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HelpEpic Test Code LAB788 Lyme Disease Serology, Serum
Reporting Name
Lyme Disease Serology, SUseful For
Diagnosing 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.
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| LYWB | Lyme Disease Ab, Immunoblot, S | Yes | No |
Testing Algorithm
If Lyme disease serology is positive or equivocal, then Lyme disease antibody confirmation (by Western blot) will be performed at an additional charge.
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
SerumSpecimen Required
Supplies: Sarstedt Aliquot Tube 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Collection Information: Centrifuge and aliquot serum into plastic vial.
Specimen Minimum Volume
0.4 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 10 days | |
| Frozen | 30 days |
Reference Values
Negative
Reference values apply to all ages.
Day(s) Performed
Monday through Friday
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, 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, 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.
Cautions
A negative result does not exclude the possibility of infection with Borrelia burgdorferi. Patients in the early stages of Lyme disease and those who have been treated with antibiotics may not exhibit detectable antibody titers. Patients with clinical history, signs, or symptoms suggestive of Lyme disease should be retested in 2 to 4 weeks if the initial test result is negative.
A positive result is not definitive evidence of infection with B burgdorferi. It is possible that other disease conditions may produce artifactual reactivity in the assay (eg, infectious mononucleosis, syphilis). All equivocal or positive results should be supplemented immunoblot testing for IgM- and IgG-class antibodies in accordance with Centers for Disease Control and Prevention, the Association of State and Territorial Public Health Laboratory and directors (CDC/ASTPHLD) recommendations.
Patients infected with other members of the B burgdorferi sensu lato complex, including Borrelia garinii, Borrelia afzelii, and Borrelia mayonii will be detected by this assay; however, they cannot be differentiated.
This test should not be performed as a screening procedure for the general population. The predictive value of a positive or negative result depends on the prevalence of analyte (antibodies present to VlsE1 and pepC10 antigens) in a given population. Testing should only be performed when clinical evidence suggests the diagnosis of Borrelia infection or related etiological conditions observed by the physician.
This test will not distinguish results that are both IgG and IgM positive from results that are either IgG or IgM positive.
Lyme serology should not be used for treatment monitoring as IgG can remain for years post-resolution of infection. Instead, monitoring resolution of symptoms in response to treatment is recommended.
Report Available
1 to 4 daysSpecimen Retention Time
14 daysReject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Heat inactivated | Reject |
NY State Approved
YesMethod Name
Enzyme-Linked Immunosorbent Assay (ELISA)
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-General Request (T239)