AIDS Test

FDA clears Cobas Amplicor HIV-1 Monitor Test

Published in AIDS Weekly, May 5th, 2003

Roche announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the Cobas Amplicor HIV-1 Monitor Test (version 1.5), an enhanced version of Roche's polymerase chain reaction (PCR) assay used to measure the amount of HIV-1 RNA (viral load) present in an infected person's blood.

The Cobas Amplicor HIV-1 Monitor Test (version 1.5) is an automated assay that amplifies and detects genetic material, allowing for accurate quantification of even small amounts of viral RNA in the blood. This new test can measure viral loads as low as 50 copies of HIV-1 RNA per millilitre (c/mL) of plasma. This level of sensitivity is critical for optimizing...

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Source: AIDS Weekly (2003-05-05)

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