Some interesting developments are afoot in Europe. The Elisa test, long touted for insensitivity (thereby missing prompt diagnosis for many patients) needs to be improved. A consortium of partners has stepped up to the challenge & are embarking on a 2 year project to develop a new ‘lab on a chip’ technology. Designed to catch those who are recently infected as well as those who are chronically ill or who have received antimicrobial treatment (which can affect results in the current system of Elisa) the test should be easily performed by staff, quickly & effectively. This will be good news for patients who are often told they do not have Lyme disease when in fact the serology may not have detected the antibodies in an infected patient (resulting in a false negative test)!
Let’s hope we will see the way to improved methods in testing & ensure effective treatment for all those who suffer from this insidious disease..
Lyme Disease is the most common tick‐borne infection in Europe and North America, and endemic in 63 countries all over the world including the EU27 countries. The illness is caused by the spiral‐shaped bacteria Borrelia burgdoferi which is transmitted by the bite of infected ticks. The World Health Organisation (WHO) estimates about 85,000 cases of LD annually in Europe but stresses that this number is largely underestimated and many infections go undiagnosed.
When detected and treated early, the infection and its symptoms are eliminated by antibiotics in most cases. Late, delayed, or inadequate treatment can lead to more serious symptoms, which can be disabling.
Borrelia is a pleomorphic bacterium with a complex life cycle that comprises multitude of forms including corkscrew shaped “parent” forms and “cyst” forms lacking a cell wall, among others. These wall-deficient forms are very difficult to detect by common imaging techniques such as light microscopy as well as by standard serological tests since they trigger a different immunological response than their walled counterparts. This fact together with their resistance to antibiotics that act on cell wall synthesis makes them truly difficult to diagnose and treat, so that they persist in the body over long time periods causing chronic diseases.
To date there is no available diagnostic tool able to detect in a sensitive and specific way the immunological response to the cell-wall deficient forms of Borrelia, thought to be responsible for borreliosis chronic severe symptoms. Traditional combination of ELISA and Western blot fails to detect up to 80% of the first stage cases and does not distinguish between acute and chronic infections. Similar sensitivity problems are encountered in the evaluation of cerebrospinal fluid where current serological tests only detect 10%‐30% of neuroborreliosis patients.
Due to the evident pitfalls of current laboratory methods, diagnosis has to be based on the clinical findings but since they are very diverse and may mimic those of many common diseases (arthritis, fibromyalgia, multiple sclerosis) patients suffering from symptoms of the chronic disease go through several months or years of repeated misdiagnosis and inadequate treatment. Besides, this represents a big economic burden for European Health Systems: Lyme Disease costs to society were estimated at €660 million with a cost per patient of €40,750 in 1993. Since then, the number of cases has more than doubled, so the current costs are well above €1000 million. Moreover, lack of diagnosis means underestimation of disease prevalence and health risks leading to critical delays in starting awareness and preventive policies.
Therefore there is a crucial need to develop a sensitive tool for laboratory diagnosis of Borrelia burgdoferi acute and chronic infections to provide novel treatment options for patients suffering from their harmful infestations. The action has to be taken at a European level, making sure that standard testing criteria are developed and disseminated so that effective control of this disease is achieved on time.
Based on the market needs, two main required features were clearly identified:
* In order to improve the current WB [Western Blot] technique which is very labour‐intensive, time consuming and difficult to standardise, the tool should be robust, easy‐to‐use and enable unambiguous interpretation of test results.
* To avoid the need of two different tests to get a diagnosis and allow chronic infections to be detected, new antigens, that have been reported in the literature in the last years but have not reach clinical use, should be included.
With these premises in mind and with the input of all the partners, the HILYSENS consortium came to the following solution:
A highly‐sensitive, specific and robust diagnostic tool for Lyme Disease, easy to use and interpret by frontline physicians and clinical laboratories that will become a standard detection tool, rising awareness of this disease among European clinicians and permitting accurate quantification of the increasing disease incidence in order to carry out prevention campaigns before the disease becomes epidemic.
The solution lays on the lab‐on‐a‐chip technology to permit robust and automatic sample processing and detection in a single step, combined with very specific antigenic proteins and peptides that will be detected by fluorescent nanoparticles due to its excellent properties in terms of enhanced signal to background detection and performance in multiplexed assays. The marriage of both technologies is highly innovative and will provide outstanding features in terms of sensitivity and assay robustness addressing therefore the gaps of existing assays.
HILYSENS will solve the major problem faced by health professionals when treating Lyme Disease patients: the lack of a reliable and standardised diagnostic test. HILYSENS will be the first lab‐on‐a‐chip tool that will allow specific and sensitive detection of acute, chronic and autoimmunity associated Lyme Disease infections and will ensure non‐invasive, fast, specific and easy diagnosing, prognosis and monitoring. Specific and sensitive detection of immunologic profiles will allow better point of care treatment and intervention of the disease. Moreover, acquired knowledge on the pleomorphic forms arising from the project, will permit future implementation of novel treatment options that will be offered to patients suffering from acute and chronic harmful infestations contributing, in all, to improve quality of life EU‐wide.
If not treated in the early stages Lyme Disease can progress to chronic stages of more serious symptoms even interfering with patients daily activities and causing inability to attend school or work. All of these make the long‐term cost of Lyme Disease to families, school systems and health care systems astounding. Autoimmune and chronic conditions represent immense costs for European Health systems and their economic impact goes beyond the costs of healthcare treatments. Indirect costs, such as those from lost productivity, can match or sometimes exceed the direct costs.
Earlier detection and treatment of Lyme Disease will thus greatly reduce the associated costs of the treatment and management of the illnesses, as well as increase the possibility of the patient making a full recovery and going on to live an active life as a contributor to society and the economy.
One tick bite can cause many diseases. Lyme Disease is the most prevalent tick-borne infection in Europe and North America. Patients with acute Lyme disease need prompt diagnosis to prevent the development of chronic infections. Current commercial laboratory methods fail to detect a huge amount of cases. As consequence, patients receive delayed or inadequate treatment, leading to more serious symptoms which can be disabling.
HILYSENS will be the first lab-on-a-chip tool allowing specific and sensitive detection of acute, chronic and autoimmunity associated Lyme Disease and ensuring non-invasive, fast, specific and easy diagnosing, prognosis and monitoring. Optimisation of resources, reduction of the associated costs and an increase in the quality of care are some of the potential impacts of HILYSENS .
HILYSENS is a 2 year R+D project funded by the European Commission’s Seventh Framework Programme (FP7) under Research for the Benefit of the SMEs. The project officially started on November 1st 2010. The Kick-off Meeting was held in Barcelona on November 8th and was hosted by AROMICS at the PCB.
To learn more about the project go to: http://www.hilysens.eu/index
Patient support groups estimate that about 500,000 to 600,000 people in Germany only are already chronically infected with Lyme disease, with yearly increases of > 50,000 (estimate of the Bavarian State Department for Health and Food Safety). If the Lyme disease is not recognized early enough, the infection can cause severe pain (e.g. chronic joint ailments) and loss of power (up to incapacity).
In contrast to the tick-borne Encephalitis (a virus, TBE) it is not yet possible to get vaccinated against Lyme disease. This is the reason why it is so important to identify the disease early enough. Every sixth to tenth tick bite leads to such a bacteria disease. Every sixth to tenth tick bite leads to such an infection.