结核感染血清学诊断技术的应用评价
|
摘要
目的评价结核感染T细胞斑点试验和结核抗体在肺结核诊断中的应用价值。方法疑似结核住院患者544例(2015.11-2016.11)的痰标本同时使用T-SPOT.TB试剂盒和2种结核抗体金标试剂进行检测,并做抗酸染色涂片及结核分枝杆菌固体培养。结果根据细菌学诊断和临床诊断标准,菌阳肺结核患者210例,菌阴肺结核患者268例,非结核病患者(对照组)66例。T-SPOT.TB检测菌阳的敏感性为84.28%(177/210),菌阴的敏感性为76.87%(206/268),T-SPOT.TB在菌阳组与菌阴组敏感性差异无统计学意义,P>0.05。TB-DOT和ASSURE TB抗体检测对菌阳肺结核患者检测敏感性分别为64.28%(135/210)和62.85%(132/210),对菌阴肺结核患者检测敏感性44.77%(120/268)和39.55%(106/268),抗体检测在菌阳组与菌阴组敏感性差异有统计学意义,P<0.05;TSPOT.TB与抗体检测方法在诊断结核病敏感性的差异有统计学意义(χ2=77.202和96.618,均P<0.05),尤其对菌阴患者有显著差异。T-SPOT.TB检测特异性为78.79%(52/66),TB-DOT和ASSURE TB特异性分别为77.27%(51/66)和75.76%(50/66),两种方法特异性无统计学差异,P>0.05。结论 T-SPOT.TB试验和结核抗体检测对结核病血清学诊断具有辅助价值;T-SPOT.TB试验对菌阴肺结核的灵敏度优于结核抗体,二者阴性结果有助于排除结核菌感染。
Objective To explore the value of TB antibody and T-SPOT.TB test in tuberculosis diagnosis.Methods544 suspected TB patients(2015.11-2016.11)were taken as research subjects,all subjects conducted TB smear and culture,serological TB-antibody and T-SPOT.TB test.Results According to TB diagnostic guideline,478 cases were defined as TB group(including 210 smear positive pulmonary TB and 268 smear negative pulmonary TB)and 66 cases defined as control group(non-TB patients).The Sensitivity of T-SPOT.TB were 84.28%(177/210)for smear positive pulmonary TB versus 76.87%(206/268)for smear negative pulmonary TB patients,the differences of sensitivity were not statistically significant,P>0.05.The Sensitivity of TB-DOT and ASSURE TB were 64.28%(135/210)and62.85%(132/210)for smear positive pulmonary TB versus 44.77%(120/268)and 39.55%(106/268)for smear negative pulmonary TB patients,the differences of sensitivity were statistically significant,P<0.05.The sensitivity differences between T-SPOT.TB and TB-Ab tests were also statistically significant(χ2=77.202 and 96.618,both P<0.05).The Specificities of T-SPOT.TB,TB-DOT and ASSURE TB were 78.79%(52/66),77.27%(51/66)and75.76%(50/66),respectively.Conclusion Both techniques played certain roles in TB diagnosis;T-SPOT.TB test provided more value on culture-negative TB patients than TB antibody test.
Objective To explore the value of TB antibody and T-SPOT.TB test in tuberculosis diagnosis.Methods544 suspected TB patients(2015.11-2016.11)were taken as research subjects,all subjects conducted TB smear and culture,serological TB-antibody and T-SPOT.TB test.Results According to TB diagnostic guideline,478 cases were defined as TB group(including 210 smear positive pulmonary TB and 268 smear negative pulmonary TB)and 66 cases defined as control group(non-TB patients).The Sensitivity of T-SPOT.TB were 84.28%(177/210)for smear positive pulmonary TB versus 76.87%(206/268)for smear negative pulmonary TB patients,the differences of sensitivity were not statistically significant,P>0.05.The Sensitivity of TB-DOT and ASSURE TB were 64.28%(135/210)and62.85%(132/210)for smear positive pulmonary TB versus 44.77%(120/268)and 39.55%(106/268)for smear negative pulmonary TB patients,the differences of sensitivity were statistically significant,P<0.05.The sensitivity differences between T-SPOT.TB and TB-Ab tests were also statistically significant(χ2=77.202 and 96.618,both P<0.05).The Specificities of T-SPOT.TB,TB-DOT and ASSURE TB were 78.79%(52/66),77.27%(51/66)and75.76%(50/66),respectively.Conclusion Both techniques played certain roles in TB diagnosis;T-SPOT.TB test provided more value on culture-negative TB patients than TB antibody test.
引文
[1]Yotsumoto H.Specific immune-based diagnosis of tuberculosis infection[J].Rinsho Byori,2008,56(11):1026.
[2]刘容枝.结核分枝杆菌抗体检测试剂注册申报资料相关问题探讨[J].中国医疗器械杂志,2016,40(4):279.
[3]中华人民共和国卫生部.WS288-2008肺结核诊断标准[M].北京:人民卫生出版社,2008.
[4]中华医学会结核病学分会.肺结核诊断和治疗指南[J].中华结核和呼吸杂志,2001,24(2):70.
[5]陈灏珠.实用内科学[M].第12版.北京:人民卫生出版社,2005.
[6]刘佳庆,张立,孙海柏,等.r干扰素释放试验在肺结核早期诊断中的应用[J].山东医药,2013,53(3):82.
[7]刘红,黄永杰,王静,等.结核感染T细胞斑点试验在疑似结核病患者诊断中的价值研究[J].中华结核和呼吸杂志,2014,37(3):192.
[8]万荣,李明武,赖明红,等.结核感染T细胞斑点试验在老年肺结核中的诊断价值[J].中国防痨杂志,2015,37(4):348.
[9]Lalvani A,Pareek M.Interferon gamma release assays:principles and practice[J].Enferm Infecc Microbiol Clín,2010,28(4):245.
[10]陶学芳,王华钧,王建华,等.T细胞斑点试验在肺结核诊断和疗效评价中的意义[J].中华临床感染病杂志,2012,5(4):221.
[11]刘毅,张旭霞,张雨晴,等.结核分枝杆菌三种蛋白在结核病血清学诊断中的评价研究[J].中国防痨杂志,2017,39(8):815.
[2]刘容枝.结核分枝杆菌抗体检测试剂注册申报资料相关问题探讨[J].中国医疗器械杂志,2016,40(4):279.
[3]中华人民共和国卫生部.WS288-2008肺结核诊断标准[M].北京:人民卫生出版社,2008.
[4]中华医学会结核病学分会.肺结核诊断和治疗指南[J].中华结核和呼吸杂志,2001,24(2):70.
[5]陈灏珠.实用内科学[M].第12版.北京:人民卫生出版社,2005.
[6]刘佳庆,张立,孙海柏,等.r干扰素释放试验在肺结核早期诊断中的应用[J].山东医药,2013,53(3):82.
[7]刘红,黄永杰,王静,等.结核感染T细胞斑点试验在疑似结核病患者诊断中的价值研究[J].中华结核和呼吸杂志,2014,37(3):192.
[8]万荣,李明武,赖明红,等.结核感染T细胞斑点试验在老年肺结核中的诊断价值[J].中国防痨杂志,2015,37(4):348.
[9]Lalvani A,Pareek M.Interferon gamma release assays:principles and practice[J].Enferm Infecc Microbiol Clín,2010,28(4):245.
[10]陶学芳,王华钧,王建华,等.T细胞斑点试验在肺结核诊断和疗效评价中的意义[J].中华临床感染病杂志,2012,5(4):221.
[11]刘毅,张旭霞,张雨晴,等.结核分枝杆菌三种蛋白在结核病血清学诊断中的评价研究[J].中国防痨杂志,2017,39(8):815.