title: European Concerted Action on Anticoagulation (ECAA): multicentre international sensitivity index calibration of two types of point-of-care prothrombin time monitor systems.
abstract: 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 <5%. It is suggested that this level of precision be adopted as the limit of acceptability of calibration of these monitor systems. In these circumstances, the modified WHO-type ISI calibration appeared to be satisfactory for the POCT whole-blood monitors.
authors.affiliation: ECAA Central Facility, School of Biological Sciences, The University of Manchester, Manchester, UK. ecaa@man.ac.uk
authors.forename: L
authors.initials: L
authors.lastname: Poller
authors.forename: M
authors.initials: M
authors.lastname: Keown
authors.forename: N
authors.initials: N
authors.lastname: Chauhan
authors.forename: A M H P
authors.initials: AM
authors.lastname: van Den Besselaar
authors.forename: A
authors.initials: A
authors.lastname: Tripodi
authors.forename: J
authors.initials: J
authors.lastname: Jespersen
authors.forename: C
authors.initials: C
authors.lastname: Shiach
authors.forename: M H
authors.initials: MH
authors.lastname: Horellou
authors.forename: D
authors.initials: D
authors.lastname: Dias
authors.forename: N
authors.initials: N
authors.lastname: Egberg
authors.forename: J A
authors.initials: JA
authors.lastname: Iriarte
authors.forename: I
authors.initials: I
authors.lastname: Kontopoulou-Griva
authors.forename: B
authors.initials: B
authors.lastname: Otridge
mesh_terms: D000818:Animals; D002138:Calibration; D006801:Humans; D019934:International Normalized Ratio; D008991:Monitoring, Physiologic / Q000295:instrumentation / Q000592:standards*; D019095:Point-of-Care Systems / Q000592:standards*; D011517:Prothrombin Time; D011817:Rabbits; D011933:Reagent Kits, Diagnostic; D012044:Regression Analysis; D012680:Sensitivity and Specificity
chemical_list: D011933:Reagent Kits, Diagnostic