Considerations for Use of Influenza A(H5) Subtyping Tests by Clinical Laboratories

The U.S. Centers for Disease Control and Prevention (CDC) continues to distribute an FDA 510k-cleared IVD influenza A(H5) assay to state and jurisdictional public health laboratories to test patients for influenza A(H5) virus. CDC is also aware of recent development and use of IVDs offered as LDTs independent of state and jurisdictional public health laboratories…