Roche Launches Dual Antibody, Antigen Hepatitis C Virus Diagnostic Test

Elecsys HCV Duo allows independent and simultaneous determination of early-stage infection and those who are recovering or showing signs of a chronic problem.

Roche has launched the Elecsys HCV Duo immunoassay in countries that accept the CE Mark.1

Elecsys HCV Duo is the first available immunoassay that allows the independent and simultaneous determination of the hepatitis C virus (HCV) antigen and antibody status from a single human plasma or serum sample. The test can be used to detect early-stage infection, as well as identify patients who are recovering or show signs of chronic infection that could lead to other diseases, including liver cancer.1

“With improved hepatitis screening, health care systems have the opportunity to eliminate the disease through improved prevention, testing and treatment services,” Thomas Schinecker, CEO of Roche Diagnostics, said in a statement.

“The addition of the Elecsys HCV Duo assay to our HCV testing portfolio can help in the fight to eliminate the hepatitis C virus. The launch of this innovative dual antigen and antibody diagnostic test underlines our commitment to support clinicians and their patients in reducing the impact of infectious diseases, where it’s needed most, Schinecker said.”1

By using the dual detection of HCV’s core antibodies and antigen, the test allows physicians to diagnose active HCV earlier compared with using antibody-only assays, as core antigen appears early in the course of infection and is used as a marker of ongoing viral replication.1

Additionally, this can lead to earlier intervention for individuals and reduce the number of clinic visits needed to take additional test samples. This can also alleviate some of the burden that testing can have on health care systems.1

Earlier detection and intervention could lead to patients getting appropriate care sooner, reducing unnecessary health care costs, and stopping the disease progression and transmission.1

There are major gaps in access to hepatitis C testing, as well as treatment in all populations but especially economically disadvantaged populations and those in rural communities, according to the statement.1

Hepatitis C is a liver infection caused by HCV, according to the CDC.2

In 2019, there were a total of 4136 cases of acute hepatitis C and an estimated 57,500 acute hepatitis C cases.3

More than half of individuals who become infected with HCV will develop a chronic infection, and of every 100 individuals infected with HCV, approximately 5 to 25 will develop cirrhosis within 10 to 20 years, according to the CDC.3

Those more likely to develop cirrhosis include individuals older than aged 50 years; males; those who consume alcohol; those who have nonalcoholic fatty liver disease, hepatitis B, or HIV coinfection; or those who are receiving immunosuppressive therapy.3

The CDC recommends universal hepatitis C screening for all adults in the United States and all pregnant women, unless they are in a setting where the prevalence of HCV infection is less than 0.1%.3

Reference

1. Roche launches innovative dual antigen and antibody diagnostic test supporting the fight to eliminate the hepatitis C virus. Roche. News release. July 18, 2022. Accessed July 18, 2022. https://www.roche.com/media/releases/med-cor-2022-07-18

2. Hepatitis C. CDC. Updated July 28, 2020. Accessed July 18, 2022. https://www.cdc.gov/hepatitis/hcv/index.htm

3. Hepatitis C questions and answers for health professionals. CDC. Updated August 7, 2020. Accessed July 18, 2022. https://www.cdc.gov/hepatitis/hcv/hcvfaq.htm#section1