Cosmi B, Palareti G, Moia M, Carpenedo M, Pengo V, Biasiolo A, Rampazzo P, Morstabilini G, Testa S
Divisione di Angiologia, Ospedale S.Orsola Malpighi, Bologna, Italy.
Thromb Res. 2000 Nov 15;100(4):279-86. doi: 10.1016/s0049-3848(00)00323-6.
A portable prothrombin time (PT) monitor allows patients on oral anticoagulant therapy (OAT) to measure their PT at home. The purpose of the study was to evaluate the accuracy and precision of a portable PT monitor (Coagucheck, Roche Diagnostics, Mannheim, Germany) as compared with laboratory methods. The prospective study was conducted in four centers of the Italian Federation of Anticoagulation Clinics. A one-month instruction phase was followed by a six-month surveillance phase. Seventy-eight subjects on stable OAT (48 men, 30 women, age range: 18-75) were selected on a volunteer basis. Dual measurements of INR values were performed in each subject both from finger capillary blood by the monitor and from venous blood by the Anticoagulation Clinic laboratory in three instruction sessions. The mean difference (bias) of the monitor INR results when compared with the average of laboratory INR and monitor INR results was -0.025 (limits of agreement-LA: -0.84/+0.81 INR units). The mean bias was -0.0675 (LA: -0.37/+0.23), +0.018 (LA: -0.39/+0.35), and +0.039 (LA: -0.49/+0.55), respectively, for INR values lower than 2.0, between 2.0 and 3.0, and greater than 3.0. The overall precision coefficient of monitor INR was 0.370, while it was 0.23, 0.46, 0.29, and 0.21, respectively, in Centers 1, 2, 3, and 4. The overall variation coefficient was 6.5% while it was 3.7%, 8.5%, 4.7%, and 4.9%, respectively, in Centers 1, 2, 3, and 4. Coagucheck has an acceptable level of accuracy for INR values in the range between 2.0 and 3.0. A wide variation in monitor performance was found among centers.
便携式凝血酶原时间（PT）监测仪可让接受口服抗凝治疗（OAT）的患者在家中测量其PT值。本研究的目的是评估一款便携式PT监测仪（Coagucheck，德国曼海姆罗氏诊断公司）相对于实验室检测方法的准确性和精密度。这项前瞻性研究在意大利抗凝诊所联合会的四个中心开展。在为期一个月的指导阶段之后是为期六个月的监测阶段。78名接受稳定OAT治疗的受试者（48名男性，30名女性，年龄范围：18 - 75岁）通过自愿报名入选。在三个指导环节中，对每位受试者分别采用监测仪从手指毛细血管血以及抗凝诊所实验室从静脉血中进行INR值的双重测量。与实验室INR平均值和监测仪INR结果相比，监测仪INR结果的平均差值（偏差）为 -0.025（一致性界限 - LA：-0.84 / +0.81 INR单位）。对于INR值低于2.0、在2.0至3.0之间以及高于3.0的情况，平均偏差分别为 -0.0675（LA：-0.37 / +0.23）、+0.018（LA：-0.39 / +0.35）和 +0.039（LA：-0.49 / +0.55）。监测仪INR的总体精密度系数为0.370，而在第1、2、3和4中心分别为0.23、0.46、0.29和0.21。总体变异系数为6.5%，而在第1、2、3和4中心分别为3.7%、8.5%、4.7%和4.9%。Coagucheck对于2.0至3.0范围内的INR值具有可接受的准确度水平。各中心之间监测仪的性能存在很大差异。
