Roche has introduced a new immunoassay that can qualitatively and quantitatively determine the hepatitis B e antigen (HBeAg) in human serum and plasma, dubbed Elecsys HBeAg quant.
Elecsys HBeAg quant test results, when used together with other laboratory results and clinical information, can help in the diagnosis and monitoring of patients with hepatitis B viral infection.
The test is intended for use on Roche’s cobas e analysers and can be used for samples from both patients with unknown HBeAg status and those who have previously tested positive.
The single test will indicate both the presence and quantity of HBeAg and inform clinicians if treatment is required and regimens are working, together with other assays, said Roche.
Roche Diagnostics CEO Matt Sause said: “Hepatitis B affects millions of people each year and is a major global health burden. An accurate diagnosis is critical to ensuring timely treatment options. If hepatitis B is left untreated, it can cause chronic infections, putting people at high risk of death from cirrhosis and liver cancer.
“The addition of the Elecsys HBeAg quant immunoassay to our viral hepatitis testing portfolio underlines Roche’s commitment to tackle healthcare’s biggest challenges to support clinicians and their patients.”
According to Roche, HBV is the most common type of viral hepatitis that affects people of all ages, putting a significant burden on people and healthcare systems globally.
The new Elecsys HBeAg quant assay is said to complement its existing HBV testing markers.
It allows clinicians to determine the suspected HBV patient’s disease phase, measure the activity of the virus in the liver and risk of liver disease and Hepatocellular carcinoma (HCC).
The Swiss company said that its new diagnostic tool reduces complexity and improves operational efficiency thanks to a leaner workflow for lab personnel.
Furthermore, the Elecsys HBeAg quant test can also be used in perinatal screening and to monitor antiviral treatment response within infected patients, said the Swiss diagnostics firm.
