Clinical Trials in US Hospitals on Abbott RealTime HIV-1 Test

Two products of the US pharma giant Abbot, Abbott RealTime HIV-1 Assay and Abbott m2000 System, are to be tried out in UK hospitals for checking on HIV prognosis. The clinical trials are to be sponsored by the National Institutes of Health (NIH).

The Abbott RealTime HIV-1 assay is not as a diagnostic test to confirm the presence of HIV-1 infection nor is it a donor-screening test for HIV-. The test is rather intended for use in conjunction with some other markers an indicator of disease prognosis and for use as an aid in assessing the efficacy of antiretroviral treatment, as measured by changes in plasma HIV-1 RNA levels.

The Abbott RealTime HIV-1 test runs on the Abbott m2000, an automated system that uses real-time polymerase chain reaction (PCR) to amplify, detect and measure minute levels of virus in blood samples as well as extremely high levels of these infectious agents. 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 more efficiently than has been the case so far.

The growing prevalence of HIV-1 subtype variant and circulating recombinant strains has made accurate viral load detection more complex,  and the Abbot-type viral load testing is considered an effective  monitoring tool to determine the amount of virus in the blood as also the efficacy of anti-HIV therapy.

The recommendation on the use of Abbot products was made by the Cross-Network Laboratory Focus Group (LFG),  a research Network, and it applies to testing performed at adult and pediatric therapeutic HIV/AIDS clinical trial sites both in the United States and internationally, as well as the centralized network laboratories in the United States.

."We're pleased that the LFG has recommended the Abbott RealTime HIV viral load assay to be the standard testing system for NIH-sponsored HIV/AIDS clinical trial networks," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "We look forward to supporting the NIH-sponsored clinical trials networks in the global effort to evaluate and monitor HIV drug treatments."

Based on several published studies, current molecular or PCR based diagnostic tests vary in their ability to detect and reliably quantify 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," O'Kelly said.

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Source-Medindia
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