Highly Sensitive, Accurate Roche HIV-1 Test Approved By FDA

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HIV Test

U.S. Food & Drug Administration has approved new HIV-1 test for diagnostic use in the United States, that enables faster results for doctors monitoring treatment response.

The highly sensitive and accurate Cobas AmpliPrep/Cobas TaqMan HIV-1 Test is the first fully automated HIV-1 diagnostic tool using real-time PCR technology in the U.S. 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.


"This approval represents a significant milestone in the automation of our virology platform in the U.S. market," said Severin Schwan, CEO of Roche Diagnostics and a member of the Roche Group's Executive Committee. "The new test system provides innovative options for combining a more sensitive HIV test with full automation that simplifies state-of-the-art molecular diagnostic testing."

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.

According to the U.S. Centers for Disease Control and Prevention, each year in the U.S. approximately 40,000 become infected with HIV. The agency estimates that at the end of 2003, approximately 1 million Americans were living with HIV/AIDS, and that approximately 300,000 more remained unaware of their HIV infections.

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. 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 labs.

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.