A national field study of quality assessment of CoaguChek point-of-care testing prothrombin time monitors.
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.
Meijer
Piet
P
European Concerted Action on Thrombosis (ECAT) Foundation, Leiden, the Netherland.
Kluft
Cornelis
C
Poller
Leon
L
van der Meer
Felix J M
FJ
Keown
Michelle
M
Ibrahim
Saied
S
van den Besselaar
Anton M H P
AM
Tripodi
Armando
A
Jespersen
Jørgen
J
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