Performance of the Genotype MTBDRPlus assay in the diagnosis of tuberculosis and drug resistance in Samara, Russian Federation.
Performance of the Genotype MTBDRPlus assay in the diagnosis of tuberculosis and drug resistance in Samara, Russian Federation.
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DOI：
10.1186/1472-6890-9-2
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发表时间：
2009-03-10
影响因子：
--
通讯作者：
Drobniewski F
中科院分区：
文献类型：
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作者：
Nikolayevskyy V;Balabanova Y;Simak T;Malomanova N;Fedorin I;Drobniewski F
俄罗斯是结核病（TB）高负担国家，耐多药结核病（MDRTB）发病率高。在俄罗斯，用于检测临床标本中MDRTB的分子检测方法并不广泛。我们对GenoType® MTBDRplus检测试剂盒（海恩Lifescience GmbH，德国）进行了评价，该试剂盒在俄罗斯中部的一家公共卫生实验室（作为耐药水平较高地区中等收入研究中心的模型）采集了来自个体患者的共计168份痰液标本。使用BACTEC 960液体培养基系统对来自相同痰液标本的培养物进行表型耐药试验（DST）。154份（91.7%）标本获得了可解释的GenoType® MTBDRplus结果，2+和3+级痰液标本的可读性显著高于1+级（RR = 1.17 95%CI 1.04-1.32）。检测利福平（RIF）、异烟肼（INH）耐药和MDR的敏感性和特异性分别为96.2%、97.4%、97.1%和90.7%、83.3%、88.9%。RIF和INH耐药株分别以rpoB基因531密码子和katG基因315密码子突变为主。表型和分子检测结果（12份样本）之间的不一致可以通过在俄罗斯流行的菌株中存在罕见突变以及痰液标本中同时存在耐药和敏感杆菌（异源耐药）来解释。高灵敏度、短周转时间和快速筛查大量样本的潜力使GenoType® MTBDRplus检测试剂盒适合作为耐药结核病的一线筛查试剂盒。
Russia is a high tuberculosis (TB) burden country with a high prevalence of multidrug resistant tuberculosis (MDRTB). Molecular assays for detection of MDRTB on clinical specimens are not widely available in Russia. We performed an evaluation of the GenoType® MTBDRplus assay (HAIN Lifescience GmbH, Germany) on a total of 168 sputum specimens from individual patients at a public health laboratory in Central Russia, as a model of a middle income site in a region with high levels of drug resistance. Phenotypic drug resistance tests (DST) were performed on cultures derived from the same sputum specimens using the BACTEC 960 liquid media system. Interpretable GenoType® MTBDRplus results were obtained for 154(91.7%) specimens with readability rates significantly higher in sputum specimens graded 2+ and 3+ compared to 1+ (RR = 1.17 95%CI 1.04–1.32). The sensitivity and specificity of the assay for the detection of rifampicin (RIF) and isoniazid (INH) resistance and MDR was 96.2%, 97.4%, 97.1% and 90.7%, 83.3%, 88.9% respectively. Mutations in codon 531 of the rpoB gene and codon 315 of the katG gene dominated in RIF and INH resistant strains respectively. Disagreements between phenotypical and molecular tests results (12 samples) could be explained by the presence of rare mutations in strains circulating in Russia and simultaneous presence of resistant and sensitive bacilli in sputum specimens (heteroresistance). High sensitivity, short turnaround times and the potential for screening large numbers of specimens rapidly, make the GenoType® MTBDRplus assay suitable as a first-line screening assay for drug resistant TB.