# Acceleration of Diagnosis and Treatment Initiation Using the Elecsys® HCV Duo Assay

## TL;DR

This study shows that testing for both HCV antibodies and RNA can help identify more patients eligible for hepatitis C treatment.

## Contribution

The study highlights the efficiency of using the Elecsys® HCV Duo Assay to accelerate diagnosis and treatment.

## Key findings

- Only 29.2% of antibody-positive patients underwent HCV RNA testing.
- RNA positivity was observed in 16.6% of tested patients.
- Approximately 66 untested patients may be HCV RNA-positive.

## Abstract

This study determined the number of patients with positive hepatitis C virus (HCV) RNA results who were eligible to receive direct-acting antiviral (DAA) therapy at Nara Medical University and identified effective screening methods in this population. Between June 2021 and May 2024, the RNA detection status of HCV antibody (Ab)-positive cases, including RNA detection rates (RNA detection number/antibody-positive number) and positive rates (RNA-positive number/RNA detection number), was evaluated. Among the 866 patients who tested positive for anti-HCV antibodies, HCV RNA testing was performed in 29.2% (n = 253), comprising 57 patients from the Department of Gastroenterology and 196 from other departments. Of these 253 patients, 26 (45.6%) from the Department of Gastroenterology and 16 (8.2%) from other departments tested positive for HCV RNA. RNA positivity was observed in 16.6% of cases (42/253). The remaining 70.8% (n = 613) of antibody-positive patients did not undergo HCV RNA testing. This group included 41 patients from the Department of Gastroenterology and 572 from other departments. Based on the observed HCV RNA positivity rates within each department, it is estimated that among these 613 untested patients, approximately 66 may be HCV RNA-positive, 19 (45.6%) from the Department of Gastroenterology and 47 (8.2%) from other departments. Overall, 66 patients will potentially remain HCV RNA-positive. The simultaneous evaluation of HCV antibodies and HCV RNA can efficiently identify patients with chronic HCV infection who are eligible for DAA therapy.