Direct Susceptibility Testing of Mycobacterium tuberculosis for Pyrazinamide by Use of the Bactec MGIT 960 System
Direct Susceptibility Testing of Mycobacterium tuberculosis for Pyrazinamide by Use of the Bactec MGIT 960 System
复制标题
DOI：
10.1128/jcm.03162-15
复制
发表时间：
2016-05-01
影响因子：
9.4
通讯作者：
Diacon, Andreas H.
中科院分区：
文献类型：
--
作者：
Demers, Anne-Marie;Venter, Amour;Diacon, Andreas H.
吡嗪酰胺（PZA）是一种重要的抗结核药物，但目前还没有商业化的快速药敏试验。 PZA 药物敏感性测试 (DST) 直接对 327 名患者的痰样本进行，并在筛选参加药物试验的患者时使用 Bactec MGIT 960 系统与间接方法进行比较。与标准间接 PZA DST 相比，直接 DST 仅在 59% 的情况下成功，但获得的结果高度准确且可更快获得。每个实验室的直接法和间接法之间的一致性从 90% 到 100% 不等。各实验室从采集样本开始获得 PZA 结果的中位时间为直接检测 11 至 16 天，间接检测 18 至 95 天。直接方法在实验室中准确且可重复。预计它可以加速 >50% 病例的结果，但它不能取代 PZA 的间接 DST。表型方法仍然是药物试验中药敏试验的黄金标准。如果未来的研究能够优化方法以减少无法解释的结果的数量，那么直接 MGIT DST 可能成为临床试验的新表型 DST 标准，从而更快速地检测实验方案中对新药的耐药性。
Pyrazinamide (PZA) is a key antituberculosis drug, yet no rapid susceptibility test is commercially available. PZA drug susceptibility testing (DST) was performed directly on sputum samples from 327 patients and compared with the indirect method by using the Bactec MGIT 960 system in the context of patient screening for participation in a drug trial. Compared to standard indirect PZA DST, direct DST was successful in only 59% of cases, but results obtained were highly accurate and available faster. Agreement between the direct and indirect methods varied from 90 to 100% in each laboratory. The median times for obtaining PZA results from the time when the specimen was collected ranged from 11 to 16 days for the direct test and 18 to 95 days for the indirect test across laboratories. The direct method is accurate and reproducible across laboratories. It can be expected to accelerate results in >50% of cases, but it cannot replace indirect DST for PZA. Phenotypic methods remain the gold standard for DST in drug trials. If future studies can optimize the method to decrease the number of uninterpretable results, direct MGIT DST could be the new phenotypic DST standard for clinical trials, providing more rapid detection of resistance to new drugs in experimental regimens.