Automated Assay for HIV Viral Load Testing

A nucleic acid probe diagnostic assay is designed for the quantitation of HIV-1 RNA in the plasma of people living with HIV. It is the first viral load test approved by the US Food and Drug Administration (FDA) that automates critical assay steps.

The Versant HIV-1RNA 3.0 Assay (bDNA) directly measures HIV-1 viral levels in plasma using branched DNA signal amplification technology. It uses more than 80 different probes targeted at the most highly conserved region of the viral genome, resulting in the detection and quantification of all major HIV-1 subtypes. It is the only FDA-approved test capable of reliably detecting significant (threefold) changes in viral load throughout its entire quantitation range. Other approved methods lack sufficient precision at the low end to reliably detect an increase of threefold at their cutoff.

An accurate measure of viral load is needed to predict disease progression, to assess whether to initiate therapy, and to monitor a given treatment and make appropriate changes. The test was developed by Bayer Diagnostics (Tarrytown, NY, USA; www.bayerdiag.com). It includes data-management software and runs on Bayer's 340 Analyzer.

"Prior to the approval of the Versant assay, labs had to endure many laborious and time-consuming steps associated with manual methods for HIV viral load,” said Peter Knueppel, senior vice president of nucleic acid diagnostics, Bayer Diagnostics.




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