Search

Browse by Name

Phone Extensions

_{Laboratory Main Line}	_208-625-5858
_{Point of Care}	_208-625-4218

Fax Extensions

Incoming Orders/Requisitions	208-769-8581
_{General Laboratory}	_208-625-5822
_{Blood Bank}	_208-625-5821
_Microbiology	_208-625-5823

Accreditations

The College of American Pathologists (CAP's) Laboratory Accreditation Program accredits the entire spectrum of laboratory test disciplines with the most scientifically rigorous customized checklist requirements.

The CAP's peer-based inspector model provides a unique balance of regulatory and educational coaching supported by the most respected worldwide pathology organization.

The Laboratory Accreditation Program inspects a variety of laboratory settings from complex university medical centers to physician office laboratories, and covers a complete array of disciplines and testing procedures.

www.cap.org

Regulatory Links

CLIA Certification (2023 to 2025)

CAP Certification

Mayo Clinic Laboratories

Test Code TLYME Lyme IgM and IgG, Whole Cell Sonicate, ELISA, Serum

Ordering Guidance

This test should only be ordered on specimens that have tested positive or equivocal by a first tier Lyme disease antibody test.

Specimen Required

Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.6 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.

Secondary ID

608104

Useful For

Supplemental testing for samples with positive or equivocal first-tier test results for antibodies to Lyme disease causing Borrelia species

This test should not be used as a screening procedure for the general population.

Highlights

Lyme disease serology positive results by the modified 2-tier testing algorithm are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease.

Testing Algorithm

For more information see Acute Tick-Borne Disease Testing Algorithm

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Lyme IgM/IgG, WCS, EIA, S

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type	Temperature	Time	Special Container
Serum	Refrigerated (preferred)	10 days
	Frozen	30 days

Reject Due To

Gross hemolysis	Reject
Gross lipemia	Reject
Gross icterus	Reject
Heat inactivated	Reject

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 LD 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 either the standard or modified 2-tiered serologic testing algorithm (STTTA or MTTTA, respectively). For the STTTA, see LYME / Lyme Disease Serology, Serum.

The MTTTA starts with an initial enzyme immunoassay (EIA) screen for detection of total antibodies against the Borrelia Vlse/pepC10 proteins. Samples that screen positive or equivocal by this first tier EIA are subsequently reflexed for supplemental assessment using 2 separate EIAs for detection of IgM and IgG antibodies against B burgdorferi whole cell sonicate material.

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.

Reference Values

Negative

Reference values apply to all ages.

Interpretation

Tier 1	Tier 2 IgM result	Tier 2 IgG result	Interpretation
Positive/equivocal	Negative	Negative	Negative for antibodies to the Borrelia (Borreliella) species causing Lyme disease. Antibodies detected by the first-tier test were not confirmed. Negative results may occur in recently infected (≤14 days) patients. If recent infection is suspected, repeat testing on a new sample collected in 7 to 14 days is recommended.
Positive/equivocal	Positive/equivocal	Negative	IgM-class antibodies to the Borrelia (Borreliella) species causing Lyme disease were detected, suggesting acute or recent infection. IgM enzyme immunoassay (EIA) results should only be considered as indicative of recent infections in patients presenting within 30 days of symptom onset. Consideration of IgM EIA results in patients with symptoms lasting more than 30 days is discouraged due to the risk of false-positive IgM results and/or prolonged IgM seropositivity following disease resolution. If both first and second tier IgM results are equivocal consider repeat testing in 7 to 14 days if clinically warranted.
Positive/equivocal	Negative	Positive/equivocal	IgG-class antibodies to the Borrelia (Borreliella) species causing Lyme disease were detected, suggesting infection in the recent or remote past. IgG-class antibodies may remain detectable for months to years following resolution of infection. Results should not be used to monitor or establish adequate response to therapy. Response to therapy is confirmed through resolution of clinical symptoms; additional laboratory testing should not be performed.
Positive/equivocal	Positive/equivocal	Positive/equivocal	IgM and IgG-class antibodies to the Borrelia (Borreliella) species causing Lyme disease were detected, suggesting infection in the recent or remote past. Antibodies may remain detectable for months to years following resolution of infection. Results should not be used to monitor or establish adequate response to therapy. Response to therapy is confirmed through resolution of clinical symptoms; additional laboratory testing should not be performed. If both first and second tests are equivocal consider repeat testing in 7 to 14 days if clinically warranted.

For specimens that did not have first tier testing performed at Mayo Clinic Laboratories, the results will also include the comment: "Interpretation assumes first tier Lyme disease causing Borrelia species antibody test was performed and resulted as positive or equivocal."

Cautions

The modified 2-tiered serologic testing (MTTT) study was conducted using the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System as the first-tier assay and the ZEUS ELISA Borrelia burgdorferi IgM and IgG Test System as the second-tier assay with testing performed in that order. The performance characteristics of the device are not established for changing the order of testing or for substituting other enzyme immunoassay (EIA) in the MTTT (2-EIA) procedure.

Sera from patients with other spirochetal diseases (syphilis, yaws, pinta, leptospirosis, and relapsing fever), or infectious mononucleosis and systemic lupus erythematosus may give false-positive results. In cases where false-positive reactions are observed, extensive clinical epidemiologic, and laboratory workups should be carried out to determine the specific diagnosis. False-positive sera from syphilis patients can be identified by running a rapid plasma reagin and a treponemal antibody assay on such specimens. True B burgdorferi disease-positive sera will be negative in these assays.

False-negative results may be obtained if serum specimens are collected too early after onset of disease before antibody levels have reached significant levels. Also, early antibiotic therapy may abort an antibody response to the spirochete.

Interpret all data in conjunction with clinical symptoms of disease, epidemiologic data, exposure in endemic areas, and results of other laboratory tests.

Do not perform screening of the general population. The positive predictive value depends on the pretest likelihood of infection. Only perform testing when clinical symptoms are present, or exposure is suspected.

The performance characteristics of the ZEUS ELISA B burgdorferi IgM and IgG Test Systems are not established with specimens from individuals vaccinated with B burgdorferi antigens.

Rheumatoid factor may cause false-positive results with the B burgdorferi IgM Test System.

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 May;21(5):290-292. doi: 10.1093/labmed/21.5.290

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

4. Centers for Disease Control and Prevention (CDC): 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

This enzyme-linked immunosorbent assay is designed to detect IgM and IgG class antibodies to Borrelia burgdorferi in human sera. The sensitized wells of plastic microwell strips are prepared by passive adsorption with B burgdorferi whole cell antigen. The test procedure involves 3 incubations steps. First, test sera (properly diluted) 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. Second, peroxidase conjugated goat anti-human IgM (mu chain specific) and IgG (Fc chain specific) is added to the wells, and the plate is incubated. The conjugate will react with IgM and IgG antibody immobilized on the solid phase in the first step. The wells are washed to remove unreacted conjugate. Third, 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. The color intensity of the solution depends upon the antibody concentration in the original sample.(Package insert: B burgdorferi IgM or IgG Test System. ZEUS Scientific, Inc; Rev Date 01/27/2020)

Day(s) Performed

Tuesday, Friday

Report Available

Same day/1 to 5 days

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US 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

86617 x 2

LOINC Code Information

Test ID	Test Order Name	Order LOINC Value
TLYME	Lyme IgM/IgG, WCS, EIA, S	34942-3

Result ID	Test Result Name	Result LOINC Value
LYMEM	Lyme Ab, IgM, S	40612-4
LYMEG	Lyme Ab, IgG, S	16480-6
LYMEI	Lyme Ab Interpretation	46248-1

Special Instructions

Acute Tickborne Disease Testing Algorithm

Forms

If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.

Kootenai Health powered by Mayo Clinic Laboratories