As I write, just a few days before the end of October, the US Centers for Disease Control and Prevention (CDC) lists the following grim statistics for the outbreak of ebola hemorrhagic fever affecting the West African countries of Guinea, Liberia, and Sierra Leone: total cases, 10,141; laboratory-confirmed cases, 5,692; deaths, 4,922. It is unfortunate that these numbers will no doubt have increased by the time you read this column.
CDC also reports that the United States has experienced four cases of ebola virus disease: two imported (including one death), and two locally acquired by healthcare workers. Propelled by public anxiety over the spread of ebola to the United States, public health authorities are working hard to prevent these numbers from changing—and much of that work centers on the need for advanced clinical diagnostics.
In a recent FDA Voice posting, Commissioner Margaret A. Hamburg, MD, emphasized the agency’s use of its power to grant emergency use authorization (EUA) for diagnostics, “when, among other reasons, based on scientific evidence available, there is no adequate, approved, and available alternative.” FDA has already granted EUA status to five ebola diagnostic tests: one developed by the US Department of Defense; two developed by CDC; and two developed by BioFire Defense, Salt Lake City, a subsidiary of in vitro diagnostic manufacturer bioMérieux.
The availability of such advanced diagnostics cannot come too soon for the endangered populations of West Africa. According to Andrew S. Thompson, PhD, senior analyst for in vitro diagnostics with research and consulting firm GlobalData, London, poor logistics and low numbers of trained staff are two of the greatest limitations to providing a sufficient molecular diagnostic capacity in the region.
“While modern molecular diagnostic testing is the most sensitive and precise way to detect the ebola virus, it is complex and expensive to perform,” says Thompson. “It is therefore extremely challenging to implement this technology in poorer regions of the world, where the healthcare infrastructure is inadequate, or even nonexistent.”
Thompson suggests that such difficulties could be overcome by implementing molecular diagnostics suitable for the African environment, including reagents that do not require refrigeration, and quick set-up instruments that are low-cost, self-powered, and simple to use. “This approach would provide a more robust model for responding to sporadic emergencies than the current approach, which depends on coordinating a global response and typically lags behind the first occurrence of the outbreak,” he says.
While Thompson believes the shortage of trained staff can be filled by deploying skilled scientists from outside the region, it will take a concerted international effort by labs, manufacturers, and regulatory authorities to make the right diagnostics available before the numbers associated with the outbreak grow much larger.
Steve Halasey
Chief Editor, CLP
[email protected]
(626) 219-0199
