A guide to aid the selection of diagnostic tests.
A guide to aid the selection of diagnostic tests.
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DOI：
10.2471/blt.16.187468
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发表时间：
2017-09-01
影响因子：
11.1
通讯作者：
Klatser PR
中科院分区：
文献类型：
--
作者：
Kosack CS;Page AL;Klatser PR
近年来，在资源有限的情况下，已经有了广泛的诊断测试。因此，已经编制了大量的准则、业绩评价和执行情况报告。然而，这些丰富的信息是非结构化的，质量参差不齐，这使得最终用户，如诊所，实验室和卫生部，难以确定哪种测试将是最好的，以改善临床护理和患者的结果在特定的情况下。本文根据无国界医生组织的实践经验，概述了选择和实施体外诊断测试的六个步骤指南：（i）确定测试目的;（ii）审查市场;（iii）确定监管批准;（iv）确定测试在理想条件下的诊断准确性;（v）确定测试在临床实践中的诊断准确性;（v）确定测试在临床实践中的诊断准确性。以及（vi）在常规使用中监测测试的性能。强调了完成这六个步骤所需信息的差距和监管制度的差距。最后，提出了提高诊断试验质量的方法，如建立基本诊断的示范清单，建立诊断研究设计的信息库，以及改进质量控制和上市后监测。
In recent years, a wide range of diagnostic tests has become available for use in resource-constrained settings. Accordingly, a huge number of guidelines, performance evaluations and implementation reports have been produced. However, this wealth of information is unstructured and of uneven quality, which has made it difficult for end-users, such as clinics, laboratories and health ministries, to determine which test would be best for improving clinical care and patient outcomes in a specific context. This paper outlines a six-step guide to the selection and implementation of in vitro diagnostic tests based on Médecins Sans Frontières’ practical experience: (i) define the test’s purpose; (ii) review the market; (iii) ascertain regulatory approval; (iv) determine the test’s diagnostic accuracy under ideal conditions; (v) determine the test’s diagnostic accuracy in clinical practice; and (vi) monitor the test’s performance in routine use. Gaps in the information needed to complete these six steps and gaps in regulatory systems are highlighted. Finally, ways of improving the quality of diagnostic tests are suggested, such as establishing a model list of essential diagnostics, establishing a repository of information on the design of diagnostic studies and improving quality control and postmarketing surveillance.