Standard Viral Load Test Recommended in HIV/AIDS Clinical Trials

A standard protocol has been recommended for viral load testing in HIV/AIDS clinical trials.

The Abbott (Abbott Park, IL, USA) RealTime HIV-1 assay and Abbott m2000 system have been recommended by the HIV/AIDS Research Network as a standard protocol for viral load testing in HIV/AIDS clinical trials sponsored by the U.S. National Institutes of Health (NIH; Bethesda, MD, USA). The Abbott m2000 is an automated system that uses real-time polymerase chain reaction (PCR) to amplify, detect, and measure minute levels, as well as extremely high levels, of virus in blood samples. Real-time PCR enables the production of large quantities of DNA from very small samples in a short period of time, making it possible to detect extremely low levels of a virus's genetic material. The Abbott m2000 system automates the important steps of the process, from sample preparation to data analysis, allowing laboratories to process molecular tests efficiently and accurately.

Viral load testing is a monitoring tool used to determine the amount of virus in the blood and the efficacy of anti-HIV therapy. The growing prevalence of HIV-1 subtype variant and circulating recombinant strains has made accurate viral load detection more complex and has prompted increasing numbers of clinical laboratories to adopt the Abbott RealTime HIV-1 assay on the m2000 system. The system is one of the fastest and most sensitive viral load tests available, with the ability to detect and precisely measure group M, N, and O strains of HIV-1, as well as all known non-B subtypes.

Current molecular or PCR-based diagnostic tests vary in their ability to detect variant strains of HIV-1 and have been found to under-quantify them. "The performance and precision of the Abbott RealTime HIV-1 assay for detecting variant subtypes allows physicians to confidently measure viral levels and provide optimal drug treatment," said Stafford O'Kelly, head of Abbott's molecular diagnostics business.

The Abbott RealTime HIV-1 test 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.

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