altona Diagnostics Launches AltoStar HDV RT-PCR Kit 1.5 (CE-IVD)

Completion of the first automated CE-IVD PCR portfolio for all five hepatitis viruses

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)

About altona Diagnostics
altona Diagnostics is a medical diagnostic company that develops and manufactures in vitro diagnostic tests for the PCR based detection of pathogens such as viruses, bacteria, or parasites. Headquartered in Hamburg-Altona, Germany, altona Diagnostics is privately owned and employs more than 350 people worldwide, thereof 300 in Hamburg, Germany. The company has been in the molecular diagnostics business for over 25 years and is ISO 13485 certified. altona Diagnostics sells its registered products to medical laboratories globally through subsidiaries and more than 40 distribution partners.

Molecular diagnostic tests from altona Diagnostics are based on real-time PCR technology. altona Diagnostics offers the AltoStar Molecular Diagnostic Workflow, an automated solution that is complete with instrumentation, reagents, consumables, and software. Furthermore, the company’s product catalog contains over 50 CE marked PCR tests that are also compatible with open real-time PCR platforms. For further information, visit www.altona-diagnostics.com

For more information about the AltoStar HDV RT-PCR Kit 1.5 https://altona-diagnostics.com/product/altostar-hdv-rt-pcr-kit-1-5/