Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, Jiangsu Province, People's Republic of China.
PLoS One. 2012;7(12):e52953. doi: 10.1371/journal.pone.0052953. Epub 2012 Dec 28.
To evaluate a biochip system in determining isoniazid and rifampicin resistances of Mycobacterium tuberculosis in sputum samples in a Chinese population.
We assembled 907 sputum smeared positive specimens of tuberculosis patients in total. Each sample would be separated into two parts for culture and biochip assay simultaneously. And those cultured positive and having full drug resistance results would be used as reference. The McNemar χ² test was adopted for evaluating the paired 2×2 table.
Compared with drug sensitivity test, the agreement rates of the two methods in detecting rifampicin and isoniazid resistances were 93.37% and 94.49%, respectively. The sensitivity and specificity of biochip in detecting isoniazid were 74.31% and 96.92%, respectively. Meanwhile, the sensitivity and specificity for rifampicin were 79.76% and 96.53%, respectively. For multi-drug resistance, the sensitivity and specificity were 64.62% and 97.75%, respectively.
The biochip system is a rapid and accurate method for drug resistant tuberculosis diagnosis using sputum samples directly, especially for rifampicin resistance detection.
评估生物芯片系统在检测中国人痰液样本中结核分枝杆菌异烟肼和利福平耐药性的能力。
我们共收集了 907 份涂阳肺结核患者的痰液标本。每个样本同时进行培养和生物芯片检测。那些培养阳性且具有完整耐药结果的样本将被用作参考。采用 McNemar χ²检验对配对 2×2 表进行评估。
与药敏试验相比，两种方法检测利福平及异烟肼耐药性的符合率分别为 93.37%和 94.49%。生物芯片检测异烟肼耐药的敏感性和特异性分别为 74.31%和 96.92%。同时，检测利福平耐药的敏感性和特异性分别为 79.76%和 96.53%。对于耐多药，敏感性和特异性分别为 64.62%和 97.75%。
生物芯片系统是一种快速、准确的方法，可直接从痰液样本中诊断耐药性结核病，尤其是用于检测利福平耐药性。
