Target Product Profile for a Rapid Diagnostic Test for West Nile Virus Disease: Request for Information

Official abstract: The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on the proposed Target Product Profile for a Rapid Diagnostic Test for West Nile Virus Disease for Use in Hospitals and Clinical Laboratories. This Request for Information (RFI) invites comments and suggestions on the proposed target product profile. HHS/ CDC is publishing this target product profile to improve the likelihood of developing a commercially available diagnostic assay that can be used to rapidly diagnose West Nile virus infection. Public input is a valuable component in developing a useful target product profile.