Sparse evidence of Lyme disease has been documented in the US for at least 90 years, but in 1975 it suddenly exploded onto the human population with an undeniable presence never witnessed before, with numerous children and adults displaying a multitude of debilitating neurologic, psychiatric, and physical symptoms. The original outbreak was investigated by a team of Yale physicians and misdiagnosed as juvenile rheumatoid arthritis. All this took place in Old Lyme, Connecticut. The condition was later named Lyme disease. The causative agent, a thin spirochete found to reside in the salivary glands and ovaries of the deer tick, was eventually identified by Dr. Wally Burgdorfer in 1982 and named in his honor, Borrelia burgdorferi (Bb). From that time on, there have been considerable diagnostic challenges and controversy in the treatment of the disease.

Controversies in the diagnosis and treatment of Lyme disease come from opposing views of the Infectious Disease Society of America (IDSA) and International Lyme and Associated Diseases Society (ILADS). The basic guidelines of the IDSA are summarized as: Lyme disease is easy to diagnose and easy to treat. This is despite all the evidence to the contrary. A thorough investigation into the IDSA and its guidelines panel was done by the Connecticut attorney general in 2006 and reported in May 2009. The attorney general found that the IDSA chairman was chosen inappropriately and held a bias regarding the existence of chronic Lyme and handpicked a like-minded panel without scrutiny or formal approval of the society's oversight committee. The IDSA refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease. The attorney general found that IDSA panel members had financial interest in drug companies, Lyme disease diagnostic testing, patents, and consulting arrangements with insurance companies. Appointments to the IDSA board were also blocked for scientists and physicians with divergent views who sought to serve on the 2006 guidelines panel.

Controversy also occurs with testing. According to the CDC, laboratory confirmation of Lyme disease is not warranted if the patient manifests with erythema migrans (EM) and classic symptoms of the disease. If diagnostic testing is required, then a two-tiered approach is what the CDC recommends. First a "sensitive" test such as an ELISA (enzyme linked immunosorbent assay) or IFA (immunofluorescent assay); second, a "specific" test such as the western blot (WB) using IgM and IgG antibodies is done.
Sadly for the practitioner, the "sensitive" ELISA tests have been consistently less than 50% sensitive, meaning that the majority of Lyme patients go undiagnosed. According to the Journal of Medical Microbiology in April 2005, sensitivity of ELISA testing on culture confirmed Lyme varied from not detectable to 70%, depending on the lab and method. Confirmatory testing with the dismally "specific" test has improved tremendously from the past, to a specificity of 36% to 42% and sensitivity of 97% according to the Journal of Clinical Pathology from June 2009. In September 1995, the Journal of Clinical Microbiology concluded that evidence supports the continuous appearance of new antigenic epitopes on spirochetes during the infection. Why the difficulty, and is there hope in new testing methods? Let me simply explain, and yes!

Bb is a stealth pathogen in that it very cleverly evades the immune system, changes its antigenic appearance, can live intra- and extracellularly as well as exist in a cyst form, and is immunosuppressive to the human host. The above testing methods, being difficult to perform in themselves, from a technical point have to rely on the body's being able to detect the stealth pathogen. Then, the host has to make antibodies for the immunosuppressive spirochete. Then, hopefully the antibodies (the immune system's response to the infection) are in sufficient quantity and the testing methods mentioned above are sensitive and specific enough to confirm an infection. If the antigen testing method of detection is being used to diagnose, then you can see from the above-referenced article that the continuous appearance of new antigenic epitome would present a diagnostic challenge to find. I have simplified the description of the diagnostic testing methods that practitioners have had to rely on in the past. Now, what about the new methods I have mentioned?

The newest and future of diagnostic testing for Lyme disease is here. It is called the polymerase chain reaction (PCR), in which the DNA of the spirochete is multiplied sometimes over a million times so that the DNA of the organism can be sequenced and identified. I like to think of it like CSI (crime scene investigation) on TV, only for spirochetes. It is hard to deny the existence of a pathogen like Bb if its DNA fingerprint is right there identified on a test. You do not have to rely on the immune system to recognize the infection. The answer is very specific and can be extremely sensitive, depending on the lab used. Are all PCRs the same? No!

In the diagnostic world of chronic degenerative disease, so many symptoms overlap. Many symptoms of Lyme look like some of the symptoms of Bartonella, Babesia, Ehrlichia, Mycoplasma, Legionella, Leptospira, food allergies, and toxic mold exposure, and so on; you get the idea. Even the seasoned Lyme expert gets confused. It is a continual drawing of blood, sending it off, and waiting for the results; if negative, we do it again and again. If it is positive, it still does not mean that this is the only infection! The number of Lyme coinfections can be in the dozens. Practitioners who specialize in chronic degenerative disease spend the lion's share of their time waiting for test results. Wouldn't it be great to have the Star Trek gadget that just scans the body and tells you what is going on? Well, I can't say we've come quite that far, but we are getting closer. A new test panel offers 30 of the most common and uncommon organisms implicated in chronic degenerative disease. One single test with a degree of accuracy not long ago thought to be technologically impossible!

The field of PCR is evolving, and there are over 20 different PCR techniques that various labs may use. The scientists working with different PCR techniques often closely guard their trade secrets as to what makes them work. Spiro Stat Technologies is no different in guarding its many secrets. Regardless of the details, it is obvious that Spiro Stat Technologies has reached a new pinnacle in the art of PCR diagnostic technologies, particularly arthropod vector species, with Bb being historically very difficult to detect. The test is performed in a CAP-inspected and CLIA-licensed laboratory. The spirochete panel offered by Spiro Stat Technologies offers diagnostic confirmation of over 30 organisms simultaneously from a single lab specimen, whether from a finger stick, venous, cerebrospinal fluid, or tissue sample. They have taken the diagnostic nightmare out of spirochetal illness diagnosis. A new fungal panel is also being offered to the clinician to aid in diagnosis of fungal-borne infection.

A great deal of gratitude is expressed to the scientists of Spiro Stat technologies for making the clinician's job much easier to diagnose spirochetal, copathogen, and fungal disease. From those of us working in the trenches of primary care and chronic degenerative disease, thank you!

Disclosure
Dr. Dalton serves on the medical advisory board and is an owner and general partner of Spiro Stat Technologies LP.

Stephen Dalton, DO
Adjunct clinical assistant professor in Department of Family and Community Medicine
Texas Tech University Regional Academic Health Center
Lubbock, Texas