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Sorted By Test Name - Mayo Medical Laboratories

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FBBIA<br />

91898<br />

FBBAB<br />

91309<br />

Serology is currently the diagnostic method of choice for Lyme disease. The Second National Conference<br />

on the Serologic Diagnosis of Lyme Disease (1994) recommended that laboratories use a 2-test approach<br />

for the serologic diagnosis of Lyme disease. Accordingly, specimens are first tested by the more sensitive<br />

EIA or enzyme-linked immunosorbent assay (ELISA). A Western blot (WB) assay is used to confirm<br />

positive Lyme EIA or ELISA results due to the presence of IgG- or IgM-class antibodies. WB identifies<br />

the specific proteins to which the patient's antibodies bind. Although there are no proteins that specifically<br />

diagnose Borrelia burgdorferi infection, the number of proteins recognized in the WB assay is correlated<br />

with diagnosis. Since serology may not be positive until 2 to 4 weeks after onset of ECM, direct detection<br />

of Borrelia burgdorferi-specific target DNA sequences using PCR is a promising adjunct to existing<br />

diagnostic tests. PCR has shown utility for detection of Borrelia burgdorferi DNA from skin biopsies of<br />

ECM lesions, and from synovial and cerebrospinal fluid in late-stage disease. Borrelia burgdorferi DNA<br />

can also, rarely, be detected from blood, but is not the test of choice from this source.<br />

Useful For: Confirmation of active Lyme disease Monitoring Lyme disease treatment PCR testing<br />

should be limited to patients with a positive, or at least an equivocal, serologic test for antibody to<br />

Borrelia burgdorferi.<br />

Interpretation: A positive result indicates the presence of DNA from Borrelia burgdorferi, the agent<br />

of Lyme disease. A negative result indicates the absence of detectable DNA from Borrelia burgdorferi in<br />

the specimen. Due to the diagnostic sensitivity limitations of the PCR assay, a negative result does not<br />

preclude the presence of the organism or active Lyme disease.<br />

Reference Values:<br />

Not applicable<br />

Clinical References: 1. Keller TL, Halperin JJ, Whitman M: PCR detection of Borrelia burgdorferi<br />

DNA in cerebrospinal fluid of Lyme neuroborreliosis patients. Neurology 1992;42:32-42 2. Nocton JJ,<br />

Bloom BJ, Rutledge BJ, et al: Detection of Borrelia burgdorferi DNA by polymerase chain reaction in<br />

cerebrospinal fluid with Lyme neuroborreliosis. J Infect Dis 1996;174:623-627 3. Nocton JJ, Dressler F,<br />

Rutledge BJ, et al: Detection of Borrelia burgdorferi DNA by polymerase chain reaction in synovial fluid<br />

from patients with Lyme arthritis. N Engl J Med 1994;330:229-234 4. Reed KD: Laboratory testing for<br />

Lyme disease: possibilities and practicalities. J Clin Microbiol 2002;40:319-324 5. CDC:<br />

Recommendation for test performance and interpretation from second national conference on serological<br />

diagnosis of lyme disease. MMWR Morb Mortal Wkly Rep 1996;45:481-484 6. Babady NE, Sloan LM,<br />

Vetter EA, et al: Percent positive rate of Lyme real-time polymerase chain reaction in blood,<br />

cerebrospinal fluid, synovial fluid, and tissue. Diagn Microbiol Infect Dis 2008;62(4):464-466<br />

Lyme Disease Antibody (IgG), IBL (CSF)<br />

Reference Values:<br />

REFERENCE RANGE: No Bands Detected<br />

No interpretive criteria for Lyme Disease (Borrelia burgdorferi) immunoblot have been established for<br />

CSF. The presence of reactive antibodies in CSF may represent either compartmental antibody production<br />

or transudation of plasma antibody. Immunoblot assays may be used to confirm the presence of B.<br />

burgdorferi-specific antibodies detected in screening assays (ELISA, IFA).<br />

<strong>Test</strong> Performed by: Focus Diagnostics, Inc.<br />

5785 Corporate Ave.<br />

Cypress, CA 90630-4750<br />

Lyme Disease Antibody Index for CNS Infection<br />

Reference Values:<br />

Lyme Disease Antibody Index:<br />

< or = 1.0 Negative<br />

1.1 - 1.2 Equivocal<br />

Current as of January 4, 2013 7:15 pm CST 800-533-1710 or 507-266-5700 or <strong>Mayo</strong><strong>Medical</strong><strong>Laboratories</strong>.com Page 1128

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