TB Research

Auxiliary Diagnostic Value of the Interferon Gamma-Induced Protein 10 mRNA Release Assay for Tuberculosis in People Living with HIV/AIDS - Beijing Municipality, China, 2022-2024.

Hongxia Yan, Hongfei Duan, Xiaoxu Han, Jin Sun, Qingtao Liang, Yan Zhao, Zhenglai Ma, Ning Ding, et al. (12 authors)

China CDC weekly · 2025-08

Abstract

INTRODUCTION: Diagnosing tuberculosis (TB) in HIV-infected individuals presents significant challenges due to difficulties in obtaining specimens containing adequate quantities of(). This study aimed to evaluate the diagnostic performance of themRNA assay independently and in combination with established diagnostic tests fordetection.

METHODS: The study cohort comprised 111 HIV-infected individuals who presented with TB at Beijing Youan Hospital from 2022 to 2024. Participants were categorized into confirmed TB, probable TB, or non-TB groups according to the diagnostic criteria for tuberculosis (WS288-2017). The performance of themRNA release assay was evaluated by the STARD guidelines on blood samples collected after enrollment.

RESULTS: ThemRNA release assay demonstrated significantly higher sensitivity than interferon-γ release assays (IGRAs) and culture methods for confirming pulmonary tuberculosis (PTB) diagnosis while maintaining comparable specificity. Receiver operating characteristic (ROC) analysis revealed that the diagnostic performance of themRNA release assay used in parallel with Xpert MTB/RIF significantly exceeded that of themRNA release assay alone (0.731. 0.687,=0.02). Among HIV-infected individuals, themRNA release assay showed superior performance compared to IGRAs for diagnosing extrapulmonary tuberculosis.

CONCLUSIONS: ThemRNA release assay exhibited excellent diagnostic performance and demonstrates substantial potential as an auxiliary tool for diagnosing TB in HIV-infected individuals. The combined application of IP-10TB and Xpert MTB/RIF further enhance diagnostic efficacy.