广西结核病重点人群主动筛查痰样本半巢式全自动实时荧光定量PCR单检和混检效果分析  

Analysis on the effect of GeneXpert MTB/RIF single test and mixed test on sputum samples for actively screening tuberculosis in key population of Guangxi

作　　者：覃慧芳[1] 梁小烟 周凌云[1] 蓝宇梅 林玫[1] 张智童 黄彦[1] 魏晓林 梁大斌[1] Qin Huifang;Liang Xiaoyan;Zhou Lingyun;Lan Yumei;Lin Mei;Zhang Zhitong;Huang Yan;Wei Xiaolin;Liang Dabin(Tuberculosis Prevention and Control Institute,Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention/Guangxi Key Laboratory of Major Infectious Disease Prevention and Control and Biosafety Emergency Response/Key Laboratory of Tuberculosis Prevention and Control Technology of Guangxi Health Commission,Nanning 530028;China 2Department of Clinical Laboratory,the People’s Hospital of Laibin,Xincheng County in Guangxi,Laibin 546299;China 3Dalla Lana School of Public Health,University of Toronto,Toronto M5S2E8,Canada)

机构地区：[1]广西壮族自治区疾病预防控制中心结核病防制所/广西重大传染病防控及生物安全应急响应重点实验室/广西卫生健康委员会结核病防控关键技术重点实验室,南宁530028 [2]广西来宾市忻城县人民医院检验科,来宾546299 [3]加拿大多伦多大学达拉拉纳公共卫生学院,多伦多M5S 2E8

出　　处：《中国防痨杂志》2023年第9期880-884,共5页Chinese Journal of Antituberculosis

基　　金：广西壮族自治区卫生健康委员会科研项目(Z-A20220360);广西壮族自治区医疗卫生重点学科建设项目(2022-06-21)。

摘　　要：目的:通过比较痰样本半巢式全自动实时荧光定量PCR(GeneXpert MTB/RIF,Xpert)单检与混检的检测效果,为广西壮族自治区(简称“广西”)结核病重点人群主动筛查工作寻找更有效的病原学检测方案。方法:收集2021年11月20日至2022年3月31日广西来宾市忻城县重点人群结核病筛查对象的痰样本共205份,使用Xpert对收集到的痰样本同时进行单检和五合一混检。对两种方法的阳性检出率、耐药率、失败率、Ct值,以及检测时间和试剂使用情况进行比较分析。结果:单检阳性率为9.76%(20/205),混检阳性率为43.90%(18/41);单检失败率为1.95%(4/205),混检失败率为7.32%(3/41),差异无统计学意义(χ^(2)=1.882,P=0.170);混检5种分子探针(Probe A、B、C、D、E)Ct值(24.95±4.01、25.06±3.38、25.07±3.54、25.81±3.87和26.25±4.72)高于单检(24.47±4.33、24.82±3.90、24.75±4.09、25.50±4.32和25.75±4.67),5种分子探针混检和单检Ct值比较差异均无统计学意义(tA=-0.717,PA=0.482;tB=-0.396,PB=0.696;tC=-0.506,PC=0.619;tD=-0.495,PD=0.626;tE=-0.748,PE=0.464);混检+单检组合检测方案的检测时间和试剂使用量比仅用单检减少了31.70%(42/132.5)和35.89%(75/209)。结论:在大规模结核病重点人群主动筛查痰样本检测中,混合标本检测阳性后再从中确认阳性标本可以有效减少检测成本和时间。Objective:To find a more effective etiological detection scheme for actively screening tuberculosis(TB)among key populations in Guangxi Zhuang Autonomous Region(Guangxi)by comparing the results of single and mixed detection of GeneXpert MTB/RIF(Xpert)on sputum samples.Methods:A total of 205 sputum samples of TB key population screening subjects in Xincheng County,Laibin City,Guangxi were collected from November 20,2021 to March 31,2022.Xpert was used to conduct single test and mixed test(five samples mixed into one sample)on the collected sputum samples.The positive detection rate,drug resistance rate,failure rate,Ct values,detection time and reagent consumption of the two methods were compared.Results:The positive rate of single test was 9.76%(20/205),and the positive rate of mixed test was 43.90%(18/41).Single test failure rate was 1.95%(4/205),mixed test failure rate was 7.32%(3/41),the difference was not statistically significant(χ^(2)=1.882,P=0.170).The average Ct values of the five molecular probes(Probe A,B,C,D,E)about mixed test were 24.95±4.01,25.06±3.38,25.07±3.54,25.81±3.87 and 26.25±4.72,higher than those of single test(24.47±4.33,24.82±3.90,24.75±4.09,25.50±4.32,and 25.75±4.67),there were no significant difference in Ct values between the mixed and single test of the five molecular probes(tA=-0.717,PA=0.482;tB=-0.396,PB=0.696;tC=-0.506,PC=0.619;tD=-0.495,PD=0.626;tE=-0.748,PE=0.464).The detection time and reagent consumption of mixed test followed by single test were reduced by 31.70%(42/132.5)and 35.89%(75/209)compared with single test only.Conclusion:For conducting large-scale sputum screening among key TB population,it can effectively reduce the cost and time of detection by performing mixed sample test first and then conducting single test on each of the samples of positive mixed samples.

关 键 词：分枝杆菌 结核 痰 分子生物学 

分 类 号：R18[医药卫生—流行病学] R52[医药卫生—公共卫生与预防医学]