基因芯片技术在耐药结核病临床诊断中的应用价值研究

The clinical value of gene chip assay for drug resistant tuberculosis diagnosis

目的探讨基因芯片技术在耐药结核病临床诊断中的应用价值。方法2016年1月-2018年12月连续纳入连云港地区各区县发现的所有肺结核病例,所有2018例涂片阳性患者的痰样本运送到连云港第四医院,进行培养、传统药物敏感性试验和基因芯片耐药检测。以传统药物敏感性试验结果为金标准,分析基因芯片耐药检测技术用于耐药结核病诊断的灵敏度和特异性。结果以固体药敏试验结果为金标准,基因芯片检测利福平耐药的灵敏度和特异度分别为82.1%和97.5%。基因芯片检测异烟肼耐药的灵敏度和特异度分别为76.8%和96.0%。2018例样本中,155例基因芯片耐药检测结果失败(7.7%),其中85.8%的样本涂片结果分布在2+以下。结论基因芯片技术灵敏度和特异度高,可以用于在地市级医院快速诊断耐药结核病。

Objective To explore the clinical value of gene chip assay for drug-resistant tuberculosis diagnosis at the prefecture-level.Methods January 2016 to December 2018,all tuberculosis cases diagnosed in various districts and counties of Lianyungang were continuously recruited.The sputum samples of 2018 smear-positive patients were transported to Lianyungang Fourth Hospital for culture,traditional drug susceptibility test(DST),and gene chip test.The sensitivity and specificity of gene chips for the diagnosis of drug-resistant tuberculosis were analyzed compared to traditional drug sensitivity tests.Results compared to traditional DST,the sensitivity and specificity of gene chip for detecting rifampicin resistance were 82.1%and 97.5%respectively.The sensitivity and specificity of the gene chip for detecting isoniazid resistance were 76.8%and 96.0%,respectively.Among the 2018 samples,155(7.7%)specimens failed for drug resistance test,and the smear result of 85.8%of specimens was 2+.Conclusion Gene chip assay has high sensitivity and specificity and can be used for rapid diagnosis of drug-resistant tuberculosis in prefectural hospitals.