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Altona Diagnostics Nabs CE Mark for HIV-1 Viral Load PCR Assay

NEW YORK – Altona Diagnostics said on Thursday that it has received CE-IVD marking for and has launched its AltoStar HIV RT-PCR Kit 1.5.

The Hamburg, Germany-based firm's assay leverages reverse transcriptase quantitative PCR to allow users to amplify two separate regions of the HIV-1 genome to monitor viral load in HIV-infected patients.

The new kit contains master reagents, a no-template control, and quantification standards.

"With this CE-IVD [RT-qPCR] test for the monitoring of HIV-1 for use with the AltoStar workflow, we complete our AltoStar blood-borne virus product portfolio," Markus Hess, general manager of Altona Diagnostics, said in a statement. "The broad AltoStar assay menu now includes test systems for reliable viral load monitoring of blood-borne viruses like HIV, hepatitis B, and hepatitis C virus."

Last April, Altona received Emergency Use Authorization from the US Food and Drug Administration and the CE-IVD mark for its PCR-based SARS-CoV-2 test kit.