NEW YORK – The National Institute of Standards and Technology announced Thursday that it can now provide diagnostics developers with genetic reference material to detect the H5N1 strain of influenza A, also known as bird flu.
The nonhazardous synthetic material can be used to calibrate molecular diagnostic tests. It was developed under a $1.5 million interagency agreement with the US Centers for Disease Control and Prevention and is intended to help commercial entities produce reliable diagnostic tests.
"We believe this genetic material will significantly advance our national readiness for potential pandemic threats," Peter Vallone, a research chemist at NIST, said in a statement. Scott Jackson, a microbial geneticist at NIST, also noted that "the sooner this genetic material reaches manufacturers, the faster we can facilitate the development and validation of new H5N1 diagnostics."
There are a limited number of diagnostic tests for the H5N1 virus currently commercially available, and although the risk to human health is still deemed low by the CDC, strains affecting dairy cows and birds may pose a pandemic risk.
Should H5N1 spread widely among humans, millions of diagnostic tests will be needed, NIST said, adding that the CDC wants private companies to develop tests to boost capacity.
The research-grade test material includes segments of RNA corresponding to the hemagglutinin, neuraminidase, and matrix proteins of the H5N1 virus. It is distributed in three 100-microliter vials, each containing one of the RNA fragments, with approximately 1 million RNA molecules per microliter. The institute also plans to release a more thoroughly characterized standard reference material in the future.
The material offers manufacturers a safe way to test and calibrate their equipment and methods, NIST said, as tests that produce positive results when using this genetic material will meet a key benchmark for diagnostic reliability.
Previously, NIST released synthetic gene fragments to support manufacturing assays detecting COVID-19 and mpox.
NIST said it is distributing the H5N1 genetic material for free to companies entering the H5N1 diagnostic market, with a small fee for shipping and packaging. Technical information and instructions for requesting the material are available on the NIST website.