摘要
目的:评估自动化EasyNAT核酸快速检测系统检测石蜡包埋组织诊断结核病的准确性.方法:选择首都医科大学附属北京胸科医院2018年至2022年患者的病例资料进行回顾性分析,连续纳入134例患者,包括结核病确诊患者101例,非结核患者33例.以临床诊断结果为参考标准,分析EasyNAT核酸快速检测系统应用于石蜡包埋组织诊断结核病的敏感性、特异性、阳性预测值、阴性预测值和准确率.结果:EasyNAT核酸快速检测系统应用于石蜡包埋组织诊断结核病的敏感性为87.1％(88/101,95％CI:79.2％～92.3％),特异性为100.0％(33/33,95％CI:89.6％～100.0％),阳性预测值为 100.0％(88/88,95％CI:95.8％～100.0％),阴性预测值为 71.7％(33/46,95％CI:57.5％～82.7％),准确率为 90.3％(121/134,95％CI:84.1％～94.2％).与实时荧光定量聚合酶链反应(quantitative real-time polymerase chain reaction,qPCR)技术检测结果的一致性检验 Kappa 值为 0.84.对肺结核的检出率为 86.4％(38/44,95％CI:73.3％～93.6％),肺外结核的检出率为87.7％(50/57,95％CI:76.8％～93.9％),与qPCR对应的检测结果比较差异均无统计学意义(P均＞0.05).而EasyNAT检测集核酸提取、扩增和分析于一体,与传统qPCR法相比,手工操作时间缩短了2 h,总检测时间缩短了3 h.结论:EasyNAT核酸快速检测系统可以快速、便捷、准确地检测出石蜡包埋组织中的结核分枝杆菌DNA,对于病理学诊断结核病具有良好的应用价值.
Abstract
Objective:Assessing the accuracy of automated EasyNAT system for rapidly detecting par-affin-embedded tissue for the diagnosis of tuberculosis.Methods:A retrospective analysis was conducted on 134 patients,comprising 101 with confirmed tuberculosis and 33 without tuberculosis,treated at Beijing Chest Hospital,Capital Medical University,between 2018 and 2022.The clinical diagnostic results served as the standard for assessing the diagnostic performance of the EasyNAT system in comparison to quantita-tive real-time polymerase chain reaction(qPCR)for tuberculosis detection in paraffin-embedded tissues.The evaluation criteria included sensitivity,specificity,positive predictive value,negative predictive value,and accuracy rate.Results:Based on the clinical diagnostic results,the EasyNAT assay demonstrated a sensitivity of 87.1％(88/101,95％CI:79.2％-92.3％)and a specificity of 100.0％(33/33,95％CI:89.6％-100.0％).The positive predictive value,negative predictive value,and accuracy rate were 100％(88/88,95％CI:95.8％-100.0％),71.7％(33/46,95％CI:57.5％-82.7％),and 90.3％(121/134,95％CI:84.1％-94.2％),respectively.In comparison,the qPCR assay exhibited a sensi-tivity of 96.0％(90.3％-98.5％)and a specificity of 100.0％(89.6％-100.0％).The positive pre-dictive value,negative predictive value,and accuracy rate for qPCR were 100.0％(96.2％-100.0％),89.2％(75.3％-95.7％),and 97.0％(92.6％-98.8％).The Cohen's kappa value of 0.84 indicated substantial agreement between EasyNAT and qPCR.The detection rate of tuberculosis using this method was 86.4％(38/44,95％CI:73.3％-93.6％),while the detection rate for extrapulmonary tuberculo-sis was 87.7％(50/57,95％CI:76.8％-93.9％).In comparison,qPCR showed a detection rate of 97.7％(88.2％-99.6％)for pulmonary tuberculosis and 94.7％(85.6％-98.6％)for extrapulmonary tuberculosis.There was no statistically significant difference in the detection results between the method and qPCR for both pulmonary and extrapulmonary tuberculosis(P＞0.05).Importantly,the EasyNAT de-tection combined nucleic acid extraction,amplification,and analysis into one process.Compared with tra-ditional qPCR methods,manual operation time was reduced by 2 hours,leading to an overall reduction in total testing time by 3 hours.Conclusion:The EasyNAT nucleic acid rapid detection system can quickly,conveniently,and accurately detect Mycobacterium tuberculosis DNA in paraffin-embedded tissues,demon-strating significant clinical utility in the pathological diagnosis of tuberculosis.
万方数据