But I Was Already Tested For Lyme & I Was Negative!
A key challenge in the diagnosis and treatment of Lyme Disease stems from the lack of sufficiently sensitive and reliable markers of the disease. Based upon currently available tests, it is difficult to determine who has the disease, the effectiveness of a course of treatment, and the end point of treatment. Due to difficulty in culturing the actual bacteria, Lyme Disease tests rely upon an antibody response. Due to testing unreliability, most Lyme Literate Medical Doctors (LLMDs) advise patients to skip the initial Lyme Disease ELISA screen, and instead start with the confirmatory test, the Western Blot.
Many prefer to have a Western Blot through the lab IGeneX for four reasons:
- IGeneX tests for multiple strains of Borrelia Burgdorferi (Bb), the bacteria that causes Lyme Disease (commercial labs such as Labcorp and Quest only test for a single strain of Bb; this is particularly important for those who live outside of the NE);
- IGeneX also considers additional highly relevant bands 31 and 34 (assuming you did not have the Lyme vaccine that was briefly on the market);
- IGeneX reveals intensity for specific bands (not present, equivocal, low, medium and high); and
- IGeneX has outperformed other labs in proficiency testing, scoring over 98% for the past 9 years. Insurance often covers IGeneX testing, particularly if you pre-certify and/or file a form provided by IGeneX when seeking reimbursement. Medicare also covers IGeneX testing.
Western Blot test results will include both IgG and IgM assays. It is critically important that one not look at the NEGATIVE or POSITIVE summary result of the Western Blot test. Instead, it is important to carefully consider Lyme-specific bands (those bands that represent evidence of serological exposure to Borrelia burgdorferi). Many Lyme specialists believe that a single Lyme-specific band, along with clinical presentation, is sufficient to diagnose Lyme Disease (with an acknowledged 3% false positive rate). Likewise, in China, a single positive IgG band coupled with a single IgM band is considered to be a positive Western Blot. The following bands are generally considered to be “significant” or Lyme-specific: 18 (most sources), 22-25, 28, 30, 31, 34, 35, 37, 39, 58 (some sources), 66 (some sources), 83 and 93.
In comparison, the CDC has taken an alarmingly restrictive position on Lyme testing, transforming criteria that was developed for surveillance purposes, into diagnostic mandates. The two-tier testing paradigm for Lyme Disease recommended by the CDC misses approximately 1/2 of actual cases pursuant to numerous peer reviewed studies. According to CDC criteria, you must first test positive using a highly unreliable antibody screen (EIA or IFA). Next, the CDC requires a highly criticized combination of 2 IgM bands (that they only recognize in the first 4-6 weeks of infection) or 5 IgG bands.
In a March 2015 study, Johns Hopkins’ researchers found that 39% of patients with physician diagnosed erythema migrans rashes (which alone is diagnostic for Lyme Disease) remained seronegative on a Western Blot. Even more tellingly, the majority of seropositive individuals on both acute and convalescent serology had a negative IgG western blot, demonstrating that IgG seroconversion on western blot was very infrequent. In Virginia, recently passed legislation requires health care providers to notify those tested for Lyme Disease that current laboratory testing can often produce false negative results. Unfortunately, many people are led to believe that they are “negative” for Lyme Disease based upon faulty tests.