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 to diagnose influenza A(H5) virus in patient specimens.

The CDC stresses that it is critical to immediately contact the state, local, territorial or tribal public health authority if a positive result for influenza A(H5) virus is obtained using an LDT to initiate important time-critical actions.

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