Document Type

Article

Publication Date

11-2011

Identifier

DOI: 10.1016/j.jmoldx.2011.05.011; PMCID: PMC3194051

Abstract

The superior sensitivity and specificity associated with the use of molecular assays has greatly improved the field of infectious disease diagnostics by providing clinicians with results that are both accurate and rapidly obtained. Herein, we review molecularly based infectious disease diagnostic tests that are Food and Drug Administration approved or cleared and commercially available in the United States as of December 31, 2010. We describe specific assays and their performance, as stated in the Food and Drug Administration's Summary of Safety and Effectiveness Data or the Office of In Vitro Diagnostic Device Evaluation and Safety's decision summaries, product inserts, or peer-reviewed literature. We summarize indications for testing, limitations, and challenges related to implementation in a clinical laboratory setting for a wide variety of common pathogens. The information presented in this review will be particularly useful for laboratories that plan to implement or expand their molecular offerings in the near term. Copyright © 2011 American Society for Investigative Pathology and the Association for Molecular Pathology.

Journal Title

Journal of Molecular Diagnostics

Volume

13

Issue

6

First Page

583

Last Page

604

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