American Red Cross announces plan to screen donated blood for West Nile Virus (WNV)

A colleague in California wishes to share the following notification received from the American Red Cross (excerpted verbatim from letter of April 22, 2003) to begin screening donated blood for West Nile Virus. Comments are encouraged.

"The Centers for Disease Control and Prevention surveillance has documented the spread of West Nile Virus (WNV) to almost every state in the United States. Twenty-one cases of confirmed transfusion-related virus transmission were documented in 2002, and this number may be on the rise. As a result, the American Red Cross and other blood centers will begin testing for WNV genetic material in blood donations under an Investigational New Drug (IND) application beginning on or about July 1, 2003.

Human West Nile Virus infection was first identified in the United States in 1999. The 4,161 human cases reported during 2002 covered 39 states and Washington, DC, and resulted in 263 WNV associated deaths and 273 cases of meningoencephalitis. Surveillance data indicates that WNV is now permanently established in the Western Hemisphere. According to preliminary estimates, the maximum risk of transfusion transmission during the 2002 peak epidemic period in the United States was approximately 1-2 cases per 10,000 transfusions.

Investigational testing for WNV will be performed by the American Red Cross in the five existing Nucleic Acid Test (NAT) laboratories. The Red Cross will employ the same process as is used for HIV-1/HCV NAT. As part of the investigation, positive donors will be contacted for follow-up samples to confirm the investigational WNV screening results and may be reinstated if confirmatory test results are negative. Blood collection agencies testing under an IND are permitted to recover the costs associated with the assay. Estimates will be submitted to the Food and Drug Administration and, once approved for cost recovery, hospital customers will be notified of the specific WNV per unit test cost. Using estimates provided by the test vendor and our own internal calculations the WNV testing cost is anticipated to be in the range of $4.00 to $5.00 for red blood cells and apheresis platelets. The final amount is expected to be available in May 2003.

The top priority of the Red Cross is to enhance the safety of the blood supply and to help customers minimize the risk of WNV transfusion transmission. The plans for this investigation do not include any intervention with, or data collection from, blood recipients. Although highly unlikely, we may become aware of an instance in which a donation from a WNV positive donor has been issued; in these cases, we will notify you and the FDA. At that time, you may wish to consider whether the recipient(s) should be managed as human subjects of research. For those patients requiring blood transfusions, it is recommended that you update your Patient Informed Consent Form to reflect the risk of WNV transfusion transmission."

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