The BBI Group has applied to the US Food and Drug Administration for Emergency Use Authorisation to allow the assay to be used to screen patients suspected of carrying the infection, and how they are then managed.
The lateral flow assay allows testing to be carried out at the bedside of patients, and does not require to be assembled by medical workers in the field.
This contrasts with the PCR (polymerase chain reaction) or molecular test for Ebola, which tests for the disease at a DNA level and requires laboratory conditions.
Cardiff-based BBI, which has had a site in Scotland since acquiring Dundee’s Alchemy Laboratories in 2006, says that with minimal training local health teams can complete tests at bedside and have a result within 20 minutes.
It believes the test, developed in collaboration with the Defence Science and Technology Laboratory, has the potential to be deployed at borders in the future to monitor and control the spread of the virus.
Fiona Marshall, managing director of BBI Detection, said the development of the kit could bring more jobs to Dundee, where the company currently employs 80 staff. The headcount has already grown by 15 in the last year.
Ms Marshall said: “What it means is we need to increase our assembly capability, so we take on local assembly workers.
“We also have been looking for scientists as well – as soon as you bring more tests on board it means you need to bring more scientists, more assembly workers and, because it is a regulated product, more expertise around regulation as well.”
The test kit currently before the FDA uses an integrated AtomoRapid platform, which reduces the number of components in the kit. This simplifies the process for end users while reducing the risk of user error and cross contaminiation.
BBI, which hopes to launch the product in the third quarter after gaining approval, has held talks with a distributor in Ghana.
The company plans to evaluate a second version of the test in combination with the Novarum DX smartphone reader, which will allow users to read and share test data.
This has the potential for patients and field workers to connect instantly with medical experts, with GPS technology allowing disease hotspots to be tracked and monitored.
Ms Marshall said earlier format of the assay has been trialled in Sierra Leone, where a 100 per cent detection rate was achieved among the 138 patients enrolled in testing. It was also tested in Liberia.
Since the initial outbreak was reported around a year ago, more than 27,000 number of Ebola cases have been reported, leading to 11,000 deaths in West Africa to date.
There was excitement last week about the potential of a vaccine that pharmaceutical giant Merck is developing to protect against the Ebola virus.
But while it was reported several weeks ago that Liberia was free of the disease, the World Health Organisation has subsequently said that 25 new cases are being presented each week.
Ms Marshall said: “They’re worried again there is going to be effectively a new outbreak on the horizon – they have obviously not completely got rid of it.”
Asked if there are comparable products available, Ms Marshall said there are companies operating at a similar stage. But she noted: “The pioneering thing about ours is the actual platform is on. Because it is all integrated in one it makes it so much easier to use.”
Ms Marshall added: “In terms of the performance of the assay compared to other assays, ours is performing better than other assays. In terms of PCR, which is the laboratory-based assay, it’s not performing as well, because that is the nature of lateral flow.
“But the fact you can use it at a bedside or point of care, and you don’t have to go into a laboratory to be tested makes it so much easier to use.”
Ms Marshall believes the test is cost effective, but noted: “Is it a dollar a test? No. It hasn’t become a commodity like malaria tests have at the moment.”
The Ebola test is the first BBI has taken from conception through to market. Until now it has typically manufactured assays for other companies, including ‘flu assays and a test for deep vein thrombosis.