Effect of chronic non-immune system diseases on the sensitivity of interferon-γ release assay for the detection of tuberculosis infection

doi:10.19982/j.issn.1000-6621.20250286

Abstract

Abstract:

Objective: To investigate the effect of chronic non-immune system diseases on the sensitivity of interferon-gamma release assay (IGRA) for detection of tuberculosis (TB) infection. Methods: A retrospective study was conducted. Electronic medical records of inpatients at the Second Hospital of Hebei Medical University from January to October 2024 were collected. A total of 3057 inpatients with complete clinical data were selected, following an approximate 1∶1 ratio of IGRA-positive to IGRA-negative cases. The data included clinical diagnosis of TB or chronic non-immunological diseases, IGRA results, and spot-forming cell counts, as well as age and gender data closely related to the above diseases. After excluding 125 patients with active TB and 98 with a history of TB, 2834 patients were included to analyze the effect of chronic non-immune diseases on the sensitivity of IGRA for detection of TB infection. Results: Among the 2834 patients without definitive evidence of TB infection, 1534 (54.13%) were male and 1300 (45.87%) were female, with an age range of 4 months to 98 years (median (IQR): 57.0 (37.0, 68.0) years). There were 1300 (45.87%) IGRA-positive and 1534 (54.13%) IGRA-negative cases. Patients with comorbidities included anemia (531, 18.74%), hypoalbuminemia (591, 20.85%), diabetes (541, 19.09%), hypertension (965, 34.05%), hepatitis B (96, 3.39%), and tumors (709, 25.02%). Among tumor cases, 393 (55.43%) were malignant tumors, 78 (11.00%) were suspected malignancies, and 238 were (33.57%) benign tumors. Multivariate logistic regression analysis showed that, compared to females, non-diabetics, and the 0-9 years age group, the risk of a positive IGRA was significantly increased in males, patients with diabetes, and those in the 10-19, 20-49, and 50-98 years age groups (OR (95%CI): 1.773 (1.507-2.085), 1.453 (1.183-1.785), 3.405 (1.143-10.142), 22.070 (8.027-60.678), and 45.822 (16.732-125.486), respectively). Conversely, patients with anemia had a decreased likelihood of a positive IGRA compared to non-anemic patients (OR (95%CI)=0.591 (0.477-0.732)). Conclusion: Anemia may lead to the false-negative results of the IGRA test, whereas diabetes mellitus may lead to the false positivity or increased TB infection. These findings suggest that IGRA results should be interpreted cautiously in patients with these comorbidities to avoid misdiagnosis.

Key words: Tuberculosis infection, Interferon-gamma, Immunologic tests, Chronic disease, Comorbidities

CLC Number:

Liu Zengbin, Liu Jiajia, Wu Yaning, Wang Yafei, Xu Da, Huang Misun, Zhang Jingrui, Li Machao, Li Xiaoyi, Li Guilian, Wei Huiqiang. Effect of chronic non-immune system diseases on the sensitivity of interferon-γ release assay for the detection of tuberculosis infection[J]. Chinese Journal of Antituberculosis, 2025, 47(11): 1481-1488. doi: 10.19982/j.issn.1000-6621.20250286

Figures/Tables 4

因素	β值	s $x ˉ$ 值	Z值	P值	OR(95%CI)值
性别
女性			参考	参考
男性	0.573	0.083	47.849	<0.001	1.773(1.507~2.085)
年龄组(岁)
0~9			参考	参考
10~19	1.225	0.557	4.840	0.028	3.405(1.143~10.142)
20~49	3.094	0.516	35.956	<0.001	22.070(8.027~60.678)
50~98	3.825	0.514	55.370	<0.001	45.822(16.732~125.486)
贫血
是	-0.526	0.110	23.100	<0.001	0.591(0.477~0.732)
否			参考	参考
高血压
是	-0.067	0.089	0.572	0.450	0.935(0.786~1.113)
否			参考	参考
低蛋白血症
是	0.000	0.104	0.000	0.999	1.000(0.816~1.226)
否			参考	参考
糖尿病
是	0.374	0.105	12.671	<0.001	1.453(1.183~1.785)
否			参考	参考
肿瘤
恶性肿瘤	-0.191	0.117	2.670	0.102	0.826(0.656~1.039)
疑似恶性肿瘤	0.473	0.246	3.711	0.054	1.606(0.992~2.599)
良性肿瘤	0.169	0.145	1.364	0.243	1.184(0.892~1.574)
非肿瘤			参考	参考

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特征	IGRA		合计 (2834例)	χ²值	P值
特征	阳性(1300例)	阴性(1534例)	合计 (2834例)	χ²值	P值
性别				52.014	<0.001
男性	799(52.09)	735(47.91)	1534(54.13)
女性	501(38.54)	799(61.46)	1300(45.87)
年龄组(岁)				302.932	<0.001
0~9	4(3.25)	119(96.75)	123(4.34)
10~19	22(9.73)	204(90.27)	226(7.97)
20~49	273(37.97)	446(62.03)	719(25.37)
50~98	1001(56.68)	765(43.32)	1766(2.32)

因素	合计 (例)	IGRA[例数(构成比,%)]		χ²值	P值
因素	合计 (例)	阳性(1300例)	阴性(1534例)	χ²值	P值
贫血				15.468	<0.001
是	531	203(38.23)	328(61.77)
否	2303	1097(47.63)	1206(52.37)
乙型病毒性肝炎				2.166	0.097
是	96	52(54.17)	44(45.83)
否	2738	1248(45.58)	1490(54.42)
高血压				20.807	<0.001
是	965	500(51.81)	465(48.19)
否	1869	800(42.80)	1069(57.20)
低蛋白血症				5.338	0.021
是	591	296(50.08)	295(49.92)
否	2243	1004(44.76)	1239(55.24)
糖尿病				18.495	<0.001
是	541	293(54.16)	248(45.84)
否	2293	1007(43.92)	1286(56.08)
肿瘤				17.081	<0.001
恶性肿瘤	393	190(48.35)	203(51.65)
疑似恶性肿瘤	78	49(62.82)	29(37.18)
良性肿瘤	238	125(44.05)	113(55.95)
无肿瘤	2125	936(45.87)	1189(54.13)

因素	例数			斑点个数[中位数(四分位数)]	Z值	P值
贫血					1.256	0.209
是	203			28.0(11.0,56.0)
否	1097			29.0(12.0,76.0)
低蛋白血症					0.755	0.451
是	296			28.0(11.0,66.0)
否	1004			29.0(12.0,75.0)
糖尿病					1.776	0.076
是	293			31.0(12.0,86.0)
否	1007			28.0(11.0,69.0)
高血压					0.163	0.870
是	500			29.0(11.3,77.0)
否	800			28.5(12.0,71.0)
乙型病毒性肝炎					1.642	0.101
是	58			45.0(13.0,83.0)
否	1242			28.0(11.8,72.0)
肿瘤					4.174	0.244
恶性肿瘤		190	26.0(10.0,56.5)
疑似恶性肿瘤		49	33.0(12.5,62.5)
良性肿瘤		125	35.0(14.0,66.5)
非肿瘤		936	28.0(11.0,78.0)