Highly Pathogenic Avian Influenza (HPAI) is a disease that is highly contagious and often deadly in poultry, caused by highly pathogenic avian influenza A (H5) and A (H7) viruses; it is also known as bird or avian flu. HPAI viruses can be transmitted by wild birds to domestic poultry and other bird and animal species. Although bird flu viruses do not normally infect humans, sporadic human infections have occurred. It is important to note that “highly pathogenic” refers to severe impact in birds, not necessarily in humans.

According to the U.S. Centers for Disease Control and Prevention (CDC), avian (bird) influenza (flu) A rarely infects people. CDC continues to monitor emergency department data and flu testing data for any unusual trends in flu-like illness, flu, or conjunctivitis. To date, surveillance systems do not show any unusual trends or activity.

In vitro diagnostic (IVD) products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions. IVDs include tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person´s overall health to help diagnose, cure, treat, or prevent diseases.

In response to requests from the public, the FDA is providing a list of in vitro diagnostic tests that have FDA 510(k) clearance, or granted de novo request, or are authorized for emergency use (EUA), for the detection of influenza in certain specimens from humans. Most tests listed below for the detection of seasonal influenza may be capable of detecting influenza A/H5N1, which is a subtype of influenza A. However, only tests specifically designed for subtyping will be able to determine if the person has seasonal flu, or influenza A/H5.