FDA Approves Screening Test for West Nile Virus in Donors
On March 2nd, the FDA approved a license supplement for a nucleic acid test to screen for West Nile Virus (WNV) among blood and tissue donors, Chiron’s PROCLEIX WNV Assay. The assay detects genetic material of the virus contained in plasma samples from donors. The test can be used for samples pooled from up to 16 donors or individual samples.
This automated system can perform components previously delegated to technologists. This capability reduces the possibility of human error while increasing capacity to screen samples. An accelerated screening process allows more extensive testing of individual samples during high levels of WNV activity. Assays are run using the same equipment as the other PROCLEIX assays.
The first case of WNV in the United States was documented in 1999 and every year since that time. Individuals can contract WNV through organ transplant or blood donation. The most common means of transmission is through infected mosquitoes. In 2002, the FDA requested manufacturers develop a test capable of screening for WNV. Screening of donors is necessary because only about 20% of people infected with WNV are symptomatic.
March 6, 2007 Related topics: Infectious Diseases, Product Approval & Certification, Laboratory Equipment