TESTING FOR LYME
"The Western blot for Lyme is so flawed that even its major manufacturer says he has found numerous “band” patterns more accurate than the one in use today. Instead of relying on flawed 20th century technology, we must look to the science of the twenty-first century, including state-of-the-art genomics and proteomics that allows for the sequencing of every gene and protein involved in every stage of Lyme. With evidence of this calibre we won’t have to fight over the truth: We will know what’s going on.”
-- Psychology Today
THE ROLE OF TESTING IN GETTING A DIAGNOSIS
It is important to note that the diagnosis of Lyme disease is never made with serology alone. Rather, it is a clinical diagnosis that can be supported by appropriate serologic test results. Serology should never be used to “screen” patients for Lyme disease who are either asymptomatic or who exhibit nonspecific constitutional symptoms. Additionally, there is no need to order serologic tests in the patient who presents with erythema migrans.
WHAT LAB TESTING IS AVAILABLE FOR LYME?
Currently, there are roughly 60 assorted serologic tests on the market for detecting the antibody to B. burgdorferi; all have been approved by the FDA. Although these tests are commercially available, the FDA has issued a public health advisory to physicians and clinical laboratories, alerting them to the potential for misdiagnosis of Lyme disease using these tests only. Because of these reservations about serologic testing, the FDA has recommended a 2-step laboratory testing paradigm for positive or equivocal first-step test results and asked manufacturers of the tests to modify their labeling to reflect this recommendation.
HOW RELIABLE IS CURRENT TESTING?
There are no completely reliable tests for Lyme disease. The limited reliability of serologic testing in general is troubling.
Your doctor must base his or her diagnosis on your symptoms, and medical history. Doctors cannot rely solely on blood tests for Lyme disease, most especially because of the nature of the spirochete bacteria. The spirochetes do not linger in the blood stream, as they burrow into the cells (such as the leukocytes) and when they do exit from the cell the cellular membrane remains covering it, thus shielding its identity from the immune system. It is not often found in blood during a blood test. At present there are a few lab blood tests available, but all have problems.
WHAT IS "TWO STEP" TESTING?
The 2-step approach to the testing of Lyme disease is the widely accepted method of serological diagnosis because it is believed to provide better sensitivity and specificity than when either test is used alone.
The 2-step approach consists of (1) an initial ELISA or immunofluorescence assay (IFA) to be followed by (2) a Western Blot test, if the first test is positive or equivocal.
If the Western blot is negative, then the patient does not have serologic evidence of Lyme disease. If the Western blot is positive, then the patient has serologic evidence of infection with B. burgdorferi.
WHAT IS THE ELISA (LYME TITER) TEST?
The blood test used to screen for Lyme that is typically used by most family doctors is called the ELISA Test (or the "Lyme Titer" test.
An ELISA test means nothing if it is negative, and it rarely indicates infection if it is performed too early after the tick bite.
Patients in later stages of Lyme disease seldom have a positive ELISA test, possibly because they have ceased to produce the antibodies the test looks for. Many working with Lyme infected persons believe that the ELISA test is only about 30-60% accurate. The ELISA test is not based on the specific Lyme bacteria strain that is most useful for accurate diagnosis.
While a positive ELISA test is a reasonably reliable indication of infection, a negative test is useless. (Positive indicates it happened to be in the blood at the moment the blood was drawn and as well tests have returned false positives for whatever reason.) A screening test should have at least 95% sensitivity and the ELISA misses 35% of culture proven Lyme disease, therefore as a first step of the screening it has been and still is unreliable. As of 2013, this testing protocol is still being used by many medical doctors as the sole diagnosis for Lyme disease. The western blot (may be more accurate) but, in Canada it is not given unless the Elisa was positive.
Because the immunofluorescent antibody test requires subjective interpretation and is time-consuming to perform, it has largely been replaced by ELISAs for the detection of antibodies against B. burgdorferi. The ELISA method sometimes produces false-positive results because of cross-reactive antibodies from patients with other spirochetal infections (e.g., syphilis, lepto-spirosis, or relapsing fever), with viral infections (e.g., varicella), or with certain autoimmune diseases (e.g., systemic lupus ery-the-ma-tosus), as well as because antibodies directed against spirochetes that are part of the normal oral flora may cross-react with antigens of B. burgdorferi.
WHAT IS THE WESTERN BLOT TEST?
The Western blot test for Lyme disease often shows infection when an ELISA test does not.
Even if the test results are not positive by these present standards, any positive Lyme-specific bands are useful indicators of infection, but often if ELISA is negative then the Western Blot is not performed
Immunoblots (Western blots) for serum antibodies to B. burgdorferi are also used as a diagnostic test for Lyme disease. Although some investigators have suggested that the immunoblot is both more sensitive and more specific than the ELISA, there is still some debate about its interpretation. The immunoblot is most useful to validate a positive or equivocal ELISA result, especially for patients with a low clinical likelihood of having Lyme disease. For serological testing for Lyme disease, it is recommended that a quantitative test (such as an ELISA) be done and, if results are either positive or equivocal, that a Western immunoblot be done to confirm the specificity of the result.
WHAT DO MY TEST RESULTS MEAN?
Finally, it is important to understand that all of the serologic tests for Lyme disease are qualitative tests. The absolute number reported by the reference labo-ratory for the B. burgdorferi enzyme immunoassay should be interpreted as positive or negative based on that particular test’s defined cut-off point.
WHAT ARE THE CDC GUIDELINES?
Unfortunately, the Centers for Disease Control have set a criteria for considering a Western blot test as positive for Lyme disease.
This criteria is very strict and misses many people in Lyme disease surveillance and thus the provincial statistics are unbelievably low. These guidelines also leave many infected patients without a diagnosis and thus the medical treatment that would stop the progression of this disease.
WHAT ARE FALSE NEGATIVE TEST RESULTS?
Even if the test results are not positive, any positive Lyme-specific bands are useful indicators of infection.
The idea that a patient could have an infection and not test positive sounds improbable, but, according to Dr. Richard Tilton, Ph.D., laboratory director of Boston Biomedica Labs (a reference laboratory that tests for Lyme disease), "Regardless of where the infection is in the body, we routinely see up to 25 % of Lyme patients test negative in late stage disease, and antibody levels can also diminish significantly after antibiotic treatment". The two tests that are relied upon by most doctors for the diagnosis of this disease cannot detect the actual organism, but instead they detect the body's production of antibodies. (35-46) Tilton explains, "Not all patients exhibit the same degree of antibody production. Some Lyme antibodies are undetectable because they can form antibody complexes that cannot be detected by the standard antibody tests." (47-49)
WHAT IS PCR TESTING?
Both direct culture and polymerase chain reaction amplification (PCR) have been used in the diagnostic evaluation of patients with Lyme disease.
PCR assays identify the presence of B. burgdorferi DNA in clinical specimens. Blood, skin, synovial fluid, cerebrospinal fluid (CSF), and urine have all been evaluated by PCR testing for B. burgdorferi. Despite reports of overall higher sensitivity than direct culture and good specificity, PCR for the diagnosis of Lyme disease remains of limited value. False - positive PCR results are problematic due to laborator y cross-contamination, and the necessary precautions required to prevent cross - contamination are often impractical for commer- cial laboratories. False-negative PCR results are also seen, in part because of the low number of spirochetes found in infected individuals. Additionally, PCR can- not differentiate between live, replicating organisms and dead spirochetes. Thus it cannot routinely be used to monitor all stages of disease or response to treatment.
Although the role of PCR in the diagnosis of Lyme disease has yet to be completely defined, it may ulti- mately be most beneficial in 2 particular settings: the evaluation of Lyme arthritis and late neurologic Lyme disease. In the largest study published to date, Nocton and colleagues showed that in synovial fluid samples of 88 patients with Lyme arthritis, PCR was found to have a sensitivity of 85% and a specificity of 100%.
WHAT OTHER TESTING MAY BE USEFUL?
Live Cell Analysis Using Dark Field Microscopy may show the presence of spirochetes, or Protozoa, or Bartonella, or fungus and other infections. These are found in offices of some MD or ND's or Health practitioners. There are other types of testing used by Natural Practitioners; Bioresonance informational machines. Muscle testing and similar. Lyme RIFE frequencies. You may also want to challenge the infections with known Lyme eradicators.