First Hepatitis D Virus Test with CE-IVD Certification
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.
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.
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.
Date Published: September 7, 2015
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