Researchers Frustrated by Failure to Roll Out ‘Game-Changing’ Ebola Test

A test kit that diagnoses Ebola rapidly using just a finger prick of blood could save lives in the ongoing epidemic in West Africa. But researchers are perplexed as to why the diagnostic kit has not been deployed in the field, despite both the World Health Organization (WHO) and the US Food and Drug Administration approving it four months ago for emergency use.

“A lot of people are frustrated,” says Nira Pollock, an infectious-diseases researcher at the Boston Children’s Hospital in Massachusetts, and the senior author of an independent field-validation study of the test kit, published on 26 June¹ in The Lancet. The results were presented to the WHO and health ministries in affected countries in March. “Many groups on the ground would like to deploy the test, but can’t, because national regulators haven’t approved it.”

The test, developed by the medical-diagnostics company Corgenix, of Broomfield, Colorado, detects Ebola specific proteins that are in the blood. Like a pregnancy test kit, it shows a positive result by coloured bands; it is simple enough to use that healthcare workers with minimal training could deploy it in remote villages and get a fast result. Existing ‘gold-standard’ methods of diagnosis require blood samples to be drawn and transported to sophisticated central laboratories for processing — which can result in long delays. The Corgenix test could not replace lab confirmation, but it would allow workers to identify infected people and isolate them faster, greatly reducing the spread of disease, says Nahid Bhadelia, an infectious-diseases physician at the Boston University School of Medicine and the Boston Medical Center in Massachusetts.