摘要
目的 评估恒温扩增荧光技术(恒温扩增法)在结核病临床检测中的效能。方法 以2020年1月—12月期间广东省4个结防机构的初诊肺结核可疑症状者作为研究对象,共纳入患者5 168例,所有患者的痰标本同时进行涂片镜检、固体培养、恒温扩增法检测,培阳菌株进行PNB菌鉴。以培养结果为标准,计算恒温扩增法检测的敏感度、特异度、阳性预测值、阴性预测值、总符合率、Kappa值。收集纳入患者的临床诊断信息,分析三种检测技术在活动性肺结核诊断中的效能。结果 共纳入5 168例肺结核可疑症状者,排除66例培养污染,共5 102例患者纳入分析,其涂片、培养及恒温扩增法阳性检出率分别为14.70%(750/5 102)、23.72%(1 210/5 102)、22.38%(1 142/5 102),三种检测技术阳性检出率差异有统计学意义(χ~2=149.55,P<0.000 1);以培养结果为标准,恒温扩增法的敏感度为85.45%(1 034/1 210),特异度为97.23%(3 784/3 892),阳性预测值90.54%(1 034/1 142),阴性预测值95.56%(3 784/3 960),总符合率为94.43%(4 818/5 102),Kappa值为0.86。5 102例肺结核可疑症状者中发现40例培阳而恒温扩增法为阴性者,经PNB菌鉴为NTM,与临床诊断复核,为NTM病。结论 恒温扩增法具有快速、安全等优势,并与固体培养结果具有较高的符合率,同时可以快速区分MTB或NTM,适宜基层对肺结核可疑症状者的早期诊断。
Objective To evaluate the efficacy of thermostatic amplification fluorescence(thermostatic amplification) in the clinical detection of tuberculosis.Methods from January 2020 to December 2020,a total of 5168 patients with suspected symptoms of pulmonary tuberculosis were enrolled in 4 prevention and control institutions in Guangdong Province.Sputum samples from all patients were examined by smear microscopy,solid culture,thermostatic amplification,and cultured strains were detected by PNB.Based on the culture results,the sensitivity,specificity,positive predictive value,negative predictive value,total coincidence rate and Kappa value were calculated.The clinical diagnostic information of the included patients was collected and the efficacy of the three detection techniques in the diagnosis of active puimonary tuberculosis was analyzed.Results A total of 5 168 patients with suspected symptoms of pulmonary tuberculosis were included in the analysis,and 66 cases of culture contamination were excluded.The positive rates of smear,culture and thermostatic amplification were 14.70%(750/5 102),23.72%(1 210/5 102) and 22.38%(1 142/5 102),respectively.The positive detection rate of the three detection techniques was statistically significant( χ~2=149.55,P<0.000 1).The sensitivity,specificity,positive predictive value and negative predictive value of thermostatic amplification were 85.45%(1 034/1 210),97.23%(3 783/3 892),90.54%(1 034/1 142) and 95.56%(3 784/3 960) respectively.The total coincidence rate was 94.43%(4 818/5 102),and the Kappa value was 0.86.Among 5 102 patients with suspected symptoms of pulmonary tuberculosis,40 patients were found to be negative by constant temperature amplification,and were identified as NTM disease by PNB bacterial identification and clinical diagnosis.Conclusion Thermostatic amplification has the advantages of fast and safe,and has a high coincidence rate with the results of solid culture.At the same time,it can distinguish MTB and NTM quickly,which is suitable for the early diagnosis of tuberculosis suspicious symptoms in the basic level.
作者
陈燕梅
彭柯皓
陈亮
徐镠粤
温文沛
CHEN Yanmei;PENG Kehao;CHEN Liang;XU Liuyue;WEN Wenpei(Guangdong Tuberculosis Control Center,Guangzhou 510630,China)
出处
《现代医院》
2022年第9期1466-1469,共4页
Modern Hospitals
基金
“十三五”国家科技重大专项课题(2018ZX10715004-003-004)
广东省医学科研基金项目(A2020072)。
关键词
恒温扩增
结核病
诊断技术
Isothermal amplification
Tuberculosis
Diagnosis
