HHS OKs Emergency Use of Unapproved Enterovirus D68 Tests

Alicia Ault

March 02, 2015

The Department of Health and Human Services (HHS) has paved the way for potentially more rapid testing of enterovirus D68 (EV-D68), an organism responsible for an outbreak of respiratory illness in 2014 that sickened more than 1000 Americans and killed more than a dozen, primarily children.

The HHS secretary determined that "there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves enterovirus D68," which, in turn, justifies "the authorization of emergency use of new in vitro diagnostics for detection of EV-D68," according to an order published in the Federal Register.

The authorization gives the US Food and Drug Administration the ability to quickly review and approve new diagnostics aimed at detecting EV-D68. These types of orders are often used to respond to perceived national security threats from bioterrorism, for instance, or in cases where military personnel might be exposed to agents or organisms in battle.

They are also used when there is the possibility of a public health emergency for Americans in the US or abroad — as was the case with such an order that expedited testing of vaccines and therapies for the Ebola virus.

EV-D68 was first discovered in 1962, and a mix of enteroviruses circulates every year, with infection most likely in the summer and fall, according to the Centers for Disease Control and Prevention (CDC).

There have been only small numbers of EV-D68 cases reported since 1987. But from mid-August 2014 to January 15, 2015, the CDC or state public health laboratories confirmed a total of 1153 cases and at least 14 deaths in 49 states and the District of Columbia. Almost all were among children. The CDC said there were likely millions of mild EV-D68 infections that were not detected.

The agency has recommended EV-D68 testing only for patients with severe respiratory illness and when the cause is unclear. Most clinicians have not had the ability to specifically test for EV-D68, so the confirmation has primarily had to be from a state or CDC lab.

The CDC received about 2600 specimens in 2014, of which a third were positive for EV-D68.

The agency developed and began using a quick EV-D68 diagnostic in October, which allowed results in days. That diagnostic may be one of the first that gets more widely disseminated under the HHS order. The order went into effect on February 6.

There are no specific treatments for EV-D68, and no antivirals that target the organism.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.