title: Quality assurance for point-of-care testing of oral anticoagulation: a large-scale evaluation of the Hemochron Junior Signature Microcoagulation System.
abstract: We report the first large-scale evaluation of the Hemochron Junior Signature (HJS) Microcoagulation System for community monitoring of oral anticoagulation and establishment of a programme of internal and external quality assurance. Over 1600 HJS results, with a simultaneous venous sample for central analysis, were obtained over a 19 month period. Monitoring of an initial period of HJS results (n = 135) revealed an International Normalized Ratio (INR) over estimation (mean +1.05), with only 27% of results within 0.5 of the central laboratory INR. A correction factor was introduced which reduced the INR bias to +0.07 and improved the percentage of results within 0.5 of the central laboratory INR to 76% (n = 353). A revised correction factor was later introduced to adjust for an under estimation at higher INR values. This changed the INR bias to -0.05, with 76% of results within 0.5 of the central laboratory INR (n = 1174). Local external quality assurance samples were distributed monthly with a total of 791 samples during the study period. 84% of test results were within 15% of the median value (range 73-97% per month). These results emphasize the value of a robust quality assurance programme when using point-of-care devices for community monitoring of oral anticoagulation.
authors.affiliation: Department of Haematology, Ninewells Hospital & Medical School, Dundee, UK. jmaddox@nhs.net
authors.forename: J M
authors.initials: JM
authors.lastname: Maddox
authors.forename: P H
authors.initials: PH
authors.lastname: Bogo
authors.forename: E
authors.initials: E
authors.lastname: McGregor
authors.forename: M J
authors.initials: MJ
authors.lastname: Pippard
authors.forename: R
authors.initials: R
authors.lastname: Kerr
mesh_terms: D000284:Administration, Oral; D000925:Anticoagulants / Q000008:administration & dosage*; D001780:Blood Coagulation Tests / Q000295:instrumentation*; D016903:Drug Monitoring / Q000295:instrumentation*; D006801:Humans; D019934:International Normalized Ratio / Q000592:standards; D019095:Point-of-Care Systems; D011786:Quality Control; D014859:Warfarin / Q000008:administration & dosage*
chemical_list: D000925:Anticoagulants; D014859:Warfarin