Test Catalog

Test Id : LYWB

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Lyme Disease Antibody, Immunoblot, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of systemic Lyme disease

 

This test should not be used as a screening assay.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Immunoblot Microarray

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Lyme Disease Ab, Immunoblot, S

Aliases
Lists additional common names for a test, as an aid in searching

Lyme Disease Antibody, Western Blot Assay, Serum

Western Blot, Lyme Disease

Western Blot Assay

Lyme Western Blot

Lyme Disease Antibody, ImmunoBlot Assay, Serum

Lyme ImmunoBlot

ImmunoBlot Assay, Lyme Disease

Borrelia burgdorferi

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube: 

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.75 mL

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

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

-General Request (T239)

-Microbiology Test Request (T244)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of systemic Lyme disease

 

This test should not be used as a screening assay.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

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 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). 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 Food and Drug Administration approved use of a modified two-tiered testing algorithm for diagnosis of Lyme disease (see SLYME / Lyme Antibody, Modified 2-Tier, ELISA, 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 of use in these late stages if performed on synovial fluid 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).

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

Reference values apply to all ages

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 following completion of treatment. IgM antibody results against B burgdorferi should only be considered during the 30 days following exposure and symptom onset.

 

Negative specimens typically demonstrate antibodies to fewer than 2 of the 3 significant B burgdorferi proteins. Additional specimens should be submitted in 2 to 3 weeks if B burgdorferi exposure has not been ruled out.

 

IgG:

IgG antibodies to B burgdorferi can be detected approximately 2 weeks after onset of disease and can remain detectable for months to years following completion of therapy.

 

Normal specimens and false-positive enzyme immunoassay (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.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The immunoblot result may be negative in specimens that are weakly positive by enzyme immunoassay (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 collected 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 patients who are immunosuppressed 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 following exposure or disease onset may suppress the antibody response to the point that diagnostic threshold levels are never attained.

 

Lyme disease serology should not be used for monitoring treatment response, as IgG can remain detectable for years post-resolution of infection.

 

False-positive reactions may occur with patients with other spirochetal diseases (syphilis, yaws, pinta, relapsing fever, or leptospirosis), recent Epstein-Barr virus infection (ie, infectious mononucleosis), influenza, autoimmune disorders (eg, present of extractable nuclear antigens: ENA), multiple sclerosis, or amyotrophic lateral sclerosis.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

Theel ES: The past, present and (possible) future of serologic testing for Lyme disease. J Clin Microbiol. 2016;54(5):1191-1196

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

The Viramed Biotech AG Borrelia B31 ViraChip IgM and IgG are protein microarray assays and can be considered modified solid-phase enzyme linked immunosorbent assays (ELISA). Highly purified antigens from the Borrelia burgdorferi B31 strain, including the 93 kD, 66 kD, 58 kD, 45 kD, 41 kD, 39 kD, 30 kD, 28 kD, 23 kD, and 18 kD proteins, are bound to the solid phase nitrocellulose membrane in triplicate. The positions of these antigen "spots" are well defined and are reliably identifiable using customized software. Each microarray also has "spots" for a negative control, serum controls, conjugate controls, and 6 calibrators. One microarray is fixed to the bottom of a well in a standard 96-well microtiter plate.

 

For each test to be performed, the diluted patient serum is added to each microarray (note: the B burgdoreri IgG and IgM microarrays are in separate wells). If specific antibodies recognizing a B burgdorferi antigen are present, they will bind to the specific antigens on the microarray. After incubation the microarray is washed to remove unbound antibodies. Alkaline-phosphatase antihuman IgG or antihuman IgM (conjugate) is then added to the well and incubated. If antibodies are present, the conjugate will bind to those respective antibodies, and after a washing step to remove unbound conjugate, substrate solution is added. If the antibody/conjugate complex is present, the substrate will undergo precipitation and color change. After an incubation period, the reaction is stopped, and the presence of precipitated substrate is visualized at specific locations on the microarray. The presence of a colored precipitation at various locations on the microarray is an indirect measurement of B burgdorferi specific antibodies in the patient specimen. Visualized spots from the reaction are compared for intensity with the integrated calibrator controls for evaluation.(Package inserts: Borrelia B31 ViraChip IgM and Borrelia B31 ViraChip IgG. VIRAMED Biotech AG; 07/2016)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86617 x 2

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports