FDA-approved HIV-1 test

The Food & Drug Administration (FDA) has approved Roche Diagnostic's HIV-1 test for diagnostic use in the United States. The 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, laboratories can deliver highly accurate results faster " a decisive advantage for doctors monitoring how well a chosen therapy is working for the patient.

The 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 5000 participants with viral load monitoring had shown a significant association between a decrease in plasma viremia and improved clinical outcome.

The test is designed for use on an automated platform that combines the Cobas AmpliPrep instrument for automated sample preparation and the Cobas TaqMan analyser or smaller Cobas TaqMan 48 analyser for automated real-time PCR amplification and detection. Configuration options also include docked instruments for "sample in/results out' testing that eliminates manual intervention between steps. The combined instrument platform fully automates the sample preparation and real-time PCR amplification and detection process for improved workflow efficiency, hands-off processing and test results integrity. Each Roche test includes AmpErase enzymes designed to prevent cross-contamination of samples or laboratories.

The test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. It can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment. The test is not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection.