Abstract
INTRODUCTION: Diagnosing tuberculosis (TB) in HIV-infected individuals presents significant challenges due to difficulties in obtaining specimens containing adequate quantities of Mycobacterium tuberculosis (Mtb). This study aimed to evaluate the diagnostic performance of the IP-10 mRNA assay independently and in combination with established diagnostic tests for Mtb detection. 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 the IP-10 mRNA release assay was evaluated by the STARD guidelines on blood samples collected after enrollment. RESULTS: The IP-10 mRNA 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 the IP-10 mRNA release assay used in parallel with Xpert MTB/RIF significantly exceeded that of the IP-10 mRNA release assay alone (0.731 vs. 0.687, P=0.02). Among HIV-infected individuals, the IP-10 mRNA release assay showed superior performance compared to IGRAs for diagnosing extrapulmonary tuberculosis. CONCLUSIONS: The IP-10 mRNA 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-10.TB and Xpert MTB/RIF further enhance diagnostic efficacy.