The National Institute of Standards and Technology (NIST) has developed a nonhazardous synthetic genetic material designed to validate diagnostic tests for the H5N1 virus, commonly known as bird flu.
“The sooner this genetic material reaches manufacturers, the faster we can facilitate the development and validation of new H5N1 diagnostics,” NIST Microbial Geneticist Scott Jackson said in a statement.
The genetic material, which was developed in conjunction with the U.S. Centers for Disease Control and Prevention (CDC), includes three segments of RNA corresponding to certain proteins of the H5N1 virus, the hemagglutinin, neuraminidase, and matrix proteins, which are the genetic targets that most H5N1 tests use to identify H5N1. Each unit of the material includes three 100-µl vials, each containing one of the RNA fragments, with approximately 1 million RNA molecules per µl. The material was designed to give manufacturers a safe way to test and calibrate their equipment and methods, NIST said.
While the H5N1 virus is currently a low-risk threat to human health among the general public, highly pathogenic strains affecting cattle and poultry and the recent spread of the virus have raised concerns about a pandemic risk. The CDC is encouraging companies to develop diagnostic tests for detecting the strain of the H5N1 virus that could cause an outbreak in humans.
The NIST forged a $1.5 million interagency agreement with the CDC to develop the genetic material in June. The agency has previously developed reference materials to assist in testing during other outbreaks, including synthetic gene fragments to aid in the development of diagnostic tests for COVID-19, and genetic material for mpox testing.
NIST is distributing the H5N1 genetic material for free, with a small fee for shipping and packaging, to companies developing H5N1 diagnostics. Technical information, guidance, and instructions for requesting the material are available on the NIST website.
