Lyme Disease Testing is Not Always Correct

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The tick-borne illness called Lyme disease has become an increasing and demanding threat to public health in Northeastern parts of the United States. Unfortunately, Lyme disease testing is not federally regulated resulting in misdiagnosed patients where doctors and patients are uncertain which tests are true. Regrettably, Lyme disease testing is not always correct.

Lyme disease testing is not always correct

The U.S. Centers for Disease Control and Prevention (CDC) reports that there are close to 30,000 reported cases of Lyme disease, each year. Since Lyme disease testing is unregulated, many labs give results that are unproven and not trustworthy. According to Harvard Medical School professor of pathology, Andrew Onderdonk, there are varieties of companies using tests that are unverified and cannot be trusted.

For instance, Advanced Laboratory Services, Inc., a company on the outskirts of Philadelphia tests for Lyme by growing bacteria that causes the microorganisms; however, Lyme researchers find this method has not been proven reliable. In addition, the company faced much criticism from regulators and scientists since the company started selling its test in 2011. Additionally, New York rejected the company claiming there isn’t any proof the tests work and inspectors found the company’s facility presented “broad substandard” laboratory practices.

Another laboratory in Wisconsin has been unable to offer New York with validation of whether their Lyme disease testing method is correct. The founder of Parmasan Labs Inc., Gottfried Kellermann, claims his tests are correct and misunderstood. However, controversy surrounds Mr. Kellermann and the companies he represents. Mr. Kellermann was convicted of a felony in 1992 for conspiracy to defraud $750,000 from the federal government of malaria research. In addition, this last May, Kellermann’s NeuroScience offices were raided by the FBI. According to Kellermann’s attorney, they suspect the raid was due to a former employee’s Medicare billing problem who was ultimately sued by the company for fraud.

Paying for unproven Lyme tests

In the U.S., there are close to 3 to 4 million federally recommended Lyme tests performed each year, costing nearly $492 million; however, it is not clear how many unproven Lyme disease testing methods are used since they do not have to register with the U.S. Food and Drug Administration (FDA). The CDC estimates that close to tens of thousands of unregulated, unproven Lyme tests are performed every year.

Most insurance companies do not cover Lyme disease testing, which range from $100 to $1,000. In New York, seven labs were denied permission to sell Lyme tests in the last ten years. The CDC has become so concerned about questionable Lyme tests that they issued a notice to the public and doctors to avoid tests unless they are CDC recommended.

Lyme disease is a major public health concern

Lyme is one of the most sinister health threats to the Northeastern U.S. population. People enjoying outdoor activities are subject to deer ticks smaller than a poppy-seed latching to their bodies. The tick is a parasite that feeds off the host’s blood and in many cases transfers the Lyme bacteria as well as other pathogens that cause diseases.

A black-legged tick’s bite spreads Lyme disease. During warmer weather, ticks are very active, especially in northeastern U.S., from Maine to Virginia. States in the northwest, like Minnesota and Wisconsin also have a large volume of ticks. Northern California and parts of the West Coast have ticks, as well.  Lyme symptoms are similar to the flu; if untreated it can eventually cause arthritis, irregular heartbeat, inflammation of the heart, or facial paralysis.

Not all Lyme test are bad. Nonetheless, it is best to know how to avoid getting Lyme disease, what the symptoms are, and what to do. Knowledge is the key.

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George Zapo, CPH
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George Zapo, CPH is certified in Public Health Promotion & Education. George focuses on writing informative articles promoting healthy behavior and lifestyles. Read more of George's articles at his website: http://georgezapo.com.