CDC testing protocol opposed for being inconsistent, producing false negatives

Lyme disease, a bacterial infection caused by the spirochete Borrelia burgdorferi, mimics many diseases. It has been misdiagnosed as other diseases or disorders in a number of cases (multiple sclerosis, several forms of arthritis including juvenile arthritis, heart disorders not limited to heart block, other neurological disorders, psychiatric disorders, chronic fatigue syndrome, fibromyalgia, Alzheimer’s disease, Crohn’s disease and other conditions).

Late-stage Lyme disease can resemble any of these other illnesses. Acute Lyme disease is in some cases more flu-like, with headaches, muscle aches, fever, stiff neck, etc. Some people do not get this initial flu-like acute phase.

Lyme disease is much more prevalent in Canada than our tests indicate. Not diagnosing and treating Lyme disease early can result in a serious decline in health and quality of life similar to untreated syphilis T. pallidum, another spriochaetal disease. B. burgdorferi has more than 1,500 gene sequences, 132 functioning genes (syphilis has only 22), 21 plasmids (three times more than any other known bacteria) and has the ability to evade the immune system. It is a formidable bacterium and has been shown in peer-reviewed research to remain as an active persistent infection after several weeks of antibiotic therapy.

The classic bull’s-eye rash (erythema migrans) by itself is diagnostic but occurs or is seen in fewer than 50% of cases. Making things more difficult, research has proven that laboratory serology is less than adequate for diagnosis. More important, serology cannot satisfactorily rule out Lyme disease in either the early or late stages.

Canadian labs follow the 1994 U.S. Association of State and Territorial Public Health Laboratory Directors (ASTPHLD) two-tier testing protocol of a screening test such as Enzyme-Linked Immunosorbant Serum Assay (ELISA), and only if that test is positive is a confirmatory positive Western Blot. We, along with scientists from around the world, oppose the CDC testing protocol. The protocol was heavily influenced by industry.

The problem is that in large, blinded multiple-laboratory studies findings indicated the labs using this ASTPHLD protocol could only identify Lyme disease via ELISA 45% to 55% of the time and could not identify the same sample consistently in the same lab.

Further problems are that the criteria looked at in the Western Blot as put forward by ASTPHLD exclude some of the most Lyme-specific bands on the blot, making this test a poor one as well.

To exemplify this point of poor testing, at a 1995 rheumatology conference in Texas, Dr. Paul Fawcett (PhD) presented an analysis of the new Lyme disease criteria. All of 66 children who had a history of tick bite, bull’s-eye rash and symptoms of Lyme disease tested positive using the pre-1994 criteria. Using the new criteria, only 20 tested positive (a 69% false negative rate while the old criteria had 0% false negative).

In October 2006, the Infectious Disease Society of America (IDSA) released their updated Lyme disease clinical practice guidelines. Other medical groups had asked to participate in the creation of the guidelines but were refused. The guidelines rely heavily on the two-tier testing protocol following the ASTPHLD criteria and ignore the global database of research. Some of the authors of these guidelines also sat on the committee in 1994 that set the ASTPHLD criteria. The insurance industry has quickly adopted these IDSA guidelines and quote them verbatim as they deny claims for treatment.

Richard Blumenthal, the Attorney General of Connecticut, announced recently he is investigating the IDSA with respect to the publishing of these guidelines under anti-trust laws, and is bringing the insurance industry into his investigation.

The IDSA guidelines and the ASTPHLD criteria have no place in Canadian health care.

Diagnosing and treating Lyme and co-infections can be complex and cannot be properly addressed here. For that information and information on testing labs visit our Web site at http://www.canlyme.org/.

Jim Wilson is president of the Canadian Lyme Disease Foundation.