Bader R, Mannucci P M, Tripodi A, Hirsh J, Keller F, Solleder E M, Hawkins P, Peng M, Pelzer H, Teijidor L M
IRCCS Maggiore Hospital and University, Policlinico Centro Hemophilia, Milano, Italy.
Thromb Haemost. 1994 Mar;71(3):292-9.
A new PT reagent based on recombinant human tissue factor and synthetic phospholipids (phosphatidyl choline and phosphatidyl serine) with defined fatty acid side chains was calibrated against BCT/253 and CRM 149R. A small but consistent bias in the International Sensitivity Index (ISI) value was obtained using either the human or rabbit brain reference material. ISI values were around 1.0 or slightly lower depending on the respective instrument. Mixing studies with factor deficient plasmas showed a high factor sensitivity especially for factor VII as compared to commercial rabbit brain or human placenta thromboplastin. In an international field trial the reagent was tested using fully or semi automated Electra coagulometers in 4 different laboratories. Results with normal samples were in excellent agreement among the different laboratories. Mean values were 10.9, 10.9, 11.0, 11.2 s with a range of 9.5 to 12.5 s. Results of males and females were not different. In patients with liver disease very similar PT activities were found as compared to sensitive rabbit brain or human placental thromboplastins. In normals and patients with oral anticoagulation INR values correlated very well against BCT (r = 0.98, regression line y = -0.07 + 0.9 x). The distribution of samples was linear over the whole range. In the comparison against sensitive rabbit brain thromboplastin or human placental thromboplastin similar correlations were found. In a few cases higher INR values were observed for the recombinant reagent especially in patients with intensive treatment. Factor assays in those patients showed at least the strong reduction of one vitamin K-dependent coagulation factor.(ABSTRACT TRUNCATED AT 250 WORDS)
一种基于重组人组织因子和具有特定脂肪酸侧链的合成磷脂（磷脂酰胆碱和磷脂酰丝氨酸）的新型凝血酶原试剂，已针对BCT/253和CRM 149R进行校准。使用人或兔脑参考物质获得的国际敏感度指数（ISI）值存在小但一致的偏差。ISI值约为1.0或略低，具体取决于各自的仪器。与因子缺乏血浆的混合研究表明，与市售兔脑或人胎盘凝血活酶相比，该试剂对因子具有高敏感性，尤其是对因子VII。在一项国际现场试验中，该试剂在4个不同实验室中使用全自动或半自动Electra凝血仪进行了测试。不同实验室对正常样本的检测结果高度一致。平均值分别为10.9、10.9、11.0、11.2秒，范围为9.5至12.5秒。男性和女性的检测结果无差异。与敏感兔脑或人胎盘凝血活酶相比，在肝病患者中发现了非常相似的凝血酶原活动。在正常人和口服抗凝剂患者中，INR值与BCT的相关性非常好（r = 0.98，回归线y = -0.07 + 0.9x）。样本分布在整个范围内呈线性。在与敏感兔脑凝血活酶或人胎盘凝血活酶的比较中也发现了类似的相关性。在少数情况下，尤其是在强化治疗患者中，观察到重组试剂的INR值较高。对这些患者的因子检测显示至少有一种维生素K依赖性凝血因子大幅降低。（摘要截短于250字）
