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HelpTest Code LAB5110 Lyme Disease Serology, Serum
Useful For
Diagnosis of Lyme disease
This test should not be used as a screening procedure for the general population.
This test should not be used for treatment monitoring.
Use: For use in diagnosis of Lyme disease. Diagnosis of LD is currently based on a 2-tiered serologic testing algorithm, as recommended by the Centers for Disease Control and Prevention (CDC), and involves an initial screening assay for detection of antibodies to LD-causing Borrelia species. Samples that are screen positive or equivocal are subsequently reflexed for supplemental assessment using a B burgdorferi immunoblot for detection of IgM- and IgG-class antibodies to specific B burgdorferi antigens.
Importantly, while serologic assessment for LD may be negative in the early weeks following infection, over 90% of patients with later stages of infection are seropositive by serology, which remains the diagnostic method of choice for this disease.
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Required
Supplies: Aliquot Tube, 5 mL (T465)
Collection Container/Tube:
Preferred: Yellow (Gold) top tube (SST)
Acceptable: Plain Red top tube
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Collection Information: Centrifuge and aliquot serum into plastic vial.
Specimen Minimum Volume
1.0 mL
Specimen Stability Information
Centrifuge and separate collection tube within 2 hours of draw. Refrigerate at 2°-8°C.
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 10 days | |
| Frozen | 30 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Heat inactivated | Reject |
Day(s) Performed
Test performed Monday through Friday.
Western Blot confirmations performed at Mayo Medical Laboratories with a 7 to 10 day turnaround time.
Positive confirmatory tests are phoned to the physician/provider. Positive results require Public Health reporting and follow-up. If reflex testing is required, test results will be delayed
Method Name
Enzyme-Linked Immunosorbent Assay (ELISA)
CPT Code Information
86618
86617 x 2-Lyme disease confirmation (if appropriate)
Clinical Information
Lyme disease (LD) is caused by infection with a member of the Borrelia burgdorferi sensu lato complex, which includes B burgdorferi sensu stricto (herein referred to as B burgdorferi), Borrelia afzelii, and Borrelia garinii. Among these species, B burgdorferi is the most frequent cause of LD in North America. These tick-borne spirochetes are transmitted to humans through the bite of Ixodes species ticks. Endemic areas for Lyme disease in the United States correspond with the distribution of 2 tick species, Ixodes scapularis (Northeastern and upper Midwestern US) and Ixodes pacificus (West Coast US).
Transmission of LD-associated Borrelia requires at least 36 hours of tick attachment. Approximately 80% of infected individuals will develop a unique expanding skin lesion with a central zone of clearing, referred to as erythema migrans (EM; stage 1). In the absence of treatment, patients may progress to early disseminated disease (stage 2), which is characterized by neurologic manifestations (eg, meningitis, cranial neuropathy, radiculoneuropathy) and is often associated with B garinii infection. Patients with late LD often present with intermittent or persistent arthralgia, most often associated with B burgdorferi infection, or with acrodermatitis chronica atrophicans (ACA), typically due to infection with B afzelii.
Diagnosis of LD is currently based on a 2-tiered serologic testing algorithm, as recommended by the Centers for Disease Control and Prevention (CDC), and involves an initial screening assay for detection of antibodies to LD-causing Borrelia species. Samples that are screen positive or equivocal are subsequently reflexed for supplemental assessment using a B burgdorferi immunoblot for detection of IgM- and IgG-class antibodies to specific B burgdorferi antigens.
Importantly, while serologic assessment for LD may be negative in the early weeks following infection, over 90% of patients with later stages of infection are seropositive by serology, which remains the diagnostic method of choice for this disease.
Interpretation
Negative:
No evidence of antibodies to Borrelia burgdorferi detected. False-negative results may occur in recently infected patients (≤2 weeks) due to low or undetectable antibody levels to B burgdorferi. If recent exposure is suspected, a second specimen should be collected and tested in 2 to 4 weeks.
Equivocal:
Not diagnostic. Supplemental testing by immunoblot has been ordered by reflex.
Positive:
Not diagnostic. Supplemental testing by immunoblot has been ordered by reflex.
Additional Tests
LYWB: lyme disease Ab, immunoblot, S Reflex order for all positive and equivocal results