Lyme Disease Diagnosis and Testing
Diagnosing Lyme disease can be difficult to say the least. Although tests exist, none are considered accurate enough to be relied upon as the sole diagnostic tool. Therefore, according to the CDC, a diagnosis of Lyme disease is made clinically based primarily on signs and symptoms and a history of possible exposure to infected ticks.
Many doctors consider a bull's-eye rash following a possible tick bite to be diagnostic, and they will treat based on that single symptom. However, since fewer than 50% of people with Lyme disease ever develop the classic bull's-eye rash, other more general symptoms may be the only evidence of infection. (See: Symptoms)
While diagnostic tests for Lyme disease do exist, they are quite controversial. The standard two-tiered antibody test approved by the FDA and recommended by the CDC has a high rate of false negatives and is thought by many Lyme experts to be only moderately useful. Other types of Lyme tests have varying degrees of reliability, each with its own set of pros and cons.
Although the CDC states that a Lyme disease diagnosis should be made based on symptoms and history, Lyme symptoms mimic so many other diseases that many physicians refuse to treat patients for Lyme disease without laboratory confirmation. Following are the Lyme disease tests currently available.
There is no one gold standard test for all Lyme disease infections that is 100% accurate. For this reason, many Lyme-literate doctors diagnose Borrelia
and co-infections based upon symptoms, lab tests and unconventional, but sometimes more sophisticated types of alternative testing, such as energetic testing.
Electrodermal screening devices (such as the ZYTO or ASYRA), for instance, use a software program and the body's galvanic skin response to detect energetic imbalances in the body. They can also be used to detect the energetic frequencies of a wide variety of pathogenic microbes, and thereby, the presence of those microbes. A software program connected to a hand cradle or other device scans the body for infections and other imbalances and then displays a report of the different pathogenic organisms that are suspected to be in the body, and at what levels. The ZYTO is considered by many Lyme-literate practitioners, such as Lee Cowden, MD, to be over 90% accurate. Other devices may be more or less accurate.
Applied Kinesiology, or muscle strength testing methods, such as Autonomic Response Testing (ART), which was developed by Lyme-literate physician Dietrich Klinghardt, MD, are another way to test the body for infections using the energy of the human body and the autonomic nervous system. Applied Kinesiology can be very useful for helping to establish a diagnosis.
For ART and some other common muscle testing methods, the practitioner applies strength to one of the patient's muscles (usually the arm), while holding a substance (in this case the energetic signature of, or physical substance of a pathogen) against the patient's body. He or she will then ask the patient to resist. The autonomic nervous system will respond to that substance or pathogen by creating either a strong or weak muscle response in the arm of the person being tested, thereby indicating to the practitioner whether the pathogen is in the body. Accurate results depend largely upon the practitioner's skill and experience, however.
Dr. Klinghardt has trained many practitioners in ART and a list of certified practitioners can be found at the Klinghardt Academy website:www.klinghardtacademy.com
The enzyme-linked immunosorbent assay (ELISA) test is the first step of the two-tiered antibody testing recommended by the CDC. ELISA is a blood test used to determine whether antibodies to Borrelia are present in a patient's blood. The problem is that Borrelia
causes immune dysregulation, which decreases the specificity of antibodies and the ELISA test is not sensitive enough to detect them. It is thought that ELISA tests may miss more than half of true cases of Lyme disease.
ELISA is used as a screening test. If a patient tests positive on the ELISA test, then the doctor will order a Western Blot test.
The Western blot is the second step of the two-tiered testing process. As a blood test looking for antibodies, it is considered to be much more accurate than the ELISA - that is IF all of the Lyme-sensitive bands are reported. This is where things start to get a bit more complicated.
doesn't cause the production of just one antibody, but rather produces a variety of antibodies against the different proteins (antigens) found on the surface of the bacteria. The Western blot test looks for and measures the reaction to each of those proteins. These Lyme-related proteins are labeled by their molecular weight, measured in kilodaltons (kDa) and are referred to as "bands."
Western blot testing looks for two different classes of antibodies in these bands: IgM and IgG. IgM antibodies are the first antibodies produced by your body and are usually indicative of recent infection. IgG antibodies are produced later and generally indicate an older infection.
In order for a Western blot test to be considered positive for Lyme disease, the CDC requires one of the following:
- On the IgM, two out of three bands (24, 39 or 41) must be positive.
- On the IgG, five out of ten bands (18, 24, 28, 30, 39, 41, 45, 58, 66, 93) must be positive.
Even though bands 31 and 34 are very specific for Borrelia
, the CDC eliminated them from Western blot analysis. The reason is that in the 1990s, a Lyme disease vaccine was developed from the 31 kDa protein. Therefore, anyone who received the vaccine would test positive for band 31. Although the vaccine was later taken off the market, the CDC has not changed their criteria.
It should be noted that the CDC criteria are for surveillance purposes to track the incidence of Lyme disease. Individual doctors are encouraged to diagnose and treat Lyme disease based on symptoms and history, using test results only as confirmation. Doctors are free to consider bands 31 and 34 in their analysis of a patient. The problem is that most labs only report the CDC criteria unless the doctor specifically asks that all bands be tested and reported.
The IGeneX laboratory is the exception. IgeneX reports on all Lyme-sensitive bands and they consider two positive bands on either the IgM or IgG test to be a positive result for Lyme disease. They additionally report whether your results are positive or negative according to both their criteria and the CDC criteria.
There are two limitations to the Western blot that are important to know:
- " IgM: The first Lyme antibodies your body makes usually take up to six weeks to develop and only stay in circulation for about six months. They will not show up if you are tested too soon after a tick bite.
- " IgG: The second Lyme antibodies take up to eight weeks to develop and are gone in less than a year. Because Lyme disease is known to inhibit the immune system, antibodies may not be detectable in patients who have been sick for a long time.
Polymerase chain reaction (PCR) is a blood test that detects the DNA of the organism. Instead of looking for antibodies to the Borrelia bacterium, the PCR looks for the organism itself. Unfortunately, PCR testing can produce a lot of false negatives because Lyme bacteria tend to only reside in the blood for short periods of time, preferring to dwell in tissues with reduced vascular circulation.
Culture tests are considered to be the gold-standard test for identifying most bacteria. However, until recently, culturing has not worked for Lyme disease for two reasons: 1) because Borrelia
bacteria need a living host to survive, it has been almost impossible to get them to grow in vitro; and 2) because they grow so slowly, results cannot be reported in a reasonable period of time.
In 2011, however, Advanced Laboratory Services and their medical director, Dr. Joseph Burrascano, Jr., announced that they had overcome many of the technical difficulties and developed a culture test for Lyme disease. The press release claims that "sensitivity exceeds 80% if the patient is symptomatic at the time of blood draw and not on antibiotics for at least four weeks." The expected turnaround time is 10 - 14 days.
This test is still considered investigational and is not covered by insurance. It has not been cleared or approved by the FDA and the CDC has issued a statement of concern about the use of this test. Nevertheless, many in the Lyme community have heralded it as an important breakthrough in Lyme disease diagnosis. Only time and additional studies will determine its reliability and accuracy. It does, however, bring great hope that there may finally be a test that can confirm chronic Lyme disease.
For more information about this culture test, see the Advanced Laboratory Services Press Release
and their website.
Future Possibilities for Diagnostic Tests
Because treatment is more effective in the early stages of Lyme disease, there is a great need to develop simple, fast and accurate tests to determine whether people have been infected. According to the National Institute of Allergy and Infectious Diseases (NIAID), "NIAID-supported scientists have identified genome sequences for multiple strains of B. burgdorferi. Greater advances in diagnostics are anticipated as genetic information is combined with advances in microarray technology, imaging, and proteomics. These growing fields of science are expected to lead to improved diagnostic tools as well as provide new insights on the pathogenesis of Lyme disease. Examples of future tools being developed with NIAID support include use of metabolomics to characterize new biomarkers of infection, next generation T-cell based measurements, and novel antigens for improved measurement of effective treatment."
How to Interpret Your Blood Work (Western Blot)
2012 CDC Webinar Presentation: HHS Federal Research Update on Lyme Disease Diagnostics Activities
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Read the transcript »
Last Updated: 4/27/15