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.
authors.affiliation: European Concerted Action on Thrombosis (ECAT) Foundation, Leiden, the Netherland.
authors.forename: Piet
authors.initials: P
authors.lastname: Meijer
authors.forename: Cornelis
authors.initials: C
authors.lastname: Kluft
authors.forename: Leon
authors.initials: L
authors.lastname: Poller
authors.forename: Felix J M
authors.initials: FJ
authors.lastname: van der Meer
authors.forename: Michelle
authors.initials: M
authors.lastname: Keown
authors.forename: Saied
authors.initials: S
authors.lastname: Ibrahim
authors.forename: Anton M H P
authors.initials: AM
authors.lastname: van den Besselaar
authors.forename: Armando
authors.initials: A
authors.lastname: Tripodi
authors.forename: Jørgen
authors.initials: J
authors.lastname: Jespersen
mesh_terms: D019934:International Normalized Ratio; D009426:Netherlands; D019095:Point-of-Care Systems / Q000592:standards*; D011517:Prothrombin Time / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D011786:Quality Control; D015203:Reproducibility of Results