Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Respiratory Epidemiology and Clinical Research Unit, Montréal Chest Institute, 1020 Pine Avenue West, Montreal H3A 1A2, Canada.
Expert Rev Respir Med. 2008 Oct;2(5):583-8. doi: 10.1586/17476348.2.5.583.
Growing concerns about the spread of multidrug-resistant tuberculosis (MDR-TB) and the emergence of extensively drug-resistant TB have triggered substantial interest in the development and application of rapid tests for the detection of drug-resistant TB. Molecular assays to detect gene mutations that signal drug resistance are widely recognized as being most suited for rapid diagnosis. Among molecular assays, line probe assays have shown great promise. Currently, two line probe assays are commercially available: the INNO-LiPA Rif. TB kit (Innogenetics NV, Gent, Belgium) and the GenoType MTBDRplus assay (Hain Lifescience GmbH, Nehren, Germany). Evidence from a systematic review suggests that INNO-LiPA is a highly sensitive and specific test for the detection of rifampicin resistance in culture isolates. The test, however, appeared to have relatively lower sensitivity when used directly on clinical specimens. Another meta-analysis showed that the GenoType MTBDR assays had excellent accuracy for rifampicin resistance, even when used directly on clinical specimens. While specificity was excellent for isoniazid, sensitivity estimates were modest and variable. Based on evidence and expert opinion, the WHO recently endorsed the use of molecular line probe assays for rapid screening of patients at risk of MDR-TB. Special initiatives have been announced to make these assays accessible and affordable for countries with high MDR-TB prevalence. With strong evidence and new policy directives, the stage is now set for the use of rapid tests for MDR-TB diagnosis. Whether molecular tools, such as line probe assays, will actually make a clinical and public-health impact remains to be determined.
人们对耐多药结核病（MDR-TB）传播和广泛耐药结核病（XDR-TB）出现的担忧日益增加，这促使人们对耐药结核病快速检测方法的开发和应用产生了浓厚兴趣。用于检测耐药性的基因突变的分子检测方法被广泛认为最适合快速诊断。在分子检测方法中，线性探针检测法显示出巨大的潜力。目前，有两种商业化的线性探针检测法：INNO-LiPA Rif. TB 试剂盒（Innogenetics NV，比利时根特）和 GenoType MTBDRplus 检测法（德国 Nehren 的 Hain Lifescience GmbH）。系统评价的证据表明，INNO-LiPA 是一种用于检测培养物分离株中利福平耐药性的高度敏感和特异的检测方法。然而，该检测方法在直接用于临床标本时，其敏感性似乎相对较低。另一项荟萃分析表明，GenoType MTBDR 检测法即使直接用于临床标本，对利福平耐药性也具有极好的准确性。虽然异烟肼的特异性很好，但敏感性估计值较低且存在差异。根据证据和专家意见，世界卫生组织（WHO）最近批准使用分子线性探针检测法快速筛查有发生耐多药结核病风险的患者。已经宣布了特别举措，以使这些检测法在耐多药结核病流行率较高的国家能够获得并负担得起。有了强有力的证据和新的政策指导，现在已经为耐多药结核病的快速诊断使用这些检测方法做好了准备。分子工具（如线性探针检测法）是否会对临床和公共卫生产生影响，还有待观察。
