Roche Diagnostics India launches Elecsys HCV Duo, the country’s first automated dual antigen and antibody diagnostic test for hepatitis C virus (HCV). The test allows simultaneous detection of early-stage and chronic infections, potentially aiding early diagnosis and treatment. With HCV becoming a major public health concern in India, this innovative test can significantly improve screening efforts and help reduce the disease burden. The assay is expected to play a crucial role in meeting WHO’s elimination goals for HCV infections and related deaths.
Roche Diagnostics India has introduced the Elecsys HCV Duo, a groundbreaking dual antigen and antibody diagnostic test, marking a significant advancement in the detection and management of hepatitis C virus (HCV) infections in the country. This innovative test is the first of its kind in India, fully automating the immunoassay process and enabling simultaneous, independent determination of both the HCV antigen and antibody status using a single human plasma or serum sample.
The Elecsys HCV Duo test can detect infections in their early stages, track patient recovery, and identify cases of chronic infection. Considering the increasing recognition of viral hepatitis as a public health concern in India, this test will play a vital role in curbing the spread of the disease.
As per the National Viral Hepatitis Control Program (NVHCP), the prevalence of Anti-HCV antibodies in the general population of India is estimated to be between 0.09% to 15%, and there are approximately 12-13 million carriers of HCV. Unfortunately, only a small percentage of those with chronic HCV infection are aware of their condition and receive treatment, leading to a substantial gap in diagnosis and care.
The diagnostic window period for acute hepatitis C, when antibodies may not be detectable, can lead to underdiagnosis in populations with ongoing transmission. The Elecsys HCV Duo, by detecting HCV core antigen, significantly shortens this window period and confirms active infection, allowing for earlier diagnosis (~3 weeks earlier) than using antibody-only tests.
With the adoption of this novel diagnostic test, there is an opportunity for India to improve its hepatitis screening efforts and consequently reduce the disease burden through enhanced prevention, testing, and treatment services.
Dr. Sandeep Sewlikar, Head of Scientific and Medical Affairs at Roche Diagnostics India, expressed enthusiasm for the launch of the Elecsys HCV Duo, emphasizing Roche’s commitment to reducing the impact of infectious diseases. The test’s ability to offer single specimen testing and simplify the diagnostic algorithm is expected to reduce the number of visits needed for additional tests and ease the burden on the healthcare system, thus preventing patient loss to follow-up and facilitating linkage to care.
Furthermore, in 2018, the European Association for the Study of Liver (EASL) also recommended the HCV Core Antigen test as a marker for HCV replication to diagnose both acute and chronic HCV infection.
Experts, including laboratory experts, hepatologists, and microbiologists, have provided positive feedback on the Elecsys HCV Duo assay, stating that it can play an instrumental role in meeting the World Health Organization’s elimination goal of reducing HCV infections by 90% and related deaths by 65% by 2030.
Dr. Nilesh Shah, President and Chief of Science & Innovation at Metropolis Healthcare Ltd., highlighted the importance of timely detection in managing hepatitis C. While there is no vaccine available, effective treatment with direct-acting antivirals (DAAs) has significantly increased cure rates to 98%. Therefore, improving disease management and cure rates begins with increasing HCV screening through efficient diagnostic tools, and Roche Diagnostics’ leadership in providing such solutions is commendable.
The Elecsys HCV Duo assay is available for use on the cobas-e402 (cobas pure system) and cobas e801 (cobas 8000 and pro system) analytical units, providing healthcare professionals with efficient and accurate tools to combat the spread of HCV infections in India.
