Instrument Measures Genetic Variations of HIV

A new diagnostic instrument detects and measures human immunodeficiency virus (HIV)-1 and all known genetic variations of the virus.

The m2000 instrument and HIV-1 test represents substantial improvement over existing methods. The assay is designed to detect and precisely measure levels of the HIV circulating in a patient's blood (viral load), including the three major groups of HIV-1 as well as non-B subtypes.

The Real-Time HIV-1 test was developed for use on the Abbott Laboratories' (Abbott Park, IL, USA) m2000 system, an automated instrument for DNA and RNA testing in molecular laboratories. The m2000 system is based on real-time polymerase chain reaction (PCR) technology and is designed to efficiently detect and measure viruses and bacteria in patient samples in less than five hours, compared to other testing methods that may take up to two days.

Abbott has received U.S. Food and Drug Administration (FDA) approval to market the Abbott Real-Time HIV-1 viral load test for use on the company's m2000 automated instrument system.

HIV-1 can be divided into groups M (major), O (outlier), and N (new). The vast majority of isolates cluster in the M group. Distinct lineages within group M have also been identified, and these lineages are called strains or subtypes. They include subtype designations A through G. 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.

The Abbott Real-Time HIV-1 assay is a sensitive viral load test, with a broad dynamic range, capable of quantitating HIV-1 in plasma down to as few as 40 RNA molecules per ml and up to as many as 10 million molecules per ml. The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels.

Additional products in development for the Abbott m2000 system include assays for hepatitis C virus (HCV), hepatitis B virus (HBV), HCV genotyping, chlamydia, and gonorrhea. Abbott markets the m2000 system and a menu of tests throughout the world as part of a strategic alliance with Celera (Rockville, MD, USA).


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