Stephen Stephen, Muzhizhizhi Donhodzo, Dhibi Nicholas, Chidemo Tinashe, Samaneka Wadzanai, Matubu Taguma Allen, Hakim James Gita, Chirenje Zvavahera Mike
University of Zimbabwe College of Health Sciences-Clinical Trials Research Centre (UZCHS-CTRC), 15 Phillips Avenue, Belgravia, Harare, Zimbabwe.
University of Zimbabwe College of Health Sciences-Clinical Trials Research Centre (UZCHS-CTRC), 15 Phillips Avenue, Belgravia; Department of Medicine, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
Int J Mycobacteriol. 2019 Jan-Mar;8(1):83-88. doi: 10.4103/ijmy.ijmy_170_18.
Multidrug-resistant tuberculosis (MDR-TB) is a public health concern globally. MDR-TB is defined as resistance to rifampicin (RIF) and isoniazid (INH), the two-major anti-TB first-line TB treatment drugs. Rapid identification of MDR-TB can contribute significantly to the control of TB. The GenoType MTBDRplus Ver 2.0 assay is a molecular assay used to detect genetic mutations that result in RIF and INH resistance. The aim of this study was to validate the performance of the GenoType MTBDRplus Ver 2.0 assay for the detection of INH and RIF resistance.
Fifty-five stored Mycobacterium tuberculosis isolates were tested using both the mycobacterial growth indicator tube (MGIT), antimicrobial susceptibility testing (AST), and the GenoType® MTBDRplus Ver 2.0 assay. The MGIT AST was done according to the BBL MGIT AST SIRE system with RIF and INH final critical concentrations of 1.0 μg/ml and 0.1 μg/ml, respectively. The GenoType MTBDRplus assay (Hain Lifescience, Germany) was performed following the manufacturer's instructions.
The GenoType MTBDRplus Ver 2.0 assay had a sensitivity, specificity, positive predictive value, and negative predictive value of 100% for INH and RIF resistance. The intra-assay precision for the assay was 100%.
The GenoType MTBDRplus Ver 2.0 assay's sensitivity and specificity show that the assay is highly accurate for the detection of RIF and INH resistance and thus can be used as an alternate platform due to its shorter results turnaround time.
耐多药结核病（MDR-TB）是全球公共卫生关注的问题。耐多药结核病被定义为对两种主要的抗结核一线治疗药物利福平（RIF）和异烟肼（INH）耐药。快速鉴定耐多药结核病对结核病的控制有显著贡献。GenoType MTBDRplus Ver 2.0检测是一种用于检测导致利福平和异烟肼耐药的基因突变的分子检测方法。本研究的目的是验证GenoType MTBDRplus Ver 2.0检测对异烟肼和利福平耐药检测的性能。
使用分枝杆菌生长指示管（MGIT）、抗菌药物敏感性试验（AST）和GenoType® MTBDRplus Ver 2.0检测对55株储存的结核分枝杆菌分离株进行检测。MGIT AST根据BBL MGIT AST SIRE系统进行，利福平和异烟肼的最终临界浓度分别为1.0μg/ml和0.1μg/ml。GenoType MTBDRplus检测（德国海因生命科学公司）按照制造商的说明进行。
GenoType MTBDRplus Ver 2.0检测对异烟肼和利福平耐药的敏感性、特异性、阳性预测值和阴性预测值均为100%。该检测的批内精密度为100%。
GenoType MTBDRplus Ver 2.0检测的敏感性和特异性表明，该检测对利福平和异烟肼耐药的检测具有高度准确性，因此由于其结果周转时间较短，可作为替代平台使用。
