Validation of the GenoType MTBDRplus assay for diagnosis of multidrug resistant tuberculosis in South Vietnam.

Validation of the GenoType MTBDRplus assay for diagnosis of multidrug resistant tuberculosis in South Vietnam.
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DOI:
10.1186/1471-2334-10-149
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发表时间:
2010-06-03
影响因子:
3.7
通讯作者:
van Soolingen D
van Soolingen D
中科院分区:
医学3区
文献类型:
--
作者:
Huyen MN;Tiemersma EW;Lan NT;Cobelens FG;Dung NH;Sy DN;Buu TN;Kremer K;Hang PT;Caws M;O'Brien R;van Soolingen D

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为了控制耐多药结核病(MDR-TB),需要药物敏感谱来指导治疗。传统的药物敏感性测试(DST)可能需要长达2至4个月。GenoType® MTBDRplus检测试剂盒是一种市售线性探针检测试剂盒,可快速检测结核分枝杆菌(MTB)复合群以及与利福平和异烟肼耐药相关的最常见突变。我们通过使用来自越南南部的具有地理代表性的MTB分离株来评估该检测的灵敏度和特异性。我们重新培养了111株根据常规DST为MDR、利福平耐药或泛敏感的MTB分离株,并使用GenoType® MTBDRplus检测试剂盒进行检测。常规DST结果显示,55株耐多药结核菌,4株利福平单一耐药,52株对所有一线药物敏感。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%;其特异性为100%。GenoType® MTBDRplus检测对MDR-TB的阳性预测值为100%,阴性预测值为90.3%。我们发现GenoType® MTBDRplus检测对耐多药结核病具有很高的特异性和阳性预测值,值得在越南的耐多药结核病治疗项目中使用。
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.
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