West Nile virus testing
This article was originally published in The Gray Sheet
Executive Summary
Focus Technologies begins shipments of Flavivirus (WNV) antibody detection reagents to public and commercial labs April 29. Based on protein antigen technology licensed from CDC, the analyte-specific reagent configurations will now be evaluated by major U.S. labs. Ongoing clinical trials at Mayo Clinic and the New York Department of Health will support a 510(k) submission to FDA this summer, and also will determine if the test is sufficiently sensitive to yield conclusive results without plaque reduction neutralization testing (RPNT), currently required for confirmation (1"The Gray Sheet" March 17, 2003, p. 8). In June, Focus will begin offering confirmatory PRNT in its lab as an alternative to public health testing options...