Department of Epidemiology, School of Public Health, China and Key Laboratory of Public Health Safety (Fudan University), Ministry of Education, Fudan University, Shanghai 200032, China.
Zigong City Center for Disease Control and Prevention, Zigong City, Sichuan, China.
J Infect. 2018 Oct;77(4):328-334. doi: 10.1016/j.jinf.2018.06.014. Epub 2018 Jun 30.
The implementation of rapid and reliable drug susceptibilities diagnosis is fundamental for effective treatment of multidrug-resistant tuberculosis(MDR-TB). The present study aimed to assess the diagnostic performance of the 2nd-version GenoType MTBDRsl kit as well as the impact of its implementation on the turnaround time in a multi-center Chinese study.
Totally 353 MDR-TB patient specimens were consecutively tested. The 2nd-version GenoType MTBDRsl assay, drug susceptibility testing with the MGIT 960 system, and sequencing were performed and compared.
MTBDRsl testing identified the major genotypes associated with fluoroquinolones resistance, predominated by gyrA MUT3B (Asp94Asn and Asp94Tyr, 26.5%) and MUT3C (Asp94Gly, 19.5%). The genotypes associated with resistance to 2nd-line injectable drugs(SLIDs) were rrsMUT1(A1401G, 64.9%) and absence of WT1(C1402T, 10.5%). The sensitivities for detection of resistance to fluoroquinolones, SLIDs, and their combination (extensively drug resistance, XDR) were 80.5%, 80.7% and 73.5% and specificities were 100.0%, 99.3% and 99.1%, respectively. Implementation of this test significantly reduced the turnaround time between sample collection and result reporting from 45 to 3 days, a reduction by 93.3% (p, 0.001).
With a favorable diagnostic performance and short turnaround time, the 2nd-version GenoType MTBDRsl assay proves its value for early diagnosis of resistance to 2nd-line drugs as well as of XDR-TB in China.
快速可靠的药敏诊断对于有效治疗耐多药结核病（MDR-TB）至关重要。本研究旨在评估第二代 GenoType MTBDRsl 试剂盒的诊断性能，以及在中国多中心研究中实施该试剂盒对检测周转时间的影响。
连续检测了 353 例 MDR-TB 患者标本。对第二代 GenoType MTBDRsl 检测、MGIT 960 系统药物敏感性检测和测序进行了比较。
MTBDRsl 检测鉴定了与氟喹诺酮类耐药相关的主要基因型，以 gyrA MUT3B（Asp94Asn 和 Asp94Tyr，26.5%）和 MUT3C（Asp94Gly，19.5%）为主。与二线注射药物（SLIDs）耐药相关的基因型为 rrsMUT1（A1401G，64.9%）和 WT1 缺失（C1402T，10.5%）。检测氟喹诺酮类药物、SLIDs 及其联合耐药（广泛耐药，XDR）的敏感性分别为 80.5%、80.7%和 73.5%，特异性分别为 100.0%、99.3%和 99.1%。该检测方法的实施将样本采集与结果报告之间的周转时间从 45 天缩短至 3 天，缩短了 93.3%（p，0.001）。
第二代 GenoType MTBDRsl 试剂盒具有良好的诊断性能和较短的检测周转时间，证明其在中国对二线药物耐药和 XDR-TB 的早期诊断具有重要价值。
