05/31/2024 Enforcement Discretion Granted for the Use of Conjunctival Swabs with the ÐÇ¿ÕÓéÀÖ¹ÙÍø Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Kit

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  • Level: Lab Advisory: Enforcement Discretion Granted for the Use of Conjunctival Swabs with the ÐÇ¿ÕÓéÀÖ¹ÙÍø Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Kit
  • Audience: Clinical Laboratory Professionals
LOCS: Laboratory Outreach Communication System

Lab Advisory: Enforcement Discretion Granted for the Use of Conjunctival Swabs with the ÐÇ¿ÕÓéÀÖ¹ÙÍø 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 ÐÇ¿ÕÓéÀÖ¹ÙÍø Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Kit.

Laboratories may now submit conjunctival swabs from patients that meet for novel influenza A virus testing to their state public health laboratories for use with the ÐÇ¿ÕÓéÀÖ¹ÙÍø 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 ÐÇ¿ÕÓéÀÖ¹ÙÍø kit.

The risk posed by novel influenza A viruses to the public still remains low.

Contact [email protected] for any additional questions, comments, or concerns.

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Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)

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