Evaluation of two serological tests and T-SPOT.TB method for tuberculosis diagnosis

doi:10.3969/j.issn.1000-6621.2018.01.008

Abstract

Abstract:

Objective To explore the value of tuberculosis antibody (TB-Ab) detection and T-SPOT.TB test in TB diagnosis. Methods Between January 1, 2016 and April 12, 2017 in Beijing Geriatric Hospital, 961 TB patients (defined as TB group; including 364 smear positive pulmonary TB cases (bacteriologically diagnosed) and 597 smear negative pulmonary TB cases (clinically diagnosed)) and 1046 non-TB patients (defined as control group) were included in this study. All subjects conducted serological TB-Ab detection by using TB-DOT (Shanghai Upper Bio-Tech Pharma Co., LTD) and ASSURE TB (MP Biomedicals Asia Pacific Pte Ltd. in Singapore) kits; among them, 574 patients in the TB group and 664 patients in the non-TB control group received both T-SPOT.TB test and TB-Ab detections using the two gold standard reagents. The sensitivity and specificity of those three kinds of laboratory detection techniques or joint detection (including tandem detection and parallel detection) were analyzed.Results The sensitivity and specificity of TB-DOT test were 52.86% (508/961) and 74.95% (784/1046), and those of ASSURE TB test were 45.99% (442/961) and 76.00% (795/1046). The sensitivity of TB-DOT and ASSURE TB were 64.84% (236/364) and 62.09% (226/364) for smear positive pulmonary TB patients versus 45.56% (272/597) and 36.18% (216/597) for smear negative pulmonary TB patients, which indicated that the sensitivity of TB-DOT and ASSURE TB was higher for smear positive patients compared with smear negative ones; the differences were statistically significant (χ²=60.99 and 33.69, all P<0.05). Tandem detection of two TB-Ab detections and T-SPOT.TB showed a sensitivity of 24.04% (138/574) and a high specificity of 89.91% (597/664). The parallel detection had a specificity of 21.23% (141/664) and a high sensitivity of 89.55% (514/574). 24.04% (138/574) patients in the TB group and 10.09% (67/664) patients in the non-TB control group reacted positively in all of the three tests including ASSURE TB, TB-DOT and T-SPOT.TB detection, while 10.45% (60/574) cases in the TB group and 21.23% (141/664) cases in the non-TB control group reacted negatively; the differences were statistically significant (χ²=43.37 and 26.32, all P<0.05).Conclusion Tandem of two TB-Ab detections and T-SPOT.TB test can improve the specificity, whereas parallel detection can improve the sensitivity in TB diagnosis. All positive and all negative profile in all of the three detections has an auxiliary value in serological diagnosis of TB.

Key words: Tuberculosis, Antibodies, Interferon-gamma, Reagent kits, diagnostic, Diagnostic techniques and procedures, Data interpretation, statistical

Jia-wen LIU,Hong-yan. LYU. Evaluation of two serological tests and T-SPOT.TB method for tuberculosis diagnosis[J]. Chinese Journal of Antituberculosis, 2018, 40(1): 26-30. doi: 10.3969/j.issn.1000-6621.2018.01.008

Figures/Tables 3

References 10

[1]	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. 中国医疗器械杂志, 2016,40(4):279-281.
[2]	中华医学会结核病学分会. 肺结核诊断和治疗指南. 中华结核和呼吸杂志, 2001,24(2):70-74. doi: 10.3760/j:issn:1001-0939.2001.02.002 URL
[3]	邵云金 . 金标TB-DOT快速血清诊断试剂盒与痰涂片对结核病的诊断价值. 职业与健康, 2006,22(12):910.
[4]	熊峻峰 . 结核分枝杆菌抗体试验对肺结核血清学诊断的临床意义. 吉林医学, 2013,34(27):5661.
[5]	张燚 . 多种血液检验指标检测对肺结核患者检测的价值评价. 中国保健营养, 2014,24(3):1753. doi: 10.3969/j.issn.1004-7484(x).2014.03.707 URL
[6]	闫世明, 杨家道, 于关成 , 等. 三种结核抗体快速诊断试剂盒对三种常见结核病的诊断价值. 中国防痨杂志, 2001,23(3):174-177. doi: 10.3969/j.issn.1000-6621.2001.03.012 URL
[7]	何建, 向启云, 魏娇 . 结核蛋白芯片、结核分枝杆菌抗体胶体金法诊断试剂盒检测血清抗结核分枝杆菌抗体对肺结核病的诊断价值探讨 . 中国医师进修杂志, 2014, 37增刊: 53-55.
[8]	杨蕾, 卢锦标, 都伟欣 , 等. 结核病诊断中酶联免疫斑点试验检测试剂临床应用的风险评估与控制. 中国防痨杂志, 2017,39(8):894-897. doi: 10.3969/j.issn.1000-6621.2017.08.020 URL
[9]	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. 中国防痨杂志, 2017,39(8):815-820. doi: 10.3969/j.issn.1000-6621.2017.08.006 URL
[10]	蒋纾芳, 张嵘, 冯晓燕 . IgG、IgM、IgA与结核分枝杆菌感染. 生物技术通讯, 2015,26(3):433-435. doi: 10.3969/j.issn.1009-0002.2015.03.030 URL

组别	检测例数	ASSURE TB检测		TB-DOT检测		合计
组别	检测例数	阳性例数	阳性率(%)	阳性例数	阳性率(%)	阳性例数	阳性率(%)
结核病组	961	442	45.99	508	52.86	627	65.24
菌阳肺结核	364	226	62.09	236	64.84	288	79.12
菌阴肺结核	597	216	36.18	272	45.56	339	56.78
对照组	1046	251	24.00	262	25.05	405	38.72

ASSURE TB+TB-DOT+ T-SPOT.TB联合检测谱型	结核病组(574例)		对照组(664例)		χ²值	P值
ASSURE TB+TB-DOT+ T-SPOT.TB联合检测谱型	例数	构成比(%)	例数	构成比(%)	χ²值	P值
阳性+阳性+阳性	138	24.04	67	10.09	43.37	<0.01
阴性+阳性+阳性	100	17.42	88	13.25	4.15	0.042
阳性+阴性+阳性	42	7.32	59	8.89	1.01	0.315
阴性+阴性+阳性	174	30.32	233	35.09	3.18	0.074
阳性+阳性+阴性	26	4.53	24	3.61	0.66	0.414
阳性+阴性+阴性	15	2.61	26	3.92	1.62	0.203
阴性+阳性+阴性	19	3.31	26	3.92	0.32	0.570
阴性+阴性+阴性	60	10.45	141	21.23	26.32	<0.01

检测方法	结核病组(574例)		对照组(664例)		敏感度 (%)	特异度 (%)	阳性预测值(%)	阴性预测值(%)
检测方法	阳性例数	阴性例数	阳性例数	阴性例数	敏感度 (%)	特异度 (%)	阳性预测值(%)	阴性预测值(%)
ASSURE TB	240	334	202	462	41.81	69.58	54.30	58.04
TB-DOT	298	276	231	433	51.92	65.21	56.33	61.07
T-SPOT.TB	454	120	447	217	79.09	32.68	50.39	64.39
ASSURE TB+TB-DOT+T-SPOT.TB串联检测	138	436	67	597	24.04	89.91	67.32	57.79
ASSURE TB+TB-DOT+T-SPOT.TB并联检测	514	60	523	141	89.55	21.23	49.57	70.15

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