracy and reliability of CoaguChek pro II (Roche Diagnostics) as an alternative for standard laboratory testing (SLT) by ACL TOP 500 top system in outpatient department setting. Methods: We enrolled a total of 174 INR results in our study which were measured by CoaguChek ProII and ACL TOP 500 top. The three arms of the study were: INR <3.5, 3.5-4.4, and ≥4.5. The results were compared using Passing Bablok regression analysis and Bland-Altman plot. The agreement between the two methods was further evaluated to demonstrate the impact on dosing decision. Furthermore, the degree of patient satisfaction with POCT in our INR clinic was assessed by participating in a survey. Results: The overall correlation of INR measurements between POCT and SLT in our study was strong (r = 0.95), however, the correlation between the two methods in the 3.5-4.4 arm was moderate (r = 0.502). The overall agreement between the two methods in all three arms of the study in terms of dosing decision was good (Kappa = 0.862), with only 12.6% of INR measurements showing a difference in dosing decision. Ninety-Seven percent of all INR values measured by CoaguChek Pro II within therapeutic range (INR<3.5) were within 0.5 INR units when compared to ACL TOP 500 Top. Furthermore, we concluded that more than 90% of the patients in our center were satisfied with the POC service. Conclusion: We concluded that POCT is a good alternative to SLT in INR values falling in therapeutic and supra-therapeutic ranges; however, additional comparative studies investigating the accuracy and reliability between the two methods for INR results between 3.5-4.4 will add to the current body of knowledge. Furthermore, the majority of patients were satisfied with the service provided in the POC INR clinic.

Published in	American Journal of Laboratory Medicine (Volume 6, Issue 3)
DOI	10.11648/j.ajlm.20210603.11
Page(s)	31-36
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2021. Published by Science Publishing Group

Keywords

Point-of-care, CoaguChek Pro II, INR Monitoring, Patient Satisfaction

References

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[2]	Sade Adedeji-Zakari, The CoaguChek S System, U.S. Pharmacist, Feb 20, 2007.
[3]	Point Of Care International Normalized Ratio (INR) Monitoring Devices for Patients on Long-term Oral Anticoagulation Therapy, Ontario Health Technology Assessment Series, 2009; Vol. 9, No. 12.
[4]	Guidance on the Use of Point -of-Care Testing of International Normalized Ratio for Patients on Oral Anticoagulant Therapy, CADTH Optimal Use Report, July 2014, Vol. 3, Issue 1C.
[5]	CoaguChek Pro II, Roche Diagnostics, November 25, 2015
[6]	Deviations of high (>4.5) CoaguChek INR values due to calibration with WHO reference standard rTF/16, Roche Diagnostics, September 20, 2018.
[7]	Benade E. L., Jacobson B. F., Louw S., Schapkaitz E. Validation of the CoaguChek XS international normalised ratio point-of-care analyser in patients at Charlotte Maxeke Johannesburg Academic Hospital, South Africa. South African Medical Journal 2016; 106 (3): 280.
[8]	Point-of-Care INR Testing Compared with Lab INR Testing: What Does The Evidence Say?, CADTH 2015.
[9]	Lawrie AS1, Hills J, Longair I, Green L, Gardiner C, Machin SJ, Cohen H. The clinical significance of differences between point-of-care and laboratory INR methods in over-anticoagulated patients. Thromb Res. 2012 Jul; 130 (1): 110-114.
[10]	Sunderji R1, Gin K, Shalansky K, Carter C, Chambers K, Davies C, Schwartz L, Fung A. Clinical impact of point-of-care vs laboratory measurement of anticoagulation. Am J Clin Pathol. 2005 Feb; 123 (2): 184-188.
[11]	Fitzmaurice DA, Machin SJ. Recommendations for patients undertaking self management of oral anticoagulation. BMJ. 2001 Oct 27; 323 (7319): 985–989.
[12]	Ignjatovic V1, Barnes C, Newall F, Hamilton S, Burgess J, Monagle P. Point of care monitoring of oral anticoagulant therapy in children: comparison of CoaguChek Plus and thrombotest methods of venous international normalized ratio. Thromb Haemost. 2004 Oct; 92 (4): 734-737.
[13]	Jackson SL, Bereznicki LR, Peterson GM, Marsden KA, Jupe DM, Vial JH, Rasiah RL, Misan G, Williams SM. Accuracy and clinical usefulness of the near-patient testing CoaguChek S international normalized ratio monitor in rural medical practice. Aust J Rural Health. 2004 Aug; 12 (4): 137-142.
[14]	Chapman DC1, Stephens MA, Hamann GL, Bailey LE, Dorko CS. Accuracy, clinical correlation, and patient acceptance of two handheld prothrombin time monitoring devices in the ambulatory setting. Ann Pharmacother. 1999 Jul-Aug; 33 (7-8): 775-780.
[15]	Amy N. Thompson, Kelly R. Ragucci, Joli D. Fermo, and Heather P. Whitley. Evaluation of patient perceptions and outcomes related to anticoagulation point-of-care testing in ambulatory care clinics. Pharm Pract (Granada). 2009 Oct-Dec; 7 (4): 213–217.

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APA Style

Aida Thabet, Danah Al-Shatti, Mohamed Elrahwan. (2021). Reliability of CoaguChek Pro II Point of Care System in Outpatient Setting in Farwaniya Hospital, Kuwait. American Journal of Laboratory Medicine, 6(3), 31-36. https://doi.org/10.11648/j.ajlm.20210603.11

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ACS Style

Aida Thabet; Danah Al-Shatti; Mohamed Elrahwan. Reliability of CoaguChek Pro II Point of Care System in Outpatient Setting in Farwaniya Hospital, Kuwait. Am. J. Lab. Med. 2021, 6(3), 31-36. doi: 10.11648/j.ajlm.20210603.11

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AMA Style

Aida Thabet, Danah Al-Shatti, Mohamed Elrahwan. Reliability of CoaguChek Pro II Point of Care System in Outpatient Setting in Farwaniya Hospital, Kuwait. Am J Lab Med. 2021;6(3):31-36. doi: 10.11648/j.ajlm.20210603.11

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@article{10.11648/j.ajlm.20210603.11,
  author = {Aida Thabet and Danah Al-Shatti and Mohamed Elrahwan},
  title = {Reliability of CoaguChek Pro II Point of Care System in Outpatient Setting in Farwaniya Hospital, Kuwait},
  journal = {American Journal of Laboratory Medicine},
  volume = {6},
  number = {3},
  pages = {31-36},
  doi = {10.11648/j.ajlm.20210603.11},
  url = {https://doi.org/10.11648/j.ajlm.20210603.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajlm.20210603.11},
  abstract = {Point of care testing (POCT) coagulometers are widely used for international normalized ratio (INR) monitoring for patients on vitamin K antagonists (VKA) therapy. In our study, we investigated the accuracy and reliability of CoaguChek pro II (Roche Diagnostics) as an alternative for standard laboratory testing (SLT) by ACL TOP 500 top system in outpatient department setting. Methods: We enrolled a total of 174 INR results in our study which were measured by CoaguChek ProII and ACL TOP 500 top. The three arms of the study were: INR <3.5, 3.5-4.4, and ≥4.5. The results were compared using Passing Bablok regression analysis and Bland-Altman plot. The agreement between the two methods was further evaluated to demonstrate the impact on dosing decision. Furthermore, the degree of patient satisfaction with POCT in our INR clinic was assessed by participating in a survey. Results: The overall correlation of INR measurements between POCT and SLT in our study was strong (r = 0.95), however, the correlation between the two methods in the 3.5-4.4 arm was moderate (r = 0.502). The overall agreement between the two methods in all three arms of the study in terms of dosing decision was good (Kappa = 0.862), with only 12.6% of INR measurements showing a difference in dosing decision. Ninety-Seven percent of all INR values measured by CoaguChek Pro II within therapeutic range (INR<3.5) were within 0.5 INR units when compared to ACL TOP 500 Top. Furthermore, we concluded that more than 90% of the patients in our center were satisfied with the POC service. Conclusion: We concluded that POCT is a good alternative to SLT in INR values falling in therapeutic and supra-therapeutic ranges; however, additional comparative studies investigating the accuracy and reliability between the two methods for INR results between 3.5-4.4 will add to the current body of knowledge. Furthermore, the majority of patients were satisfied with the service provided in the POC INR clinic.},
 year = {2021}
}

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TY - JOUR
T1 - Reliability of CoaguChek Pro II Point of Care System in Outpatient Setting in Farwaniya Hospital, Kuwait
AU - Aida Thabet
AU - Danah Al-Shatti
AU - Mohamed Elrahwan
Y1 - 2021/05/14
PY - 2021
N1 - https://doi.org/10.11648/j.ajlm.20210603.11
DO - 10.11648/j.ajlm.20210603.11
T2 - American Journal of Laboratory Medicine
JF - American Journal of Laboratory Medicine
JO - American Journal of Laboratory Medicine
SP - 31
EP - 36
PB - Science Publishing Group
SN - 2575-386X
UR - https://doi.org/10.11648/j.ajlm.20210603.11
AB - Point of care testing (POCT) coagulometers are widely used for international normalized ratio (INR) monitoring for patients on vitamin K antagonists (VKA) therapy. In our study, we investigated the accuracy and reliability of CoaguChek pro II (Roche Diagnostics) as an alternative for standard laboratory testing (SLT) by ACL TOP 500 top system in outpatient department setting. Methods: We enrolled a total of 174 INR results in our study which were measured by CoaguChek ProII and ACL TOP 500 top. The three arms of the study were: INR <3.5, 3.5-4.4, and ≥4.5. The results were compared using Passing Bablok regression analysis and Bland-Altman plot. The agreement between the two methods was further evaluated to demonstrate the impact on dosing decision. Furthermore, the degree of patient satisfaction with POCT in our INR clinic was assessed by participating in a survey. Results: The overall correlation of INR measurements between POCT and SLT in our study was strong (r = 0.95), however, the correlation between the two methods in the 3.5-4.4 arm was moderate (r = 0.502). The overall agreement between the two methods in all three arms of the study in terms of dosing decision was good (Kappa = 0.862), with only 12.6% of INR measurements showing a difference in dosing decision. Ninety-Seven percent of all INR values measured by CoaguChek Pro II within therapeutic range (INR<3.5) were within 0.5 INR units when compared to ACL TOP 500 Top. Furthermore, we concluded that more than 90% of the patients in our center were satisfied with the POC service. Conclusion: We concluded that POCT is a good alternative to SLT in INR values falling in therapeutic and supra-therapeutic ranges; however, additional comparative studies investigating the accuracy and reliability between the two methods for INR results between 3.5-4.4 will add to the current body of knowledge. Furthermore, the majority of patients were satisfied with the service provided in the POC INR clinic.
VL - 6
IS - 3
ER -

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Author Information

Aida Thabet

Department of Clinical Pathology, Banha University, Banha, Egypt
Danah Al-Shatti

Department of Hematopathology, Farwaniya Hospital, Farwaniya, Kuwait
Mohamed Elrahwan

Department of Hematopathology, Farwaniya Hospital, Farwaniya, Kuwait

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APA Style

Aida Thabet, Danah Al-Shatti, Mohamed Elrahwan. (2021). Reliability of CoaguChek Pro II Point of Care System in Outpatient Setting in Farwaniya Hospital, Kuwait. American Journal of Laboratory Medicine, 6(3), 31-36. https://doi.org/10.11648/j.ajlm.20210603.11

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ACS Style

Aida Thabet; Danah Al-Shatti; Mohamed Elrahwan. Reliability of CoaguChek Pro II Point of Care System in Outpatient Setting in Farwaniya Hospital, Kuwait. Am. J. Lab. Med. 2021, 6(3), 31-36. doi: 10.11648/j.ajlm.20210603.11

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AMA Style

Aida Thabet, Danah Al-Shatti, Mohamed Elrahwan. Reliability of CoaguChek Pro II Point of Care System in Outpatient Setting in Farwaniya Hospital, Kuwait. Am J Lab Med. 2021;6(3):31-36. doi: 10.11648/j.ajlm.20210603.11

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@article{10.11648/j.ajlm.20210603.11,
  author = {Aida Thabet and Danah Al-Shatti and Mohamed Elrahwan},
  title = {Reliability of CoaguChek Pro II Point of Care System in Outpatient Setting in Farwaniya Hospital, Kuwait},
  journal = {American Journal of Laboratory Medicine},
  volume = {6},
  number = {3},
  pages = {31-36},
  doi = {10.11648/j.ajlm.20210603.11},
  url = {https://doi.org/10.11648/j.ajlm.20210603.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajlm.20210603.11},
  abstract = {Point of care testing (POCT) coagulometers are widely used for international normalized ratio (INR) monitoring for patients on vitamin K antagonists (VKA) therapy. In our study, we investigated the accuracy and reliability of CoaguChek pro II (Roche Diagnostics) as an alternative for standard laboratory testing (SLT) by ACL TOP 500 top system in outpatient department setting. Methods: We enrolled a total of 174 INR results in our study which were measured by CoaguChek ProII and ACL TOP 500 top. The three arms of the study were: INR <3.5, 3.5-4.4, and ≥4.5. The results were compared using Passing Bablok regression analysis and Bland-Altman plot. The agreement between the two methods was further evaluated to demonstrate the impact on dosing decision. Furthermore, the degree of patient satisfaction with POCT in our INR clinic was assessed by participating in a survey. Results: The overall correlation of INR measurements between POCT and SLT in our study was strong (r = 0.95), however, the correlation between the two methods in the 3.5-4.4 arm was moderate (r = 0.502). The overall agreement between the two methods in all three arms of the study in terms of dosing decision was good (Kappa = 0.862), with only 12.6% of INR measurements showing a difference in dosing decision. Ninety-Seven percent of all INR values measured by CoaguChek Pro II within therapeutic range (INR<3.5) were within 0.5 INR units when compared to ACL TOP 500 Top. Furthermore, we concluded that more than 90% of the patients in our center were satisfied with the POC service. Conclusion: We concluded that POCT is a good alternative to SLT in INR values falling in therapeutic and supra-therapeutic ranges; however, additional comparative studies investigating the accuracy and reliability between the two methods for INR results between 3.5-4.4 will add to the current body of knowledge. Furthermore, the majority of patients were satisfied with the service provided in the POC INR clinic.},
 year = {2021}
}

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