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Roche Diagnostics Developed First-of-its-kind Dual Antigen and Antibody Diagnostic Test

Roche Diagnostics has developed first-of-its-kind fully automated immunoassay, the Elecsys® HCV Duo, which allows for simultaneous and independent determination of both hepatitis C virus (HCV) antigen and antibody status from a single human plasma or serum sample. 

This remarkable test has a wide range of applications, from detecting early-stage infections to identifying patients in recovery or those with chronic infections.

The Elecsys® HCV Duo immunoassay is a game-changer when it comes to diagnosing active HCV infection. It enables significantly earlier diagnosis compared to traditional antibody-only tests, detecting active hepatitis C virus infection approximately 3 weeks earlier. 

This is achieved by leveraging the dual detection of HCV core antigen and antibodies. The presence of HCV core antigen serves as an early indicator of ongoing viral replication.

The adoption of the Elecsys® HCV Duo offers multiple benefits for patients and the healthcare system as a whole. It reduces the need for multiple visits and additional tests, simplifying the diagnostic process. This streamlined approach is crucial in preventing patients from being lost to follow-up and ensuring they receive timely care.

Acute hepatitis C is often asymptomatic, and antibodies may not be present in the early stages of infection, only appearing after a diagnostic window period of 6-13 weeks. Relying solely on HCV antibody tests as the initial diagnostic approach can lead to underdiagnosis, especially in populations with ongoing transmission. 

Detection of HCV core antigen significantly shortens this diagnostic window period, confirming active infection promptly. This innovation represents a significant advancement in hepatitis C diagnosis and care.