Accuracy of a portable prothrombin time monitor (Coagucheck) in patients on chronic oral anticoagulant therapy: A prospective multicenter study

被引:37
作者
Cosmi, B
Palareti, G
Moia, M
Carpenedo, M
Pengo, V
Biasiolo, A
Rampazzo, P
Morstabilini, G
Testa, S
机构
[1] Univ Bologna, Osped S Orsola Malpighi, Div Angiol & Malattie Coagulaz, I-40138 Bologna, Italy
[2] Osped Maggiore, IRCCS, Ctr Emofilia & Trombosi A Bianchi Bonomi, Milan, Italy
[3] Univ Padua, Dipartimento Med Clin & Sperimentale, I-35100 Padua, Italy
[4] Ist Ospitalieri Cremona, Ist Patol Clin, Cremona, Italy
关键词
oral anticoagulants; prothrombin time; point-of-care testing; anticoagulation clinic; accuracy; precision;
D O I
10.1016/S0049-3848(00)00323-6
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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. (C) 2000 Elsevier Science Ltd. All rights reserved.
引用
收藏
页码:279 / 286
页数:8
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