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World’s First Approved Hepatitis D Virus Test Introduced

Apr 18, 2017

IVD product CE approved

The first kit with CE-IVD certification for the molecular diagnostic quantification of Hepatitis delta virus (HDV) RNA is now available, thus reaching an important new milestone in standardization of HDV nucleic acid amplification tests.

Quantitative real-time PCR is the method of choice for diagnostics and therapy monitoring due to its outstanding range of sensitivity. Analytik Jena AG (Jena, Germany) now expands its hepatitis diagnostics line with RoboGene HDV RNA Quantification Kit 2.0. “Hepatitis-delta is viewed as one of the most severe forms of the viral hepatitis infection. It is solely connected to a coexistingHepatitis B virus (HBV) infection and very frequently leads to chronic cirrhosis of the liver in cases of super-infection. 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 first WHO Standard for HDV RNA,” said Dr. Ingolf Lachmann, site manager for Analytik Jena subsidiary AJ Roboscreen GmbH (Leipzig, Germany).

Both the HBV and HDV RoboGene kits were validated with nucleic acid samples purified with the INSTANT Virus RNA/DNA Kit developed by another subsidiary, AJ Innuscreen, based on the patented Dual Chemistry (DC) Technology. This allows for 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 tests. 

The combination kit thus offers a unique testing package for HBV positive patients who are additionally infected with HDV. “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,” said Alexander Berka, general manager, Life Science business unit, Analytik Jena.