Specimen:

Serum

Collection Medium:

Minimum:

2 ml; red top tube (no additive)

Testing
Schedule:

Test is performed twice weekly.

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 more
sensitive screening EIA.  Specimens that are positive or equivocal will
automatically be sent to the University Hygienic Laboratory for
confirmatory testing with the more specific IgG and IgM Western
blot.  Positive EIA results should be considered presumptively
positive and should not be used to make therapeutic decisions.  
Negative EIA 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 EIA 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)

Sample
Processing:

Label transport tube with two patient identifiers, date and time of 
collection.
Aliquot serum into labeled container and cap.
Centrifuge at 3000 RPM for 10 minutes.
Centrifuge within one hour of draw time.

Sample
Storage:

Refrigerate serum 2-8 degree C.

Transport
Instructions:

Place requisition into outside pocket of bag.
Place specimen into zip-lock type bag, seal bag.
Use refrigerated coolant packs.

CPT Code:

86618

See Additional Information:
Microbiology Specimen Collection and Transport