CAJ | 학술논문

目的：比较两种γ-干扰素释放试验（IGRA）检测试剂盒在结核病诊断中的性能，探讨IGRA的临床应用价值。方法采集结核病患者、健康志愿者的外周血，分别用武汉海吉力生物科技有限公司研制的结核杆菌特异性细胞免疫反应检测试剂盒（酶联免疫吸附法）（简称海吉力试剂）和北京万泰生物药业有限公司生产的结核杆菌相关γ-干扰素检测试剂盒（体外酶联免疫法）（简称万泰试剂）进行检测，比较两种检测试剂的诊断性能（配对χ2检验）、一致性（Kappa 检验），并分析其结果。结果共检测结核病患者270例（其中菌阳122例、菌阴148例，老年60例、中青年210例）、健康志愿者161例。海吉力试剂的敏感性为81.5%，特异性为90.1%，万泰试剂的敏感性为79.6%，特异性为88.8%，二者的敏感性或特异性没有统计学差异（P值为0.441或0.845，P＞0.05）。两种检测结果一致率为87.7%，Kappa值为0.752（P＜0.01）。海吉力试剂、万泰试剂对菌阳结核病患者的敏感性为81.1%、78.7%，与对菌阴结核病患者的敏感性81.8%、80.4%比较，差异均没有统计学意义（P＞0.05）；二者对老年结核病患者的敏感性为71.7%、70.0%，与对中青年结核病患者的敏感性84.3%、82.4%比较，差异均有统计学意义（P＜0.05）。结论海吉力试剂与万泰试剂对结核病的诊断性能相当，二者具有较好的一致性。IGRA对菌阴结核病、糖尿病合并结核病、激素治疗结核病患者的应用价值更高，对老年结核病的诊断价值相对较低。
목적：비교량충γ-간우소석방시험（IGRA）검측시제합재결핵병진단중적성능，탐토IGRA적림상응용개치。방법채집결핵병환자、건강지원자적외주혈，분별용무한해길력생물과기유한공사연제적결핵간균특이성세포면역반응검측시제합（매련면역흡부법）（간칭해길력시제）화북경만태생물약업유한공사생산적결핵간균상관γ-간우소검측시제합（체외매련면역법）（간칭만태시제）진행검측，비교량충검측시제적진단성능（배대χ2검험）、일치성（Kappa 검험），병분석기결과。결과공검측결핵병환자270례（기중균양122례、균음148례，노년60례、중청년210례）、건강지원자161례。해길력시제적민감성위81.5%，특이성위90.1%，만태시제적민감성위79.6%，특이성위88.8%，이자적민감성혹특이성몰유통계학차이（P치위0.441혹0.845，P＞0.05）。량충검측결과일치솔위87.7%，Kappa치위0.752（P＜0.01）。해길력시제、만태시제대균양결핵병환자적민감성위81.1%、78.7%，여대균음결핵병환자적민감성81.8%、80.4%비교，차이균몰유통계학의의（P＞0.05）；이자대노년결핵병환자적민감성위71.7%、70.0%，여대중청년결핵병환자적민감성84.3%、82.4%비교，차이균유통계학의의（P＜0.05）。결론해길력시제여만태시제대결핵병적진단성능상당，이자구유교호적일치성。IGRA대균음결핵병、당뇨병합병결핵병、격소치료결핵병환자적응용개치경고，대노년결핵병적진단개치상대교저。
Objective To compare the diagnostic performance of two detection kits for interferon-gamma(IFN-γ) release assay(IGRA) on tuberculosis(TB), discuss the clinical value of IGRA. Methods The serum specimens of 270 TB patients (including 122 bacterial-positive TB patients and 148 bacterial-negative TB patients) and 161 healthy individuals with low risk of exposure were detected by Mycobacterium Tuberculosis Specific Cell Mediated Immune Response Detection Kit(ELISA) (HG-IGRA, Wuhan Hygeianey Bioscience Co. Ltd.) and Diagnostic Kit for Mycobacterium tuberculosis correlative IFN-γ release assay(TB-IGRA, Beijing Wantai Biological Pharmacy Co. Ltd.), respectively. Compare the sensitivity or specificity and evaluate the agreement between the two kits. Results The sensitivity and specificity of HG-IGRA were 81.5% and 90.1%, compared with 79.6%and 88.8%for TB-IGRA. There were no significant differences in sensitivity or specificity (P>0.05). In total 431 patients, the tested agreement between the two kits was 87.7%with a Kappa value of 0.752 (P<0.01). There were no significant differences in sensitivity of HG-IGRA or TB-IGRA between bacterial-positive TB patients and bacterial-negative TB patients(P>0.05). There were significant differences in sensitivity of HG-IGRA or TB-IGRA between elderly TB patients and non-elderly TB patients(P<0.05). Conclusion HG-IGRA and TB-IGRA had the same diagnostic performance on TB, they had good consistency. The clinical value of IGRA was high in the bacterial-negative or low-immunity TB patients, and was low in the elderly TB patients.