title: Recombinant tissue factor as substitute for conventional thromboplastin in the prothrombin time test.
abstract: Relipidated recombinant tissue factor (r-TF) has been assessed in comparison with conventional rabbit brain thromboplastin (Manchester Reagent) for its suitability for measurement of prothrombin time (PT). The International Sensitivity Index (ISI) of r-TF calibrated against the International Reference Preparation BCT/253 (human plain) was found to be 0.96 and 1.12 with instrumental and manual techniques. Our study of plasmas from patients with congenital deficiencies of clotting factors covering a wide range of severity demonstrates that r-TF is able to detect even minor deficiencies of factors involved in the extrinsic and common coagulation pathways. Patients with liver diseases were correctly diagnosed with a prevalence of abnormal results comparable for both reagents. Between-assay reproducibility expressed as coefficient of variation was 2.3% and 3.9% at normal and abnormal PT levels. In conclusion, our evaluation shows that relipidated r-TF possesses the necessary requisites of sensitivity, diagnostic accuracy and reproducibility which make it a suitable candidate for PT determination both for monitoring oral anticoagulant therapy and diagnosing congenital and acquired clotting factor deficiencies. Moreover, being a highly defined reagent it may constitute a step forward in the standardization of PT testing.
authors.affiliation: A. Bianchi Bonomi Hemophilia and Thrombosis Center, IRCCS Maggiore Hospital and University, Milano, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Tripodi
authors.forename: A
authors.initials: A
authors.lastname: Arbini
authors.forename: V
authors.initials: V
authors.lastname: Chantarangkul
authors.forename: P M
authors.initials: PM
authors.lastname: Mannucci
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects; D001778:Blood Coagulation Disorders / Q000175:diagnosis / Q000209:etiology; D005069:Evaluation Studies as Topic; D006801:Humans; D007202:Indicators and Reagents / Q000592:standards; D008107:Liver Diseases / Q000097:blood / Q000150:complications; D011517:Prothrombin Time; D011994:Recombinant Proteins; D012015:Reference Standards; D015203:Reproducibility of Results; D013925:Thromboplastin / Q000592:standards
chemical_list: D000925:Anticoagulants; D007202:Indicators and Reagents; D011994:Recombinant Proteins; D013925:Thromboplastin