Test ID: CLYWB
Lyme Disease Antibody, Immunoblot, Spinal Fluid
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
Supplementing positive Lyme disease antibody screen (EIA) results and serving as an aid in the serologic diagnosis of Lyme neuroborreliosis
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
Borrelia burgdorferi
Lyme
Tick-borne
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: Sterile vial
Specimen Volume: 0.5 mL
Additional Information: This test is not available for specimens originating in New York.
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 OK |
| Lipemia | Mild OK; Gross OK |
| Icterus | NA |
| Other | NA |
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 |
|---|---|---|
| CSF | 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. Any of the following clinical manifestations may be present in patients with Lyme disease: skin lesions or cardiac or neurological disease. In the first stage of disease, 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. Culture of skin biopsies obtained near the margins of ECM are frequently positive. 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 a tick bite or rash.
The presence of antibodies to Borrelia burgdorferi in cerebrospinal fluid (CSF) is suggestive of neurologic Lyme disease (Lyme neuroborreliosis). PCR testing also may be used to confirm late-stage neurologic disease. However, the sensitivity of PCR is low when testing CSF.
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.(1)
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: none detected
IgM: none detected
Interpretation Provides information to assist in interpretation of the test results
Currently no criteria exist for the interpretation of immunoblot testing on cerebrospinal fluid. The presence of any bands may represent either intrathecal antibody production or passive transfer of antibody from blood.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
A negative result does not rule out Lyme neuroborreliosis.
Results should be interpreted in the context of clinical findings.
False-positive results may be caused by breakdown of the blood-brain barrier, or by the introduction of blood into the cerebrospinal fluid at collection.
Because clinical studies are limited, the advantage of immunoassays over PCR (or vice versa) has not been conclusively demonstrated for diagnosing central nervous system Lyme disease. If the result for the immunoassay is negative and there is a high suspicion of Lyme neuroborreliosis, consider performing the PCR assay (PBORR/80574 Lyme Disease [Borrelia burgdorferi], Molecular Detection, PCR).
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Steere AC: Borrelia burgdorferi (Lyme disease, Lyme borreliosis). In Principles and Practice of Infectious Diseases. Fifth edition. Edited by GL Mandell, JE Bennett, R Dolin. Philadelphia, Churchill Livingstone, 2000, pp 2504-25182
2. 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, the 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 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 Commun 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 |
|---|---|---|
| 83857 | IgG Immunoblot | 13202-7 |
| 29598 | IgG Band(s) | 23979-8 |
| 26363 | IgM Immunoblot | 13203-5 |
| 29599 | IgM Band(s) | 23985-5 |
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