Article
Diagnostic performance of a novel Mycobacterium Tuberculosis specific T-Cell based assay for tuberculosis
Pan Liping, Gao Mengqiu, Jia Hongyan, Huang Mailing, Wei Rongrong, Sun Qi, Xing Aiying, Du Boping, Zhang Zongde
Published 2021-05-12
Cite as Chin J Tuberc Respir Dis, 2021, 44(5): 443-449. DOI: 10.3760/cma.j.cn112147-20200821-00916
Abstract
ObjectiveTo evaluate the diagnosic performance of a novel Mycobacterium tuberculosis (MTB) specific T-cell based assay for tuberculosis, which targets the mRNA detection of interferon gamma-induced protein 10 (IP-10).
MethodsSuspected tuberculosis patients were prospectively and consecutively recruited in Beijing Chest Hospital between March 2018 and November 2019, and individuals with lower risk of MTB infection were also recruited. IP-10.TB and T-SPOT.TB assays were simulataneously performed on peripheral blood samples. The diagnostic performance of IP-10.TB and T-SPOT.TB were analyzed using the receiver operating characteristic curve. Accordance of IP-10.TB and T-SPOT.TB was analyzed by Cohen′s kappa test, while the correlation between the expression level of IP-10 mRNA in IP-10.TB test and the number of SFCs in T-SPOT.TB test were analyzed by Pearson correlation test.
ResultsA total of 235 patients with tuberculosis, 110 patients with other diseases and 153 individuals with lower risk of MTB infection were included in the final analysis. No significant difference was detected in the rate of indeterminate results between IP-10.TB assay (3/498, 0.60%) and T-SPOT.TB assay (6/498, 1.21%). The total sensitivity and specificity of IP-10.TB assay were 91.3% (95%CI 86.8%-94.6%) and 81.1% (95%CI 75.8%-85.7%). The specificity of IP-10.TB in individuals with lower risk of MTB infection was 98.0% (95%CI 94.4%-99.6%). The total sensitivity and specificity of T-SPOT.TB assay were 93.0% (95%CI 88.9%-96.0%) and 83.8% (95%CI 78.7%-88.1%). The specificity of T-SPOT.TB in individuals with lower risk of MTB infection was 100% (95%CI 97.6%-100.0%). No significant differences were detected in sensitivity and specificity between IP-10.TB and T-SPOT.TB assays (P>0.05). The positive coincidence rate of these 2 methods was 91.0% (95%CI 87.5%-94.5%), and the negative coincidence rate was 88.9% (95%CI 84.9%-92.9%) and the total coincidence rate was 90.0% (95%CI 87.3%-92.6%). The Cohen′s kappa value was 0.80 (95%CI 0.75-0.85, P<0.001) between IP-10.TB and T-SPOT.TB assays.
ConclusionThese results showed that the diagnostic performance of IP-10.TB was consistent with that in T-SPOT.TB, and this test could be a novel adjunctive tool for the diagnosis of tuberculosis.
Key words:
Tuberculosis; Mycobacterium tuberculosis; Interferon gamma-induced protein 10; IGRA
Contributor Information
Pan Liping
Department of Tuberculosis, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing 110149, China
Gao Mengqiu
Department of Tuberculosis, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing 110149, China
Jia Hongyan
Department of Tuberculosis, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing 110149, China
Huang Mailing
Department of Tuberculosis, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing 110149, China
Wei Rongrong
Department of Tuberculosis, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing 110149, China
Sun Qi
Department of Tuberculosis, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing 110149, China
Xing Aiying
Department of Tuberculosis, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing 110149, China
Du Boping
Department of Tuberculosis, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing 110149, China
Zhang Zongde
Department of Tuberculosis, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing 110149, China
