Siemens Healthcare Diagnostics has announced that its new VERSANT kPCR HCV RNA 1.0 Assay is now CE-marked for use on the company’s VERSANT kPCR Molecular System. This development will give diagnostic laboratories in Europe and Australia access to a new test for the management of hepatitis C (HCV) patients undergoing anti-viral therapy.
HCV is one of the main causes of chronic liver disease worldwide. Chronic infection with HCV can lead to liver scarring and cirrhosis, however early detection and appropriate treatment can cure the majority of patients.
The European Association for the Study of the Liver (EASL) recommends response guided therapy for HCV, which includes the monitoring of treatment efficacy using a real-time PCR-based assay, with a lower limit of detection of 10-20 IU/ml. The VERSANT HCV RNA 1.0 Assay has a limit of detection of 15 IU/ml, provides outstanding precision across the dynamic range and 100 percent specificity. The assay features technology that is compatible with all HCV genotypes enabling clinicians to manage patient therapy effectively.
This new, highly sensitive automated viral load assay is an important addition to the company’s portfolio of diagnostic solutions for managing patients with liver disease, which includes routine chemistry tests, hepatitis serology tests, viral load testing and ultrasound systems.
Company websiteSiemens Healthcare Diagnostics