Rapid Influenza Tests Should Be Ready This Year, Says HHS Pandemic Update

According to a recently released recap of HHS' efforts to date to assure the nation is prepared to meet a possible influenza pandemic head-on, the agency says it expects point-of-care influenza rapid test devices to be ready for prime time by the end of the year. Availability of such tests means that doctors and other health care professionals would be able to diagnose avian or any other potentially pandemic form of influenza quickly and easily.

According to HHS' Pandemic Planning Update VI, (19-page PDF; About PDFs) which was released in January, the agency is funding development of the tests, along with numerous other related endeavors. It's expected that clinical trials will be completed and FDA approval secured by the end of 2009.

That announcement, along with word of advances in the production of so-called prepandemic vaccines, is welcome news, given that as of March 11, the World Health Organization, or WHO, had confirmed 411 human cases of avian influenza A (H5N1) and 256 deaths in 15 countries since 2003.

There were 44 lab-confirmed H5N1-induced illnesses and 33 deaths last year in Bangladesh, Cambodia, China, Egypt, Indonesia and Vietnam. WHO officials already have received reports of 16 confirmed illnesses and six deaths this year in China, Egypt and Vietnam.

According to the CDC, cases of severe H5N1 illness probably have been reported, but it is possible that many milder cases of H5N1 infection in humans have not been reported. The agency said in a fact sheet about avian influenza and H5N1 infection that more than half of people infected with the virus have died. Most cases have occurred in previously healthy children and young adults and have resulted from direct or close contact with H5N1-infected poultry or H5N1-contaminated surfaces.

Overall, H5N1 remains a rare disease in people, does not infect humans easily and is not readily transmissible.

"Nonetheless, because all influenza viruses have the ability to change, scientists are concerned that H5N1 virus one day could be able to infect humans and spread easily from one person to another," the CDC said. "Because these viruses do not commonly infect humans, there is little or no immune protection against them in the human population. If H5N1 virus were to gain the capacity to spread easily from person to person, an influenza pandemic ... could begin."

HHS said in its January report that it has stockpiled 12.2 million treatment courses of H5N1 pre-pandemic influenza vaccine, some of which is intended for use in clinical trials now under way, as well as those planned for the future. The remainder is designated to protect health care workers and other critical workers in the early stages of a pandemic.

If the virus mutates to the point of having pandemic properties, HHS said a new vaccine would be developed, but the stockpile would provide some protection in the interim. The agency's goal is to be able to produce enough vaccine for every American within six months of a pandemic virus being identified.

In November 2008, the CDC released updated interim guidance for testing of suspected human cases of H5N1 infection, as well as guidance for follow-up of close contacts of individuals with suspected or confirmed cases of H5N1 virus infection.