May 18, 2007
The FDA has approved a new HIV-1 test from Roche for diagnostic use in the United States.

The highly sensitive and accurate Cobas AmpliPrep/Cobas TaqMan HIV-1 Test uses real-time PCR technology to provide a broader range of viral load data than earlier generation tests, quantifying the amount of virus in the blood from very high to very low levels.

The test will allow labs to deliver accurate results faster than before.

The new test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy during the treatment course.

The new test is designed for use on an automated platform that combines the Cobas AmpliPrep instrument for automated sample preparation and the Cobas TaqMan analyzer or smaller Cobas TaqMan 48 analyzer for automated real-time PCR amplification and detection.