The WHO will announce the end of a two-year Ebola outbreak on January 15, 2016, to "mark 42 days since the last Ebola cases in Liberia were tested negative" (AFP Photo/Evan Schneider)
Tulane University scientists have created an Ebola diagnostic device that they say is as easy to use and nearly as fast as a home pregnancy test.
The potentially game-changing device, which takes only a drop of blood and 15 minutes to identify the disease, is awaiting federal approval before it can be used in West Africa. Doctors there say it is sorely needed to prevent people from spreading the deadly virus while they wait days for lab results.
Robert Garry, a professor of microbiology at Tulane, has teamed up with Corgenix, a Colorado-based company, to create the device with nearly $3 million in federal funds. They are awaiting a green light from the Food and Drug Administration to fast-track approval for its use in West Africa. Another company, Genalyte of San Diego, says it has developed a test that takes just 10 minutes and also needs only one drop of blood to diagnose.
The tests “would really be a game changer,” said Ranu Dhillon, a doctor who is advising the president’s office in Guinea on its national response to Ebola.
Guinea and the other West African countries battling the disease are aiming to get 70 percent of their Ebola sufferers isolated to stem the rapid spread of the deadly virus.
But this process can take days right now, because diagnosing Ebola is so cumbersome. Its symptoms resemble those of malaria and many other common diseases. Currently, trained health workers must take a vial of blood from a patient — raising their chances of infecting themselves in the process — and then send it to one of 12 labs in the region that can diagnose Ebola. Those machines take just four hours to detect the disease, but getting the blood samples there and back can take days.
“Then you go back and more often than not the person is not there or the person has died and in the interim they’ve probably infected several other people,” Garry said.
Dhillon thinks with this device, the time from symptoms appearing to isolation could be reduced to under a day. Someone with a fever could call the country’s 911 line, and a health worker could show up at the door and tell the individual if he or she has Ebola. “Just as important as getting people isolated is getting people isolated quickly,” Dhillon said.
Currently, when people suspect they have Ebola, they go to the closest regional health center and wait with other patients, who also might have the virus. That spreads the disease farther. Dhillon said officials in Guinea were considering recruiting phlebotomists to go house to house on motorbikes and take blood samples from people who feared they had Ebola for testing in the closest lab. But a shortage of trained health workers made that plan untenable.
The FDA announced this week it would give special emergency-use authorization to two other fast tests made by BioFire Diagnostics, a Salt Lake City company. These devices can detect Ebola through DNA analysis of blood, saliva or urine in just an hour.
But the BioFire tests still must be conducted in a lab, which means they would only slightly speed up the process that health workers are currently using in West Africa. Doctors Without Borders’ diagnostics tests take four hours, but transporting the samples in the rainy season over bad roads can add days to that process.
“It’s still going to take a lab; it’s still going to take electricity,” Garry said of the BioFire tests. “I don’t think it’s all that easy to get them out into the field or strap them on your back.”
In contrast, Garry’s test requires only 15 minutes and 30 microliters — or just a drop — of blood from a patient. Volunteers would prick the patient’s finger with a lancet, transfer the blood onto a pad and then put the pad into a test tube. A test strip placed in the tube would show within 15 minutes if the patient has Ebola. (If two stripes appear, instead of one, the patient has Ebola.)
The World Health Organization announced on Wednesday that 5,000 people have died from the Ebola virus worldwide and that the death rate for those who contract it is around 70 percent. Even though WHO plans to test vaccines for the virus in West Africa as early as December, a rapid test is still needed.
“Even if you vaccinate everyone, it takes you a while to get 100 percent coverage,” Dhillon said. “You’re still going to have cases happening.”