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規制と法律 · 2014/8/281 分で読めます

Announcement of Requirements and Registration for the Culture-Independent Straintyping and Characterization Challenge

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概要

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) launches a challenge competition for the development of a method or process to accurately and efficiently identify, subtype, and characterize pathogenic microorganisms directly from clinical or environmental samples without the need for culture or culture-based enrichment. Laboratory-based infectious disease surveillance programs, such as PulseNet, the National Tuberculosis Surveillance System, and the Active Bacterial Core Surveillance program, rely on primary culture and microbiologic testing in community hospital and clinical laboratories. A new generation of non-culture-based diagnostic tests are now beginning to enter the marketplace offering physicians faster results and, in some cases, more types of information than were previously available. Unfortunately, these new tests do not typically result in isolates being available for public health purposes, and, as their use continues to grow, it will likely become increasingly difficult or impossible to detect and investigate outbreaks or other important infectious disease trends. New laboratory approaches that do

情報源の原言語: Federal Register — All Documents原文の発表を開く →

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