Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
PRNewswire - November 26, 2001
"Our experience in providing this test to facilities outside the United States has shown the NucliSens(R) HIV-1 QT assay to be a very valuable tool for physicians, helping them to optimize therapeutic treatment regimens for those who suffer with HIV," states Benoit Adelus, CEO of bioMerieux. "Now, laboratories and physicians in the United States can choose a single viral load procedure to monitor their patients. They can get an accurate viral load result the first time without reflex testing."
Clinical trial data and published articles support the excellent sensitivity and HIV-1 subtype reactivity of the test. In a comparison study with the current FDA-approved test, the NucliSens(R) HIV-1 QT assay showed excellent correlation -- with an improved dynamic range across various viral load levels.
According to Christine Ginocchio, Ph.D., Director of Microbiology/Virology and Molecular Diagnostics at North Shore LIJ Health System Laboratories in New York, "I have used the NucliSens(R) HIV-1 QT assay in a research setting for more than five years. The linearity of the assay and its reproducibility, particularly at low levels of viral load, have been excellent."
NASBA technology can selectively amplify RNA sequences in a DNA background, making it ideal for detecting and quantifying retroviruses. The NucliSens(R) HIV-1 QT assay uses three internal calibrators, enabling accurate quantitation of very low to very high concentrations of HIV-1 RNA. The test does not require an ultracentrifugation step, nor is thermocycling necessary. The entire testing procedure is internally controlled from sample to result. Calculation of viral load is automated using an electrochemiluminescent endpoint for high accuracy and precision. Results are available the same day.
The new test also offers safety advantages. The use of a lysis buffer inactivates viral particles and nucleases. Solid-phase binding of nucleic acids reduces aerosol formation and contamination risk compared to ultracentrifugation. For more information, visit http://www.nuclisens.com.
Current estimates indicate there are more than 1 million HIV-infected individuals in the United States, and more than 36 million worldwide (Source: UNAIDS).
BioMerieux, a division of the bioMerieux-Pierre Fabre Group, is based in France and specializes in infectious disease diagnostics, coagulation diagnostics, and industrial microbiology control. It is the eighth-largest biological diagnostics company in the world and is the international leader in the field of microbiology.
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