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www.fdanews.com/articles/73400-hiv-1-real-time-pcr-viral-load-test-given-ce-marking

HIV-1 Real-Time PCR Viral Load Test Given CE Marking

June 16, 2005

Abbott and Celera Diagnostics -- a joint venture between the Applied Biosystems Group and Celera Genomics Group of Applera -- said Abbott has received CE mark certification for a real-time PCR (polymerase chain reaction) test for monitoring HIV-1 viral load in patients, allowing 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 Abbott m2000 system, including methods for detecting hepatitis C, hepatitis B, chlamydia and gonorrhea.

The assay has a broad dynamic range, capable of detecting HIV-1 in plasma down to as few as 40 RNA molecules per milliliter and as high as 10 million RNA molecules per milliliter, reducing the need for sample dilutions and additional testing. The Abbott m2000 instrument system purifies the nucleic acid from the specimen and automatically combines this with the assay reagents.