FDA Approval for WNV External Quality Controls

AcroMetrix Corporation, a leading provider of quality controls for clinical diagnostic and blood testing laboratories, has received 510(k) clearance from the FDA for the VeriSure® Pro West Nile Virus (WNV) External Quality Controls.

These controls are for use with Chiron’s Procleix® WNV assay that was approved in December 2005 by the FDA for the testing of WNV using nucleic acid amplification. The clearance from the FDA allows these controls to be the first WNV control to be marketed and sold in the United States for "In vitro diagnostic use" in blood screening.

AcroMetrix external quality controls for WNV were selected by Chiron for use in clinical trials designed to evaluate the safety and effectiveness of a new screening test based upon the detection of WNV nucleic acid in donor blood.

Frequent testing of independent quality control samples is expected to provide blood testing centers with a means of monitoring the performance of the Procleix® WNV assay. Routine use of the AcroMetrix WNV external quality controls can enable sites to monitor day-to-day test variation, lot-to-lot performance of test kits and operator variation, for the purpose of identifying increases in random or systematic error.