February 20, 2015
The World Health Organization has approved the first rapid test for Ebola in a potential breakthrough for ending an epidemic that has killed almost 10,000 people in West Africa, it said on Friday.
The test, developed by U.S. firm Corgenix Medical Corp, is less accurate than the standard test but is easy to perform, does not require electricity, and can give results within 15 minutes, WHO spokesman Tarik Jasarevic said.
"It's a first rapid test. It's definitely a breakthrough," he said.
The standard laboratory test has a turnaround time of 12-24 hours. While the Corgenix test is not failsafe, it could quickly identify patients who need quarantine and make it much easier to verify rapidly any new outbreaks.
Procurement and roll-out of the test kits will not begin immediately because the company is still working out costing and needs a week or two more to finish administrative procedures with the U.S. Food and Drug Administration, Jasarevic said.
The health charity Medecins Sans Frontieres, which has been at the forefront of the fight against Ebola, had expressed an interest, he said.
The so-called ReEBOV Antigen Rapid Test involves putting a drop of blood on a small paper strip and waiting 15 minutes for a reaction in a test tube. It is able to correctly identify about 92 percent of Ebola infected patients and 85 percent of those not infected with the virus, the WHO said.
Knowing that margin of error is a major help, said Robyn Meurant, from the WHO's department of essential medicines and health products.
"The big fear has been that the market gets flooded with tests of unknown quality, or unknown performance, and with Ebola you need to know what are the limitations. A false negative has enormous implications. So does a false positive," she said.
"So this is not a perfect test but... for a rapid test, (it is) not too bad at all."
It would be especially useful if a cluster of suspected cases flared up, she said.
"If you had five patients with suspected symptoms and you went ahead and tested them and they were all positive you'd have a high degree of confidence that you've got Ebola."
Because of the margin of error, the Corgenix test would then need to be followed up by the standard laboratory test.
The WHO is still assessing four or five other rapid test candidates, but Meurant said it was not possible to say when the next approval might be.