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Altona Diagnostics Hepatitis C Virus Kit Gets CE-IVD Mark

NEW YORK (GenomeWeb) – Altona Diagnostics said today that it has received CE-IVD marking for and has launched the AltoStar HCV RT-PCR Kit 1.5.

The kit leverages real-time RT-PCR technology to detect and quantify hepatitis C virus-specific RNA with genotypes 1 to 6. The Hamburg, Germany-based company said that the assay is its first List A test, in compliance with the In vitro Diagnostic Directive 98/79/EC.

The assay, which received CE-IVD designation on Wednesday, was developed to be used with Altona's AltoStar Automation System AM16, the AltoStar Purification Kit 1.5, the AltoStar Internal Control 1.5, and Bio-Rad Laboratories' CFX96 Deep Well Real-Time PCR Detection system.

Altona added that additional AltoStar products would soon be available, including tests for hepatitis E virus, hepatitis B virus, and alpha herpesviruses.