Test ID: CLYME
Lyme Disease Serology, Spinal Fluid
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
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
Aiding in the diagnosis of Lyme neuroborreliosis
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| CLYWB | Lyme Disease Ab, Immunoblot, CSF | Yes | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
If Lyme disease serology is positive, then immunoblot testing will be performed at an additional charge.
Method Name A short description of the method used to perform the test
CLYME/83856: Enzyme-Linked Immunosorbent Assay (ELISA)
CLYWB/83857: 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.
Collection Container/Tube: Sterile vial
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Additional Information:
1. When this test is ordered, serum and spinal fluid are recommended. In addition to this test, order LYME Lyme Disease Serology, Serum under a separate order number. The serum specimen is used to aid interpretation of spinal fluid results. If the spinal fluid result is positive, the serum specimen will determine if spinal fluid results are real or due to blood leaking into the spinal fluid.
2. 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, cardiac disease, 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 cerebrospinal fluid antibodies to Borrelia burgdorferi is indicative of neurologic Lyme disease (Lyme neuroborreliosis). PCR testing also may be used to confirm late-stage neurologic disease.
Early antibiotic treatment of Lyme disease can resolve clinical symptoms and prevent progression of the disease to later stages. Treatment with beta lactams such as amoxicillin, cefixime or ceftriaxone, or doxycycline are considered the most appropriate therapy.
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.
Negative
Reference values apply to all ages.
Interpretation Provides information to assist in interpretation of the test results
Intrathecal synthesis of antibody to Borrelia burgdorferi is indicative of neurological Lyme disease.
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.
According to the manufacturer’s package insert, patients in early stages of infection may not produce detectable levels of antibody. Antibiotic therapy in early disease may prevent antibody production from reaching detectable levels.(1) Patients with clinical history and/or symptoms suggestive of Lyme disease or where early Lyme disease is suspected, but with negative test results should be retested in 2 to 4 weeks.
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 PBORR Lyme Disease (Borrelia burgdorferi), Molecular Detection, PCR.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Package insert: Immunetics C6 B burgdorferi (Lyme) ELISA Kit, Immunetics, Inc, Boston, MA, 2006
2. 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 2504-2518
Method Description Describes how the test is performed and provides a method-specific reference
This Borrelia burgdorferi (Lyme) assay is based on a synthetic peptide antigen (C6 peptide) in microwell enzyme-linked immunosorbent assay (ELISA) format. The antigen is derived from the vlsE protein of Borrelia burgdorferi. In the assay procedure, diluted cerebrospinal fluid specimens are added and incubated in wells of an antigen-coated microwell plate. Antibodies specific to the C6 peptide in the specimen are bound by the immobilized antigen, and unbound antibodies are removed by wash steps. The bound antibodies are detected by addition of a horseradish peroxidase-conjugated goat antihuman IgG/IgM conjugate. After removal of excess conjugate by further wash steps, a chromogenic peroxidase substrate containing tetramethylbenzidine is added. A blue-green product is produced in wells where antibodies have been bound to the antigen. The color development reaction is quenched by addition of dilute sulfuric acid, after which optical absorbance at 450 nm is measured in each well using an ELISA plate reader.(Package insert: Immunetics C6 B. burgdorferi [Lyme] ELISA Kit. Immunetics, Boston, MA;2006; Liang FT, Steere AC, Marques AR, et al: Sensitive and specific serodiagnosis of Lyme disease by enzyme-linked immunosorbent assay with a peptide based on an immunodominant conserved region of Borrelia burgdorferi vlsE. J Clin Microbiol 1999;37[12]:3990-3996)
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; 10 a.m.
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.
86618-Lyme disease serology
86617 x 2-Lyme blot (if appropriate)
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 |
|---|---|---|
| CLYME | Lyme Disease Serology, CSF | 16475-6 |
External
link
PDF
document
Excel
document
Word
document