Test ID: LYWB Lyme Disease Antibody, Immunoblot, Serum
Reporting Name
Lyme Disease Ab, Immunoblot, SUseful For
Aiding in the diagnosis of systemic Lyme disease
This test should not be used as a screening assay.
Clinical Information
Lyme disease is caused by the spirochete Borrelia burgdorferi. The spirochete is 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 dammini (Northeastern and upper Midwestern US) and Ixodes pacificus (West Coast US). In Europe, Ixodes ricinus transmits the spirochete.
Lyme disease exhibits a variety of symptoms that may be confused with immune and inflammatory disorders. Inflammation around the tick bite causes skin lesions. Erythema chronicum migrans (ECM), a unique expanding skin lesion with central clearing, which results in a ring-like appearance, is the first stage of the disease. Any of the following clinical manifestations may be present in patients with Lyme disease: arthritis, neurological or cardiac disease, or skin lesions. Neurologic and cardiac symptoms may appear with stage 2 and arthritic symptoms with stage 3 of Lyme disease. In some cases, a definitive distinction between stages is not always seen. Further, secondary symptoms may occur even though the patient does not recall having a tick bite or a rash.
The Second National Conference on the Serologic Diagnosis of Lyme Disease (1994) recommended that laboratories use a 2-test approach for the serologic diagnosis of Lyme disease. Accordingly, specimens are first tested by the more sensitive enzyme immunoassay (EIA). An immunoblot assay is used to supplement positive or equivocal Lyme EIA results. An immunoblot identifies the specific proteins to which the patient's antibodies bind. Although there are no proteins that specifically diagnose B burgdorferi infection, the number of proteins recognized in the immunoblot assay is correlated with diagnosis. Recently, the Centers for Disease Control and Prevention and US Food and Drug Administration approved the use of a modified two-tiered testing algorithm for diagnosis of Lyme disease (see SLYME / Lyme Antibody Modified 2-Tier with Reflex, Serum).
Culture or polymerase chain reaction (PCR) of skin biopsies obtained near the margins of ECM are frequently positive. In late (chronic) stages of the disease, serology is often positive and the diagnostic method of choice. PCR testing also may be useful in these late stages if performed on synovial or cerebrospinal fluid.
Diagnosis of neuroinvasive Lyme disease (ie, neuroborreliosis) can be achieved by determining the Lyme antibody index value using paired serum and cerebrospinal fluid samples (LNBAB / Lyme Central Nervous System Infection IgG with Antibody Index Reflex, Serum and Spinal Fluid).
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. |
Testing Algorithm
For information see Acute Tick-Borne Disease Testing Algorithm.
Report Available
Same day/1 to 4 daysDay(s) Performed
Monday, Wednesday, Friday
Clinical Reference
Theel ES. The past, present and (possible) future of serologic testing for Lyme disease. J Clin Microbiol. 2016;54(5):1191-1196
Method Name
Immunoblot Microarray
Specimen Type
SerumSpecimen 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 Minimum Volume
0.5 mL
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Serum | Refrigerated (preferred) | 14 days | |
Frozen | 30 days |
Reference Values
IgG: Negative
IgM: Negative
Reference values apply to all ages
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)
mml-Behavioral, mml-Demyelinating-Diseases, mml-CNS-Infections, mml-Neuromuscular, mml-Pediatric, mml-Spinal-Cord