Why All The False Negative Test Results In Lyme Disease Testing?

Current Lyme testing is very inaccurate, especially in those with a long-term chronic illness. Lyme disease has always been meant to be a clinical diagnosis, and not based upon blood tests. From their inception, the blood tests designed by the Center for Disease Control (CDC) were known to be very flawed (the CDC even states this on their site). The designer of the Lyme blood tests has said in interviews that he knew the Western Blot was a terribly flawed test for Lyme disease and that when he tried to get funding for a more sensitive and specific test, he was declined by the CDC.

What many people do not know is that when you are tested for Lyme disease through a hospital or commercial lab throughout the country, there is a 2-step process (most doctors do not tell this to their patients). First, the lab will perform the Lyme enzyme-linked immunosorbent assay (ELISA) to screen for Lyme disease. If you test positive on the ELISA test, they will then perform the Western Blot test. Now, why this 2-step process is so flawed is that the ELISA blood test is known to miss 50% of the cases due to the assay’s lack of sensitivity and variability with antibiotic treatment. So, if you don’t test positive on the ELISA, then they will not perform the Western Blot test. But it gets better! The Western Blot test itself is flawed as well:

“The Centers for Disease Control and Prevention (CDC) surveillance criteria for Lyme disease were devised to track a narrow band of cases for epidemiologic purposes. As stated on the CDC website, the surveillance criteria were never intended to be used as diagnostic criteria, nor were they meant to define the entire scope of Lyme disease…

“…Of patients with acute culture-proven Lyme disease, 20–30% remain seronegative on serial Western Blot sampling. Antibody titers also appear to decline over time; thus while the Western Blot may remain positive for months, it may not always be sensitive enough to detect chronic infection with the Lyme spirochete. For “epidemiological purposes” the CDC eliminated from the Western Blot analysis the reading of bands 31 and 34. These bands are so specific to Borrelia burgdorferi that they were chosen for vaccine development. Since a vaccine for Lyme disease is currently unavailable, however, a positive 31 or 34 band is highly indicative of Borrelia burgdorferi exposure. Yet these bands are not reported in commercial Lyme tests.”(ILADS.com)

You should be aware that many people with Lyme disease are actually asymptomatic and Lyme can have a long latency period where symptoms can present themselves many years later after the initial infection or bite.

I was first tested for Lyme disease in 2005 – about 9 months after falling ill. The results came back with my having 3 positive bands on the Western Blot and was told it was not significant as this did not meet the CDC’s requirement of 5 positive bands; therefore, “I could not have Lyme disease”. I was retested for Lyme disease 4 years later – in the summer of 2009 – and this time I had 7 positive bands on the Western Blot (I had 5 bands that the CDC considers as being counted toward a positive Lyme test). I was retested through IGeneX, a lab in California that has more sensitive and specific tests for Lyme disease. Now, the Lyme disinformation group, a la IDSA, would like people to think that somehow IGeneX is messing with the tests as “too many people test positive” through IGeneX. Well, the IGeneX tests for Lyme disease and other tick-borne diseases were designed differently than the inferior tests used predominantly throughout the world, such as IGeneX’s use of more than one strain of Borrelia burgdorferi to prepare their Western Blot strips. They also designed their tests to pick up not just early Lyme, but all stages of the disease. IGeneX is not some fringe lab that is evading the watchful eye of the government, rather, as they state clearly on their website, “Our laboratory is regularly inspected and recertified to perform high complexity testing. To further monitor our effectiveness, we have frequent inspections by outside consultants who were former state and federal laboratory inspectors or laboratory directors.” Even though IGeneX is the preferred lab for Lyme disease testing for most Lyme Literate doctors(LLMDs), no test for Lyme disease is 100% reliable and they can still miss cases of Lyme (see “Lyme Testing” on my toolbar above for more reasons why some people will never test positive on current Lyme disease tests even if they have Lyme disease).

Pamela Weintraub, author of Cure Unknown: Inside the Lyme Epidemic (amazing book), wrote a wonderfully thorough article on why current tests for Lyme disease produce so many false negatives. Here is a snippet from the article:

“The answers won’t be found in the twentieth-century technology of the Western blot, by today’s standards crude yet still trotted out by IDSA as evidence absolute that they are right. (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.

“What we will find,” says Ben Luft of Stony Brook, “are proteins we never tested for on our ELISAs and Western blots—proteins we were never even aware of. But they will be the critical markers for invasive, infectious Lyme disease. Perhaps people who test negative on the old tests will become positive when we look for the right markers,” he adds.”

To read the entire article, click here.

Tags: IGeneX, lyme, lyme disease, lyme disease test, lyme disease testing, tick, western blot