Enhanced detection of occult and active infections using multiplex HIV/HBV/HCV nucleic acid testing in high-risk populations: a cross-sectional study
Cong Jin1, Yu Wang1, Zuyang Zhang2,3
1National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention & Chinese Academy of Preventive Medicine, Beijing, China.
Introduction:
Given the shared modes of transmission, HIV, HBV, and HCV confer a high risk of co-infection, particularly among key populations. Currently, clinical screening for these viruses still relies predominantly on serological assays, which fail to detect a substantial proportion of infections, including occult HBV infection (OBI, defined as HBsAg-negative but HBV DNA-positive) and current HCV infection. HIV/HBV/HCV multiplex nucleic acid testing (NAT) has been widely adopted in blood screening due to its superior sensitivity, specificity, and shorter window period. However, this highly effective screening assay has not yet been translated into routine clinical screening for high-risk populations.
Methods:
To evaluate its clinical performance and feasibility, we conducted a cross-sectional study enrolling 802 people who use drugs (PWUD) and 400 men who have sex with men (MSM) in China. All participants underwent parallel serological screening and HIV/HBV/HCV multiplex NAT, with final infection status confirmed by supplementary testing, epidemiological history, and clinical symptoms.
Results:
Upfront HIV/HBV/HCV multiplex NAT identified 12 additional OBI cases (incremental yield 12/1,202) that were missed by HBsAg-only screening and HBsAg-triggered reflex testing. HCV RNA testing distinguished current from non-current HCV infection, but this benefit was not specific to the multiplex strategy. Acceptance of multiplex NAT and post-diagnosis treatment was high among participants.
Conclusion:
Our findings suggest that HIV/HBV/HCV multiplex NAT could detect clinically relevant infections undetectable by serology in key populations, suggesting potential clinical benefits. However, further prospective implementation studies and cost-effectiveness analyses are warranted before routine integration into clinical practice.
