Fully-Automated HIV-1 Test Uses Real Time PCR Technology

It provides a broader range of viral load data than earlier generation tests and enables labs to deliver highly accurate results faster.

Called the Cobas AmpliPrep/Cobas TaqMan HIV-1 and developed by Roche (Basel, Switzerland), the test has been approved for use in the United States by U.S. Food & Drug Administration (FDA). 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.

The 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. 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.

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.


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