A national field study of quality assessment of CoaguChek point-of-care testing prothrombin time monitors

Piet Meijer; Cornelis Kluft; Leon Poller; Felix J M Van Der Meer; Michelle Keown; Saied Ibrahim; Anton M H P Van Den Besselaar; Armando Tripodi; Jørgen Jespersen

doi:10.1309/6Q8DY5J1THA8BQG3

A national field study of quality assessment of CoaguChek point-of-care testing prothrombin time monitors

Piet Meijer, Cornelis Kluft, Leon Poller, Felix J M Van Der Meer, Michelle Keown, Saied Ibrahim, Anton M H P Van Den Besselaar, Armando Tripodi, Jørgen Jespersen

Research output: Contribution to journal › Article › peer-review

Abstract

A system for quality assessment (QA) of the CoaguChek (Roche Diagnostics, Mannheim, Germany) point-of-care testing prothrombin time monitor has been developed by the European Concerted Action on Anticoagulation. Hitherto there has not been an adequate rapid method for CoaguChek QA. Sets of 5 certified international normalized ratio (INR) plasma samples were tested on 539 CoaguChek monitors by experienced staff at 9 Netherlands Thrombosis Centers and results compared with certified INR. A 15% or more deviation has been classified as significant deviation. Overall mean and certified INR values were similar, but 20.3% of participants showed a 15% or more deviation from the certified INR on at least 1 of the 5 QA plasma samples. Statistically significant differences in results with different lots of CoaguChek test strips were found. There is need for large scale QA of CoaguChek monitors. The importance of the 5 CoaguChek certified INR QA plasma samples being tested on a single occasion is demonstrated. © American Society for Clinical Pathology.

Original language	English
Pages (from-to)	756-761
Number of pages	5
Journal	American journal of clinical pathology
Volume	126
Issue number	5
DOIs	https://doi.org/10.1309/6Q8DY5J1THA8BQG3
Publication status	Published - Nov 2006

Keywords

CoaguChek monitors
Prothrombin time
Quality assessment
Significant deviation

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10.1309/6Q8DY5J1THA8BQG3

Cite this

@article{c9c33220831c41f4bd5fdc155b68b6a7,

title = "A national field study of quality assessment of CoaguChek point-of-care testing prothrombin time monitors",

abstract = "A system for quality assessment (QA) of the CoaguChek (Roche Diagnostics, Mannheim, Germany) point-of-care testing prothrombin time monitor has been developed by the European Concerted Action on Anticoagulation. Hitherto there has not been an adequate rapid method for CoaguChek QA. Sets of 5 certified international normalized ratio (INR) plasma samples were tested on 539 CoaguChek monitors by experienced staff at 9 Netherlands Thrombosis Centers and results compared with certified INR. A 15% or more deviation has been classified as significant deviation. Overall mean and certified INR values were similar, but 20.3% of participants showed a 15% or more deviation from the certified INR on at least 1 of the 5 QA plasma samples. Statistically significant differences in results with different lots of CoaguChek test strips were found. There is need for large scale QA of CoaguChek monitors. The importance of the 5 CoaguChek certified INR QA plasma samples being tested on a single occasion is demonstrated. {\textcopyright} American Society for Clinical Pathology.",

keywords = "CoaguChek monitors, Prothrombin time, Quality assessment, Significant deviation",

author = "Piet Meijer and Cornelis Kluft and Leon Poller and {Van Der Meer}, {Felix J M} and Michelle Keown and Saied Ibrahim and {Van Den Besselaar}, {Anton M H P} and Armando Tripodi and J{\o}rgen Jespersen",

year = "2006",

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doi = "10.1309/6Q8DY5J1THA8BQG3",

language = "English",

volume = "126",

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AU - Meijer, Piet

AU - Kluft, Cornelis

AU - Poller, Leon

AU - Van Der Meer, Felix J M

AU - Keown, Michelle

AU - Ibrahim, Saied

AU - Van Den Besselaar, Anton M H P

AU - Tripodi, Armando

AU - Jespersen, Jørgen

PY - 2006/11

Y1 - 2006/11

N2 - A system for quality assessment (QA) of the CoaguChek (Roche Diagnostics, Mannheim, Germany) point-of-care testing prothrombin time monitor has been developed by the European Concerted Action on Anticoagulation. Hitherto there has not been an adequate rapid method for CoaguChek QA. Sets of 5 certified international normalized ratio (INR) plasma samples were tested on 539 CoaguChek monitors by experienced staff at 9 Netherlands Thrombosis Centers and results compared with certified INR. A 15% or more deviation has been classified as significant deviation. Overall mean and certified INR values were similar, but 20.3% of participants showed a 15% or more deviation from the certified INR on at least 1 of the 5 QA plasma samples. Statistically significant differences in results with different lots of CoaguChek test strips were found. There is need for large scale QA of CoaguChek monitors. The importance of the 5 CoaguChek certified INR QA plasma samples being tested on a single occasion is demonstrated. © American Society for Clinical Pathology.

AB - A system for quality assessment (QA) of the CoaguChek (Roche Diagnostics, Mannheim, Germany) point-of-care testing prothrombin time monitor has been developed by the European Concerted Action on Anticoagulation. Hitherto there has not been an adequate rapid method for CoaguChek QA. Sets of 5 certified international normalized ratio (INR) plasma samples were tested on 539 CoaguChek monitors by experienced staff at 9 Netherlands Thrombosis Centers and results compared with certified INR. A 15% or more deviation has been classified as significant deviation. Overall mean and certified INR values were similar, but 20.3% of participants showed a 15% or more deviation from the certified INR on at least 1 of the 5 QA plasma samples. Statistically significant differences in results with different lots of CoaguChek test strips were found. There is need for large scale QA of CoaguChek monitors. The importance of the 5 CoaguChek certified INR QA plasma samples being tested on a single occasion is demonstrated. © American Society for Clinical Pathology.

KW - CoaguChek monitors

KW - Prothrombin time

KW - Quality assessment

KW - Significant deviation

U2 - 10.1309/6Q8DY5J1THA8BQG3

DO - 10.1309/6Q8DY5J1THA8BQG3

M3 - Article

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SN - 0002-9173

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SP - 756

EP - 761

JO - American journal of clinical pathology

JF - American journal of clinical pathology

IS - 5

ER -

A national field study of quality assessment of CoaguChek point-of-care testing prothrombin time monitors

Abstract

Keywords

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