验证 GenoType MTBDRplus assay 在泰国公共卫生实验室检测耐多药结核病的能力。
Validation of the GenoType MTBDRplus assay for detection of MDR-TB in a public health laboratory in Thailand.
机构信息
Bangkok Metropolitan Administration, Health Laboratory Division, Bangkok, Thailand.
出版信息
BMC Infect Dis. 2010 May 20;10:123. doi: 10.1186/1471-2334-10-123.
BACKGROUND
Over the past several years, new diagnostic techniques have been developed to allow for the rapid detection of multidrug resistant tuberculosis. The GenoType MTBDRplus test is a deoxyribonucleic acid (DNA) strip assay which uses polymerase chain reaction (PCR) and hybridization to detect genetic mutations in the genes that confer isoniazid (INH) and rifampn (RIF) resistance. This assay has demonstrated good performance and a rapid time to results, making this a promising tool to accelerate MDR-TB diagnosis and improve MDR-TB control. Validation of rapid tests for MDR-TB detection in different settings is needed to ensure acceptable performance, particularly in Asia, which has the largest number of MDR-TB cases in the world but only one previous report, in Vietnam, about the performance of the GenoType MDRplus assay. Thailand is ranked 18th of 22 "high-burden" TB countries in the world, and there is evidence to suggest that rates of MDR-TB are increasing in Thailand. We compared the performance of the GenoType MTBDRplus assay to Mycobacterial Growth Indicator Tube for Antimycobacterial Susceptibility Testing (MGIT AST) for detection INH resistance, RIF resistance, and MDR-TB in stored acid-fast bacilli (AFB)-positive sputum specimens and isolates at a Public TB laboratory in Bangkok, Thailand.
METHODS
50 stored isolates and 164 stored AFB-positive sputum specimens were tested using both the MGIT AST and the GenoType MTBDRplus assay.
RESULTS
The GenoType MTBDRplus assay had a sensitivity of 95.3%, 100%, and 94.4% for INH resistance, RIF resistance, and MDR-TB, respectively. The difference in sensitivity between sputum specimens (93%) and isolates (100%) for INH resistance was not statistically significant (p = 0.08). Specificity was 100% for all resistance patterns and for both specimens and isolates. The laboratory processing time was a median of 25 days for MGIT AST and 5 days for the GenoType MTBDRplus (p < 0.01).
CONCLUSION
The GenoType MTBDRplus assay has been validated as a rapid and reliable first-line diagnostic test on AFB-positive sputum or MTB isolates for INH resistance, RIF resistance, and MDR-TB in Bangkok, Thailand. Further studies are needed to evaluate its impact on treatment outcome and the feasibility and cost associated with widespread implementation.
背景
在过去的几年中，已经开发出了新的诊断技术，以实现对多种耐药结核病的快速检测。GenoType MTBDRplus 测试是一种脱氧核糖核酸（DNA）条带分析，它使用聚合酶链反应（PCR）和杂交来检测赋予异烟肼（INH）和利福平（RIF）耐药性的基因中的基因突变。该检测方法表现出良好的性能和快速的结果，这使其成为加速 MDR-TB 诊断和改善 MDR-TB 控制的有前途的工具。需要在不同环境中验证快速检测 MDR-TB 的准确性，以确保可接受的性能，特别是在亚洲，亚洲是世界上 MDR-TB 病例最多的地区，但只有一份之前在越南的报告涉及 GenoType MDRplus 检测方法的性能。泰国在世界上 22 个“高负担”结核病国家中排名第 18 位，有证据表明泰国的 MDR-TB 发病率正在上升。我们比较了 GenoType MTBDRplus 检测法与分枝杆菌生长指示管抗分枝杆菌药敏试验（MGIT AST）在曼谷公共结核病实验室检测储存的酸性快速分枝杆菌（AFB）阳性痰标本和分离物中的 INH 耐药性、利福平耐药性和 MDR-TB 的性能。
方法
对 50 株储存分离株和 164 份储存 AFB 阳性痰标本同时进行 MGIT AST 和 GenoType MTBDRplus 检测。
结果
GenoType MTBDRplus 检测法对 INH 耐药性、利福平耐药性和 MDR-TB 的敏感性分别为 95.3%、100%和 94.4%。INH 耐药性检测中，痰标本（93%）与分离株（100%）之间的敏感性差异无统计学意义（p=0.08）。所有耐药模式的特异性均为 100%，无论是标本还是分离株。实验室处理时间中位数为 MGIT AST 的 25 天和 GenoType MTBDRplus 的 5 天（p<0.01）。
结论
GenoType MTBDRplus 检测法已在泰国曼谷的 AFB 阳性痰或 MTB 分离物中得到验证，可作为 INH 耐药性、利福平耐药性和 MDR-TB 的快速可靠的一线诊断检测方法。需要进一步研究评估其对治疗结果的影响以及广泛实施的可行性和成本。
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