Foundation for Innovative New Diagnostics, Kampala, Uganda.
BMC Infect Dis. 2010 Feb 26;10:41. doi: 10.1186/1471-2334-10-41.
About 500 new smear-positive Multidrug-resistant tuberculosis (MDR-TB) cases are estimated to occur per year in Uganda. In 2008 in Kampala, MDR-TB prevalence was reported as 1.0% and 12.3% in new and previously treated TB cases respectively. Line probe assays (LPAs) have been recently approved for use in low income settings and can be used to screen smear-positive sputum specimens for resistance to rifampicin and isoniazid in 1-2 days.
We assessed the performance of a commercial line probe assay (Genotype MTBDRplus) for rapid detection of rifampicin and isoniazid resistance directly on smear-positive sputum specimens from 118 previously treated TB patients in a reference laboratory in Kampala, Uganda. Results were compared with MGIT 960 liquid culture and drug susceptibility testing (DST). LPA testing was also performed in parallel in a University laboratory to assess the reproducibility of results.
Overall, 95.8% of smear-positive specimens gave interpretable results within 1-2 days using LPA. Sensitivity, specificity, positive and negative predictive values were 100.0%, 96.1%, 83.3% and 100.0% for detection of rifampicin resistance; 80.8%, 100.0%, 100.0% and 93.0% for detection of isoniazid resistance; and 92.3%, 96.2%, 80.0% and 98.7% for detection of multidrug-resistance compared with conventional results. Reproducibility of LPA results was very high with 98.1% concordance of results between the two laboratories.
LPA is an appropriate tool for rapid screening for MDR-TB in Uganda and has the potential to substantially reduce the turnaround time of DST results. Careful attention must be paid to training, supervision and adherence to stringent laboratory protocols to ensure high quality results during routine implementation.
乌干达每年估计约有 500 例新的涂阳耐多药结核病(MDR-TB)病例。2008 年在坎帕拉,新发病例和既往治疗病例中 MDR-TB 的患病率分别报告为 1.0%和 12.3%。线探针分析(LPAs)最近已被批准用于低收入国家/地区使用,可用于在 1-2 天内筛查涂阳痰液标本中利福平与异烟肼的耐药性。
我们在乌干达坎帕拉的参考实验室评估了一种商业线探针分析(基因型 MTBDRplus)在快速检测涂阳痰标本中利福平与异烟肼耐药性的性能,该分析共纳入 118 例既往治疗的结核病患者。结果与 MGIT 960 液体培养和药敏试验(DST)进行了比较。为了评估结果的可重复性,在大学实验室中也同时进行了 LPA 检测。
总体而言,使用 LPA 在 1-2 天内可获得 95.8%的涂阳标本的可解释结果。对于检测利福平耐药性,LPA 的敏感性、特异性、阳性预测值和阴性预测值分别为 100.0%、96.1%、83.3%和 100.0%;对于检测异烟肼耐药性,分别为 80.8%、100.0%、100.0%和 93.0%;对于检测耐多药,分别为 92.3%、96.2%、80.0%和 98.7%,与传统结果相比。两个实验室之间的 LPA 结果高度一致,结果的符合率为 98.1%。
LPA 是乌干达快速筛查 MDR-TB 的合适工具,具有大大缩短 DST 结果周转时间的潜力。在常规实施过程中,必须密切关注培训、监督和严格遵守实验室方案,以确保高质量的结果。