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Test Code LAB1230745 Lyme Disease Serology, Serum

Additional Codes

Mayo Test code: LYME

Reporting Name

Lyme Disease Serology, S

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.

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
LYWB Lyme Disease Ab, Immunoblot, S Yes No

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Specimen Required


Supplies: Aliquot Tube, 5 mL (T465)

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) and Time(s) Performed

Monday through Friday; 10 a.m.

Test Classification

This test has been cleared, approved or is exempt by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86618

86617 x 2-Lyme disease confirmation (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
LYME Lyme Disease Serology, S 20449-5

 

Result ID Test Result Name Result LOINC Value
LYME Lyme Disease Serology, S 20449-5

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.

Clinical Reference

1. Theel ES: The past, present and (possible) future of serologic testing for Lyme disease. J Clin Microbiol. 2016; May;54(5):1191-1196. doi: 10.1128/JCM.03394-15

2. Dattwyler RJ: Lyme borreliosis: an overview of clinical manifestations. Lab Med. 1990;21:290-292

3. Schwan TG, Burgdorfer W, Rosa PA: Borrelia. In: Murray PR, eds. Manual of Clinical Microbiology. 7th ed. ASM Press; 1999:746-758

4. Center for Disease Control and Prevention: Recommendation for test performance and interpretation from second national conference on serological diagnosis of Lyme disease. MMWR Morb Mortal Wkly Rep 1996;45:481-484

Method Description

The first-tier Lyme disease screening enzyme-linked immunosorbent assay (ELISA) used is the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system (Branchburg, NJ) The Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system is designed to detect IgG- and IgM-class antibodies (not differentiated by the assay in the final result) in human sera to VlsE1 and pepC10 antigens. Diluted test sera are incubated in antigen coated microwells. Any antigen-specific antibody in the sample will bind to the immobilized antigen. The plate is washed to remove unbound antibody and other serum components. Peroxidase conjugated goat antihuman IgG and IgM are added to the wells and the plate incubated. The conjugate will react with IgG and IgM antibodies immobilized on the plate. The wells are washed to remove unreacted conjugate. The microwells containing immobilized peroxidase conjugate are incubated with peroxidase substrate solution. Hydrolysis of the substrate by peroxidase produces a color change.  After a period of time the reaction is stopped and the color intensity of the solution is measured photometrically. (Package insert: Borrelia VlsE1/pepC10 IgG/IgM Test System. Zeus Scientific, Inc; Rev. date 12/18/2017)

Analytic Time

1 day

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Heat inactivated Reject

Method 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)

-Microbiology Test Request (T244)