The U.S. Food and Drug Administration has approved the first fully automated West Nile virus nucleic acid test for donor screening.
March 6, 2007 (Press Release) --
The U.S. Food and Drug Administration has approved the first fully automated West Nile virus nucleic acid test for donor screening.
The Procleix West Nile Virus Assay is licensed to detect the virus' genetic material in plasma specimens from individual donors of blood, tissue and organs, and other living donors. It is not intended for use on cord blood specimens or as an aid in the diagnosis of such infections, the FDA noted.
The system can be used for testing individual donor samples or for testing pooled samples from up to 16 individual donations of whole blood and blood components. The FDA said the assay system is fully automated and capable of performing certain steps that are generally performed by technologists when using semi-automated systems.
"The capability of full automation can reduce the potential for human error while accelerating donor screening and enhancing the safety of blood and tissues," said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research. "This is the latest step forward in what has been a very successful industry-government effort to keep blood safe from the emerging threat of West Nile virus."
Source: http://www.playfuls.com/
The Procleix West Nile Virus Assay is licensed to detect the virus' genetic material in plasma specimens from individual donors of blood, tissue and organs, and other living donors. It is not intended for use on cord blood specimens or as an aid in the diagnosis of such infections, the FDA noted.
The system can be used for testing individual donor samples or for testing pooled samples from up to 16 individual donations of whole blood and blood components. The FDA said the assay system is fully automated and capable of performing certain steps that are generally performed by technologists when using semi-automated systems.
"The capability of full automation can reduce the potential for human error while accelerating donor screening and enhancing the safety of blood and tissues," said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research. "This is the latest step forward in what has been a very successful industry-government effort to keep blood safe from the emerging threat of West Nile virus."
Source: http://www.playfuls.com/
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