NPHL Newsletter




May 2024 Edition



Tick Season

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Ticks are out! It's time to be prepared to prevent them, remove them, and, if you are one of the lucky ones in the laboratory, identify them.


Below are some valuable resources.





Highly Pathogenic Avian Influenza (HPAI) (H5N1)


On April 5, the Centers for Disease Control and Prevention (CDC) released a health advisory regarding Highly Pathogenic Avian Influenza Virus: Identification of Human Infection and Recommendations for Investigations and Response. This advisory noted that a farmer working on a commercial dairy farm in Texas, tested positive for HPAI A (H5N1) infection. The advisory stated that the current risk to the public remains low while also providing recommendations to the public, the farmer, and the clinician for infection control, testing, patient monitoring, and treatment.


On April 29, 2024, Region VII Disaster Health Response Ecosystem presented a Region 7 Special Pathogen Outbreak Report: Highly Pathogenic Avian Influenza webinar. Objectives for this include identifying the characteristics and origin of HPAI, modes of transmission, and current guidance for healthcare facilities and clinicians.


If your laboratory receives a call from a clinician regarding the testing of a patient with suspected HPAI direct them to their state or local health department for approval. Once approval is received, send an appropriate specimen to NPHL for testing. Since the previous-positive patient reported conjunctivitis, a conjunctival specimen would be acceptable to send along with nasopharyngeal swabs.


Also, if a laboratory performs influenza testing by a molecular mean and receives a result of Influenza A, no subtype, notify the Nebraska Department of Health and Human Services, and subsequently send the specimen to NPHL for further subtyping. 

U.S. Department of Transportation Releases a Safety Advisory Notice - MPXV


On March 11, 2024, the U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration released Safety Advisory Notice1 - Classification of MPXV Diagnostic Samples and Waste.

 

In this document it states that "most MPXV materials, including patient diagnostic samples and clinical waste - are appropriately classified for transportation as Category B infectious substances." Patient specimens for Mpox testing can continue to be shipped to NPHL according to UN3373, biological substance, Category B, 6.2 regulations.

 

MPXV Clade I Viral cultures (materials containing propagated virus) are still classified as Category A substances. This would be appropriate for laboratories that perform viral cell culture. 


If there are any questions regarding packaging and shipping, contact NPHL.

U.S. Food & Drug Administration is Tightening Oversight on Lab-developed Tests


The U.S. Food and Drug Administration is providing a webinar on May 14, 2024, at 12:00 PM CDT to provide an overview of its amendments to laboratory-developed test regulations.


If you are interested in watching this webinar, go to Webinar - Final Rule: Medical Devices; Laboratory Developed Tests - 05/14/2024 | FDA. The Zoom link is accessible on the website.


NPHL Website


April Lab Advisory Meeting

Do you have an idea for the Newsletter? Do you have something you'd like to submit? Is there something you'd like presented at the Statewide Laboratory Advisory Meeting?


Email us at NPHLab@unmc.edu.

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