Alipanah Narges, Shete Priya B, Nguyen Hanh, Nguyen Nhung Viet, Luu Lien, Pham Thuong, Nguyen Hung, Nguyen Phuong, Tran Minh Chi, Pham Nam, Phan Ha, Phillips Patrick P J, Cattamanchi Adithya, Nahid Payam
Santa Clara Valley Medical Center, San Jose, CA 95128, USA.
UCSF Center for Tuberculosis, San Francisco, CA 94110, USA.
Diagnostics (Basel). 2019 May 30;9(2):56. doi: 10.3390/diagnostics9020056.
A rapid diagnosis of drug-resistant tuberculosis (TB) is critical for early initiation of effective therapy. Molecular testing with line probe assays (MTBDR and MTBDR) on culture isolates has been available for some time and significantly reduces the time to diagnosis of drug resistance. However, routine use of this test directly on sputum is less common. As part of enrollment screening procedures for tuberculosis clinical trials conducted in Hanoi, Vietnam, we evaluated the feasibility and performance of line probe assay (LPA) testing directly on sputum samples from 315 participants with no prior history of TB treatment. Test performance characteristics for the detection of rifampin (RIF) and isoniazid (INH) drug resistance as compared to culture-based drug susceptibility testing (DST) reference standard were calculated. LPA demonstrated high sensitivity and specificity for the diagnosis of drug resistance. Scaling up molecular testing on sputum as part of time-sensitive clinical trial screening procedures in high TB burden settings is feasible and will reduce both time to initiation of appropriate therapy and the risk of late exclusions due to microbiologic ineligibility.
快速诊断耐药结核病对于尽早开始有效治疗至关重要。对培养分离株进行线性探针分析（MTBDR和MTBDR）的分子检测已经开展了一段时间，可显著缩短耐药诊断时间。然而，直接在痰液上常规使用该检测方法的情况较少见。作为在越南河内进行的结核病临床试验入组筛查程序的一部分，我们评估了直接对315名无结核病治疗史参与者的痰液样本进行线性探针分析（LPA）检测的可行性和性能。计算了与基于培养的药敏试验（DST）参考标准相比，检测利福平（RIF）和异烟肼（INH）耐药性的检测性能特征。LPA在耐药诊断方面表现出高灵敏度和特异性。在高结核病负担地区，将痰液分子检测作为时间敏感型临床试验筛查程序的一部分进行推广是可行的，这将减少开始适当治疗的时间以及因微生物学不合格而导致后期排除的风险。
