Analytik Jena Introduces the World’s First Hepatitis D Virus Test with CE-IVD Certification Applying WHO Standard to the Market

Analytik Jena AG is the world’s first company to bring to the market a kit with CE-IVD certification for the molecular diagnostic quantification of hepatitis delta virus (HDV) RNA, thus reaching a major new milestone in the standardization of HDV nucleic acid amplification tests. The Jena-based company is building on years of experience in the development of in vitro diagnostic assays to add the RoboGene® HDV RNA Quantification Kit 2.0 to its range of diagnostics for hepatitis B and C.

As Dr. Ingolf Lachmann, Site Manager for the Analytik Jena subsidiary AJ Roboscreen GmbH in Leipzig explained: “Hepatitis delta is viewed as one of the most severe forms of the viral hepatitis infection. It is solely connected to a coexisting hepatitis B virus (HBV) infection and very frequently leads to chronic cirrhosis of the liver in cases of superinfection. We are very proud to have developed, in addition to RoboGene® HBV DNA Quantification Kit 2.0, a corresponding diagnostic tool for HDV RNA, and to be the first company to receive CE-IVD certification applying the 1st WHO Standard for HDV RNA.”

HDV occurs most frequently in the Mediterranean basin, the Middle East, South and Central Asia, West Africa, and the Amazon region of South America. The quantitative real-time PCR is the method of choice for the confirmation of an existing infection and for antiviral therapy monitoring due to its outstanding range of sensitivity from 5 to 25 IU/ml.

As Alexander Berka, General Manager of the Life Science business unit at Analytik Jena AG, said: “This is a further milestone for Analytik Jena on the road to establishing ourselves as an innovative provider of molecular diagnostic kits. We will immediately begin to offer the kit, which was developed for routine diagnostics for HBV DNA and HDV RNA, and which involves nucleic acid extraction processes and subsequent detection. We are also working intensively on adapting the kit to Analytik Jena’s current automation platforms.”

Both the RoboGene® HBV DNA Quantification Kit 2.0 and the RoboGene® HDV RNA Quantification Kit 2.0 were validated after purification with the INSTANT Virus RNA/DNA Kit, which was developed by another subsidiary, AJ Innuscreen, on the basis of the patented Dual Chemistry (DC) Technology. The INSTANT Virus RNA/DNA Kit allows for the simultaneous purification of high-purity viral RNA and DNA from serum and plasma samples and provides a basis for the excellent output parameters of the RoboGene® Hepatitis range of products. The Analytik Jena combination kit thus offers a unique testing package for hepatitis-B positive patients who are additionally infected with hepatitis delta.