Cepheid HBV Viral Load Test Gets CE-IVD Clearance

Cepheid announced recently it has received CE-IVD clearance for a rapid molecular assay to measure viral load of hepatitis B in infected patients.

The Xpert HBV Viral Load test measures HBV DNA levels in plasma or serum using the firm's GeneXpert systems and provides quantitative results in less than one hour. It is intended to be used as an indicator of prognosis and to aid in assessing response to antiviral treatment.

Infection with HBV can lead to acute and chronic liver failure, cirrhosis, and hepatocellular carcinoma. Approximately 292 million people worldwide have chronic HBV infection, and 780,000 people die from complications of infection each year, according to the Hepatitis B Foundation.

Antiviral therapies require confirmation of HBV DNA in plasma prior to treatment, David Persing, Cepheid's chief medical and technology officer, noted in a statement. The Xpert HBV Viral Load test "provides sensitive and accurate quantitation of a wide range of HBV genotypes on a widely available random-access platform that is suitable for implementation both in central labs and at the point of impact," Persing added.

The Xpert HBV Viral Load test is now available in the EU and countries that recognize the CE mark. It adds to a CE-marked rapid molecular virology test menu that also includes qualitative and quantitative assays for HIV-1, a quantitative reverse-transcriptase PCR assay for hepatitis C virus (HCV) RNA, and an HCV RNART-qPCR viral load test that uses fingerstick whole-blood samples.