KNCV Tuberculosis Foundation, PO Box 146, 2501CC The Hague, The Netherlands.
BMC Infect Dis. 2010 Jun 3;10:149. doi: 10.1186/1471-2334-10-149.
To control multidrug resistant tuberculosis (MDR-TB), the drug susceptibility profile is needed to guide therapy. Classical drug susceptibility testing (DST) may take up to 2 to 4 months. The GenoType MTBDRplus test is a commercially available line-probe assay that rapidly detects Mycobacterium tuberculosis (MTB) complex, as well as the most common mutations associated with rifampin and isoniazid resistance.We assessed sensitivity and specificity of the assay by using a geographically representative set of MTB isolates from the South of Vietnam.
We re-cultured 111 MTB isolates that were MDR, rifampin-resistant or pan-susceptible according to conventional DST and tested these with the GenoType MTBDRplus test.
By conventional DST, 55 strains were classified as MDR-TB, four strains were rifampicin mono-resistant and 52 strains were susceptible to all first-line drugs. The sensitivity of the GenoType MTBDRplus was 93.1% for rifampicin, 92.6% for isoniazid and 88.9% for the combination of both; its specificity was 100%. The positive predictive value of the GenoType MTBDRplus test for MDR-TB was 100% and the negative predictive value 90.3%.
We found a high specificity and positive predictive value of the GenoType MTBDRplus test for MDR-TB which merits its use in the MDR-TB treatment program in Vietnam.
为了控制耐多药结核病（MDR-TB），需要药物敏感性谱来指导治疗。经典的药物敏感性测试（DST）可能需要 2 到 4 个月。GenoType MTBDRplus 测试是一种市售的线探针分析，可快速检测结核分枝杆菌（MTB）复合体，以及与利福平耐药和异烟肼耐药相关的最常见突变。我们使用来自越南南部的具有地理代表性的一组 MTB 分离株评估了该检测方法的敏感性和特异性。
我们重新培养了 111 株根据传统 DST 分类为 MDR-TB、利福平耐药或全敏感的 MTB 分离株，并使用 GenoType MTBDRplus 测试进行了检测。
根据传统 DST，55 株被归类为 MDR-TB，4 株为利福平单耐药株，52 株对所有一线药物均敏感。GenoType MTBDRplus 对利福平的敏感性为 93.1%，对异烟肼的敏感性为 92.6%，对两者联合的敏感性为 88.9%；特异性为 100%。GenoType MTBDRplus 试验对 MDR-TB 的阳性预测值为 100%，阴性预测值为 90.3%。
我们发现 GenoType MTBDRplus 试验对 MDR-TB 具有较高的特异性和阳性预测值，值得在越南的 MDR-TB 治疗方案中使用。
