PDF(Pubmed)
Abstract：
Infections caused by mycobacteria, including Mycobacterium tuberculosis complex (MTBC) and non-tuberculous mycobacteria (NTM), are a major public health issue worldwide. An accurate diagnosis of mycobacterial species is a challenge for surveillance and treatment, particularly in high-burden settings usually associated with low- and middle-income countries. In this study, we analyzed the clinical performance of two commercial PCR kits designed for the identification and differentiation of MTBC and NTM, available in a high-burden setting such as Ecuador. A total of 109 mycobacteria isolates were included in the study, 59 of which were previously characterized as M. tuberculosis and the other 59 as NTM. Both kits displayed great clinical performance for the identification of M. tuberculosis, with 100% sensitivity. On the other hand, for NTM, one of the kits displayed a good clinical performance with a sensitivity of 94.9% (CI 95%: 89-100%), while the second kit had a reduced sensitivity of 77.1% (CI 95%: 65-89%). In conclusion, one of the kits is a fast and reliable tool for the identification and discrimination of MTBC and NTM from clinical isolates.
摘要：
由分枝杆菌引起的感染，包括结核分枝杆菌复合体（MTBC）和非结核分枝杆菌（NTM），是世界范围内的重大公共卫生问题。分枝杆菌种类的准确诊断是监测和治疗的挑战，特别是在通常与低收入和中等收入国家相关的高负担环境中。在这项研究中,我们分析了两种用于MTBC和NTM鉴定和分化的商业PCR试剂盒的临床性能，在厄瓜多尔等高负担环境中可用。共有109株分枝杆菌被纳入研究,其中59个先前被表征为结核分枝杆菌和其他59个为NTM。两种试剂盒在鉴定结核分枝杆菌方面均表现出良好的临床表现，100%灵敏度另一方面,对于NTM，其中一个试剂盒显示出良好的临床表现，灵敏度为94.9%(CI95%:89-100%)，而第二套试剂盒的灵敏度降低了77.1%(CI95%:65-89%)。总之,该试剂盒之一是用于从临床分离株中鉴定和区分MTBC和NTM的快速且可靠的工具。
