结核抗体检测辅助诊断结核病的价值研究

doi:10.3969/j.issn.1000-6621.2018.01.011

摘要/Abstract

摘要：

目的探讨应用结核抗体IgG检测试剂盒辅助诊断结核病的价值。方法选择2013年1月至2016年12月在西安市胸科医院明确诊断为结核病的患者795例(TB组)、非结核分枝杆菌病的患者36例(NTM组),及除外TB与NTM的其他肺部疾患的患者185例(对照组)。回顾性分析所有患者采用结核抗体检测的结果,以临床诊断及结核分枝杆菌培养结果为标准计算结核抗体检测的敏感度、特异度、阳性预测值、阴性预测值等,TB组与NTM组、对照组阳性率的比较采用卡方检验,评价结核抗体检测的应用价值。结果以临床诊断为标准,结核抗体IgG检测的敏感度、特异度、阳性预测值、阴性预测值、漏诊率、误诊率、患病率、准确度、约登指数分别为42.01%(334/795)、82.81%(183/221)、89.78%(334/372)、28.42%(183/644)、57.99%(461/795)、17.19%(38/221)、78.25%(795/1016)、50.89%(517/1016)、0.25;以结核分枝杆菌培养结果为标准,结核抗体检测的敏感度、特异度、阳性预测值、阴性预测值、漏诊率、误诊率、患病率、准确度、约登指数分别为51.12%(160/313)、69.84%(491/703)、43.01%(160/372)、76.24%(491/644)、48.88%(153/313)、30.16%(212/703)、30.81%(313/1016)、64.07%(651/1016)、0.21。TB组、NTM组、菌阳肺结核、菌阴肺结核、结核性脑膜炎、结核性胸膜炎和(或)腹膜炎、结核性心包炎的结核抗体检测的阳性率分别为42.01%(334/795)、61.11%(22/36)、50.00%(80/160)、41.99%(97/231)、46.43%(13/28)、38.76%(138/356)、30.00%(6/20),各类结核病结核抗体检测阳性率差异无统计学意义(χ ²=7.14,P=0.128)。而TB组(42.01%,334/795)、NTM组(61.11%,22/36)、对照组(8.65%,16/185)中以NTM组结核抗体检测阳性率最高,三组差异有统计学意义(χ ²=81.63,P=0.000)。结论应用结核分枝杆菌抗体IgG检测的敏感度、准确度均较低,漏诊率、误诊率均较高,不建议临床继续应用。

关键词: 结核, 肺, 抗原抗体反应, 芯片分析技术, 实验室技术和方法, 评价研究

Abstract:

Objective To explore the value of applying Mycobacterium tuberculosis IgG antibody test kit in the diagnosis of tuberculosis.Methods A total of 795 confirmed patients with tuberculosis diagnosed in Xi’an Chest Hospital from January 2013 to December 2016 were selected as the TB group; 185 patients with other lung diseases (except NTM) were selected as the control group, and 36 patients with non-tuberculosis mycobacteria (NTM) were selected as the NTM group. The sensitivity, specificity, positive predictive value and negative predictive value of TB antibody test kit in all patients were analyzed retrospectively in comparison with the clinical diagnosis and culture of the Mycobacterium tuberculosis as the gold standard. The positive rate of TB group versus NTM and control group was analyzed by chi-square test, and the application value of the method was evaluated.Results Using the clinical diagnosis standard as the standard, the sensitivity, specificity, positive predictive value, negative predictive value, missed diagnosis rate, misdiagnosis rate, prevalence rate, accuracy and Youden index were 42.01% (334/795), 82.81% (183/221), 89.78% (334/372), 28.42% (183/644), 57.99% (461/795), 17.19% (38/221), 78.25% (795/1016), 50.89% (517/1016), 0.25. Using tuberculosis culture results as the reference, the sensitivity, specificity, positive predictive value, negative predictive value, missed diagnosis rate, misdiagnosis rate, prevalence rate, accuracy and Youden index were 51.12% (160/313), 69.84% (491/703), 43.01% (160/372), 76.24% (491/644), 48.88% (153/313), 30.16% (212/703), 30.81% (313/1016), 64.07% (651/1016), 0.21. The positive rate of tuberculosis antibody test kit in the TB group, NTM group, and groups with smear positive pulmonary tuberculosis, smear negative pulmonary tuberculosis, tuberculous meningitis, tuberculous pleurisy/peritonitis, tuberculous pericarditis were 42.01% (33.4/795), 61.11% (22/36), 50.00% (80/160), 41.99% (97/231), 46.43% (13/28), 38.76% (138/356), 30.00% (6/20); no statistically significant difference was found between the positive rate of tuberculosis antibody testing between these different groups (χ ²=7.14, P=0.128). The positive rate of Mycobacterium tuberculosis IgG antibody test in TB group (42.01%,334/795), NTM group (61.11%,22/36) and control group (8.65%,16/185) was statistically different (χ ²=81.63, P=0.000) but the highest rate belonged to the NTM group, which might easily lead to misdiagnosis. Conclusion Because the sensitivity and accuracy of Mycobacterium tuberculosis IgG antibody test kit in detecting tuberculosis antibody are comparatively low, while the missed diagnosis and misdiagnosis rates are comparatively high, it is not recommended for clinical application anymore.

Key words: Tuberculosis, pulmonary, Antigen-antibody reactions, Microchip analytical procedures, Laboratory techniques and procedures, Evaluation studies

黄芳,党丽云. 结核抗体检测辅助诊断结核病的价值研究[J]. 中国防痨杂志, 2018, 40(1): 41-46. doi: 10.3969/j.issn.1000-6621.2018.01.011

Fang HUANG,Li-yun. DANG. Application of tuberculosis antibody tests in the diagnosis of tuberculosis[J]. Chinese Journal of Antituberculosis, 2018, 40(1): 41-46. doi: 10.3969/j.issn.1000-6621.2018.01.011

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结核抗体检测结果	临床诊断(例)		合计 (例)
结核抗体检测结果	TB组	NTM组+对照组	合计 (例)
阳性	334^a	38^b	372
阴性	461^c	183^d	644
合计	795	221	1016

结核抗体检测结果	MTB培养(例)		合计 (例)
结核抗体检测结果	阳性	阴性	合计 (例)
阳性	160^a	212^b	372
阴性	153^c	491^d	644
合计	313	703	1016

实验室评价指标	以临床诊断为标准	以MTB培养为标准	二者差值	χ²值	P值
敏感度(%)	42.01	51.12	-9.11	7.54	0.006
特异度(%)	82.81	69.84	12.97	14.31	0.000
阳性预测值(%)	89.78	43.01	46.77	182.39	0.000
阴性预测值(%)	28.42	76.24	-47.82	295.25	0.000
患病率(%)	78.25	30.81	47.44	461.11	0.000
误诊率(%)	17.19	30.16	-12.97	14.31	0.000
漏诊率(%)	57.99	48.88	9.11	7.54	0.000
准确度(%)	50.89	64.07	-13.18	36.16	0.000
约登指数	0.248	0.210	0.038	-	-