Invention: Diagnostic kits for developing countries
The invention from researcher Helen Lee at the University of Cambridge is an instant blood diagnostic kit developed for resource-poor regions of the globe, allowing for on-the-spot detection of infectious diseases such as HIV, hepatitis B and chlamydia. Through fast, simply-to-read results, the kits are helping to track and better treat some of the world's deadliest diseases.
Introduced in 2011, the robust diagnostic tests developed by
blood researcher Helen Lee have unlocked an unprecedented level of infectious
disease management in sub-Saharan Africa and other developing regions. Administered
as a simple blood plasma test, the invention delivers results within a matter
of minutes - requiring no trained personnel or clinical infrastructure - while
also monitoring levels of viral load in the blood as an important feedback signal
during medical treatment.
Lee achieved her breakthrough by focusing on a testing method that would yield results visible to the naked eye, instead of relying on costly microscopes or visualisation techniques. Her simple test consists of mixing a patient's blood with so-called nucleic acid-based assays, a combination of chemicals in a disposable cartridge that will change colour in the presence of viral RNA in blood plasma samples. Unlike other tests, the cartridges do not require cold storage or transport - making them perfectly suited for conditions in Africa - and the kits can be stored at temperatures of up to 37°C for nine months.
Societal benefit
While the spread of HIV is largely contained in developed countries, the disease continues to proliferate in regions such as sub-Saharan Africa. Here, around 25 million people are currently living with the virus, accounting for 70% of the global total according to the World Health Organisation. Diagnosis and treatment are keys to stopping the pandemic, but a lack of clinical infrastructure continues to impede progress.
Inexpensive and precise, Lee's invention solves three fundamental problems of infectious disease outreach in resource-poor areas. Firstly, the tests deliver results without need for refrigeration, trained personnel or elaborate equipment - perfect for "test-and-treat" facilities in the developing world. Secondly, "instant" test results prevent patients being "lost to care" - in other words leaving before diagnosis results are ready - which can account for 30-70% of all patients. Thirdly, the tests monitor viral load in patients' blood, critical for gauging drug dosages for treatment.
Economic benefit
Marketed by Lee's start-up company Diagnostics for the Real World Ltd (DRW) as the SAMBA (Simple AMplification Based Assay) system, the tests have been used to screen 40 000 people for HIV in Malawi, Uganda and a growing number of other sites in co-operation with Doctors Without Borders, among others. A SAMBA machine can run up to four samples at a time, costing EUR 15 (USD 17) for each test. It runs on electricity but can switch to eight-hour batteries during outages. The SAMBA HIV Assay for therapy monitoring has recently received the CE regulatory approval for use in the European territories.
Headquartered in Sunnyvale, California, and in Cambridge, UK, as a non-profit academic unit at the University of Cambridge, Diagnostics for the Real World has successfully raised around EUR 60 million (USD 65 million) in research and health grants to date from organisations such as UNITAD, NIH and the Wellcome Trust. DRW operates under a 15% cap on profits to develop point-of-care diagnostic assays for resource-strained regions. Point-of-care diagnostics are an international growth market, estimated at EUR 12.7 billion (USD 14.1 billion) in 2013 and expected to grow at a CAGR of 9.7% to EUR 28.7 billion (USD 32.7 billion) by 2022.
