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.
|Titolo:||A national field study of quality assessment of coaguchek point-of-care testing prothrombin time monitors|
TRIPODI, ARMANDO (Penultimo)
|Parole Chiave:||CoaguChek monitors; Prothrombin time; Quality assessment; Significant deviation|
|Settore Scientifico Disciplinare:||Settore MED/15 - Malattie del Sangue|
|Data di pubblicazione:||2006|
|Digital Object Identifier (DOI):||10.1309/6Q8DY5J1THA8BQG3|
|Appare nelle tipologie:||01 - Articolo su periodico|