鹿特丹血栓中心使用显色凝血酶原时间测试的实验室和治疗控制。

J J Jonker, A J Azar, P F van Bergen, R A Klarenberg, E F Przespolewski
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引用次数: 1

摘要

人们对显色底物测定法的兴趣日益浓厚,因为它们具有更好的精度、性能和自动化的可能性。应用Cobas Bio离心分析仪,我们比较了Nycotest-Chrom (N-test)和Thromboquant-PT (Tbq)与Thrombotest (TT)。采用TT治疗范围的正常(45秒)、低(100秒)、中(150秒)和高(200秒)4个血浆池进行精密度测试。与Tbq法相比,n法在法内测定和法间测定中均具有最好的精密度。两种显色底物法在这方面都优于TT法。通过正交回归计算312个测定值的临时治疗范围,然后在946个测定值的自然对数回归验证实验中进行调整。与105 ~ 180秒的治疗时间相比,n试验的治疗时间为71 ~ 120秒,Tbq治疗时间为63 ~ 103秒。在临床治疗对照期,110例患者按等比例随机分为a组和b组,每2周检测血液N-test、Tbq和TT,共16周。A组剂量调整基于n试验,B组剂量调整基于Tbq。A组监测医师盲测Tbq和TT, b组监测医师盲测N-test和TT,各组间平均TT、N-test、Tbq和平均剂量无差异,并发症发生率无差异。使用敏感性/特异性曲线及其95%置信限确定治疗范围。给定TT 105-180秒,N-test的治疗范围从80(95%置信限:77-82)到110(95%置信限:108-115)秒,Tbq的治疗范围从68(95%置信限:66-71)到95(95%置信限:91-98)秒。结论是,尽管与参考TT的诊断对应性存在差异,但两种显色底物测定法在监测口服抗凝治疗患者方面同样安全。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Laboratory and therapeutic control in the Thrombosis Centre Rotterdam using chromogenic prothrombin time tests.

Growing interest is observed in chromogenic substrate assays, because of their better precision, performance and possibilities for automation. Applied to a Cobas Bio centrifugal analyzer, we compared Nycotest-Chrom (N-test) and Thromboquant-PT (Tbq) with Thrombotest (TT). Precision tests were performed with samples from 4 plasma pools: normal (45 sec), low (100 sec), middle (150 sec) and high (200 sec) segments of the therapeutic range of TT. N-test had the best precision profile in both intraassay and interassay determinations compared with Tbq. Both chromogenic substrate assays were better than TT in this respect. By orthogonal regression a provisional therapeutic range was calculated from 312 determinations and later adjusted in a confirmation experiment with natural logarithm regression in 946 determinations. Compared with a TT range of 105-180 sec, the therapeutic ranges were 71-120 sec for N-test and 63-103 sec for Tbq. In a clinical therapeutic control phase, 110 patients were randomized in equal proportions to two groups A and B. Every 2 weeks for a period of 16 weeks, blood samples were tested for N-test, Tbq and TT. In group A, dose adjustment was based on N-test, and in group B on Tbq. The monitoring physician was blinded for Tbq and TT in group A and for N-test and TT in group B. No differences were found between the groups for mean TT, N-test, Tbq or mean dosage, nor differences were found in complication rate. A definite therapeutic range was complied using sensitivity/specificity curves together with their 95% confidence limits. Given TT 105-180 sec, the therapeutic range of N-test is from 80 (95% confidence limits: 77-82) to 110 (95% confidence limits: 108-115) sec, and of Tbq from 68 (95% confidence limits: 66-71) to 95 (95% confidence limits: 91-98) sec. It was concluded that the two chromogenic substrate assays performed equally safe in the monitoring of patients on oral anticoagulant therapy, despite differences in diagnostic correspondence with the reference TT.

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