HIGHLY SENSITIVE AND SPECIFIC LOW-COST LAB-ON-A-CHIP SYSTEM FOR LYME DISEASE DIAGNOSIS
 

BACKGROUND

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.

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Borrelia Burgdorferi Cyst-form Bacteria.

Picture taken from The Top 10 Lyme Disease Treatments (2007), Bryan Rosner.

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.

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