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The Challenges of Testing for Lyme Disease

Lyme disease has become increasingly challenging to diagnose, making accurate and reliable testing even more essential to inform and support physician diagnoses. However, recent research has revealed that the standard two-tier testing recommended by the Centers for Disease Control and Prevention (CDC) as well as a growing number of new tests can often lead to false positive and negative results. Diagnosis is made even more challenging by the fact that Lyme disease symptoms closely resemble other diseases. In fact, Lyme disease is often called "The Great Imitator" because its symptoms mimic so many other illnesses, including Chronic Fatigue, Fibromyalgia, Rheumatoid Arthritis, Multiple Sclerosis, Parkinson's disease, ALS, Depression and Alzheimer's disease.


Most labs use the two-tier testing for Lyme disease recommended by the CDC, which includes both the ELISA and Western Blot, or ImmunoBlot, tests. But these tests don’t provide a complete diagnostic picture.

IGenex Test

Made from recombinant proteins of several species of Borrelia burgdorferi. Detects antibodies to following B. burgdorferi sensu lato species.

  B. garinii  B. burgdorferi 297
  B. afzelii  B. mayonii
  B. californiensis  B. burgdorferi B31
  B. spielmanii   B. valaisiana

 

Western Blot Test

Made from recombinant proteins of Borrelia burgdorferi B31. Therefore antibodies to most species of B. burgdorferi sensu lato cannot be detected.

 B. burgdorferi B31

The two-tier ELISA/Western Blot testing recommended by the CDC uses result criteria that was developed in 1994, when far less was known about Lyme disease. These tests can provide useful information by detecting antibodies for Lyme, but they don’t provide physicians with a complete picture for accurate diagnosis.

The Western Blot test is used to determine if a patient with characteristic signs and symptoms of Lyme disease has been infected by Borrelia burgdorferi, the bacterium that causes Lyme disease. The test can detect antibodies that are produced by a patient’s immune system in response to the infection. Specifically, the Western Blot test looks for the presence of both IgG and IgM antibodies to confirm exposure to B. burgdorferi.  However, various factors can influence test findings, including:

 

  • IgM Antibodies: These antibodies are the earliest to appear in response to a patient’s exposure to .
  • IgG Antibodies: These antibodies are produced four-to-six weeks following infection and can persist for years. Tests for IgG antibodies can be an indicator of Chronic Lyme or long-term exposure to Lyme disease.

It is important to note that testing positive for all antibodies does not mean a person has Lyme disease. It only confirms that a patient has been exposed to the disease-causing pathogens. Evaluation of a patient’s IgG and IgM test results together with symptoms in order to diagnose Lyme disease and provide the best course of treatment.

 

Lyme ImmunoBlot IgM

IGeneX Specific Protiens (band-kDa): 23kDa, 31kDa, 39kDa and 41kDa

CDC Recommended Specific Protiens (band-kDa): 23kDa, 39kDa, and 41kDa

IGeneX Result Criteria

Positive Result: Combination of any two or more of the above bands

Negative Result: Any profile that does not meet positive criteria

CDC Result Criteria

Positive Result: Combination of two or more of the above bands

Negative Result: Any profile that does not meet positive criteria

Lyme ImmunoBlot IgG

IGeneX Specific Protiens (band-kDa): 18kDa, 23kDa, 28kDa, 30kDa, 31kDa,34kDa,39kDa, 41kDa, 45kDa, 58kDa, 66kDa,and 93kDa

CDC Recommended Specific Protiens (band-kDa): 18kDa, 23kDa, 28kDa, 30kDa, 39kDa, 41kDa, 45kDa, 58kDa, 66kDa,and 93kDa

IGeneX Result Criteria

Positive Result: Combination of any two or more of the above bands

Negative Result: Any profile that does not meet positive criteria

CDC Result Criteria

Positive Result: Combination of any five of the above bands

Negative Result: Any profile that does not meet positive criteria

   


Both IGeneX tests and the CDC-recommended Lyme serology tests are designed to detect IgG and IgM antibodies, but the IGeneX test result criteria produces a higher sensitivity for detecting Lyme exposure.

IGeneX result criteria produce a higher sensitivity for detecting Lyme or TBRF exposure

Lyme Disease

By combining the result criteria of reporting more significant protein bands, IGenex testing provides higher sensitivity for detecting Lyme exposure. Specifically, IGeneX uses recombinant proteins to detect antibodies to more B. burgdorferi sensu lato species than the current Western blot does.  Prepared from two strains of B. burgdorferi, IGeneX produces a higher sensitivity and the most comprehensive testing for Lyme disease antibodies in patient serum samples.

TBRF

Most laboratories in the United States and Europe offer only the B. miyamotoi GlpQ protein serological assay. In contrast, IGeneX testing is able to provide superior sensitivity to these tests by including more recombinant antigens from several species of TBRF Borrelia on the ImmunoBlot. Based on limited studies, more than 50 percent of patients with TBRF are missed by tests that only use B. miyamotoi GlpQ.

 

 

IGeneX TBRF Immunoblot Tests

Made from recombinant proteins of several species of TBRF Borrelia species. Detects antibodies to TBRF Borrelia species from US, Europe and Australia.

 B. miyamotoi

 B. hermsii

 B. turicatae

 B. coriacea

Other Labs Using Immunoblot Tests

Made with only one recombinant Borrelia miyamotoi GIpQ protein. Therefore, antimodies to all species of TBRF Borrelia cannot be detected

 miyamotoi GIpQ protein only