In response to the current H5N1 avian influenza outbreak, the National Institute of Standards and Technology (NIST) has developed a research grade test material to support the development and validation of diagnostic tests for the H5N1 virus.
This genetic material includes three segments of RNA corresponding to certain proteins of the H5N1 virus. Each unit of the material includes three 100-microliter vials, each containing one of the RNA fragments, with approximately 1 million RNA molecules per microliter. Because this genetic material is synthetic and noninfectious, it offers manufacturers a safe way to test and calibrate their equipment and methods. Tests that produce positive results when using this genetic material will meet a key benchmark for diagnostic reliability.
The material was developed in collaboration with the U.S. Centers for Disease Control and Prevention (CDC).
“The sooner this genetic material reaches manufacturers, the faster we can facilitate the development and validation of new H5N1 diagnostics,” added NIST microbial geneticist Scott Jackson.
The synthetic RNA fragment kits are being provided by NIST on a collaborative basis for recipients to evaluate the material’s potential fitness-for-purpose as a reference material for RT-qPCR assay development and evaluation, calibration of RT-qPCR methods and benchmarking other H5N1 control materials.
The institute similarly released SARS-CoV-2 research materials in 2020 to support diagnostic assay development to assist COVID-19 pandemic response, and positive controls for mpox tests in 2022.
“We believe this genetic material will significantly advance our national readiness for potential pandemic threats,” said NIST research chemist Peter M. Vallone.
Should H5N1 spread widely among humans, millions of diagnostic tests will be needed. To boost capacity, the CDC wants private companies to develop tests for detecting infections caused by the strain of the H5N1 virus that could cause an outbreak in humans. In June 2024, NIST entered a $1.5 million interagency agreement with the CDC to develop a genetic material that will help commercial entities produce reliable diagnostic tests.
“NIST is known for producing high-quality reference materials to support pathogen detection,” said Todd Davis, acting chief of CDC’s Virology, Surveillance and Diagnosis Branch. “Our collaboration with NIST exemplifies how the U.S. government unites expertise to prepare for pandemics.”
The H5N1 (Avian Influenza) Synthetic RNA Fragments are available through the NIST Office of Reference Materials.
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