Partners in the RDT REAG project have developed the world’s first rapid test for tick-borne encephalitis (TBE), a life-threatening neurological disease caused by a virus found throughout the Northern Hemisphere. Suitable for small laboratories and doctors’ offices, the test provides a low-cost diagnosis from almost as soon as a patient has been bitten, allowing faster treatment.
Tick-borne encephalitis (TBE) is an important and rapidly growing public health problem in Europe and Asia, especially in Austria, the Baltics, Russia and the Nordic countries. Caused by the TBE virus, it is transmitted through ticks – small parasites that feed on blood. Although rapid treatment can save lives, getting a result from the traditional laboratory ELISA test usually takes days.
A test that gives results in only 20 minutes is now available - the ReaScan® test. Developed by medical diagnostics SME, Reagena Oy in Finland, with support from the University of Helsinki in Finland and the Karoliniska Institutet in Sweden, it is designed for smaller testing facilities.
“Our collaborators provided top-class science; we translated it into a product.”
A small plastic cartridge contains the test, which requires only a drop of blood. “The technical platform is similar to that used in existing tests produced by Reagena, but has been adapted to a test for TBE,” says Reagena R&D Manager Eira Kelo.
The test detects infection from the patient’s blood by looking for antibodies produced to combat the virus, explains Kelo. “We focused on antibodies rather than the virus because the virus is present in blood for a very short time and is not necessarily detectable when the symptoms appear.”
The antibodies it detects – immunoglobulin M (IgM) - are proteins that the body produces to attack viruses soon after exposure to the pathogen. This means that doctors can detect the virus infection very quickly after the patient has been bitten by a carrier tick or drunk milk from an infected animal, she adds.
Evaluations in five diagnostic laboratories in five countries familiar with TBE infection showed that the ReaScan® test is stable and reliable, even for patients with other diseases known to produce false positives for TBE. It compared well to other commonly used laboratory methods. “With this test, there are fewer false positive and false negatives. It is more accurate and specific,” says Reagena CEO Markku Parviainen.
The project also produced two ELISA TBE tests. One detects IgM antibodies and the other is used to determine the later-appearing, longer-lasting IgG antibodies. The ELISAs are suitable for bigger labs that process large batches of samples at a time.
Commercially viable diagnosis products often take years to develop and require intense industry-research collaboration. “EUREKA’s support was of utmost importance,” says Parviainen. “Our collaborators provided top-class science; we translated it into a product.”
Because of the scientific challenges in developing the test, there are no competitor devices, he adds. “This is a new concept. We are developing scientific data from trials, contacting opinion leaders and taking part in congresses and commercial exhibitions to convince the medical community and customers that the test is reliable.”
Some of the rapid test technology has been patented, and associated trademarks have been registered. The products are already on sale in Finland, the Nordic countries, the Czech Republic, Poland and Germany, with the sales network still expanding.
As well as improving diagnosis and therefore treatment for patients, it has benefited the project partners, adds Parviainen. “Our turnover has increased annually by more than 20%, and we have been able to add our skilled personnel. Over 10% of our turnover is now from this product and this is growing.”