European Concerted Action on Anticoagulation (ECAA): multicentre international sensitivity index calibration of two types of point‐of‐care prothrombin time monitor systems

A multicentre modified World Health Organization (WHO)‐type international sensitivity index (ISI) calibration has been performed at 10 European Concerted Action on Anticoagulation (ECAA) national laboratories using non‐citrated whole‐blood on two point‐of‐care test (POCT) prothrombin time (PT) monit...

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Bibliographic Details
Published in:British journal of haematology 2002-03, Vol.116 (4), p.844-850
Main Authors: Poller, L., Keown, M., Chauhan, N., Van Den Besselaar, A. M. H. P., Tripodi, A., Jespersen, J., Shiach, C., Horellou, M. H., Dias, D., Egberg, N., Iriarte, J. A., Kontopoulou‐Griva, I., Otridge, B.
Format: Article
Language:English
Subjects:
Animals
Biological and medical sciences
Blood. Blood coagulation. Reticuloendothelial system
Calibration
Hematology
Humans
International Normalized Ratio
international sensitivity index
Medical sciences
Monitoring, Physiologic - instrumentation
Monitoring, Physiologic - standards
multicentre calibration
Pharmacology. Drug treatments
Point-of-Care Systems - standards
point‐of‐care test monitors
Prothrombin Time
Rabbits
Reagent Kits, Diagnostic
Regression Analysis
Sensitivity and Specificity
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Summary:A multicentre modified World Health Organization (WHO)‐type international sensitivity index (ISI) calibration has been performed at 10 European Concerted Action on Anticoagulation (ECAA) national laboratories using non‐citrated whole‐blood on two point‐of‐care test (POCT) prothrombin time (PT) monitor systems, CoaguChek Mini and TAS PT‐NC, using single lots of test cards/strips. The relevant species (human and rabbit) WHO international reference preparations (IRPs) were tested with the manual PT technique on citrated plasma from the same blood donations. The ISI was calculated from the slope of the orthogonal regression line relating log PT (POCT) to log PT (IRP). The mean ISI of the CoaguChek Mini system was 1·75 and 1·13 with the prothrombin time non‐citrated Thrombolytic Assessment System (TAS PT‐NC). With the CoaguChek Mini system, seven out of 10 calibrations exceeded the current 3% WHO recommended limit for the coefficient of variation (CV) of the slope with conventional PT testing, whereas with the TAS PT‐NC system, it was eight out of 10. All the POCT calibrations had a CV of the slope
ISSN:0007-1048
1365-2141
DOI:10.1046/j.0007-1048.2002.03361.x