Sorted By Test Name - Mayo Medical Laboratories

LYME
9129
< or = 0.90 Antibody Not Detected
0.91 - 1.09 Equivocal; submission of a
second specimen (collected
3-4 weeks after initial
specimen) suggested if
clinically warranted.
> or = 1.10 Antibody Detected
This ELISA detects both IgG and IgM antibodies against the C6 peptide derived from the V1sE protein
of Borrelia burgdorferi, the causative agent of Lyme disease. IgM-specific titers usually peak 4 to 6 weeks
after onset of infection and may persist in the presence of disease. IgG levels tend to rise above
background levels about 2 to 3 weeks after infection, and may remain elevated in cases of prolonged
disease. The C6 peptide antibody ELISA exhibits sensitivity and specificity values greater than 95% for
Lyme disease.
As recommended by the Food and Drug Administration (FDA) Public Health Advisory, July 7, 1997),
all samples with positive or equivocal results in the Lyme Disease C6 Antibody EIA (Screening) should
be tested by Western Blot/Immunoblot.
Positive or equivocal screening test results should not be interpreted as truly positive until verified as
such using a confirmatory assay. [e.g. Lyme Disease Antibodies (IgG, IgM), IBL (serum)]. The screening
test and/or immunoblot for Lyme disease antibodies may be falsely negative in early stages of Lyme
disease, including the period when erythema migrans is apparent.
Test Performed by: Focus Diagnostics, Inc.
5785 Corporate Ave.
Cypress, CA 90630-4750
Lyme Disease Serology, Serum
Clinical Information: Lyme disease is caused by the spirochete Borrelia burgdorferi. The spirochete
is transmitted to humans through the bite of Ixodes species ticks. Endemic areas for Lyme disease in the
United States (US) correspond with the distribution of 2 tick species, Ixodes dammini (Northeastern and
Upper Midwestern US) and Ixodes pacificus (West Coast US). In Europe, Ixodes ricinus transmits the
spirochete. Lyme disease exhibits a variety of symptoms that may be confused with immune and
inflammatory disorders. Inflammation around the tick bite causes skin lesions. Erythema chronicum
migrans (ECM), a unique expanding skin lesion with central clearing that results in a ring-like
appearance, is the first stage of the disease. Any of the following clinical manifestations may be present in
patients with Lyme disease: arthritis, neurological disease, cardiac disease, or skin lesions. Neurologic and
cardiac symptoms may appear with stage 2 and arthritic symptoms with stage 3 of Lyme disease. In some
cases, a definitive distinction between stages is not always seen. Further, secondary symptoms may occur
even though the patient does not recall a tick bite or a rash. Serology may not be positive until 2 to 4
weeks after onset of ECM; however, culture of skin biopsies obtained near the margins of ECM are
frequently positive. In late (chronic) stages of the disease, serology is often positive and the diagnostic
method of choice. PCR testing also may be of use in these late stages if performed on synovial or
cerebrospinal fluid. Early antibiotic treatment of Lyme disease can resolve clinical symptoms and prevent
progression of the disease to later stages. Treatment with penicillin, tetracycline, erythromycin,
chloramphenicol, or ceftriaxone is considered appropriate therapy The Second National Conference on the
Serologic Diagnosis of Lyme Disease (1994) recommended that laboratories use a 2-test approach for the
serologic diagnosis of Lyme disease. Accordingly, specimens are first tested by the more sensitive EIA or
enzyme-linked immunosorbent assay (ELISA). A Western blot assay is used to confirm positive Lyme
EIA or ELISA results due to the presence of IgG or IgM class antibodies. WB identifies the specific
proteins to which the patient's antibodies bind. Although there are no proteins that specifically diagnose
Borrelia burgdorferi infection, the number of proteins recognized in the WB assay is correlated with
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