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Nature Reviews Microbiology , S16-S28 | doi:10.1038/nrmicro1523
Evaluation of diagnostic tests for infectious diseases: general principles
感染性疾病诊断检测的评估:一般原则
Shabir Banoo1, David Bell2, Patrick Bossuyt3, Alan Herring4, David Mabey5, Freddie Poole6, Peter G Smith7, N. Sriram8, Chansuda Wongsrichanalai9, Ralf Linke10, Rick O'Brien10, Mark Perkins10, Jane Cunningham11, Precious Matsoso11, Carl Michael Nathanson11, Piero Olliaro11, Rosanna W. Peeling11 & Andy Ramsay11
Top of pageAbstractThe TDR Diagnostics Evaluation Expert Panel
I. Introduction
A diagnostic test for an infectious agent can be used to demonstrate the presence or absence of infection, or to detect evidence of a previous infection (for example, the presence of antibodies). Demonstrating the presence of the infecting organism, or a surrogate marker of infection, is often crucial for effective clinical management and for selecting other appropriate disease control activities such as contact tracing. To be useful, diagnostic methods must be accurate, simple and affordable for the population for which they are intended. They must also provide a result in time to institute effective control measures, particularly treatment. For some infections, early diagnosis and treatment can have an important role in preventing the development of long-term complications or in interrupting transmission of the infectious agent. In a broader context, diagnostic tests can have multiple uses, including: patient management, especially when clinical symptoms are not specific for a particular infection (as is often the case); screening for asymptomatic infections; surveillance; epidemiological studies (for example, rapid assessments of disease burden or outbreak investigations); evaluating the effectiveness of interventions, including verification of elimination; and detecting infections with markers of drug resistance.
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