Kumar Vimal, Jorwal Pankaj, Soneja Manish, Sinha Sanjeev, Nischal Neeraj, Sethi Prayas, Mondal Saikat, Abdullah Zia, Pandey R M
Department of Medicine, All India Institute of Medical Sciences, 3rd Floor Teaching Block, New Delhi, India.
Department of Emergency Medicine, JPN Trauma Centre, All India Institute of Medical Sciences, Ring Road, New Delhi, India.
J Family Med Prim Care. 2020 Feb 28;9(2):1028-1034. doi: 10.4103/jfmpc.jfmpc_883_19. eCollection 2020 Feb.
Early diagnosis and treatment of drug-resistant tuberculosis (TB) is crucial to halt the spread of drug resistance in the community.
The aim of the study was to compare rapid diagnostic tests (GeneXpert and line probe assay, LPA) with conventional liquid culture for the diagnosis of drug-resistant TB and to assess the risk factors for it.
This cross-sectional study recruited 229 multidrug-resistant TB suspects who were sputum smear positive. They were evaluated by the rapid diagnostic tests and sensitivity, specificity, positive predictive value and negative predictive value were calculated for drug resistance detection as compared to liquid culture drug susceptibility testing. The risk factors for the development of drug resistance were also assessed and the value of < 0.05 was considered significant.
In the final comparison, 193 samples were included. The sensitivity and specificity of GeneXpert for detection of drug resistance (rifampicin) was 100% (95% confidence interval, CI: 88.8-100%) and 99.4% (95% CI: 96.6-99.9%), respectively. Whereas sensitivity and specificity of LPA was 94.3% (95% CI: 80.8-99.3%) and 100% (95% CI: 97.7-100%), respectively. Only three discordant samples were observed. Defaulting to antitubercular therapy, contact with resistant TB, and disseminated disease were found to be significant risk factors for the development of drug-resistant TB with high statistical significance ( value < 0.05).
Both rapid diagnostic tests have very high sensitivity and specificity for detection of drug resistance in sputum smear positive with the advantage of short turn-around time. Defaulting to antitubercular therapy, contact with resistant TB, and disseminated disease are significant risk factors for drug resistance.
耐药结核病的早期诊断和治疗对于阻止耐药性在社区中的传播至关重要。
本研究旨在比较快速诊断检测(GeneXpert和线性探针分析,LPA)与传统液体培养用于诊断耐药结核病,并评估其危险因素。
这项横断面研究招募了229例痰涂片阳性的耐多药结核病疑似患者。他们接受了快速诊断检测,并计算了与液体培养药物敏感性检测相比的耐药性检测的敏感性、特异性、阳性预测值和阴性预测值。还评估了耐药性发展的危险因素,P值<0.05被认为具有统计学意义。
在最终比较中,纳入了193个样本。GeneXpert检测耐药性(利福平)的敏感性和特异性分别为100%(95%置信区间,CI:88.8 - 100%)和99.4%(95%CI:96.6 - 99.9%)。而LPA的敏感性和特异性分别为94.3%(95%CI:80.8 - 99.3%)和100%(95%CI:97.7 - 100%)。仅观察到三个不一致的样本。未坚持抗结核治疗、接触耐药结核病和播散性疾病被发现是耐药结核病发展的显著危险因素,具有高度统计学意义(P值<0.05)。
两种快速诊断检测对痰涂片阳性患者耐药性的检测均具有很高的敏感性和特异性,且周转时间短。未坚持抗结核治疗、接触耐药结核病和播散性疾病是耐药的重要危险因素。