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Automated Roche HIV-1 Test Using RT-PCR Gets FDA Approval

The FDA has approved Roche's new HIV-1 test for diagnostic use in the United States. The highly accurate Cobas AmpliPrep/Cobas TaqMan HIV-1 Test is the first fully automated HIV-1 diagnostic tool using real-time PCR technology in the US. It provides 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. With the test, labs can deliver highly accurate results faster – a decisive advantage for doctors monitoring how well a chosen therapy is working for the patient.

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. One key goal of therapy is a viral load below the limits of detection of approved molecular diagnostic tests. Analysis of 18 trials with over 5,000 participants with viral load monitoring had shown a significant association between a decrease in plasma viremia and improved clinical outcome.

NOTE: This item is from our 'historic' database and may contain information which is not up to date.

Source: Roche Diagnostics View latest company information

Posted: May 21, 2007
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