Lyme Disease Serology, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Diagnosing Lyme disease
As a sensitive screening (enzyme-linked immunosorbent assay [ELISA]) test for Lyme disease
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|
|LYWB||Lyme Disease Ab, Immunoblot, S||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 Lyme disease antibody confirmation (by Western blot) will be performed at an additional charge.
See Acute Tick-Borne Disease Testing Algorithm in Special Instructions.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
LYME: Enzyme-Linked Immunosorbent Assay (ELISA)
LYWB: Western Blot
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Lyme Disease Serology, S
Lyme C6 Peptide Assay
Lyme C6 Peptide Assay
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.
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.
Mild OK; Gross reject
Mild OK; Gross reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Refrigerated (preferred)||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 disease, 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 a tick bite or a rash.
Serology may not be positive until 2 to 4 weeks after onset of ECM; however, culture 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 or cerebrospinal fluid.
Early antibiotic treatment of Lyme disease can resolve clinical symptoms and prevent progression of the disease to later stages. Treatment with penicillin, tetracycline, erythromycin, chloramphenicol, or ceftriaxone is considered appropriate therapy
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 or enzyme-linked immunosorbent assay (ELISA). A Western blot (WB) assay is used to confirm positive Lyme EIA or ELISA results due to the presence of IgG or IgM class antibodies. WB 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 WB assay is correlated with diagnosis.
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 result: no antibody to Borrelia burgdorferi detected. This result does not exclude the possibility of Borrelia burgdorferi infection. Patients in early stages of infection may not produce detectable levels of antibody. According to the manufacturer’s package insert, antibiotic therapy in early disease may prevent antibody production from reaching detectable levels. 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.
Equivocal result: the imprecision inherent in any method implies a lower degree of confidence in the interpretation of specimens with absorbance values very close to the calculated cutoff value. For this reason an equivocal category has been designated. Equivocal specimens will be tested by Western blot (WB) assays in accordance with Centers for Disease Control and Prevention (CDC)/Association of Public Health Laboratories (APHL) recommendations.
Positive result: antibody to Borrelia burgdorferi detected. All positive results will be supplemented by retesting the serum by WB for the detection of IgG and IgM antibodies to Borrelia burgdorferi, in accordance with CDC/APHL recommendations.
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 exclude the possibility of infection with Borrelia burgdorferi.
A positive result is not definitive evidence of infection with Borrelia burgdorferi. It is possible that other disease conditions, including syphilis, periodontal disease, rheumatoid arthritis, systemic lupus erythematosus, and other autoimmune diseases, may produce artifactual reactivity in the assay.
This test should not be used to screen the general population. The predictive value of the assay is a function of the pretest probability of Lyme disease in the population tested. Hence, only patients with clinical symptoms of Lyme disease or suspected exposure to Borrelia burgdorferi should be tested.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Dattwyler RJ: Lyme borreliosis: an overview of clinical manifestations. Lab Med 1990;21:290-292
2. Schwan TG, Burgdorfer W, Rosa PA: Borrelia. In Manual of Clinical Microbiology. Seventh edition. Edited by PR Murray. Washington, DC, ASM Press, 1999, pp 746-758
3. CDC: Recommendation for test performance and interpretation from second national conference on serological diagnosis of lyme disease. MMWR Morb Mortal Wkly Rep 1996;45:481-484
4, Package insert: Immunetics C6 B burgdorferi (Lyme) ELISA Kit, Immunetics, Inc, Boston, MA 02210-2377, 2013
Method Description Describes how the test is performed and provides a method-specific reference
The C6 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 VisE protein of Borrelia burgdorferi. In the assay procedure, diluted serum specimens are added to and incubated in wells of an antigen-coated microwell plate. Antibodies specific to the C6 peptide in the serum 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 (HRP) 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 45 nm is measured in each well using an ELISA plate reader.(Package insert: Immunetics C6 Borrelia 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 VisE. J Clin Microbiol 1999;37:3990-3996)
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.
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 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 disease confirmation (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|
|LYME||Lyme Disease Serology, S||20449-5|