评价 Xpert MTB/XDR 检测在乌干达用于检测结核分枝杆菌对一线和二线药物敏感性的效果。
Evaluation of Xpert MTB/XDR test for susceptibility testing of Mycobacterium tuberculosis to first and second-line drugs in Uganda.
机构信息
Department of Medicine, School of Medicine, Clinical Epidemiology and Biostatistics Unit and Uganda Implementation Research Consortium, Makerere University, Kampala, Uganda.
Department of Medical Microbiology, Makerere University, Kampala, Uganda.
出版信息
PLoS One. 2023 Aug 17;18(8):e0284545. doi: 10.1371/journal.pone.0284545. eCollection 2023.
BACKGROUND
Drug-Resistant Tuberculosis (DR-TB) is one of the major challenges to TB control.
DESIGN AND METHODS
This was a blinded, laboratory-based cross-sectional study using sputum samples or culture isolates. Samples were from patients with rifampicin-resistant-TB and/or with high risk for isoniazid (INH) resistance and/or 2nd line fluoroquinolones (FQ) and injectable agents (IAs). The diagnostic accuracy of the Xpert® MTB/XDR test was compared to MGIT960 and the Hain Genotype® MTBDRplus and MDRsl assays (LPA) as reference DST methods. Factors for laboratory uptake of the Xpert® MTB/XDR test were also evaluated.
RESULTS
Of the 100 stored sputum samples included in this study, 65/99 (65.6%) were resistant to INH, 5/100 (5.0%) were resistant to FQ and none were resistant to IAs using MGIT960. The sensitivity and specificity, n (%; 95% Confidence Interval, CI) of Xpert® MTB/XDR test for; INH was 58 (89.2; 79.1-95.5) and 30 (88.2; 72.5-96.6) and for FQ; 4 (80.0; 28.3-99.4) and 95 (100; 96.2-100), respectively. Using LPA as a reference standard, a total of 52/98 (53.1%) were resistant to INH, 3/100 (3.0%) to FQ, and none to IA. The sensitivity and specificity, n (%; 95%CI) of Xpert® MTB/XDR test compared to LPA for; INH was 50 (96.1; 86.7-99.5) and 34 (74.0; 58.8-85.7) for FQ 3 (100; 29.2-100) and 96 (99.0; 94.3-99.9) respectively. The factors for laboratory uptake and roll-out of the Xpert® MTB/XDR test included: no training needed for technicians with, and one day for those without, previous Xpert-ultra experience, recording and reporting needs were not different from those of Xpert-ultra, the error rate was 4/100 (4%), one (1%) indeterminate rate and test turn-around-time were 1hr/45 minutes.
CONCLUSION
There is high sensitivity and specificity of Xpert® MTB/XDR test for isoniazid and fluoroquinolones. There are acceptable Xpert® MTB/XDR test attributes for the test uptake and roll-out.
背景
耐多药结核病（DR-TB）是结核病控制的主要挑战之一。
设计与方法
这是一项基于实验室的、盲法的横断面研究，使用痰液样本或培养分离物。样本来自利福平耐药性-TB 患者和/或异烟肼（INH）耐药高风险患者和/或二线氟喹诺酮类药物（FQ）和注射用药物（IA）。Xpert® MTB/XDR 检测的诊断准确性与 MGIT960 以及 Hain Genotype® MTBDRplus 和 MDRsl 检测（LPA）作为参考药物敏感性试验（DST）方法进行了比较。还评估了实验室采用 Xpert® MTB/XDR 检测的因素。
结果
在本研究纳入的 100 份储存的痰液样本中，99 份中有 65/（65.6%）对 INH 耐药，100 份中有 5/（5.0%）对 FQ 耐药，MGIT960 未检测到对 IA 耐药。Xpert® MTB/XDR 检测对 INH 的敏感性和特异性，n（%；95%置信区间，CI）分别为 58（89.2；79.1-95.5）和 30（88.2；72.5-96.6），对 FQ 的敏感性和特异性分别为 4（80.0；28.3-99.4）和 95（100；96.2-100）。使用 LPA 作为参考标准，98 份中有 52/（53.1%）对 INH 耐药，100 份中有 3/（3.0%）对 FQ 耐药，对 IA 均未耐药。Xpert® MTB/XDR 检测与 LPA 相比，对 INH 的敏感性和特异性分别为 50（96.1；86.7-99.5）和 34（74.0；58.8-85.7），对 FQ 的敏感性和特异性分别为 3（100；29.2-100）和 96（99.0；94.3-99.9）。Xpert® MTB/XDR 检测的实验室采用和推广因素包括：有 Xpert-ultra 经验的技术人员无需培训，无 Xpert-ultra 经验的技术人员培训一天即可上手，记录和报告需求与 Xpert-ultra 相同，错误率为 4/100（4%），1%（1%）不确定率，检测周转时间为 1 小时/45 分钟。
结论
Xpert® MTB/XDR 检测对异烟肼和氟喹诺酮类药物具有较高的敏感性和特异性。Xpert® MTB/XDR 检测具有可接受的检测采用和推广属性。
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