Strengths and Weaknesses of FDA-Approved/Cleared Diagnostic Devices for the Molecular Detection of Respiratory Pathogens

被引：35

作者：

Ginocchio, Christine C. ^{[1
,2
]}

机构：

[1] N Shore LIJ Hlth Syst Labs, Div Infect Dis Diagnost, Dept Pathol & Lab Med, Hofstra N Shore LIJ Sch Med, Lake Success, NY 11041 USA

[2] N Shore LIJ Hlth Syst Labs, Hofstra N Shore LIJ Sch Med, Dept Mol Med, Lake Success, NY 11041 USA

来源：

CLINICAL INFECTIOUS DISEASES | 2011年 / 52卷

关键词：

TUBERCULOSIS DIRECT TEST; REVERSE TRANSCRIPTION-PCR; INFLUENZA-A VIRUS; MYCOBACTERIUM-TUBERCULOSIS; SYNCYTIAL VIRUS; RAPID DIAGNOSIS; INFECTIONS; PANEL; AMPLIFICATION; PERFORMANCE;

D O I：

10.1093/cid/cir046

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

The rapid, sensitive, and specific identification of the microbial etiological characteristics of respiratory tract infections enhances the appropriate use of both antibiotics and antiviral agents and reduces the risk of nosocomial transmission. This article reviews the current nucleic acid amplification tests approved by the U.S. Food and Drug Administration (FDA) for the detection of respiratory pathogens. In addition, Emergency Use Authorization tests for the detection of 2009 influenza A H1N1 are discussed. The advantages and limitations of the current FDA-approved/cleared tests are reviewed.

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收藏

页码：S312 / S325

页数：14

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