altona Diagnostics completes CE-IVD PCR portfolio for hepatitis viruses

Launch of the AltoStar HDV RT-PCR Kit 1.5 enables CE-IVD–compliant PCR testing for all five hepatitis viruses

The AltoStar^® HDV RT-PCR Kit 1.5 (CE-IVD) is available now. It is an in vitro diagnostic test, based on real-time PCR technology, 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 offers 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 an increased risk of liver-related complications and is the most severe form of chronic viral hepatitis. Reliable HDV RNA quantification is critical for clinical diagnosis, disease monitoring, and evaluating treatment response.

The AltoStar® HDV RT-PCR Kit 1.5 (CE-IVD) was developed for use with the AltoStar® Molecular Diagnostic Workflow, enabling automated extraction, PCR setup, amplification, and data analysis within an integrated platform. The new kit 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 on the market for complete hepatitis diagnostics,” says Dr. Sönke Friedrichsen, General Manager at altona Diagnostics. “Laboratories can now perform reliable PCR testing for all 5 hepatitis viruses using an integrated workflow.”

Source: altona Diagnostics,