Borrelia burgdorferi Antibodies (Lyme) IgG & IgM
| Order Code: | LYME |
| Order Form: | Laboratory Requisition |
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.
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.
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°C.
Transport
Instructions:
Place requisition into outside pocket of bag.
Place specimen into zip-lock type bag, seal bag.
Use refrigerated coolant packs.
Place specimen into zip-lock type bag, seal bag.
Use refrigerated coolant packs.
CPT Code:
86618