More than one year after the initial outbreak, the number of Ebola cases sits at over 27,000 cases reported and 11,000 deaths in West Africa to date (1). Accurate diagnosis currently relies on skilled laboratory staff and equipment, largely unavailable in the field, resulting in delays in diagnosis and difficulty containing spread of the virus (2).
Using lateral flow technology, BBI’s assay will make testing simpler and quicker than assays such as RT-PCR that requires technical infrastructure. With minimal training, local health teams can complete the test at bedside and have a result in 20 minutes. In field data suggests the test could be used as a negative agreement ‘rule-out’ test and screening method (3). In the future, such a test could possibly be deployed at borders to monitor and control spread of the virus.
Through collaboration with partners, a lateral flow test has already been evaluated in the field. In trials in Sierra Leone, of 138 participants enrolled in testing, a 100% detection rate was achieved. At a low positive the test achieved 100% sensitivity and 92% specificity, and at a high positive, 100% sensitivity and 97% specificity (3), making the BBI assay potentially more sensitive and specific than other lateral flow or dipstick type assays currently available to date.
Using the unique integrated AtomoRapid™ platform, the number of components in the kit is reduced, simplifying the process for end users whilst reducing the risk of user error and cross contamination.
Aiming for a 3rd quarter launch following regulatory approval, the test will be available for immediate deployment in affected areas. BBI will then roll out to all global territories following their respective regulatory registration and acceptance.
In addition, a second version of the test will be evaluated in combination with the Novarum DX Smartphone reader. Allowing users to read and share test data using smartphone technology. This development could potentially allow instant connectivity of patients and field workers with medical experts, while also utilising built in GPS capability to track and monitor disease ‘hot spots’.
Leigh Thomas, Chief Commercial Officer commented “BBI has developed high performance lateral flow tests for some of the world’s leading diagnostic companies for over 25 years. Our expertise and flexibility has allowed us to quickly deploy a team and develop a rapid test in 9 months which, based on field testing, promises to have an immediate and positive impact on the Ebola crisis. We are pleased that our test will meet an immediate need in the field and ultimately improve the lives of others”.
References:
(1) WHO Ebola Situation Report 04 June 2015
(2) J Virol. 2004;78(8):4330-41
(3) Eurosurveillance, 2015, 20 (12):4-6