Borrelia burgdorferi Antibodies (Lyme) IgG & IgM, Serum

Borrelia burgdorferi Antibodies (Lyme) IgG & IgM

Order Code:	LYME
Epic Lab Code:	LAB2358
Order Form:	A-1a General Lab or Epic Req

Chemistry
6240 RCP
356-3527

Specimen:

Serum

Collection Medium:

Red top tube

Minimum:

3 mL; red top tube

Rejection Criteria:

Hemolyzed, icteric or Lipemic specimens, plasma specimens.

Testing Schedule:

Test performed on Monday, Wednesday and Friday.

Analytic Time:

3 days

Reference Range:

Negative

Test Limitations:

This test is a qualitative enzyme linked fluorescent immunoassay (ELFA) for the presumptive detection of antibodies (IgG and IgM) to Borrelia burgdorferi to aid in the diagnosis of Lyme disease. Lyme disease is caused by infection with a tick-borne spirochete, B. burgdorferi, and is endemic in at least 15 states (1). The diagnosis of Lyme disease is based on clinical findings, exposure history, and antibody production (1). A two test approach is recommended for the serologic diagnosis of Lyme disease (2). Specimens are first tested with the ELFA. Specimens that are positive or equivocal will automatically be sent to a reference laboratory for confirmatory testing with the more specific IgG and IgM Western blots. Positive ELFA results should be considered presumptively positive and should not be used to make therapeutic decisions. Negative ELFA results will be reported accordingly and no further testing will be performed. The sensitivity and specificity of the serologic tests vary in relation to the length of time since exposure (2). In early disease, a serologic response may not be detectable. Patients who receive antimicrobial therapy during the early stages of infection may not produce detectable levels of antibodies (3). False positive ELFA results can occur in patients with syphilis, relapsing fever, Rocky Mountain Spotted Fever, other spirochetal diseases, autoimmune disease, rheumatoid arthritis, systemic lupus erythematosus, EBV or CMV infection (4). Clinical symptoms, epidemiology, and other laboratory tests such as the more specific Western blot should allow these conditions to be distinguished from Lyme disease.

References
1. Steere AC. 2001. Medical progress: Lyme disease. New Eng J Med 345:115-125.
2. CDC. 1996. Recommendation for test performance and interpretation from the Second National Conference on Serological Diagnosis of Lyme Disease. MMWR 45:481-484.
3. Callister SM, KL Case, RF Schell. 1990. Diagnostic testing for Lyme disease. Labmedica Feb/March 11-14.
4. Magnarelli L, et al. 1987. Cross reactivity in serologic tests for Lyme disease and other spirochetal infections. J Infect Dis 156:183- 188.

Methodology:

Enzyme Linked Fluorescent Immunoassay (ELFA)

CPT Code:

86618