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Test Code Billings Clinic: 9728 Mayo: LYWB Lyme Disease Antibody, Immunoblot, Serum

Reporting Name

Lyme Disease Ab, Immunoblot, S

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Aiding in the diagnosis of systemic Lyme disease

 

This test should not be used as a screening assay.

Method Name

Immunoblot Microarray


Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume:0.75 mL

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


Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
  Frozen  30 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Heat-inactivated specimen Reject

Reference Values

IgG: Negative

IgM: Negative

Reference values apply to all ages

Interpretation

Per Centers for Disease Control and Prevention criteria, the Lyme IgG Immunoblot is interpreted as positive if IgG-class antibodies are detected to greater than or equal to 5 Borrelia burgdorferi proteins, and the Lyme IgM Immunoblot is interpreted as positive if IgM-class antibodies are detected to greater than or equal to 2 B burgdorferi proteins. Immunoblot patterns not meeting these criteria should not be interpreted as positive. Epitopes from certain B burgdorferi proteins (eg, p41) are conserved across other bacteria, which may lead to the detection of IgM- and/or IgG-class antibodies on the Lyme disease immunoblots in patients without Lyme disease. Immunoblot should only be ordered on specimens that are positive or equivocal by a US Food and Drug Administration-licensed Lyme disease antibody screening test (eg, enzyme immunoassay). Results of the Lyme IgM immunoblot should not be considered in patients with greater than or equal to 30 days of symptoms.

 

Result

Interpretation

IgG and IgM negative

Specific serologic response to B burgdorferi infection is not detected but cannot rule out early infection during which low or undetectable antibody levels to B burgdorferi may be present. If clinically indicated, a new serum specimen should be submitted in 7-14 days.

IgG positive and IgM negative

Consistent with infection with B burgdorferi at some time in the past

IgG and IgM positive

Consistent with active or previous infection for B burgdorferi. IgM blot criteria is of diagnostic utility only during the first 4 weeks of early Lyme disease.

IgG negative and IgM positive

IgM-class antibodies to B burgdorferi (Lyme disease) detected. Results are consistent with acute or recent infection with B burgdorferi. Testing of a new specimen collected in 7-14 days to demonstrate IgG seroconversion may be considered to confirm infection if the diagnosis is in doubt. IgM immunoblot results should only be considered as indicative of recent infection in patients presenting within 30 days of symptom onset. Consideration of IgM immunoblot results in patients with symptoms lasting >30 days is discouraged due to the risk of false positive IgM immunoblot results and/or prolonged IgM seropositivity following disease resolution.

IgG and/or IgM uninterpretable

Immunoblot invalid due to blurring or indistinct reactivity.

Due to an invalid Lyme IgG immunoblot, an interpretation cannot be provided. Please submit a new specimen.

Day(s) Performed

Monday, Wednesday, Friday

Report Available

Same day/1 to 4 days

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
LYWB Lyme Disease Ab, Immunoblot, S 18203-0

 

Result ID Test Result Name Result LOINC Value
5744 IgG Immunoblot 6320-6
2992 IgG detected against: 13502-0
23931 IgM Immunoblot 6321-4
23932 IgM detected against: 13503-8
6241 Interpretation 12781-1

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-General Request (T239)

-Infectious Disease Serology Test Request (T916)

Testing Algorithm

For information see Acute Tick-Borne Disease Testing Algorithm.