May 30, 2007
Abbott has received FDA approval to market the Abbott RealTime HIV-1 viral load test for use on the company’s m2000 automated instrument system.
The Abbott RealTime HIV-1 assay, for use on the new m2000 system, is designed to detect and precisely measure levels of HIV circulating in a patient’s blood including the three major groups of HIV-1 as well as non-B subtypes. The test is intended for use as a marker of disease prognosis and an aid in assessing viral response to antiretroviral treatment.
While HIV-1 subtype B continues to be the most common strain found in the United States, studies suggest that an increasing number of newly diagnosed patients are infected with non-B subtype viruses and various circulating recombinants as a result of the influx of immigrants from countries where variant strains of HIV are more common.