Inaccurate Tests for Lyme Disease Are Causing Harm

Faulty Serological Blood Tests for Lyme Disease Are Harming People

While a diagnosis Lyme Disease should be based upon Clinical Symptoms, most Physicians today are requiring a positive blood test before providing treatment. There is significant scientific evidence proving the two-tier blood test for Lyme Disease is inconsistent and inaccurate. Imprecise results are leading to wrongful diagnoses and/or delayed diagnoses, which greatly increases the severity of illness and human suffering. (See: A Negative Lyme Test Doesn't Exclude the Diagnosis of Borreliosis)

Lyme Disease Meets the NIH's Eight Characteristics of Pandemics 

1. The disease has World wide distribution;
2. Is moved long distances by birds;
3. Has a high attack rate and explosive spread;
4. Offers minimal immunity;
5. Can lead to a wide range of chronic manifestations not previously described;
6. Is transmitted by a vector;
7. Can lead to severe illness or death. (What Is  Pandemic? A.S. Fauci et al)

Should The 2-Tier Test for Lyme Disease Be Banned?

1. There is proven scientific evidence that the serodiagnostic tests for Lyme Disease provide inconsistent and imprecise results despite the high reliance on it's accuracy. 
2. The dependance on such unreliable tests can be harmful, as many patients will be denied treatment during the early phase of infection. 
3. Lyme Disease is an infection caused by a corkscrew-shaped bacteria called Borrelia burgdorferi (Bb). Similar to other bacterial infections, like Syphilis, Tuberculosis and Leprosy, the longer a Lyme infection goes untreated the more damage it causes and the more difficult it is to treat. 

The WHO Set a Precedence with TB-Testing in 2011

In 2011 The World Health Organization (WHO) released a policy statement calling for an end to the use of commercial serodiagnostic blood tests for Tuberculosis because the tests are "inconsistent, imprecise and put patients lives in danger." (WHO Statement on TB Testing) The following year the Ministry of Health in India passed a law banning the use of these inaccurate TB tests.

All Public Health Organizations should thoroughly scrutinize the current standards for Lyme Disease testing. In the U.S. alone, over 300,000 people per year are diagnosed with Lyme Disease, many of them going two years or more before receiving treatment due to faulty testing. A good percentage of these patients are also co-infected with other tick-borne diseases because ticks often carry multiple pathogens. Sensitive and reliable tests for all species of Borrelia and as well as all Tick-borne Diseases are desperately needed throughout the World. 

Why is Lyme Disease Difficult to Diagnosis? 

1. Two Tier Testing. The Most widely used method to detect Lyme Disease is the CDC recommended two-tier serologic test. Unfortunately, neither tier of this test is capable of distinguishing between active and convalescent infection. 
• The first tier is the enzyme-linked immunosorbent assay (ELISA) which detects antibodies that are produced after the immune system has had a chance to respond to the infection. It takes the average person 4 weeks or more to develop antibodies to Bb. One study demonstrated a delay in treatment by as little as 9-19 days is predictive of persistent Lyme symptoms. (Aucott, Chiu 2016)  
• The second tier is the Western blot which is used to identify amino-acid sequences in proteins. The Western blot is designed to detect multiple sequences (or bands) of antigens, although not all of these 'bands' are specific to Borrelia. The bands associated with the outer surface proteins of Borrelia burgdorferi (OSP-A, OSP-B, OSP-C) are the most specific to Lyme Disease. Any one of these three bands should constitute a 'positive' test for Lyme, however the CDC requires 5 out of 10 Western Blot bands, increasing the likelihood of a false-negative test result. (Engstrom 1995)  
2. Low Sensitivity. Low sensitivity results in an unacceptably high number of patients with active infection receiving a 'false-negative' test result. This can lead to untreated infection increasing the risk for arthritis, encephalitis, permanent nerve damage, heart block or death. The average sensitivity for the Two-Tier Lyme Test is 46%. 

   

   Image from LymeDisease.org

3. Variable Specificity. Some tests have a low specificity which will result in more people being wrongly diagnosed 'false-positive' with Lyme Disease. This can lead to patients receiving unnecessary treatment and a delay in proper diagnosis of the real cause of their illness. The standard Lyme ELISA is most sensitive to Borrelia burgdorferi sensu stricto strain B-31, one of 300 strains of Borrelia found throughout the World. The more specific a Lyme test is to B-31, the more likely it is to miss various other strains of Borrelia--Mayonii and Miyamotio, for example.  
4. Non-cultivability. The gold standard for isolation of most bacteria is by culture with confirmation by PCR. Unfortunately, Borrelia is extremely difficult to grow in culture. In addition, PCR takes 2-6 weeks and is only 40-70% sensitive for erythema migrans rash, 3-17% for cerebral spinal fluid and lower than 3% for synovial or tissue samples. Not only does this type of testing waste valuable time, it does not rule-in or rule-out a Lyme infection. (Borchers 2015)  
5. Immune Disruption. People who have multiple co-infections and/or are immunocompromised may never develop antibodies to Bb increasing the likelihood of a false-negative. Through antigenic variation Bb can evade the immune system and disrupt B-cell and T-cell function suppressing a normal immune response. (Eisner, Baumgarth 2015)  

Significant Evidence of Faulty Lyme Testing 

1. ELISA. 78 Studies evaluating the ELISA were reviewed. The results demonstrated that sensitivity and specificity from individual studies were highly variable. Pooled results of the most widely used tests showed sensitivity as follows: erythema migrans 50%; neuroborreliosis 77%; acrodermatitis chronic atrophicans 97%; unspecified Lyme borreliosis 73%. Specificity was 95% for health controls but dropped to 80% in cross-sectional studies. Which means at-worst 50% and at-best 80% of patients who have active Lyme Disease will receive an accurate diagnosis based off of serological testing. (Leeflang 2016)  
2. Western Blot. Comparison of 4 commercial ELISA and 3 Western Blots demonstrated considerable variation in their ability to correctly diagnose Lyme borreliosis. The positive predictive value (PPV) ranged from a low of 40% to a high of 92%. The whole cell sonicate (WCS) western immunoblot had a higher PPV when specific purified proteins were added to increase the range of Borrelia species being tested. (Dickson 2016)  

What the Experts Say

"What is more clear is that the tests that we have for diagnosing Lyme are woefully inadequate and are doing our patients a great disservice." ~ Dr. Judy Stone, Infectious Disease Physician, Author "Conducting Clinical Research," Contributor at Forbes Health. 

"A Test for distinguishing between an active [Lyme] infection and someone who has been clinically and biologically cured, that would be essential." ~ Monica Embers, PhD, Tulane National Primate Research Center, Division of Bacteriology and Parasitology.

"Most cases of Lyme disease don't have sufficient levels of bacteremia to make PCR testing of blood a sensitive method for diagnosis." ~ Dr. Bobbi Pritt, Pathologist, Medical Parasitologist and Microbiologist, Professor at Mayo Medical Clinic Department of Laboratory Medicine and Pathology. 

"So there's two problems with diagnosis. The biggest is the currently available blood test for Lyme Disease, which is based on antibodies, doesn't turn positive for the first few weeks of infection. So there's this window where the test is falsely negative, at the crucial time when you want to make an early diagnosis. That's one. The second is the telltale rash - the target lesion that people are used to seeing pictures of -- actually, typically doesn't look like a target lesion." ~ Dr. John Aucott, Professor and Clinical researcher at Johns Hopkins University School of Medicine, founder and president of Lyme Disease Research Foundation.

"There are people who don't fit the classic mold of a bull's-eye rash... I'm an example of somebody who is a physician scientist who was dismissed as being stressed when in fact I had a serious, life-threatening [Lyme] infection that almost took my life." ~ Dr. Neil Spector, Professor Department of Medicine, Pharmacology and Cancer Biology at the Duke University School of Medicine, "Author Gone In A Heartbeat: A Physician's Search For True Healing."  

During his lecture at ILADS in Ft. Lauderdale, Fl in October 2015, Dr. Neil Spector talked about "How Lessons from Personalized Cancer Care Can Inform Management of Lyme Disease." The following is a slide from his lecture depicting the similarities between Cancer and Lyme Disease, and highlighting the need for a new approach to Lyme Disease. 

Image from Dr. Neil Spector (with permission)