"We have compared the swine fever virus' sequence with our assays. The primers, which define the starting and end points of a genetic sequence that is amplified to make the target sequence visible, match 100 percent for the artus kit and almost 100 percent for the Resplex kit", said Dr Thomas Grewing, senior director, R&D. "We are now working closely with reference institutions to have both assays further re-validated and optimized based on clinical samples".
Both test kits are for research use only. They have not been cleared or approved by authorities including the United States Food and Drug Administration or any other regulatory agency in the United States, or under the European IVD Directive, for human diagnostic or other clinical use, and are not intended and should not be used for human diagnostic or any other clinical purposes.
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