Test Id : LYME
Lyme Disease Serology, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
Diagnosing Lyme disease
This test should not be used as a screening procedure for the general population.
This test should not be used for treatment monitoring.
Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| LYWB | Lyme Disease Ab, Immunoblot, S | Yes | No |
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If Lyme disease serology is positive or equivocal, then Lyme disease antibody confirmation (by Western blot) will be performed at an additional charge.
Method Name
A short description of the method used to perform the test
Enzyme-Linked Immunosorbent Assay (ELISA)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Lyme C6 Peptide Assay
Borrelia burgdorferi
B. burgdorferi
Tick-borne
Tick
VlsE1/pepC10 Assay
Lymes
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If Lyme disease serology is positive or equivocal, then Lyme disease antibody confirmation (by Western blot) will be performed at an additional charge.
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
Supplies: Sarstedt Aliquot Tube 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Collection Information: Centrifuge and aliquot serum into plastic vial.
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-General Request (T239)
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
0.4 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Heat inactivated | 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) | 10 days | |
| Frozen | 30 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Diagnosing Lyme disease
This test should not be used as a screening procedure for the general population.
This test should not be used for treatment monitoring.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If Lyme disease serology is positive or equivocal, then Lyme disease antibody confirmation (by Western blot) will be performed at an additional charge.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Lyme disease (LD) is caused by infection with a member of the Borrelia burgdorferi sensu lato complex, which includes B burgdorferi sensu stricto (herein referred to as B burgdorferi), Borrelia afzelii, and Borrelia garinii. Among these species, B burgdorferi is the most frequent cause of LD in North America. These tick-borne spirochetes are 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 scapularis (Northeastern and upper Midwestern US) and Ixodes pacificus (West Coast US).
Transmission of LD-associated Borrelia requires at least 36 hours of tick attachment. Approximately 80% of infected individuals will develop a unique expanding skin lesion with a central zone of clearing, referred to as erythema migrans (EM; stage 1). In the absence of treatment, patients may progress to early disseminated disease (stage 2), which is characterized by neurologic manifestations (eg, meningitis, cranial neuropathy, radiculoneuropathy) and is often associated with B garinii infection. Patients with late LD often present with intermittent or persistent arthralgia, most often associated with B burgdorferi infection, or with acrodermatitis chronica atrophicans, typically due to infection with B afzelii.
Diagnosis of LD is currently based on a 2-tiered serologic testing algorithm, as recommended by the Centers for Disease Control and Prevention, and involves an initial screening assay for detection of antibodies to LD-causing Borrelia species. Samples that are screen positive or equivocal are subsequently reflexed for supplemental assessment using a B burgdorferi immunoblot for detection of IgM- and IgG-class antibodies to specific B burgdorferi antigens.
Importantly, while serologic assessment for LD may be negative in the early weeks following infection, over 90% of patients with later stages of infection are seropositive by serology, which remains the diagnostic method of choice for this disease.
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
Negative:
No evidence of antibodies to Borrelia burgdorferi detected. False-negative results may occur in recently infected patients (< or =2 weeks) due to low or undetectable antibody levels to B burgdorferi. If recent exposure is suspected, a second specimen should be collected and tested in 2 to 4 weeks.
Equivocal:
Not diagnostic. Supplemental testing by immunoblot has been ordered by reflex.
Positive:
Not diagnostic. Supplemental testing by immunoblot has been ordered by reflex.
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. Patients in the early stages of Lyme disease and those who have been treated with antibiotics may not exhibit detectable antibody titers. Patients with clinical history, signs, or symptoms suggestive of Lyme disease should be retested in 2 to 4 weeks if the initial test result is negative.
A positive result is not definitive evidence of infection with B burgdorferi. It is possible that other disease conditions may produce artifactual reactivity in the assay (eg, infectious mononucleosis, syphilis). All equivocal or positive results should be supplemented immunoblot testing for IgM- and IgG-class antibodies in accordance with Centers for Disease Control and Prevention, the Association of State and Territorial Public Health Laboratory and directors (CDC/ASTPHLD) recommendations.
Patients infected with other members of the B burgdorferi sensu lato complex, including Borrelia garinii, Borrelia afzelii, and Borrelia mayonii will be detected by this assay; however, they cannot be differentiated.
This test should not be performed as a screening procedure for the general population. The predictive value of a positive or negative result depends on the prevalence of analyte (antibodies present to VlsE1 and pepC10 antigens) in a given population. Testing should only be performed when clinical evidence suggests the diagnosis of Borrelia infection or related etiological conditions observed by the physician.
This test will not distinguish results that are both IgG and IgM positive from results that are either IgG or IgM positive.
Lyme serology should not be used for treatment monitoring as IgG can remain for years post-resolution of infection. Instead, monitoring resolution of symptoms in response to treatment is recommended.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Theel ES. The past, present and (possible) future of serologic testing for Lyme disease. J Clin Microbiol. 2016;54(5):1191-1196. doi:10.1128/JCM.03394-15
2. Dattwyler RJ. Lyme borreliosis: an overview of clinical manifestations. Lab Med. 1990;21:290-292
3. Schwan TG, Burgdorfer W, Rosa PA. Borrelia. In: Murray PR, eds. Manual of Clinical Microbiology. 7th ed. ASM Press; 1999:746-758
4. Center for Disease Control and Prevention: 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
Method Description
Describes how the test is performed and provides a method-specific reference
The first-tier Lyme disease screening enzyme-linked immunosorbent assay (ELISA) is the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system. The Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system is designed to detect IgG- and IgM-class antibodies (not differentiated by the assay in the final result) in human sera to VlsE1 and pepC10 antigens. Diluted test sera are incubated in antigen coated microwells. Any antigen-specific antibody in the sample will bind to the immobilized antigen. The plate is washed to remove unbound antibody and other serum components. Peroxidase conjugated goat antihuman IgG and IgM are added to the wells and the plate incubated. The conjugate will react with IgG and IgM antibodies immobilized on the plate. The wells are washed to remove unreacted conjugate. The microwells containing immobilized peroxidase conjugate are incubated with peroxidase substrate solution. Hydrolysis of the substrate by peroxidase produces a color change. After a period of time the reaction is stopped and the color intensity of the solution is measured photometrically.(Package insert: Borrelia VlsE1/pepC10 IgG/IgM Test System. Zeus Scientific, Inc; Rev. date 05/2021)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
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
Indicates the location of the laboratory that performs the test
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.
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- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. 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.
CPT codes are provided by the performing laboratory.
86618
86617 x 2-Lyme disease confirmation (if appropriate)
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| LYME | Lyme Disease Serology, S | 20449-5 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| LYME | Lyme Disease Serology, S | 20449-5 |