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Mar. 1997, p. 537-543 Vol. 35, No. 3

Interlaboratory Comparison of Test Results for Detection of Lyme Disease by 516 Participants in the Wisconsin State Laboratory of Hygiene/College of American Pathologists Proficiency Testing Program

LORI L. BAKKEN,1,2† STEVEN M. CALLISTER,3 PHILIP J. WAND,2 AND RONALD F. SCHELL,2,4†* Departments of Continuing and Vocational Education1 and Medical Microbiology and Immunology,4 and Wisconsin State Laboratory of Hygiene,2 University of Wisconsin, Madison, Wisconsin 53706; and Microbiology Research Laboratory, Gundersen Medical Foundation, La Crosse, Wisconsin 546013

It ain't what you don't know that gets you into trouble. It's what you know for sure that just ain't so. Mark Twain

In 1991, we reported that 55% of laboratories participating in the Wisconsin Proficiency Testing Program could not accurately identify serum samples from Lyme disease patients containing antibody against Borrelia burgdorferi.

The purpose of this study [published in 1997 -- my insert] was to determine whether the accuracy of Lyme disease test results reported by approximately 500 participants in the Wisconsin State Laboratory of Hygiene/College of American Pathologists Lyme Disease Survey had improved.

From 1992 through 1994, 50 serum samples were sent to participants of the survey. Each laboratory received 28 serum samples from individuals with Lyme disease according to the case definition of the Centers for Disease Control and Prevention and 22 serum samples from healthy individuals. Unfortunately, the serodiagnosis of Lyme disease by participants had not improved. [My italics and bold]

The specificity of the Lyme disease assays steadily decreased from approximately 95% to approximately 81% during the 3-year period of the survey. [Specificity means the tests ability to pick out Lyme from other infections -- my insert]

False-positive test results approached 55% with some of the serum samples from healthy donors. A serum sample containing antibody against Treponema pallidum [Venereal syphilis -- my insert] was reported as positive by 70% of the participants.

In addition, the sensitivity fluctuated between 93 and 75%, depending upon the conjugate used by the laboratories. [Meaning that patients with certain and utterly clear Lyme, were missed 7%-25% of the time -- my insert] These results suggest that stronger criteria must be applied for approving and continuing to approve commercially available kits for the serodiagnosis of Lyme disease.

According to these authors, Lyme is a very serious illness, and not one to treat trivially. They mention:

Lyme borreliosis, caused by the spirochete Borrelia burgdorferi... can affect numerous organ systems including the skin, connective tissue, heart, and central nervous system. Symptoms range from mild, flu-like abnormalities to severe disabling conditions. Since the illness can resemble aseptic meningitis, rheumatoid arthritis, influenza, or other syndromes, clinicians tend to rely upon serological tests as the primary indicator for detection of infection with B. burgdorferi... Serological tests for Lyme borreliosis, however, have demonstrated poor sensitivity and specificity...

They further mention:

We showed previously that significant inter- and intralaboratory variations existed among test results obtained from 45 laboratories performing Lyme disease proficiency testing in an area where Lyme disease is endemic. Approximately 4 to 21% of the laboratories failed to identify correctly positive serum samples with titers of 512 or more ... [Italics mine. And this level is very high in my opinion, so to miss it is serious. Especially since Lyme hides over time and antibody titers will fall.]

With lower levels of anti-B. burgdorferi antibody in the serum samples, approximately 55% of participating laboratories did not identify a case-defined serum sample from an individual with Lyme disease according to the case definition of the Centers for Disease Control and Prevention...

[My insert comment -- In other words, using the very conservative CDC criteria that requires massive finger print antibodies to various parts of the Lyme bug, and with a stealth organism that usually has the ability to hide from your immune system and make lower antibodies, the labs missed 55%. So the risk of all the damage Lyme can cause is high for the 45% missed.]

We also observed a steady decline in the sensitivity of the tests from 1992 through 1994. We found that the sensitivity of the IgM and IgG tests markedly declined when the index values for the serum samples were 1.50 or less. [My insert -- Lyme hides and over time my experience is the antibodies against it usually decrease as the immune system is weaken. So the normal chronic Lyme patient with low antibodies is often missed].

The decline in sensitivity was even greater with the IgG and IgM tests when the index values for the serum samples were 1.10 or less (1.10 was the cutoff value of our reference immunoassay).

For example, nine serum samples with an index value of 1.10 or less were identified by only 74% or less (range, 36 to 74%) of the laboratories that used the IgG tests. Similarly, five of six serum samples with index values of 1.10 or less were reported to be positive by 61% or less (range, 3 to 61%) of the laboratories that used the IgM conjugates. [My bold] Collectively, these results affirm our previous finding (1) that laboratories have the greatest difficulty in identifying serum samples with lower levels of B. burgdorferi antibody. [My bold italics. In my experience, these are the most common levels in chronic patients off antibiotics].

My only appeal with this article is the issue of who is a "healthy control" person. The authors were troubled that some in their healthy "non-Lyme" group had positives. While I am not sure I have even seen this clinically, the real issue is this: could the CDC number one vector illness in the USA be more dispersed than we realized?

And that the healthy folks are able to mobilize a better antibody response to it, and therefore show up as a positive? My sickest folks have a very hard time showing positives on routine Lyme tests, and we have to use specialized testing from tick only labs. Also, in homes with a high Lyme rate, the healthiest person often has the highest antibodies, since you have to be healthy to have good antibody production.

To order a copy of this interesting article go to: jcm.asm.org/misc/reprints.shtml

So be careful in trusting any ELISA test!

Best regards,

Dr. J

Bank Towers, Tamiami Trail, Naples, FL
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