title: Quality control of the prothrombin time and international normalized ratios. National and international schemes.
abstract: The international normalized ratios (INR) system allows valid comparisons in results and quality of performance to be made between users of different thromboplastin reagents. In the international quality control surveys currently over 80% of the 53 countries participating report INR. Stated local international sensitivity index (ISI) values show fair agreement with values calculated from quality control returns obtained with local and reference reagents. The coefficient of variations (CV) of the INR in these surveys are between 11-22% depending upon INR values. In comparison, CV of the UK national scheme are currently 7-13%. However, analysis of UK results has shown high CV with high ISI reagents. This is due to the ISI effect as CV of INR is CV of prothrombin ratio (PR) multiplied by the ISI. Ideal thromboplastins should show good precision of PR and a low ISI to prevent this apparent deterioration when PR results are transformed into the INR scale. Instrumentation has a further effect on the INR result. Unfortunately, the effect is not uniform even within instrument type and model or even between normal and therapeutic results. Local instrument adjustment or local calibration is therefore necessary. Thus, quality control surveys continue to highlight problems in prothrombin time standardization.
authors.affiliation: National (UK) Reference Laboratory for Anticoagulant Reagents and Control, Withington Hospital, Manchester.
authors.forename: D A
authors.initials: DA
authors.lastname: Taberner
authors.forename: L
authors.initials: L
authors.lastname: Poller
authors.forename: J M
authors.initials: JM
authors.lastname: Thomson
mesh_terms: D001331:Automation; D005069:Evaluation Studies as Topic; D006801:Humans; D007202:Indicators and Reagents; D011517:Prothrombin Time; D011786:Quality Control; D012015:Reference Standards; D013925:Thromboplastin / Q000592:standards; D006113:United Kingdom
chemical_list: D007202:Indicators and Reagents; D013925:Thromboplastin