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Test ID LYWB Lyme Disease Antibody, Immunoblot, Serum

Useful For

Diagnosing Lyme disease

 

IgM assay is useful for confirming stage 1 (acute) Lyme disease.

 

IgG assay is useful for confirming stage 2 and stage 3 Lyme disease.

Testing Algorithm

See Acute Tick-Borne Disease Testing Algorithm in Special Instructions.

Method Name

Immunoblot

Reporting Name

Lyme Disease Ab, Immunoblot, S

Specimen Type

Serum

Container/Tube: 

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL

Forms: If not ordering electronically, complete, print, and send a General Request Form (T239) with the specimen (http://www.mayomedicallaboratories.com/it-mmfiles/general-request-form.pdf).

Specimen Minimum Volume

0.2 mL

Specimen Stability Information

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

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 (US) 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 that 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.

 

According to the manufacturers package insert, early antibiotic treatment of Lyme disease can resolve clinical symptoms and prevent progression of the disease to later stages. However, the early administration of antibiotics may suppress the antibody response to levels that are undetectable by current laboratory tests.(1) 

 

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 EIA. An immunoblot assay is used to supplement positive or equivocal Lyme (EIA). An immunoblot identifies the specific proteins to which the patient's antibodies bind. Although there are no proteins that specifically diagnose Borrelia burgdorferi infection, the number of proteins recognized in the immunoblot assay is correlated with diagnosis.

 

Culture or 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 of use in these late stages if performed on synovial fluid or cerebrospinal fluid.

Reference Values

IgG: negative

IgM: negative

Cautions

The immunoblot should not be used as a screening assay. In addition, immunoblot may be negative in specimens that are weakly-positive by EIA, or in patients with early Lyme disease.

 

Test results should be used in conjunction with clinical evaluation and information related to tick exposure.

 

A negative test result does not necessarily rule out current or recent infection. The specimen may have been drawn before demonstrable antibody developed. Patients with early disease often have serum antibody titers below the diagnostic threshold for several weeks following disease onset.

 

Test results from immunosuppressed patients and pregnant women may be difficult to interpret.

 

Positive test results may not be valid in persons who have received blood or blood product transfusions within the past several months.

 

Antibiotic therapy administered early in the first-stage of disease may suppress the antibody response to the point that diagnostic threshold levels are never attained.

 

False-positive reactions may occur with patients with other spirochetal diseases (syphilis, yaws, pinta, relapsing fever, or leptospirosis), influenza, autoimmune disorders, multiple sclerosis, or amyotrophic lateral sclerosis.

Day(s) Performed

Monday through Friday; 9 a.m.

Saturday, Sunday; varies

Report Available

Same day/1 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been cleared or approved 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

86617 x 2

NY State Approved

Yes