Importance of device evaluation for point-of-care prothrombin time international normalized ratio testing programs

Robert D. McBane, Cindy L. Felty, Mindy L. Hartgers, Rajeev Chaudhry, Lisa K. Beyer, Paula J. Santrach

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

OBJECTIVE: To determine the accuracy of 2 commercially available point-of-care devises relative to plasma international normalized ratio (INR) values. PATIENTS AND METHODS: Point-of-care INR testing was performed with the CoaguChek and ProTime 3 devices in consecutive patients attending an anticoagulation clinic between June 18, 2003, and August 6, 2003. Results were compared with plasma INRs using a sensitive thromboplastin (International Sensitivity Index, 1.0). RESULTS: Ninety-four patients agreed to participate in the study. Relative to the plasma INR, values were in agreement ±0.4 INR unit 82% and 39% of the time for the CoaguChek and ProTime 3 devices, respectively. The mean ± SD CoaguChek INRs were 0.2±0.31 unit lower, whereas ProTime 3 INRs were 0.8±0.68 unit higher than plasma INR values. Treatment decisions based on these data would have resulted in inappropriate dose adjustments 10% and 22% of the time for these 2 respective devices. Correlation with plasma was greater for the CoaguChek (r 2=0.90) compared with the ProTime 3 device (r2=0.73). CONCLUSIONS: Optimal warfarin treatment requires accurate measurement of the IMR. The choice of a point-of-care device for INR management depends on the reliability of INR data generated by the device.

Original languageEnglish (US)
Pages (from-to)181-186
Number of pages6
JournalMayo Clinic Proceedings
Volume80
Issue number2
StatePublished - 2005

Fingerprint

Point-of-Care Systems
International Normalized Ratio
Prothrombin Time
Equipment and Supplies
Thromboplastin
Warfarin

ASJC Scopus subject areas

  • Medicine(all)

Cite this

McBane, R. D., Felty, C. L., Hartgers, M. L., Chaudhry, R., Beyer, L. K., & Santrach, P. J. (2005). Importance of device evaluation for point-of-care prothrombin time international normalized ratio testing programs. Mayo Clinic Proceedings, 80(2), 181-186.

Importance of device evaluation for point-of-care prothrombin time international normalized ratio testing programs. / McBane, Robert D.; Felty, Cindy L.; Hartgers, Mindy L.; Chaudhry, Rajeev; Beyer, Lisa K.; Santrach, Paula J.

In: Mayo Clinic Proceedings, Vol. 80, No. 2, 2005, p. 181-186.

Research output: Contribution to journalArticle

McBane, RD, Felty, CL, Hartgers, ML, Chaudhry, R, Beyer, LK & Santrach, PJ 2005, 'Importance of device evaluation for point-of-care prothrombin time international normalized ratio testing programs', Mayo Clinic Proceedings, vol. 80, no. 2, pp. 181-186.
McBane RD, Felty CL, Hartgers ML, Chaudhry R, Beyer LK, Santrach PJ. Importance of device evaluation for point-of-care prothrombin time international normalized ratio testing programs. Mayo Clinic Proceedings. 2005;80(2):181-186.
McBane, Robert D. ; Felty, Cindy L. ; Hartgers, Mindy L. ; Chaudhry, Rajeev ; Beyer, Lisa K. ; Santrach, Paula J. / Importance of device evaluation for point-of-care prothrombin time international normalized ratio testing programs. In: Mayo Clinic Proceedings. 2005 ; Vol. 80, No. 2. pp. 181-186.
@article{bf1271cc00f54e37a461c67e80532e49,
title = "Importance of device evaluation for point-of-care prothrombin time international normalized ratio testing programs",
abstract = "OBJECTIVE: To determine the accuracy of 2 commercially available point-of-care devises relative to plasma international normalized ratio (INR) values. PATIENTS AND METHODS: Point-of-care INR testing was performed with the CoaguChek and ProTime 3 devices in consecutive patients attending an anticoagulation clinic between June 18, 2003, and August 6, 2003. Results were compared with plasma INRs using a sensitive thromboplastin (International Sensitivity Index, 1.0). RESULTS: Ninety-four patients agreed to participate in the study. Relative to the plasma INR, values were in agreement ±0.4 INR unit 82{\%} and 39{\%} of the time for the CoaguChek and ProTime 3 devices, respectively. The mean ± SD CoaguChek INRs were 0.2±0.31 unit lower, whereas ProTime 3 INRs were 0.8±0.68 unit higher than plasma INR values. Treatment decisions based on these data would have resulted in inappropriate dose adjustments 10{\%} and 22{\%} of the time for these 2 respective devices. Correlation with plasma was greater for the CoaguChek (r 2=0.90) compared with the ProTime 3 device (r2=0.73). CONCLUSIONS: Optimal warfarin treatment requires accurate measurement of the IMR. The choice of a point-of-care device for INR management depends on the reliability of INR data generated by the device.",
author = "McBane, {Robert D.} and Felty, {Cindy L.} and Hartgers, {Mindy L.} and Rajeev Chaudhry and Beyer, {Lisa K.} and Santrach, {Paula J.}",
year = "2005",
language = "English (US)",
volume = "80",
pages = "181--186",
journal = "Mayo Clinic Proceedings",
issn = "0025-6196",
publisher = "Elsevier Science",
number = "2",

}

TY - JOUR

T1 - Importance of device evaluation for point-of-care prothrombin time international normalized ratio testing programs

AU - McBane, Robert D.

AU - Felty, Cindy L.

AU - Hartgers, Mindy L.

AU - Chaudhry, Rajeev

AU - Beyer, Lisa K.

AU - Santrach, Paula J.

PY - 2005

Y1 - 2005

N2 - OBJECTIVE: To determine the accuracy of 2 commercially available point-of-care devises relative to plasma international normalized ratio (INR) values. PATIENTS AND METHODS: Point-of-care INR testing was performed with the CoaguChek and ProTime 3 devices in consecutive patients attending an anticoagulation clinic between June 18, 2003, and August 6, 2003. Results were compared with plasma INRs using a sensitive thromboplastin (International Sensitivity Index, 1.0). RESULTS: Ninety-four patients agreed to participate in the study. Relative to the plasma INR, values were in agreement ±0.4 INR unit 82% and 39% of the time for the CoaguChek and ProTime 3 devices, respectively. The mean ± SD CoaguChek INRs were 0.2±0.31 unit lower, whereas ProTime 3 INRs were 0.8±0.68 unit higher than plasma INR values. Treatment decisions based on these data would have resulted in inappropriate dose adjustments 10% and 22% of the time for these 2 respective devices. Correlation with plasma was greater for the CoaguChek (r 2=0.90) compared with the ProTime 3 device (r2=0.73). CONCLUSIONS: Optimal warfarin treatment requires accurate measurement of the IMR. The choice of a point-of-care device for INR management depends on the reliability of INR data generated by the device.

AB - OBJECTIVE: To determine the accuracy of 2 commercially available point-of-care devises relative to plasma international normalized ratio (INR) values. PATIENTS AND METHODS: Point-of-care INR testing was performed with the CoaguChek and ProTime 3 devices in consecutive patients attending an anticoagulation clinic between June 18, 2003, and August 6, 2003. Results were compared with plasma INRs using a sensitive thromboplastin (International Sensitivity Index, 1.0). RESULTS: Ninety-four patients agreed to participate in the study. Relative to the plasma INR, values were in agreement ±0.4 INR unit 82% and 39% of the time for the CoaguChek and ProTime 3 devices, respectively. The mean ± SD CoaguChek INRs were 0.2±0.31 unit lower, whereas ProTime 3 INRs were 0.8±0.68 unit higher than plasma INR values. Treatment decisions based on these data would have resulted in inappropriate dose adjustments 10% and 22% of the time for these 2 respective devices. Correlation with plasma was greater for the CoaguChek (r 2=0.90) compared with the ProTime 3 device (r2=0.73). CONCLUSIONS: Optimal warfarin treatment requires accurate measurement of the IMR. The choice of a point-of-care device for INR management depends on the reliability of INR data generated by the device.

UR - http://www.scopus.com/inward/record.url?scp=13244277897&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=13244277897&partnerID=8YFLogxK

M3 - Article

VL - 80

SP - 181

EP - 186

JO - Mayo Clinic Proceedings

JF - Mayo Clinic Proceedings

SN - 0025-6196

IS - 2

ER -