Kidney Week

Abstract: SA-PO1070

A Multicenter Study Comparing Elecsys HCV Duo to Standard-of-Care Algorithmic Testing in Chinese Patients on Hemodialysis

Session Information

• Kidney Replacement Therapy and Care Delivery Innovations
  October 24, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

• 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

• Gan, Liangying, Peking University People's Hospital, Beijing, China

Liangying Gan, MD

• Zuo, Li, Peking University People's Hospital, Beijing, China

Li Zuo, MD

Background

Maintenance hemodialysis (HD) patients face high HCV risk and blunted immunity, prolonging traditional antibody diagnostic windows. The Elecsys® HCV Duo simultaneously detects HCV antibodies (Ab) and core antigen (Ag) to shorten this window. This study compared its performance to standard of care (SOC) in HD patients.

Methods

This multicenter study enrolled 840 HD patients across nine centers. Pre-dialysis samples were analyzed using the Elecsys® HCV Duo and Cobas® HCV nucleic acid amplification testing (NAAT, reference). Baseline characteristics and SOC lab data were collected. Concordance of Duo Ab with SOC anti-HCV and performance of Duo Ag against NAAT were evaluated. The study protocol was approved by ethics committees (2024PHB272-001).

Results

The cohort (N=840; median age 59; HD vintage 4 years) included 69 (8.2%) anti-HCV positive and 16 (1.9%) RNA-positive patients. The HCV Duo identified NAAT-confirmed active infections in 100% (10/10) of Ag+/Ab+ patients and ruled it out in 100 % (771/771) of Ag-/Ab- cases. Duo Ab module showed 92.8% positive and 99.6% negative percent agreements with SOC anti-HCV. Compared to NAAT, the Duo Ag module demonstrated 62.5% sensitivity (10/16), 100% specificity (824/824), 100% positive predictive value (10/10), 99.3% negative predictive value (824/830), and 99.3% accuracy (834/840). Collectively, HCV Duo captured 100% (16/16) of RNA-positive patients. Furthermore, the Duo Ag Cutoff Index values strongly correlated with HCV RNA levels (Spearman's r = 0.8260, P < 0.0001), achieving 100% (10/10) sensitivity for active infections with viral loads > 4.11 ×10⁵ IU/mL.

Conclusion

The HCV Duo assay demonstrates comparable performance to SOC testing. By reliably confirming or ruling out active infections, it can substantially streamline the diagnostic algorithm and reduce the reliance on NAAT for HD patients. However, supplemental NAAT remains essential for resolving discordant (Ag-/Ab+) cases.