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For Consumers

FDA Approves Viral Load Test ~ VERSANT® HIV-1 RNA 3.0 Assay (bDNA)

9/23/2002

The Food and Drug Administration, on September 11, 2002, approved the VERSANT HIV-1 RNA 3.0 Assay (bDNA). This device is indicated for the direct quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) in plasma of HIV-infected individuals.

The VERSANT® HIV-1 RNA 3.0 Assay (bDNA) is an in vitro signal amplification nucleic acid probe assay for the direct quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in plasma of HIV-1 infected individuals using the Bayer® System 340 bDNA Analyzer. The test can quantitate HIV-1 RNA over the range of 75 - 500,000 HIV-1 RNA copies/mL. Plasma samples containing Group M Subtypes A - G have been validated for use in the assay.

This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease status as an aid in management of individuals infected with HIV-1. HIV-1 RNA results from the assay can be used to assess prognosis of disease progression and to monitor the effects of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of therapy. Monitoring the effects of antiretroviral therapy by serial measurements of plasma HIV-1 RNA has been validated for patients with viral loads ³ 25,000 copies/mL.

The VERSANT HIV-1 RNA 3.0 Assay (bDNA) is not intended for use as a screening assay for HIV infection or as a diagnostic test to confirm the diagnosis of HIV infection.

The VERSANT HIV-1 RNA 3.0 Assay is manufactured by Bayer Corporation of Berkeley, CA.

 

Richard Klein
Office of Special Health Issues
Food and Drug Administration
 

Page Last Updated: 08/01/2014
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