线性探针技术在耐药结核病诊断中的应用

Application of line probe technology in the diagnosis of drug⁃resistant tuberculosis

目的应用线性探针技术(LiPA)检测结核病的耐药情况。方法连续纳入安徽省胸科医院2018年9—12月结核病疑似病人479例,同时用LiPA和传统BACTECTM MGIT 960快速液体法(以下简称为“MGIT 960法”)进行结核分枝杆菌复合群(MTBC)检测和利福平、异烟肼药敏试验,评价其检测效能。结果以MGIT 960法为标准,LiPA检出MTBC的灵敏度、特异度分别为96.82%和97.45%,两者差异无统计学意义(χ^2=0.64,P=0.424);检测利福平耐药的灵敏度、特异度为95.18%和96.34%,检测异烟肼耐药的灵敏度、特异度为81.61%和95.72%,两者均差异无统计学意义(利福平:χ^2=0.36,P=0.549;异烟肼:χ^2=2.04,P=0.152)。此外,LiPA检测利福平耐药株突变率最高的是S531L位点,占62.791%(54/86),异烟肼耐药株突变率最高的是单独KatG基因突变,占84.810%(67/79)。结论以MGIT 960法为标准,线性探针技术诊断耐药结核病具有灵敏度高、特异度强、快速准确的特点,能为耐药结核病的早期发现和治疗提供诊断依据。

Objective To evaluate the performance of Line probe assay(LiPA)for rapid screening drug resistance of tuberculosis.Methods A total of 479 suspected tuberculosis patients were enrolled consecutively in the Anhui Chest Hospital from September to December 2018.Meanwhile,the detection of Mycobacterium tuberculosis(MTBC)and the drug sensitivity tests of rifampicin and isoniazid were carried out by LiPA and BACTECTM MGIT 960(MGIT 960)liquid culture,respectively.The detection efficiency was evaluated.Results Compared with MGIT 960,the sensitivity,specificity of LiPA for MTBC detection were 96.82%and 97.45%.There is no statistically significant differences between them(χ^2=0.64,P=0.424).The sensitivity and specificity of the de⁃tection of rifampicin resistance were 95.18%and 96.34%,respectively;and the sensitivity and specificity of the detection of isonia⁃zid resistance were 81.61%and 95.72%,without statistically significant differences(RFP:χ^2=0.36,P=0.549;INH:χ^2=2.04,P=0.152).Additionally,the highest mutation rate of rifampicin resistant strains detected by LiPA was S531L site,accounting for 62.791%(54/86),and the highest mutation rate of isoniazid resistant strains was katG single gene mutation,accounting for 84.810%(67/79).Conclusion Compared with MGIT 960,LiPA has characteristics of high sensitivity,specificity and rapid accu⁃racy for rapid screening and detection of drug⁃resistant tuberculosis,which can provide diagnostic basis for the early detection and treatment of drug⁃resistant tuberculosis.