SHalasey BBB_1136_crop100x100pSince the middle of 2014, health authorities throughout the world have been on heightened alert for signs of the overseas spread of the ebola virus currently ravaging the West African nations of Guinea, Liberia, and Sierra Leone. In the United States, a great deal of that attention has focused on refining the standard operating procedures necessary to protect caregivers, including new standards for donning and doffing personal protective equipment.

Mostly outside of the public view, clinical laboratorians have faced their own challenges for dealing with patient samples that might be infected with the ebola virus—or something else. As described in this issue’s feature on emerging infectious diseases, by contributing writer Shara Rosen, laboratory personnel have responded with an abundance of caution beyond the guidelines issued by the US Centers for Disease Control and Prevention (CDC). Meanwhile, news related to the ebola outbreak has continued to flow.

On December 23, FDA issued its seventh emergency use authorization (EUA) for an ebola virus test. The EUA was granted to Roche Molecular Systems Inc, Pleasanton, Calif, as exclusive distributor of the LightMix Ebola Zaire rRT-PCR test, manufactured by TIB Molbiol, Berlin, Germany. Authorized for use only by CLIA high-complexity laboratories or their non-US equivalents, the test can produce 96 test results in just over 3 hours, and runs on Roche’s LightCycler 480 or Cobas z 480 qPCR instruments.

The following day, the New York Times reported that a sample-handling error in the CDC special pathogens branch had potentially exposed a lab technician to live ebola virus in a sample that was supposed to have contained only killed virus. The technician was to be monitored during the ebola incubation period of 21 days.

At the beginning of January, at last, some good news, as CDC announced that travelers from Mali would no longer be required to undergo enhanced screening and monitoring when entering the United States. According to the agency, the last Ebola patient in Mali tested negative on December 5, 2014, and there are currently no active cases.

Infectious disease experts have confidence that better testing technologies will play a key role in ending the current ebola crisis—and minimizing the impact of future emerging-disease outbreaks. But first, they say, we will have to get past the use of thermometers as our first line of diagnostic defense.

“Hi-tech solutions are already available today and with the right resources and collective consciousness can be promptly deployed to combat the current global ebola crisis,” wrote Anita Goel, MD, PhD, chairman and CEO of the Nanobiosym Research Institute and Nanobiosym Diagnostics, Cambridge, Mass, in a recent guest post for Forbes.com. “For example, by precision controlling nanomachines that read and write DNA, it is now possible to rapidly and affordably detect and quantify genetic fingerprints of various pathogens like ebola, HIV, and the flu at the point of care with gold-standard accuracy.”

Focusing the power of emerging diagnostic technologies on emerging infectious diseases may require less technological achievement than simple will. The pace of healthcare systems’ responses to current and future challenges may depend on whether a willingness to advance such technologies can be created among payors and policymakers.

Steve Halasey
Chief Editor, CLP
[email protected]
(626) 219-0199