Analytical and clinical performance characteristics of the Abbott RealTime MTB RIF/INH Resistance, an assay for the detection of rifampicin and isoniazid resistant Mycobacterium tuberculosis in pulmonary specimens.
作者： Joshua Kostera , Gregor Leckie , Ning Tang , John Lampinen , Magdalena Szostak
DOI: 10.1016/J.TUBE.2016.09.006
关键词:
摘要: Clinical management of drug-resistant tuberculosis patients continues to present significant challenges global health. To tackle these challenges, the Abbott RealTime MTB RIF/INH Resistance assay was developed accelerate diagnosis rifampicin and/or isoniazid resistant within a day. This article summarizes performance assay; including reliability, analytical sensitivity, and clinical sensitivity/specificity as compared Cepheid GeneXpert MTB/RIF version 1.0 Hain MTBDRplus 2.0. The limit detection (LOD) determined be 32 colony forming units/milliliter (cfu/mL) using Mycobacterium (MTB) strain H37Rv cell line. For resistance detection, demonstrated statistically equivalent sensitivity specificity MTB/RIF. MTBDRplus. data presented herein demonstrate that is sensitive, robust, reliable test for realtime simultaneous first line anti-tuberculosis antibiotics in patient specimens.
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