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即时检验(POCT)国际标准化比值(INR):希望还是幻想?

Point-of-care test (POCT) INR: hope or illusion?

作者信息

Dusse Luci Maria Sant'Ana, Oliveira Nataly Carvalho, Rios Danyelle Romana Alves, Marcolino Milena Soriano

机构信息

Departamento de Análises Clínicas e Toxicológicas, Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brasil.

出版信息

Rev Bras Cir Cardiovasc. 2012 Apr-Jun;27(2):296-301. doi: 10.5935/1678-9741.20120047.

DOI:10.5935/1678-9741.20120047
PMID:22996982
Abstract

In the last decade, point-of-care tests were developed to provide rapid generation of test results. These tests have increasingly broad applications. In the area of hemostasis, the international normalized ratio, INR point-of-care test (POCT INR), is the main test of this new proposal. This test has great potential benefit in situations where the quick INR results influences clinical decision making, as in acute ischemic stroke, before surgical procedures and during cardiac surgery. The INR POCT has the potential to be used for self-monitoring of oral anticoagulation in patients under anticoagulant therapy. However, the precision and accuracy of INR POCT still need to be enhanced to increase effectiveness and efficiency of the test. Additionally, the RDC / ANVISA Number 302 makes clear that the POCT testing must be supervised by the technical manager of the Clinical Laboratory in the pre-analytical, analytical and post-analytical. In practice, the Clinical Laboratory does not participate in the implementation of POCT testing or release of the results. Clinicians have high expectation with the incorporation of INR POCT in clinical practice, despite the limitations of this method. These professionals are willing to train the patient to perform the test, but are not legally responsible for the quality of it and are not prepared for the maintenance of equipment. The definition of who is in charge for the test must be one to ensure the quality control.

摘要

在过去十年中,即时检验得到了发展,以快速生成检测结果。这些检测的应用越来越广泛。在止血领域,国际标准化比值即时检验(POCT INR)是这项新提议的主要检测项目。在快速的INR结果影响临床决策的情况下,如急性缺血性中风、手术前和心脏手术期间,这项检测具有很大的潜在益处。INR POCT有潜力用于接受抗凝治疗患者的口服抗凝自我监测。然而,INR POCT的精密度和准确性仍需提高,以增强检测的有效性和效率。此外,RDC/ANVISA第302号文件明确规定,POCT检测必须在临床实验室技术经理的监督下进行,包括分析前、分析中和分析后阶段。实际上,临床实验室并不参与POCT检测的实施或结果发布。尽管这种方法存在局限性,但临床医生对将INR POCT纳入临床实践寄予厚望。这些专业人员愿意培训患者进行检测,但对检测质量不承担法律责任,也没有准备好维护设备。必须明确由谁负责检测,以确保质量控制。

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