Evaluation of the diagnostic efficacy of AIMTB-fluorescent immunochromatography for screening latent tuberculosis infection

doi:10.19982/j.issn.1000-6621.20250300

Abstract

Abstract:

Objective: To evaluate the diagnostic performance of the AIMTB-fluorescent immunoassay ( AIMTB-FIA) for screening latent tuberculosis infection (LTBI) in different populations. Methods: A cross-sectional study was conducted. Participants were enrolled according to inclusion criteria from a welfare institution in Zhenjiang City and community healthcare workers in Yancheng City, Jiangsu Province, in March-Apirl, 2025. QuantiFERON-TB Gold Plus (QFT-Plus) assay was used as the reference standard. Consistency and diagnostic efficacy of AIMTB-FIA relative to QFT-Plus were assessed by calculating the Kappa coefficient, overall agreement rate, and the area under the receiver operating characteristic curve (AUC). Subgroup analyses were further performed to compare the diagnostic performance of AIMTB-FIA across different population sources (welfare institution residents vs. community healthcare workers) and age groups (≥65 years vs. <65 years). Results: A total of 396 participants were enrolled, including 239 from welfare institution and 157 community healthcare workers. The positivity rate of QFT-Plus was 11.62% (46/396), while that of AIMTB-FIA was 17.93% (71/396). Using QFT-Plus as the reference standard, the AIMTB-FIA demonstrated a sensitivity of 97.80% (45/46), specificity of 92.60% (324/350), overall agreement rate of 93.20%, Kappa value of 0.731, and an AUC of 0.988. Subgroup analyses revealed that the Kappa values ranged from 0.628 to 0.879, and AUCs ranged from 0.977 to 0.992 across different populations and age groups, indicating consistently robust diagnostic performance. Spearman’s correlation analysis showed a moderate positive correlations between the T-N values of the AIMTB-FIA and the interferon-gamma (IFN-γ) levels of TB1-Nil and TB2-Nil of the QFT-Plus assay (r=0.631, 0.638; Ps<0.001). Conclusion: As an optimized interferon-gamma release assay, AIMTB-FIA exhibits high concordance with QFT-Plus, with advantages of simplified operation and reduced detection time. It has potential as a reliable alternative for LTBI screening in primary healthcare settings.

Key words: Mycobacterium infections, Fluoroimmunoassay, Interferon-gamma, Diagnostic techniques and procedures, Evaluation studies

CLC Number:

R521
R446

Zhou Cang, Li Guoli, Jiang Hui, Shao Yan, Song Honghuan, Xue Hao, Ning Jingxian, Pan Yuchen, Fei Xinru, Sun Zheng, Chen Cheng, Zhu Limei, Liu Qiao. Evaluation of the diagnostic efficacy of AIMTB-fluorescent immunochromatography for screening latent tuberculosis infection[J]. Chinese Journal of Antituberculosis, 2026, 48(2): 289-298. doi: 10.19982/j.issn.1000-6621.20250300

Figures/Tables 8

References 31

[1]	虞浩, 竺丽梅. 江苏省2012—2022年结核病防治进展及展望. 江苏预防医学, 2023, 34(3): 302-304. doi:10.13668/j.issn.1006-9070.2023.03.016.
[2]	World Health Organization. WHO consolidated guidelines on tuberculosis: module 1: prevention: tuberculosis preventive treatment. Geneva: World Health Organization, 2020.
[3]	陈诚, 刘炯雅, 孙郑, 等. 结核病防控进展. 中华疾病控制杂志, 2025, 29(4): 373-377. doi:10.16462/j.cnki.zhjbkz.2025.04.001.
[4]	刘巧, 李忠奇, 竺丽梅, 等. 中国结核病防治服务体系运行现状、问题与对策研究. 中国防痨杂志, 2025, 47(5): 559-568. doi:10.19982/j.issn.1000-6621.20240544.
[5]	Gong W, Wu X. Differential Diagnosis of Latent Tuberculosis Infection and Active Tuberculosis: A Key to a Successful Tuberculosis Control Strategy. Front Microbiol, 2021, 12:745592. doi:10.3389/fmicb.2021.745592.
[6]	Carranza C, Pedraza-Sanchez S, de Oyarzabal-Mendez E, et al. Diagnosis for Latent Tuberculosis Infection: New Alternatives. Front Immunol, 2020, 11:2006. doi:10.3389/fimmu.2020.02006.
[7]	Mwaba P, Chakaya JM, Petersen E, et al. Advancing new diagnostic tests for latent tuberculosis infection due to multidrug-resistant strains of Mycobacterium tuberculosis-End of the road?. Int J Infect Dis, 2020, 92S:S69-S71. doi:10.1016/j.ijid.2020.02.011. pmid: 32119979
[8]	高妍, 万珈旭, 樊昌林, 等. 结核病γ干扰素释放试验刺激抗原研究进展. 动物医学进展, 2024, 45(9): 88-94. doi:10.3969/j.issn.1007-5038.2024.09.016.
[9]	Kadkhoda K, Dee M, Simeone J. Comparison of LIAISON QuantiFERON-TB Gold Plus with QuantiFERON-TB Gold Plus. Microbiol Spectr, 2023, 11(1):e0475422. doi:10.1128/spectrum.04754-22.
[10]	Al Abri S, Kowada A, Yaqoubi F, et al. Cost-effectiveness of IGRA/QFT-Plus for TB screening of migrants in Oman. Int J Infect Dis, 2020, 92S:S72-S77. doi:10.1016/j.ijid.2020.03.010. pmid: 32171953
[11]	Yoopetch P, Wu O, Jittikoon J, et al. Economic evaluation of diagnosis and treatment for latent tuberculosis infection among contacts of pulmonary tuberculosis patients in Thailand. Sci Rep, 2024, 14(1):17693. doi:10.1038/s41598-024-68452-1. pmid: 39085338
[12]	Cao X, Chen Y, Xin H, et al. The performance of a new rapid interferon gamma release assay based on fluorescence immunochromatography for Mycobacterium tuberculosis infection testing in village doctors in China. Epidemiol Infect, 2024, 152:e155. doi:10.1017/S0950268824001146.
[13]	Rudeeaneksin J, Srisungngam S, Klayut W, et al. Quanti-FERON-TB Gold Plus and QuantiFERON-TB Gold In-tube assays for detecting latent tuberculosis infection in Thai healthcare workers. Rev Inst Med Trop Sao Paulo, 2023, 65:e13. doi:10.1590/S1678-9946202365013.
[14]	Rickman HM, Phiri MD, Mbale H, et al. Low concordance between QIAreach QuantiFERON-TB, a novel interferon-gamma release assay, and QuantiFERON-TB Gold Plus, in a population-based survey in Blantyre, Malawi. J Clin Microbiol, 2025, 63(1):e0132324. doi:10.1128/jcm.01323-24.
[15]	辛赫男, 高磊. 《世界卫生组织结核病整合指南模块3:诊断——结核感染检测》解读. 中国防痨杂志, 2023, 45(7): 639-643. doi:10.19982/j.issn.1000-6621.20230128.
[16]	张爽, 赵弘, 杨美霞. 结核潜伏感染检测方法的研究进展. 上海预防医学, 2025, 37(1): 94-99. doi:10.19428/j.cnki.sjpm.2025.24611.
[17]	Jonas DE, Riley SR, Lee LC, et al. Screening for Latent Tuberculosis Infection in Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA, 2023, 329(17):1495-1509. doi:10.1001/jama.2023.3954. pmid: 37129650
[18]	许晶晶, 卢鹏, 薛浩, 等. 盐城市大丰区高一新生结核潜伏感染筛查及影响因素分析. 华南预防医学, 2024, 50 (5): 420-423. doi:10.12183/j.scjpm.2024.0420.
[19]	王慧, 李锦成, 陆兴, 等. 重组结核杆菌融合蛋白皮肤试验筛查HIV/AIDS病例结核分枝杆菌潜伏感染的效果分析. 预防医学, 2024, 36(7): 639-643. doi:10.19485/j.cnki.issn2096-5087.2024.07.021.
[20]	高磊, 张慧, 胡茂桂, 等. 基于多中心调查数据和空间统计模型的全国结核分枝杆菌潜伏感染率估算. 中国防痨杂志, 2022, 44 (1): 54-59. doi:10.19982/j.issn.1000-6621.20210661.
[21]	中国医学科学院病原生物学研究所, 中国疾病预防控制中心, 中国科学院地理科学与资源研究所. 全国结核分枝杆菌潜伏感染率估算专家共识. 中国防痨杂志, 2022, 44(1): 4-8. doi:10.19982/j.issn.1000-6621.20210662.
[22]	Banaei N, Gaur RL, Pai M. Interferon Gamma Release Assays for Latent Tuberculosis: What Are the Sources of Variability?. J Clin Microbiol, 2016, 54(4):845-850. doi:10.1128/JCM.02803-15. pmid: 26763969
[23]	Zellweger JP, Sotgiu G, Corradi M, et al. The diagnosis of latent tuberculosis infection (LTBI): currently available tests, future developments, and perspectives to eliminate tuberculosis (TB). Med Lav, 2020, 111(3):170-183. doi:10.23749/mdl.v111i3.9983. pmid: 32624559
[24]	吴绣岑, 陈贵华. 2023年美国预防医学服务工作组《成人结核分枝杆菌潜伏感染筛查》解读. 结核与肺部疾病杂志, 2024, 5(5): 398-403. doi:10.19983/j.issn.2096-8493.2024105.
[25]	Hopewell P, Hill PC, Brookes RH, et al. Serial testing for tuberculosis can we make sense of T cell assay conversions and reversions. PLoS Med, 2007, 4(6):e208. doi:10.1371/journal.pmed.0040208.
[26]	Diel R, Schablon A, Nienhaus A, et al. Occupational Screening for Tuberculosis and the Use of a Borderline Zone for Interpretation of the IGRA in German Healthcare Workers. PLoS One, 2014, 9(12):e115322. doi:10.1371/journal.pone.0142541.
[27]	周崇兴, 梁大斌, 黄彦, 等. 三种结核潜伏感染试验在HIV感染人群中的应用评价. 中国现代医生, 2023, 61(16): 23-26. doi:10.3969/j.issn.1673-9701.2023.16.006.
[28]	刘艳, 张红, 麦美拉·艾赛提, 等. 四种国产试剂盒在结核分枝杆菌感染早期诊断中的应用评价. 中华医院感染学杂志, 2024, 34(24): 3707-3710. doi:10.11816/cn.ni.2024-240387.
[29]	中华医学会结核病学分会, 《中华结核和呼吸杂志》编辑委员会. γ-干扰素释放试验在中国应用的建议. 中华结核和呼吸杂志, 2014, 37(10): 744-747. doi:10.3760/cma.j.issn.1001-0939.2014.10.011.
[30]	Liu Z, Liang Q, Ren Y, et al. Immunosenescence: molecular mechanisms and diseases. Signal Transduct Target Ther, 2023, 8(1): 200. doi:10.1038/s41392-023-01451-2.
[31]	姚寒砺, 刘巧, 陈诚, 等. 2005—2023年江苏省≥65岁老年人群结核病发病趋势Joinpoint回归分析. 江苏预防医学, 2025, 36(2): 152-155, 205. doi:10.13668/j.issn.1006-9070.2025.02.005.

QFT-Plus					AIMTB-FIA
Nil (IU/ml)	TB1-Nil (IU/ml)	TB2-Nil (IU/ml)	Mitogen-Nil (IU/ml)	结果	N (IU/ml)	T-N-U (IU/ml)	P-N (IU/ml)	结果
	≥0.35且≥25%Nil值	任何值	任何值	阳性		≥0.4且≥25%N	任何值	阳性
≤8.0	任何值	≥0.35且≥25%Nil值			≤20	≥0.4且<25%N	≥0.5	阴性
	<0.35或≥0.35且 <25%Nil	<0.35或≥0.35且 <25%Nil	≥0.5	阴性		<0.4	≥0.5	阴性

特征	合计(例)	LTBI组(46例)	非LTBI组(350名)	统计检验值	P值
年龄	396	55.0(43.5,63.0)	48.0(30.0,59.0)	Z=-2.665	0.008
性别				χ²=11.419	<0.001
男性	183	32(69.57)	151(43.14)
女性	213	14(30.43)	199(56.86)
人群来源				χ²=1.455	0.228
福利院人员	239	24(52.17)	215(61.43)
社区医务工作者	157	22(47.83)	135(38.57)
体质量指数(kg/m²)				χ²=2.391	0.303
<18.5	66	4(8.70)	62(17.71)
18.5~<24.0	183	23(50.00)	160(45.71)
≥24.0	147	19(41.30)	128(36.57)
合并高血压				χ²=0.520	0.471
否	333	37(80.43)	296(84.57)
是	63	9(19.57)	54(15.43)
合并糖尿病				-	0.031
否	357	37(80.43)	320(91.43)
是	39	9(19.67)	30(8.57)
合并其他基础疾病				χ²=0.022	0.882
否	324	38(82.61)	286(81.71)
是	72	8(17.39)	64(18.29)
吸烟史				-	<0.001
无吸烟史	335	33(71.74)	322(92.00)
目前吸烟	35	10(21.74)	25(7.14)
有吸烟史已戒烟	6	3(6.52)	3(0.86)
饮酒史				-	0.011
无饮酒史	375	39(84.78)	336(96.00)
目前仍饮酒	17	6(13.04)	11(3.14)
有饮酒史已戒酒	4	1(2.17)	3(0.86)

AIMTB-FIA	QFT-Plus(例)		合计 (例)	敏感度 (%)	特异度 (%)	阳性预测值(%)	阴性预测值(%)	一致率 (%)	Kappa值
AIMTB-FIA	阳性	阴性	合计 (例)	敏感度 (%)	特异度 (%)	阳性预测值(%)	阴性预测值(%)	一致率 (%)	Kappa值
所有人员				97.80	92.60	63.38	99.69	93.20	0.731
阳性	45	26	71
阴性	1	324	325
合计	46	350	396
福利院人员				95.85	90.20	52.27	99.49	90.79	0.628
阳性	23	21	44
阴性	1	194	195
合计	24	215	239
社区医务工作者				100.00	96.30	81.48	100.00	96.82	0.879
阳性	22	5	27
阴性	0	130	130
合计	22	135	157
65岁以下				100.00	92.81	62.07	100.00	93.57	0.731
阳性	36	22	58
阴性	0	284	284
合计	36	306	342
65岁及以上				90.00	90.91	69.23	97.56	90.74	0.725
阳性	9	4	13
阴性	1	40	41
合计	10	44	54

IFN-γ水平	合计	非LTBI组	LTBI组	Z值	P值
TB1-Nil	0.00(-0.01,0.03)	0.00(-0.01,0.01)	0.88(0.49,3.30)	121.086	<0.001
TB2-Nil	0.00(-0.01,0.02)	0.00(-0.01,0.01)	0.96(0.47,3.30)	121.970	<0.001
T-N	0.03(0.00,0.12)	0.02(0.00,0.06)	1.99(1.10,7.09)	120.269	<0.001
Z值^a	2.671	2.903	-0.622
P值	1.000	1.000	1.000
Z值^b	-238.976	-268.343	-24.544
P值	<0.001	<0.001	0.009
Z值^c	-236.305	-265.440	-23.922
P值	<0.001	<0.001	0.011

组别/指标	社区医务工作者	福利院人员	Z值	P值	65岁以下	65岁及以上	Z值	P值
非LTBI组
TB1-Nil	0.00(-0.01,0.01)	0.00(-0.01,0.01)	-0.901	0.368	0.00(-0.01,0.01)	0.01(0.00,0.05)	-2.980	0.003
TB2-Nil	0.00(-0.01,0.01)	0.00(-0.01,0.01)	-1.619	0.106	0.00(-0.01,0.01)	0.01(0.00,0.04)	-3.032	0.002
T-N	0.11(0.00,0.05)	0.32(0.00,0.07)	-3.189	0.001	0.02(0.00,0.06)	0.06(0.01,0.19)	-3.007	0.003
LTBI组
TB1-Nil	1.61(0.71,5.46)	0.62(0.43,2.86)	-1.794	0.073	1.09(0.49,3.68)	0.60(0.38,2.10)	0.173	0.181
TB2-Nil	1.54(0.72,4.59)	0.67(0.36,3.01)	-1.737	0.082	1.31(0.53,4.22)	0.62(0.35,2.25)	0.119	0.123
T-N	2.06(1.05,7.58)	1.99(1.13,6.47)	0.000	1.000	2.00(1.19,7.71)	1.38(0.74,4.23)	0.112	0.116