Test Catalog

Test Id : ELYME

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Lyme Disease European Antibody Screen, 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 Lyme disease caused by infection with Borrelia species endemic to Europe and Asia, including Borrelia garinii and Borrelia afzelii

 

This test should not be used to screen the general population. It is only intended for use in patients with recent travel to and exposure to ticks in Europe or regions of Asia who are suspected to have Lyme disease caused by Borrelia species endemic to Europe/Asia.

Highlights

The first-tier screening assay detects antibodies to the VlsE protein. C6 is a conserved epitope in the VlsE protein. Therefore, this assay will detect antibodies to C6, in addition to other epitopes on VlsE and pepC10.

 

This test should be ordered for evaluation of possible Lyme disease in individuals who have recently traveled to Europe or Asia and who have been exposed to or bitten by a tick.

 

This panel includes a screening test capable of detecting antibodies to the most common Lyme disease causing Borrelia species found in Europe and Asia. Specimens with positive or equivocal results by the screening assay will be reflexed to a supplemental immunoblot able to detect antibodies to Borrelia afzelii or Borellia garinii, both Lyme disease-causing Borrelia species endemic to Europe and regions of Asia.

 

The immunoblot does not distinguish between infection with B afzelli or B garinii.

 

Patients infected with B afzelii or B garinii may be serologically negative by diagnostic assays used in North America, which are designed to detect antibodies to the Borrelia burgdorferi B31 strain.

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
ELYMI Lyme Disease European Immunoblot, S No No

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

If this test is positive or equivocal, then immunoblot testing will be performed at an additional charge.

 

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

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.

Yes

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

Lyme Disease European Ab Screen, S

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

European Lyme Disease

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

If this test is positive or equivocal, then immunoblot testing will be performed at an additional charge.

 

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

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

This test should only be ordered for patients who present with Lyme disease symptoms and who have recently returned from travel to Europe or Asia. These patients may be infected with Lyme disease causing Borrelia species endemic to Europe (eg, Borrelia afzelii, Borrelia garinii), which may not be detected using diagnostic tests in North America. The North American serologic assays for Lyme disease are developed specifically for detection of antibodies to Borrelia burgdorferi (strain B31), the most commonly encountered species.

 

Patients who are suspected to have Lyme disease who have not traveled to Europe should be tested by the LYME / Lyme Disease Serology, Serum assay for detection of antibodies specifically to B burgdorferi, the most common agent of Lyme disease in North America.

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

Supplies: Aliquot Tube, 5 mL (T465)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Pediatric: 0.5 mL

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

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

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

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 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) 10 days
Frozen 30 days

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

Aiding in the diagnosis of Lyme disease caused by infection with Borrelia species endemic to Europe and Asia, including Borrelia garinii and Borrelia afzelii

 

This test should not be used to screen the general population. It is only intended for use in patients with recent travel to and exposure to ticks in Europe or regions of Asia who are suspected to have Lyme disease caused by Borrelia species endemic to Europe/Asia.

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

If this test is positive or equivocal, then immunoblot testing will be performed at an additional charge.

 

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 (LD) is caused by infection with a member of the Borrelia burgdorferi sensu lato complex. Among the genospecies within this complex, B burgdorferi sensu stricto (B burgdorferi) is the primary agent causing LD in North America. While B burgdorferi is also found abroad, Borrelia garinii and Borrelia afzelii are more prevalent in Europe and regions of Asia. These spirochetes are transmitted to humans through the bite of Ixodes species ticks, primarily Ixodes ricinus and, to a lesser extent, Ixodes persulcatus, which are both found throughout Europe, the Baltic regions, and parts of Asia. Therefore, residents of, or travelers to, these areas who are bitten by ticks are at increased risk for LD caused by a European Borrelia species.

 

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 (ACA), typically due to infection with B afzelii.

 

Diagnosis of LD is currently based on a 2-tiered serologic testing algorithm to detect antibodies to LD-associated Borrelia species. Importantly, patients may be seronegative until 2 weeks post onset of symptoms. An IgM-class antibody response usually peaks 3 to 6 weeks after infection but may persist for years in some cases. IgG-class antibodies to Borrelia spirochetes are detectable 2 to 3 weeks postinfection and may remain elevated for years after resolution of symptoms. In patients with EM, culture of skin biopsies obtained near the margins of the rash are frequently positive, though this technique is not commonly available. In late (chronic) stages of the disease, serology is often positive and is the diagnostic method of choice. Polymerase chain reaction (PCR) testing may also be of use in these late stages if performed on synovial fluid or tissue.

 

Early antibiotic treatment of Lyme disease can resolve clinical symptoms and prevent progression of the disease to later stages. Also, if provided early in disease, treatment may suppress the immune response to the bacteria leading to negative serologic results.

 

The 2-tiered testing algorithm for LD involves an initial screening assay for detection of total antibodies to LD-causing Borrelia species. For this algorithm, the C6 enzyme-linked immunosorbent assay (ELISA) is used to screen all specimens, and those with positive or equivocal results are reflexed for supplemental testing by immunoblot for detection of IgM and IgG antibodies to LD-causing Borrelia species. Importantly, while most screening ELISAs detect antibodies to all major LD-associated Borrelia species, the immunoblots used for supplemental testing in North America are specifically designed to detect antibodies to the B burgdorferi B31 strain. Despite similarity between the genospecies, the North America immunoblots have a reported sensitivity of approximately 50% for LD caused by the European Borrelia species (eg, B afzelii and B garinii). In order to improve upon the ability to detect antibodies to the European Borrelia species, immunoblot tests designed to detect IgM- and IgG-class antibodies B garinii, B afzelii and B burgdorferi are used for supplemental testing of all specimens with positive or equivocal results by the LD screening ELISA.

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

Interpretation
Provides information to assist in interpretation of the test results

Negative result:

No antibodies to Lyme disease Borrelia species (eg Borrelia afzelii, Borrelia burgdorferi, Borrelia garinii) detected. Repeat testing on a new specimen collected in 2 to 3 weeks should be considered if acute Lyme disease due to one of these Borrelia species is suspected. 

 

Equivocal result:

Not diagnostic. Supplemental immunoblot testing has been ordered by reflex.

 

Positive result:

Not diagnostic. Supplemental immunoblot testing 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

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 with recent travel to or residence in Europe or parts of Asia should be tested for Lyme disease caused by Borrelia species endemic to Europe.

 

A negative result does not exclude the possibility of infection with Lyme disease-associated Borrelia species, including Borrelia afzelii or Borrelia garinii.

 

A positive result is not definitive evidence of infection with Lyme disease-associated Borrelia species. Supplemental testing of all specimens that result as positive or equivocal by the Lyme disease screening enzyme-linked immunosorbent assay (ELISA) require supplemental testing by immunoblot for IgM- and IgG-class antibodies to Borrelia species endemic in Europe and regions of Asia.  

 

Falsely reactive screening ELISA results may occur in patients with other disease conditions, including syphilis, periodontal disease, rheumatoid arthritis, systemic lupus erythematosus, and other autoimmune diseases.

 

Test results should be used in conjunction with exposure history, travel history, clinical presentation, and other clinical findings.

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

1. Branda JA, Strle F, Strle K, Sikand N, et al: Performance of United States serologic assays in diagnosis of Lyme borreliosis acquired in Europe. Clin Infect Dis. 2013;57:333-340

2. 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(12):3990-3996

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 first-tier Lyme disease screening enzyme-linked immunosorbent assay (ELISA) used is the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system. This test system is designed to detect IgG- and IgM-class antibodies (not differentiated) 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 is 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. The color intensity of the solution depends upon the antibody concentration in the original test sample.(Instruction manual: Borrelia VlsE1/pepC10 IgG/IgM Test System. Zeus Scientific, Inc; Rev. Date 12/18/2017)

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 4 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.

86618

86617 x 2 - Lyme Disease European Immunoblot, S (if appropriate)

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