PROCLEIX® WNV Assay

FAQ

Q
Why is it important to screen blood donations for WNV RNA?

A
Only 20% of people infected with WNV are symptomatic; thus the vast majority do not know they are infected. Although donors may never develop symptoms of WNV infection, the virus may be present in their blood at sufficient levels to infect transfusion recipients. WNV NAT was designed for early detection of WNV infection in donors to prevent the transfusion of WNV-infected units in order to increase the safety of the blood supply.
Q
Why did Chiron and Gen-Probe specifically target WNV?

A
Based on the initial call set forth by the FDA in October 2002, Chiron and Gen-Probe developed a flexible and robust assay to specifically detect West Nile virus. The PROCLEIX® WNV Assay was designed to be performed on existing instrument platforms to minimize the operational impact of adding a new test and to enable ease of implementation.
Q
How many different types of donors can NAT labs screen with the PROCLEIX WNV Assay under IND?

A
Voluntary blood and plasma donors, including organ and tissue donors and non-heart beating donors. See the Intended Use for details.

Q
What has been the experience under IND of U.S. blood centers with the assay?

A
Since June 2003, the PROCLEIX WNV Assay has intercepted more than 1,500 WNV infected blood donors.