altona Diagnostics GmbH announces the launch of the AltoStar® HDV RT-PCR Kit 1.5 (CE-IVD), a new PCR test for the detection and quantification of hepatitis delta virus (HDV) specific RNA in human EDTA plasma and serum. This launch marks a unique milestone in molecular diagnostics: altona Diagnostics now provides the first and only complete automated CE-IVD PCR portfolio covering all five hepatitis viruses (A, B, C, D, and E).
HDV infection, which occurs as a co-infection or superinfection with HBV, is associated with the most severe form of viral hepatitis and an increased risk of liver-related complications. Reliable HDV RNA quantification is critical for clinical diagnosis, disease monitoring, and evaluating treatment response.
The AltoStar® HDV RT-PCR Kit 1.5 is configured for use with the AltoStar® Molecular Diagnostic Workflow, enabling automated extraction, PCR setup, amplification, and data analysis within an integrated platform. The new assay is designed for the 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 first automated CE-IVD PCR solution for complete hepatitis diagnostics,” says Dr. Sönke Friedrichsen, General Manager at altona Diagnostics. “Laboratories can now perform reliable PCR testing for all five hepatitis viruses using a single workflow.”
Key Features of the AltoStar® HDV RT-PCR Kit 1.5 CE-IVD
- Quantitative detection of HDV RNA (genotypes 1–8)
- Automated processing with the AltoStar® Workflow
- Calibrated against the 1st WHO International Standard for HDV NAT (PEI code: 7657/12)
- CE-IVD compliance under the European In Vitro Diagnostic Regulation (98/79/EC)
- Harmonized workflow with AltoStar® hepatitis A, B, C, and E CE-IVD assays
The AltoStar® HDV RT-PCR Kit 1.5 expands the altona Diagnostics molecular testing portfolio for infectious diseases, which includes assays in the following pathogen panels:
- Bloodborne
- Fever, tropical, emerging (FTE)
- Gastrointestinal
- Respiratory
- STI
- Transplant & immunocompromised (opportunistic infections)
