Analysis of screening effect of recombinant Mycobacterium tuberculosis fusion protein in screening Mycobacterium tuberculosis infection in close contacts of pulmonary tuberculosis patients

doi:10.19982/j.issn.1000-6621.20240137

Chinese Journal of Antituberculosis ›› 2024, Vol. 46 ›› Issue (8): 897-902.doi: 10.19982/j.issn.1000-6621.20240137

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Analysis of screening effect of recombinant Mycobacterium tuberculosis fusion protein in screening Mycobacterium tuberculosis infection in close contacts of pulmonary tuberculosis patients

Xu Chunhua¹, Zhu Shiyu², Hu Yi³, Yi Kehua⁴, Song Canlei⁵, Wang Zichun¹, Wu Yong⁶, Wang Qing¹, Yang Qianru⁷, Shen Xin⁸()

¹Department of Sexually Transmitted Diseases and Tuberculosis Prevention and Control, Fengxian District Center for Disease Control and Prevention, Shanghai 201499,China
²Department of Sexually Transmitted Diseases and Tuberculosis Prevention and Control,Jinshan District Center for Disease Control and Prevention, Shanghai 201599,China
³Department of Epidemiology, School of Public Health, Fudan University, Shanghai 200032,China
⁴Fengxian District Center for Disease Control and Prevention, Shanghai 201499, China
⁵Jinshan District Center for Disease Control and Prevention, Shanghai 201599, China
⁶Department of Preventive Healthcare, Haiwan Community Health Service Center in Fengxian District, Shanghai 201419,China
⁷School of Life Sciences, Fudan University, Shanghai 200032,China
⁸Shanghai Municipal Center for Disease Control and Prevention, Shanghai 200336,China

Received:2024-04-11 Online:2024-08-10 Published:2024-08-01
Contact: Shen Xin E-mail:shenxin@scdc.sh.cn
Supported by:
Three-Year Initiative Plan (2023—2025) for Strengthening Public Health System Construction in Shanghai(GWVI-9);Key Disciplines of Three-Year Initiative Plan (2023—2025) for Strengthening Public Health System Construction in Shanghai(GWVI-11.1-05);Shanghai Oriental Talents Plan Top-notch Project(2023-2025);The Youth Backbone Talent Training Project of Shanghai Center for Disease Control and Prevention(22QNGG18)

Abstract

Abstract:

Objective: To evaluate the accuracy and feasibility of recombinant Mycobacterium tuberculosis fusion protein (EC) skin test in tuberculosis screening among close contacts of pulmonary tuberculosis patients and to provide technical recommendations for improving tuberculosis control,and to understand the status of latent infection of Mycobacterium tuberculosis (LTBI) in close contacts. Methods: A total of 140 close contacts of tuberculosis patients from Fengxian and Jinshan Districts in Shanghai City were selected as the study subjects. Both IGRA and EC skin tests were administered. Kappa test was used to assess the consistency between the results of those two methods, and chi-square test was employed to compare the differences between these two detection methods. A P-value of <0.05 was considered statistically significant. Results: A total of 140 subjects were included in the study, consisting of 55 males and 85 females. The positive rate of IGRA was 15.00% (21/140), while the positive rate of EC skin test was 14.29% (20/140). There was no statistically significant difference between them (χ²=0.029, P=0.866), with a Kappa value of 0.857 (P=0.001), indicating a high degree of consistency. When IGRA was used as the reference standard for tuberculosis infection, EC skin test demonstrated a sensitivity of 85.71% (18/21), a specificity of 98.32% (117/119), a positive predictive value of 90.00% (18/20), and a negative predictive value of 97.50% (117/120). The positive rate of EC in males (32.73%, 18/55) was significantly higher than that in females (2.35%, 2/85), and the difference was statistically significant (χ²=17.983,P<0.001). Conclusion: EC skin test demonstrates high specificity and can be utilized for Mycobacterium tuberculosis infection screening among close contacts of tuberculosis patients. However, due to limitations regarding age range and contraindications for use, implementing a combined screening method of EC and IGRA is advisable.

Key words: Mycobacterium tuberculosis, Contact tracing, Mycobacterium infections, Recombinant Mycobacterium tuberculosis fusion protein

CLC Number:

R521
R184.6

Xu Chunhua, Zhu Shiyu, Hu Yi, Yi Kehua, Song Canlei, Wang Zichun, Wu Yong, Wang Qing, Yang Qianru, Shen Xin. Analysis of screening effect of recombinant Mycobacterium tuberculosis fusion protein in screening Mycobacterium tuberculosis infection in close contacts of pulmonary tuberculosis patients[J]. Chinese Journal of Antituberculosis, 2024, 46(8): 897-902. doi: 10.19982/j.issn.1000-6621.20240137

Figures/Tables 4

References 19

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EC皮肤试验	IGRA检测(名)		敏感度 [%(95%CI)]	特异度 [%(95%CI)]	阳性预测值 [%(95%CI)]	阴性预测值 [%(95%CI)]	一致率 (%)	Kappa值 [%(95%CI)]
EC皮肤试验	阳性	阴性	敏感度 [%(95%CI)]	特异度 [%(95%CI)]	阳性预测值 [%(95%CI)]	阴性预测值 [%(95%CI)]	一致率 (%)	Kappa值 [%(95%CI)]
阳性	18	2	85.71	98.32	90.00	97.50	96.43	0.857
阴性	3	117	(63.66~96.95)	(94.06~99.80)	(68.30~98.77)	(92.87~99.48)		(0.735~0.979)

特征	总人数 (名)	IGRA检测			EC皮肤试验
特征	总人数 (名)	阳性[名,率(%)]	χ²值	P值	阳性[名,率(%)]	χ²值	P值
密切接触者分类型			0.005	0.943		0.061	0.805
学校密切接触者	90	13(14.44)			13(14.44)
家庭密切接触者	50	8(16.00)			7(14.00)
性别			25.160	<0.001		17.983	<0.001
男性	55	17(30.91)			18(32.73)
女性	85	4(4.71)			2(2.35)
年龄组(岁)			2.285	0.515		2.967	0.397
<20	87	10(11.49)			10(11.49)
20~39	11	3(27.27)			3(27.27)
40~59	19	3(15.79)			3(15.79)
≥60	23	5(21.74)			4(17.39)
户籍类型			2.100	0.147		0.504	0.478
上海户籍	70	9(12.86)			7(10.00)
流动人口	70	12(17.14)			13(18.57)

检测方法	检测人数(名)	检测成本(元)	合计费用(元)	阳性(例)	例均费用(元)
EC	140	31.03	4344.20	20	217.21
IGRA	140	300.00^a	42000.00	21	2000.00

Analysis of screening effect of recombinant Mycobacterium tuberculosis fusion protein in screening Mycobacterium tuberculosis infection in close contacts of pulmonary tuberculosis patients

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