NIST Announces New Standard for H5N1 Influenza Tests

Testing Times

On the morning of January 2, 2025, the National Institute of Standards and Technology (NIST) in the United States revealed the development of a standard specifically for H5N1 influenza tests. This innovative standard will enable regional testing centers to calibrate their equipment for H5N1 bird flu, in addition to other influenza strains. In collaboration with the Centers for Disease Control and Prevention (CDC), NIST scientists have created a synthetic segment of viral genetic material that is non-infectious and incapable of replication. The CDC and NIST aim to expedite the availability of assays to help the U.S. and North America prevent another pandemic. NIST research chemist Peter M. Vallone stated in a press release, “We believe this genetic material will significantly advance our national readiness for potential pandemic threats.”

H5N1 Test Standards

Government researchers identified three sections of the H5N1 virus that differ slightly from other flu virus strains and are non-pathogenic, meaning they do not cause disease. These short RNA segments were replicated in a lab and packaged into vials for distribution. The aim is to send out these standards promptly, with vials being dispatched to testing facilities at no cost other than shipping. NIST microbial geneticist Scott Jackson commented, “The sooner this genetic material reaches manufacturers, the faster we can facilitate the development and validation of new H5N1 diagnostics.”

Lessons Learned

The swift action by the CDC to establish H5N1 standards stands in stark contrast to the delayed response to the COVID-19 outbreak in late 2019. According to the Brown University School of Public Health, critical missteps in the U.S. response to SARS-CoV-2 included a failure to utilize its extensive network of high-quality laboratories for timely diagnosis and characterization of infections. This oversight allowed COVID-19 to spread rapidly within communities before diagnostic testing became available. Once the tests were ready, inadequate infrastructure and slow distribution led to delays in results reaching facilities. Additionally, these delays left the CDC struggling to keep up with emerging genetic variants of the virus.

The proactive measures taken by NIST indicate that the current U.S. government has learned from the challenges faced during the COVID-19 pandemic and is enhancing its pandemic preparedness program. Whether the U.S. will fare better in future health crises remains to be seen.

References

NIST Develops Genetic Material for Validating H5N1 Bird Flu Diagnostic Tests. NIST. Published online January 2, 2025. Accessed January 2, 2025. https://www.nist.gov/news-events/news/2025/01/nist-develops-genetic-material-validating-h5n1-bird-flu-diagnostic-tests

Why Did the Best Prepared Country in the World Fare So Poorly during COVID? | Pandemic Center | School of Public Health | Brown University. Accessed January 2, 2025. https://pandemics.sph.brown.edu/why-did-best-prepared-country-world-fare-so-poorly-during-covid