Precision and accuracy of point-of-care testing coagulometers used for self-testing and self-management of oral anticoagulation therapy

Precision and accuracy of point-of-care testing coagulometers used for self-testing and self-management of oral anticoagulation therapy
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DOI:
10.1111/j.1538-7836.2011.04568.x
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发表时间:
2012-02-01
影响因子:
10.4
通讯作者:
Larsen, T. B.
Larsen, T. B.
中科院分区:
医学2区
文献类型:
--
作者:
Christensen, T. D.;Larsen, T. B.

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。背景:口服抗凝治疗使用国际标准化比率(INR)进行监测。进行自我检测或自我管理的患者使用护理点检测(POCT)凝血仪(INR监测器)来估计他们的INR。香豆素正确剂量的前提是正确的INR估计,而用于提供INR测量的方法和设备在这方面是至关重要的。关于POCT凝血仪的精密度和准确度,已经发表了几项研究,并导致了不同的结论。由于文献数量众多,在设计、统计分析等方面存在差异,对文献进行综述是困难和具有挑战性的。目的:本次系统综述的目的是分析当前文献,特别是关于POCT凝血仪的精密度和准确性的文献,为临床应用和质量控制提供建议,并指出未来研究的领域。方法:共纳入22项研究,其中4项为高质量研究。结果:POCT血凝仪的测量精度基本满足临床要求。他们在准确性方面的表现必须放在INR测量固有不准确的背景下来看待。结论:在这方面,POCT凝血仪的准确性似乎是普遍可以接受的,它们可以在临床环境中使用。
. Background: Oral anticoagulation therapy is monitored by the use of the International Normalized Ratio (INR). Patients who perform self-testing or self-management use a point-of-care testing (POCT) coagulometer (INR monitor) to estimate their INRs. A precondition for a correct dosage of coumarins is a correct INR estimation, and the method and apparatus used for providing the INR measurements are crucial in this context. Several studies have been published regarding the precision and accuracy of these POCT coagulometers, and have led to diverse conclusions. It is difficult and challenging to perform an overview of the literature, owing to the vast amount of papers, with differences in design, statistical analysis, etc. Objectives: The aim of this systematic review was to analyze the current literature, especially regarding the precision and accuracy of the POCT coagulometers, to provide recommendations for clinical use and quality control, and to point out areas for future research. Methods: We included a total of 22 studies, of which four were characterized as high-quality studies. Results: The precision of the POCT coagulometers was generally adequate for clinical use. Their performance in terms of accuracy has to be viewed in the context of the inherent inaccuracies of INR measurements. Conclusions: The accuracy of POCT coagulometers seems, in this respect, to be generally acceptable, and they can be used in a clinical setting.