The analytic performance studies of Mycobacterium tuberculosis Complex DNA detection reagents

doi:10.3969/j.issn.1000-6621.2015.03.018

Chinese Journal of Antituberculosis ›› 2015, Vol. 37 ›› Issue (3): 312-314.doi: 10.3969/j.issn.1000-6621.2015.03.018

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The analytic performance studies of Mycobacterium tuberculosis Complex DNA detection reagents

LIU Rong-zhi

Center for Medical Device Evaluation，CFDA，Beijing 100044, China

Received:2014-04-14 Online:2015-03-10 Published:2015-04-03
Contact: LIU Rong-zhi E-mail:liurz@cmde.org.cn

Abstract

Abstract: The material of the analytic performance studies of Mycobacterium tuberculosis Complex DNA detection reagents is an important technical document of the application materials for reagent registration. The main aim of this paper is to summarize the main projects and related technical details of analytic performance evaluation studies in order to guide manufactures to conduct research and development of reagents scientifically and rationally.

Key words: Mycobacterium tuberculosis, DNA, bacterial, Reagent kits, diagnostic

LIU Rong-zhi. The analytic performance studies of Mycobacterium tuberculosis Complex DNA detection reagents[J]. Chinese Journal of Antituberculosis, 2015, 37(3): 312-314. doi: 10.3969/j.issn.1000-6621.2015.03.018

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The analytic performance studies of Mycobacterium tuberculosis Complex DNA detection reagents

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