Test ID: LYWB
Lyme Disease Antibody, Immunoblot, Serum
NY State Approved 
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
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.
Method Name A short description of the method used to perform the test
Immunoblot
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Western Blot, Lyme Disease
Western Blot Assay
Lyme Western Blot
Lyme Disease Antibody, ImmunoBlot Assay, Serum
Lyme ImmunoBlot
ImmunoBlot Assay, Lyme Disease
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.5 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | NA |
| Other | Heat-inactivated specimen |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 14 days |
| Frozen | 14 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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 manufacturer’s 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.(4)
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 Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
IgG: negative
IgM: negative
Interpretation Provides information to assist in interpretation of the test results
IgM:
IgM antibodies to Borrelia burgdorferi may be detectable within 1 to 2 weeks following the tick bite; they usually peak during the third to sixth week after disease onset, and then demonstrate a gradual decline over a period of months. IgM antibody may persist for months even though antimicrobial agents are given. The IgM assay is more likely to be useful during early disease, and should only be tested during the first 4 to 6 weeks after disease onset.
Negative specimens typically demonstrate antibodies to less than 2 of the 3 significant Borrelia burgdorferi proteins. Additional specimens should be submitted in 2 to 3 weeks if Borrelia burgdorferi exposure has not been ruled out.
Individuals who have recently seroconverted due to infection with Borrelia burgdorferi may display incomplete banding patterns, but may develop increased reactivity (both in band intensity and number) when followed for a period of 4 to 6 months.
IgG:
Serum IgG is detected as early as 2 weeks after onset of disease. Significant concentrations of antibody and immunoblot banding patterns for Borrelia burgdorferi can be found years after onset.
Normal specimens and false-positive EIA specimens generally have antibodies to 4 or fewer proteins. Except for early patients, antibodies from patients with Lyme disease generally bind to 5 or more proteins.
For persons who have received recombinant OspA vaccine and who are not infected with Borrelia burgdorferi, an intense band representing antibody to the OspA protein (band 30) should be visible on the immunoblot.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
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.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Dressler F, Whalen JA, Reinhardt BN, Steere AC: Western blotting in the serodiagnosis of Lyme disease. J Infect Dis 1993;167(2):392-400
2. Brown SL, Hansen SL, Langone JJ: Role of serology in the diagnosis of Lyme disease. JAMA 1999;282:62-66
3. Anonymous: Lyme disease-United States, 1995. MMWR Morb Mortal Wkly Rep 1996;June 14;45(23):481-484
4. Package insert: Viramed Biotech AG-Borrelia B31 IgG ViraStripe, Viramed Biotech AG, Steinkirchen, Germany, 2009
Method Description Describes how the test is performed and provides a method-specific reference
In the immunoblot analysis, an antigen mixture prepared from Borrelia burgdorferi strain B31 is separated by SDS-polyacrylamide gel electrophoresis (SDS-PAGE). After the antigens have been resolved by SDS-PAGE, they are electrophoretically transferred and bound to a nitrocellulose membrane. Patient specimen is then added to the nitrocellulose membrane. If Lyme-specific antibodies are present in the specimen, they will bind to antigen on the nitrocellulose membrane. Bands are then detected by the addition of an enzyme-labeled antihuman-IgG or antihuman-IgM reagent that allows for the visualization of bands on the nitrocellulose membrane.(Towbin H, Gordon J: Immunoblotting and dot immunobinding--current status and outlook. J Immunol Methods:1984;72:313-340; Johnson CM, Helgeson SC: Glycoproteins synthesized by cultured cardiac valve endothelial cells: unique absence of fibronectin production. Biochem Biophys Res Comm 1988;153:46-50; Grodzicki RL, Steere AC: Comparison of immunoblotting and indirect enzyme-linked immunosorbent assay using different antigen preparations for diagnosing early Lyme disease. J Infect Dis 1988;157:790-797)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 9 a.m.
Saturday, Sunday; varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86617 x 2
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 5744 | IgG Immunoblot | 6320-6 |
| 2992 | IgG Band(s) | N/A |
| 23931 | IgM Immunoblot | 6321-4 |
| 23932 | IgM Band(s) | N/A |
| 6241 | Interpretation | 59464-8 |
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