Multi-center evaluation of GenoType MTBDRsl line probe assay for rapid detection of pre-XDR and XDR Mycobacterium tuberculosis in China. Issue 4 (October 2018)

• Record Type: Journal Article
• Authors: Gao, Yazhou; Zhang, Zhengdong; Deng, Jianping; Mansjö, Mikael; Ning, Zhu; Li, Yang; Li, Xuliang; Hu, Yi; Hoffner, Sven; Xu, Biao
• Is Part Of: Journal of infection. Volume 77:Issue 4(2018)
• Page Start: 328
• Page End: 334
• Publication Date: 2018-10
• Subjects: Tuberculosis -- Diagnostic accuracy -- Line probe assay -- Extensively drug resistance; Infection -- Periodicals; Bacterial Infections -- Periodicals; Communicable Diseases -- Periodicals; Electronic journals; 616.905
• DOI: 10.1016/j.jinf.2018.06.014
• Languages: English
• ISSNs: 0163-4453

Abstract

Highlights: Compared to phenotypic DST, the second version of MTBDRsl assay proven its satisfactory performance in detecting resistance to fluoroquinolone and 2nd-line injectable agents both in TB high and low burden settings of China. The molecular diagnosis assay significantly reduced the turnaround time between sample collection and result reporting. Specific genetic mutations identified by molecular diagnosis assay, were strongly associated with different levels of resistance to second-line drugs. The assay can be used routinely in high MDR-TB burden settings to shorten the drug susceptibilities testing and guide the treatment. Summary: Objectives: 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. Methods: 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. Results: 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 rrs MUT1(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). Conclusion: 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.