HIV/AIDS Testing

CE Mark granted for HIV-1 real-time PCR viral load test

Published in Hepatitis Weekly, July 18th, 2005

Abbott and Celera Diagnostics, a joint venture between the Applied Biosystems Group (ABI) and Celera Genomics Group (CRA) of Applera Corporation, announced that Abbott has received CE Mark certification for a real-time polymerase chain reaction (PCR) test for monitoring HIV-1 viral load in patients.

Under the In Vitro Diagnostics Directive 98/79/EC, CE marking allows the test to be sold in the European Union. The Abbott RealTime HIV-1 assay has been developed for use on the Abbott m2000 system, an automated instrument using real-time PCR technology for the detection and quantification of infectious agents that cause disease. Additional tests are in development for the...

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Source: Hepatitis Weekly (2005-07-18)

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