Development of a Pathogen Blood Test for patients with Lyme-like symptoms

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For chronic illnesses such as Lyme-like Illness, Chronic Fatigue Syndrome, and Chronic Pain, differential diagnosis is regularly made on the basis of signs and symptoms rather than specific medical tests. This means that the cause of such illnesses often remains unidentified. For Lyme Disease or Borreliosis, standard diagnostic testing typically involves indirect serology testing of antibodies made by the body in response to an infection or foreign agent. However, such indirect forms of testing can be problematic as antibodies produced in response to infection by a specific foreign agent can bind not only with antigens of the specific foreign agent, but also to antigens of other infectious agents. For instance, cross-reacting antibodies can be produced in response to both Borrelia burgdorferi bacteria (causative agent for Lyme disease) and certain types of viruses or other infections, potentially causing diagnostic confusion in interpreting the results of serological testing (such as Western blot technique). “Many diseases have been reported to cause significant cross-reactivity in IgM and/or IgG assays. Among such diseases are autoimmune disorders, Epstein-Barr virus infection, bacterial endocarditis, syphilis, other spirochetal infections, and Helicobacter pylori infection.” [Ref: Reed, Kurt D. "Laboratory testing for Lyme disease: possibilities and practicalities." Journal of clinical microbiology 40.2 (2002): 319-324.] Moreover, antibodies may circulate in the body long after an acute infection (for example, around ten to twenty years after a Borrelia infection), further adding to the diagnostic confusion. This observational study aims to identifying DNA containing non-human cells or pathogens present in a patient’s blood sample. The study combines blood filtration, microscopy and PCR-DNA genetic analysis.

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