Singh Binit Kumar, Sharma Surendra K, Sharma Rohini, Sreenivas Vishnubhatla, Myneedu Vithal P, Kohli Mikashmi, Bhasin Dinkar, Sarin Sanjay
Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.
Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
PLoS One. 2017 Aug 22;12(8):e0182988. doi: 10.1371/journal.pone.0182988. eCollection 2017.
To evaluate the performance of Genotype MTBDRplus VER 2.0 in the diagnosis of Mycobacterium tuberculosis (MTB) in sputum smear-negative pulmonary TB cases.
A total of 572 Ziehl-Neelsen sputum smear-negative samples were selected and subjected to line probe assay (Genotype MTBDRplus VER 2.0), and culture in mycobacterial growth indicator tube (MGIT-960). Immunochromatographic test was used to confirm the MTB-complex (MTBC) in culture-positive samples and phenotypic drug-susceptibility testing was done using MGIT-960.
The line probe assay was able to diagnose MTBC in 38.2% (213/558) of specimens after excluding 14 nontuberculous mycobacteria. Sensitivity and specificity of the assay were 68.4% and 89.3% respectively, considering MGIT-960 culture as gold standard after excluding contaminated and invalid results. On comparing with composite reference standard, the assay had 71.5% sensitivity and 100% specificity in the diagnosis of tuberculosis. The sensitivity and specificity for detecting resistance to rifampicin (RMP) were 100% and 99.24% respectively and for resistance to isoniazid (INH) were 97.62% and 98.55%, respectively.
Genotype MTBDRplus VER 2.0 is a rapid and precise diagnostic tool for detection of MTB in sputum smear-negative samples. It also facilitates accurate diagnosis of RMP and INH resistance within turn around-time.
评估Genotype MTBDRplus VER 2.0在痰涂片阴性肺结核病例中诊断结核分枝杆菌（MTB）的性能。
共选取572份萋-尼氏痰涂片阴性样本，进行线性探针分析（Genotype MTBDRplus VER 2.0）以及在分枝杆菌生长指示管（MGIT-960）中培养。采用免疫层析试验确认培养阳性样本中的MTB复合群（MTBC），并使用MGIT-960进行表型药敏试验。
排除14株非结核分枝杆菌后，线性探针分析能够在38.2%（213/558）的标本中诊断出MTBC。以排除污染和无效结果后的MGIT-960培养作为金标准，该分析方法的敏感性和特异性分别为68.4%和89.3%。与综合参考标准相比，该分析方法在结核病诊断中的敏感性为71.5%，特异性为100%。检测利福平（RMP）耐药性的敏感性和特异性分别为100%和99.24%，检测异烟肼（INH）耐药性的敏感性和特异性分别为97.62%和98.55%。
Genotype MTBDRplus VER 2.0是一种用于检测痰涂片阴性样本中MTB的快速、精确的诊断工具。它还有助于在周转时间内准确诊断RMP和INH耐药性。
