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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.


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.

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

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."

Day(s) Performed

Tuesday, Friday

Report Available

Same day/1 to 5 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

Forms

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