The performance of interferon gamma-induced protein 10 mRNA detection technology in auxiliary diagnosis of tuberculosis

doi:10.19982/j.issn.1000-6621.20220518

Abstract

Abstract:

Objective: To evaluate the performance of the interferon gamma-induced-protein 10 (IP-10) assay (IP-10.TB) in auxiliary diagnosis of tuberculosis (TB), and analyze the concordance between IP-10.TB assay and the whole blood interferon gamma release assay (QFT-GIT). Methods: Suspected TB patients were prospectively and consecutively recruited in Beijing Chest Hospital, Capital Medical University between November 2021 and July 2022. According to the clinical manifestations, routine biochemical examinations, histopathological, radiological and (or) etiological examinations, a total of 158 cases with conclusive diagnosis were finally included, and the subjects were divided into definite TB group (88 cases), clinically diagnosed TB group (29 cases) and non-TB group (41 cases). IP-10.TB and QFT-GIT assays were simultaneously performed on peripheral blood samples. The diagnostic performance of IP-10.TB and QFT-GIT were analyzed using the receiver operating characteristic curve. Accordance of IP-10.TB and QFT-GIT was analyzed by Cohen’s Kappa test. Results: Among the 158 participants, there were 7 cases (4.4%) with indeterminate results of IP-10.TB and 5 cases (3.2%) with indeterminate results of QFT-GIT, respectively. No significant difference was detected in the ratio of indeterminate results between IP-10.TB assay and QFT-GIT (χ²=0.346, P=0.556). The total sensitivity and specificity of IP-10.TB assay were 96.3% (95%CI: 90.1%-98.8%) and 64.1% (95%CI:47.2%-78.3%), respectively; while the total sensitivity and specificity of QFT-GIT assay were 97.2% (95%CI: 91.4%-99.3%) and 64.1% (95%CI: 47.2%-78.3%), respectively. The total concordance rate of these two methods was 92.5% (95%CI: 88.2%-96.8%), the positive concordance rate was 95.0% (95%CI: 91.0%-98.9%) and the negative concordance rate was 82.1% (95%CI: 68.0%-96.3%). The Cohen’s Kappa value was 0.760 (95%CI: 0.624-0.895, P<0.001) between IP-10.TB and QFT-GIT assays. Conclusion: These results showed that the performance of IP-10.TB was consistent with that of QFT-GIT for auxiliary diagnosis of TB.

Key words: Tuberculosis, Interferons, Interferon inducers, Diagnosis, differentiation, Comparative study

CLC Number:

R52
R825.2

Song Ruixue, Wei Rongrong, Dong Jing, Jia Hongyan, Du Boping, Sun Qi, Xing Aiying, Li Zihui, Zhu Chuanzhi, Zhang Zongde, Pan Liping. The performance of interferon gamma-induced protein 10 mRNA detection technology in auxiliary diagnosis of tuberculosis[J]. Chinese Journal of Antituberculosis, 2023, 45(5): 471-476. doi: 10.19982/j.issn.1000-6621.20220518

Figures/Tables 3

References 19

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特征	确诊结核病组(88例)	临床诊断结核病组(29例)	非结核病组(41例)
年龄[岁,M(Q₁,Q₃)]	45(32,58)	37(29,56)	56(44,67)
性别[例(构成比,%)]
男性	64(72.7)	14(48.3)	24(58.5)
女性	24(27.3)	15(51.7)	17(41.5)
肺结核[例(构成比,%)]	85(96.6)	24(82.8)	-
肺外结核[例(构成比,%)]	3(3.4)	5(17.2)	-
骨关节结核	1(1.1)	1(3.4)	-
淋巴结结核	-	2(7.0)	-
泌尿生殖系统结核	1(1.1)	-	-
结核性脑膜炎	-	1(3.4)	-
支气管结核	1(1.1)	-	-
肠结核	-	1(3.4)	-
其他疾病[例(构成比,%)]
肺癌	-	-	13(31.7)
肺炎	-	-	22(53.7)
非结核分枝杆菌肺病	-	-	4(9.8)
其他	-	-	2(4.8)

检测技术	综合诊断(例)		敏感度 [%(95%CI)]	特异度 [%(95%CI)]	阴性预测值 [%(95%CI)]	阳性预测值 [%(95%CI)]	阴性似然比 (95%CI)	阳性似然比 (95%CI)
检测技术	结核病组 (107例)	非结核病组(39例)	敏感度 [%(95%CI)]	特异度 [%(95%CI)]	阴性预测值 [%(95%CI)]	阳性预测值 [%(95%CI)]	阴性似然比 (95%CI)	阳性似然比 (95%CI)
IP-10.TB			96.3(90.1~ 98.8)	64.1(47.2~ 78.3)	86.2(67.4~ 95.5)	88.0(80.4~ 93.1)	0.058(0.022~ 0.157)	2.682(1.760~ 4.086)
阳性	103	14
阴性	4	25
QFT-GIT			97.2(91.4~ 99.3)	64.1(47.2~ 78.3)	89.3(70.6~ 97.2)	88.1(80.6~ 93.1)	0.044(0.014~ 0.137)	2.708(1.778~ 4.123)
阳性	104	14
阴性	3	25
联合诊断			100.0(95.7~ 100.0)	59.0(42.2~ 74.0)	100.0(82.2~ 100.0)	87.0(79.4~ 92.1)	-	2.440(1.673~ 3.551)
阳性	107	16
阴性	0	23