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05/31/2024: Lab Advisory: Enforcement Discretion Granted for the Use of Conjunctival Swabs with the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Kit
Audience: Clinical Laboratory Professionals
Level: Lab Advisory: Enforcement Discretion Granted for the Use of Conjunctival Swabs with the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Kit
On May 24, 2024, the U.S. Food and Drug Administration (FDA) granted enforcement discretion for the use of conjunctival swabs as an acceptable specimen type with the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Kit.
Laboratories may now submit conjunctival swabs from patients that meet Epidemiologic criteria AND either Clinical OR Public Health Response criteria for novel influenza A virus testing to their state public health laboratories for use with the CDC assay alongside a paired nasopharyngeal swab (NPS). These conjunctival swabs must be collected and transported using the same media as the paired NPS used with the currently cleared CDC kit.
The risk posed by novel influenza A viruses to the public still remains low.
Contact flusupport@cdc.gov for any additional questions, comments, or concerns.
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Online Resources
- Avian Flu
- H5N1 in Animals: Interim Recommendations for Prevention, Monitoring, and Public Health Investigations
- Health Alert Network (HAN) – 00506 | Highly Pathogenic Avian Influenza A(H5N1) Virus: Identification of Human Infection and Recommendations for Investigations and Response
- Clarification for A/H5 Influenza Assay Licensing | LOCS Message
Questions?
- If you are a clinical or public health laboratory professional, contact LOCS.
- For media inquiries, contact the CDC Newsroom.
- For all other questions, contact CDC-INFO.
Thank you,
The Laboratory Outreach Communication System
Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)
Center for Laboratory Systems and Response (CLSR)
Centers for Disease Control and Prevention (CDC)