The new PCR test detects and quantifies hepatitis delta virus (HDV)-specific RNA in human EDTA plasma and serum.
Altona Diagnostics GmbH has launched the AltoStar HDV RT-PCR Kit 1.5 (CE-IVD), completing its automated CE-IVD PCR portfolio covering all five hepatitis viruses (A, B, C, D, and E).
The new PCR test detects and quantifies hepatitis delta virus (HDV)-specific RNA in human EDTA plasma and serum. HDV infection, which occurs as a co-infection or superinfection with HBV, is associated with severe viral hepatitis and increased risk of liver-related complications.
The kit is configured for use with the AltoStar Molecular Diagnostic Workflow, enabling automated extraction, PCR setup, amplification, and data analysis within an integrated platform. The assay is designed for quantitative detection of all known HDV genotypes (1–8) with high analytical sensitivity, precision, and reproducibility.
“With the launch of the AltoStar HDV RT-PCR Kit 1.5, we have achieved a major milestone—offering laboratories the automated CE-IVD PCR solution for complete hepatitis diagnostics,” says Dr Sönke Friedrichsen, general manager at Altona Diagnostics, in a release. “Laboratories can now perform reliable PCR testing for all five hepatitis viruses using a single workflow.”
Key Features and Specifications
The AltoStar HDV RT-PCR Kit 1.5 provides quantitative detection of HDV RNA across genotypes 1–8 with automated processing through the AltoStar Workflow. The assay is calibrated against the WHO International Standard for HDV NAT (PEI code: 7657/12) and maintains CE-IVD compliance under the European In Vitro Diagnostic Regulation (98/79/EC).
The kit features a harmonized workflow with AltoStar hepatitis A, B, C, and E CE-IVD assays, allowing laboratories to standardize their hepatitis testing protocols across all five virus types.
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