WHO
approves 15-minute Ebola test by Corgenix
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[February 20, 2015] By
Tom Miles
GENEVA
(Reuters) - 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.
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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.
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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.
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"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.
(Reporting by Tom Miles; Editing by Kevin Liffey and Crispian
Balmer)
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