If you think you may have Lyme disease, or worse yet chronic Lyme disease the following information is crucial for getting accurate test results. Countless people have experienced negative Lyme test results from trusted doctors who have verified that their nagging to severe symptoms were likely caused by Lyme disease (Borrelia burgdorferi).
And for those who have had mysterious unidentified ailments that come and go over the years including chronic neck pain and frequent flu, sinus or GI complaints…do you have chronic Lyme disease? Why so much fuss about identifying a bacteria?
A large part of the confusion is the insurance mandated testing protocol.
Add to that the numerous co-infections that can accompany just one tick bite at a time when the tick population continues to grow, and recent reports prove that Lyme disease bacteria has species that can be spread not only by many ticks (previously thought incapable of spreading the disease – check this out to see how many possible tick carriers live in the US: http://lymediseaseresource.com/wordpress/the-myth-of-the-deer-tick-and-lyme-disease), but also by biting flies, fleas and mosquitoes which was scientifically studied, documented and reported in 1986 by L A Magnarelli and J F Anderson in the Journal of Clinical Microbiology and by the same scientists in 1988 for the American Society of Microbiology also in JCM.
It should be noted here that mainstream medical doctors ignore any studies that do not have the EM rash as evidence of infection in spite of the fact that researchers around the world, most notably Dr. Benjamin Luft’s team at SUNY have identified strains of Borrelia burgdorferi that do not cause a rash but infect the entire body, and some strains that leave a bulls-eye (EM) rash but infect only the skin. This is reported in “Cure Unknown” by Pamela Weintraub.
The truth we are all facing is that the CDC (Federal Center for Disease Control and Prevention) can’t be trusted to protect the US citizens from contracting, spreading, being correctly diagnosed or treated from this terrible disease for the reasons set forth below.
The big problem that is at the heart of every medical debate about chronic Lyme disease, and the accurate statistical data count for disease control is the accepted criteria for determining whether a person is infected with Lyme disease.
As most people know, mainstream medicine ordained by the IDSA (Infectious Disease Society of America) and the CDC require a two-tier testing before diagnosing Lyme disease and insist even with the astounding facts listed below that there is an over abundance of false positives for patients, even though all clinical symptoms are present and especially is symptoms are chronic.
And yet the CDC website states and has always maintained that:
“Lyme disease is diagnosed on the basis of physician-observed clinical manifestations and a history of probable exposure to infected ticks . Laboratory tests are neither suggested nor required to confirm diagnosis for patients with recent onset (2–3 weeks) of a characteristic EM rash. However, positive results of recommended two-tiered serologic testing can provide confirmation of infection in patients with musculo-skeletal, neurological, or cardiac symptoms. Testing methods that have not been adequately validated can be misleading and are not recommended.”
Until recently there have not been any reliable tests to confirm the existence of Lyme disease.
The CDC refers to the recommended two-tiered serologic testing to provide confirmation of Lyme disease (even though they say that is NOT how it is diagnosed in the first line), but they know very well how unreliable these tests are (as opposed to blood cultures or molecular DNA assays).
The two-tiered testing refers to testing the blood of a patient when Lyme is suspected with first the ELISA assay, and if it comes back positive then taking another sample of blood and having a Western Blot test performed. The likelihood of a person with Lyme disease actually having both tests come back positive are about 50% depending on the lab, the strain of Babesiosis, and the length of time between the tick bite and your blood tests. Many believe it is much lower than that.
These tests are based on methods that were discovered 150 years ago!
Why would modern medicine use such antiquated methods with unreliable results in today’s modern hospitals?
Well, not surprisingly the ELISA (Enzyme-Linked Immunosorbant Serum Assay) is the simplest, least expensive, and easiest Lyme test to perform. It is a test based on detecting the antibodies that our bodies make in response to being exposed to Borrelia burgdorferi (Bb). It is a preferred test by laboratories, not because it is more accurate than other Lyme tests, but because it is automated. Many different patient samples can be performed by a single machine simultaneously. This allows for a faster turnover, less costs, and theoretically, standardized test results that are consistent from lab to lab.
We are told by manufacturers, health departments and clinics that the Lyme ELISA tests are good, useful tests, but in two blinded studies that tested laboratories for accuracy, they failed miserably. Lorie Bakken, MS/MPH, showed in her studies that there was not only inaccuracy and inconsistency between competing laboratories, but also between identical triple samples sent to the same lab. In other words, identical samples often resulted in different results. In the first study, forty-five labs correctly identified the samples only 55% of the time.
In the latest study by the College of American Pathologists, 516 labs were tested. The overall result was terrible. There were almost equal numbers of false positives as false negatives. Overall, the labs were 55% inaccurate. The labs could only give a correct result 45% of the time, and yet it is the most common Lyme test ordered.
The ELISA test sounds simple and straight forward, but it has a couple of major flaws. Borrelia species are some of the most polymorphic bacteria known to exist. In other words, most Borrelia species can significantly change its surface proteins enough during cell division as to evade our immune system, and may differ from laboratory strains enough to result in negative tests, even if Bb antibodies are present. In Europe, this problem is intensified because they have recognized three species of Borrelia that cause Lyme disease, and so they have available three separate ELISA tests.
When a lab reports that their ELISA test has had high specificity and high sensitivity, it is usually interpreted by doctors as being a more accurate test, but the doctors don’t know what the lab is actually measuring. One of the hidden problems of serologic Lyme tests is the fact that the tests must be primed with a source of bacteria to create the reactions with the patient’s antibodies.
To do this, virtually all labs rely on a laboratory strain of Bb known as strain B-31.Taking purified antigens from strain B-31 and injecting them into mice, they then can extract one type of antibody to each antigen, or many. This antibody is concentrated and purified, and then added to the ELISA test to test the efficacy and performance of the test.
Unlike the wild strains, B-31 grows well in culture, and this makes it a perfect choice as a consistent and inexpensive source of Bb. But the affinity the mouse antibody has to B-31 antigen is quite different from the affinity the patients’ antibodies have to the same antigen. This means the test may register as negative because the test cannot detect the slightly different antibody profile that a wild strain of Bb produces.
In other words, the labs are really testing for an artificially pure strain when humans have wild strains. We can only hope that the wild strain is similar enough to the automated strain to be categorized as positive.
Otherwise the unsuspecting patient breathes a sigh of relief and goes home to have symptoms resolve themselves thanks to our immune system and the stealthy way Borrelia grows in the body. Years can go by with Lyme disease and co-infections growing in biofilm colonies without any symptoms or mild symptoms that come and go which causes a weakening immune system and an invasive chronic Lyme disease.
Not only does the ELISA test often fail to detect antibodies from wild or related strains of Borrelia, but it also fails to detect different genospecies that cause some co-infections such as Relapsing Fever.
Worse yet is that the ELISA test can only detect free antibodies. It cannot detect any antibody that has become mixed with antigen. (Antibodies are large proteins created by the immune system to destroy specific antigens.)
The ELISA test depends on the active, free antibodies to attach to free spirochetes that embed themselves on the walls of the test tube. If the antibodies in the serum being tested are already attached to the bacteria, then the enzyme reaction cannot take place.
What makes this test so misleading is that many doctors accept high antibody readings as an indication that the patient must really be sick. This logic is exactly backwards. If a patient is really infected with lots of bacteria, that means they have a lot of bacterial antigens floating around in the blood. So, as free antigen increases, free antibody decreases.
Since the ELISA test detects only free antibody, a negative test might actually indicate a MORE serious infection. Many times totally asymptotic patients with ELISA titers over 1000 will be treated as though they were on death’s doorstep simply because they had a high titer, while patients with borderline titers who are practically disabled are ignored, because a low titer is perceived as meaning LESS infected! These conclusions are erroneous and actually opposite to the truth, which is that a high titer means greater natural immunity.
What a high ELISA test may be a better indicator of is what level of immunity is the patient capable of mounting against this infection? A high titer is the same thing as saying the patient has a high natural immunity, and a low can mean that the patient may be overwhelmed by infection.
In one year-long study by Dr. Sam Donta, MD, (in Boston) did on chronic Lyme patients, the initial ELISA tests proved to be more than 66+% inaccurate (1996 LDF Conference lecture). Other researchers have also found the ELISA tests to be inaccurate. Using a 45-panel diagnostic testing protocol from the NIH for testing the efficacy of the ELISA and Western Blot, researchers found the accuracy of the Lyme ELISA varied from about 5075%, and were routinely inconsistent. The CDC’s ELISA test did no better on average than any other ELISA. It is the CDC ELISA test which is used for surveillance of emerging Lyme disease in the United States, yet the test was correct only about two out every three tests. Too often, a single negative ELISA test can prevent a sick patient from getting treatment, even despite having serious symptoms.
Now assuming you have a positive ELISA (Tier One), then you run the Western Blot gauntlet (Tier Two.)
The Western Blot is a much more complex test that essentially makes a map some of the different antibodies the immune system produces to the bacteria. The map separates the antibodies by the weight of their respective antigens and are reported in units called kilo daltons or kDa.
For example, a Western Blot may report bands at 22, 23, 25, 31, 34, 39, and 41 kDa. Each of these bands represents an antibody response to a specific protein found on the spirochete. The 41 band indicates an antibody to the flagella 41 kDa protein and is nonspecific. The 31 kDa band represents the OSPA protein and is specific for just a few species of Borrelia, as is the 34 band OSPB, and 23 kDa OSPC.
In 1994, the Association of State and Territorial Public Health Laboratory Directors, under a CDC grant, decided that there should be consistency between labs reporting Lyme disease Western Blots, and that a specific reporting criteria should be established. The consensus committee, chaired by Dr. Michael Osterholm, Ph.D., MN, set nationwide standards for Western Blot reporting. This sounds good, but one could argue they made a bad situation worse. Prior to the hearing, virtually every lab had accepted bands 22, 23, 25, 31, and 34 kDa as specific and significant, and reported them as positive for exposure to Borrelia burgdorferi. Not only are these bands specific for Borrelia species, but they represent all of the major outer surface proteins being used to develop the Lyme vaccines.
However, the committee, without any clear reasoning, disqualified those bands as even being report-able Thus, after the consensus meeting, those bands were no longer acceptable, and the result was that what had been a fair-to-good test for detecting Lyme disease had now become poor, or even worse, arguably useless.
Many scientists have questioned these new reporting criteria, and several wrote letters of protest to both the committee and to laboratory journals. Many labs stopped reporting the actual bands and instead, simply reported the test as positive or negative, thus preventing any further interpretations.
How badly did the Lab Directors bootstrap this test? The following is an analysis of the new guidelines presented as an abstract and lecture at the 1995 Rheumatology Conference in Texas, chaired by Dr. Alan Steere, MD. (1995 Rheumatology Symposia Abstract #1254, Dr. Paul Fawcett, et al.)
This was a study designed to test the recently proposed changes to Western Blot interpretation by the Second National Conference on Serological Testing for Lyme Disease, sponsored by the CDC. The committee proposed limiting the bands that could be reported in a Western Blot for diagnosis of Lyme disease. Out of a possible 25 bands, 10 specific bands were selected as being reportable. An lgG Western Blot must have five or more of these bands: 18, 21,28, 30, 39, 41,,45, 58, 66 and 93 kDa. An lgM Western Blot must have two or more of the following three bands: 23, 39, 41.
Conspicuously absent are the most important bands, 22, 23, 25, 31, and 34, which include OSPA, OSP-B and OSP-C antigens – the three most widely accepted and recognized Bb antigens. These include proteins from the strain “B31” which researchers have found to be the most virulent and vicious. How is this going to help us diagnose the disease or track the epidemic?
An abstract was performed using 66 children who tested positive under the old test, but under the new criteria only 20 children were now considered positive. That means 46 children who were all symptomatic would have been sent home untreated. That’s an accuracy rate of only 31%.
The conclusion of the researchers was: “the proposed Western Blot reporting criteria are grossly inadequate, because it excluded 69% of the infected children.”
But the problem with the western blot is actually even worse. The Second Committee based all assumptions on a possible 25 proteins (antibodies), and yet researchers have known for quite some time that the Borrelia species morph from one strain into another. This has been shown repeatedly in labs where animals without Borreliosis were injected with a specific strain, and several weeks later were found to have a completely different strain active in their body. Additionally, according to Molecular Biology there are at least 40 known species of Borrelia that we know of, (then add to that the unlimited number of mutations. )
According to Dr. Luft at SUNY School of Medicine, to make the Western Blot accurate, every genome in every known species of Borrelia would have to be mapped – 1800 proteins in all – a far cry from 25!
NOTE: From Feb 2011 to Jan 2012 (and ongoing) Dr. Luft and his team of scientists have been mapping these enormous genomes and currently have published their results in the “Journal of Bacteriology”: Strain 31 with 13 variations, another Borrellia sensu variation from Finland, four more species (four isolates from two of the Borrelia species that cause human Lyme disease, B. afzelii isolates ACA-1 and PKo and B. garinii isolates PBr and Far04), and three species B. valaisiana VS116, B. spielmanii A14S, and B. bissettii DN127. That is a total of 21 species of Borrelia thus far.
Other hopeful news is that recently, a Chinese study found that changing western blot criteria to detect the prevalent strain of Lyme bacteria in their region increased the accuracy of the tests. Another study in the United States proved that mixing two infectious Borrelia strains in a western blot assay increased the test’s sensitivity. If simply adding other strains of the same Lyme species increases the western blot’s sensitivity, the changes needed in order to detect various Lyme species may be incredible. course all of these changes make an expensive and complex test even more expensive and complex.
To read the full article I wrote on my blog go to http://lymediseaseresource.com/wordpress/is-the-western-blot-capable-of-more-accuracy-2.
However we are still discussing a technology that was developed in 1851!
So what is the most technologically advanced testing method? Molecular genotyping of the DNA.
PCR tests have been available but not reliable until recently due to the difficulty of extracting the bacteria from blood. Even in early cases there are low levels of free floating bacteria, but as time goes on (days and weeks) the spiral bacteria drill into soft tissue, cartilage and joints. It can enter the central nervous system within 24 hours and even with spinal taps researchers liken the process to looking for a needle in a haystack.
There was great excitement when ITT came out with “My Lyme ID test” which is based on testing the white blood cells. In the ITT portion of the test, the isolated white blood cells are cultured for five days with individual B. burgdorferi-specific antigens, such as VlsE-1 and other proteins. If T cells that respond to a particular antigen are present in the culture, they become activated and proliferate. This indicates that the person has been exposed toB. burgdorferi.
It’s important to note that the ITT by itself cannot distinguish between an immune response that is currently in progress, and one that happened in the past. That’s because it cannot tell the difference between so-called “effector” T cells that are currently fighting an active infection, and “memory” T cells that responded years ago to a prior infection and continue to circulate in the bloodstream. Knowing whether the infection is active is key to determining what type of treatment regimen, if any, is warranted. This test can be very helpful in combination with other tests and a doctor trained in the evaluation of the test and effective treatment protocols based on the results but it can be confusing and inaccurate. There are some talented doctors who have effectively been using this test since it was developed.
However, exciting new research is taking place as you read this. As mentioned earlier, Dr. Luft’s team at SUNY has mapped every one of the 1800 strands of DNA in a number of Bb strains which helps other researchers as well as laying the foundation for understanding the bacteria better for diagnosis and treatment.
In May 2012 a cutting-edge research paper was published showing how direct molecular blood tests could be successfully and reliably run for early Lyme disease even though it is known that there are low amounts of circulating Borrelia burgdorferiDNA. Read about how these researchers developed a sensitive strategy to both detect and genotype B. burgdorferi directly from whole blood collected during the initial patient visit. See http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3348129.
Advanced Laboratory Services has utilized a culture for some time but in the last year with the help of specialists (including Dr. Joseph Burrascano), the company has designed a test that uses a blood sample which is incubated, and after ten to fourteen days it is tested by darkfield microscopy, polyclonal and monoclonal immunostaining, and by multivalent nested PCR. If Borrelia are seen then, a final report of a positive result is generated and sent to the practitioner. If no Borrelia are seen with these methods, then the sample is placed into Long Term Culture that is assayed once, at two months, and a final report is generated at that time. Less than half of the samples need the Long Term Culture.
This unique combination of culture and molecular testing allows for the many species and forms of the bacteria and is considered 100% reliable by Dr. Burrascano who publicly announced his endorsement as of August 1, 2012. Unfortunately it is not available outside the US and currently only 48 states.
Other good reading on this topic is https://www.neurorelief.com/index.php?p=cms&cid=408&pid=149