Test Catalog

Test Id : ELYMI

Lyme Disease European Immunoblot, Serum

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 or Borrelia afzelii

 

This test 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

 

This test should not be used to screen the general population.

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

Only orderable as a reflex. For more information see ELYME / Lyme Disease European Antibody Screen, Serum.

 

If antibody screen is positive or equivocal, then this test 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

Only orderable as a reflex. For more information see ELYME / Lyme Disease European Antibody Screen, Serum.

 

Immunoblot Microarray

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 Immunoblot, 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.

Only orderable as a reflex. For more information see ELYME / Lyme Disease European Antibody Screen, Serum.

 

If antibody screen is positive or equivocal, then this test 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

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 Borrelia 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

Only orderable as a reflex. For more information see ELYME / Lyme Disease European Antibody Screen, Serum.

 

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

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

0.2 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus 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 14 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 or Borrelia afzelii

 

This test 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

 

This test should not be used to screen the general population.

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

Only orderable as a reflex. For more information see ELYME / Lyme Disease European Antibody Screen, Serum.

 

If antibody screen is positive or equivocal, then this test 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 immunoblot tests 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 our ability to detect antibodies to the European Borrelia species, immunoblot tests designed to detect IgM and/or 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.

Only orderable as a reflex. For more information see ELYME / Lyme Disease European Antibody Screen, Serum.

 

IgG: Negative

IgM: Negative

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

Immunoglobulin M:

The interpretation of IgM immunoblots for Lyme disease caused by Borrelia species endemic to Europe differs from the interpretive criteria for IgM immunoblots used for evaluation of Lyme disease caused by Borrelia burgdorferi in North America. The European Lyme disease IgM immunoblot interpretive criteria is as follows:

-Positive: The presence of a band at 1 or more of the following 5 proteins - p39, OspC, Osp17 (DbpA), VlsE, and/or p41 (high intensity)

 -Interpretation: Specific antibodies against Lyme disease associated Borrelia species detected suggesting recent infection.

-Negative: No distinct bands

 -Interpretation: No specific antibodies against Lyme disease associated Borrelia species were detected. If infection remains suspected, repeat testing on a new specimen collected in 2 to 3 weeks is suggested.

 

IgM-class antibodies to Borrelia species that cause Lyme disease, including Borrelia afzelii and Borrelia garinii, may be detectable as early as 1 to 2 weeks following a tick bite, however, they typically peak during the third to sixth week postinfection. IgM-class antibodies to these agents may persist for months following disease resolution and antimicrobial treatment. Results of the IgM immunoblot should only be interpreted and considered during the first 4 to 6 weeks after disease onset.

 

Patients tested soon after disease onset may be negative for IgM-class antibodies to Lyme disease-associated Borrelia species. Repeat testing should be performed in 2 to 3 weeks if infection with a European species of Borrelia continues to be suspected.

 

Immunoglobulin G:

The interpretation of IgG immunoblots for Lyme disease caused by Borrelia species endemic to Europe differs from the interpretive criteria for IgG immunoblots used to for evaluation of Lyme disease caused by B burgdorferi in North America. The European Lyme disease IgG immunoblot is interpreted as follows:

-Positive: The presence of a band at 2 or more of the following 10 proteins: p38, p58, p43, p39, p30, OspC, p21, Osp17(DbpA), p14, VlsE

 -Interpretation: Specific antibodies against Lyme disease associated Borrelia species were detected, suggesting infection at some point in the recent or remote past. Clinical correlation required.

-Equivocal: One distinct band at the VlsE protein only

 -Interpretation: Specific antibodies to the VlsE protein of Lyme disease associated Borrelia species were detected, suggesting possible infection. Repeat testing on a new specimen collected in 2 to 3 weeks is recommended to confirm infection.

-Negative: One or no distinct bands (except VlsE)

 - Interpretation: No specific antibodies against Lyme disease-associated Borrelia species were detected. If infection remains suspected, repeat testing on a new specimen collected in 2 to 3 weeks is suggested.

 

IgG-class antibodies to Lyme disease causing Borrelia species may remain detectable for months to years following resolution of disease and/or antimicrobial treatment.

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. Specimens collected soon after infection (less than 2 weeks) may be negative for IgM- and IgG-class antibodies to Lyme disease-associated Borrelia species. Repeat testing on a new specimen collected 2 to 3 week following tick bite and exposure is recommended in cases of suspected acute Lyme disease due to infection with Borrelia species endemic to Europe and regions of Asia.

 

This assay does not differentiate between infection with B afzelii or B garinii

 

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

 

False-positive reactions may occur with patients with other spirochetal diseases (syphilis, yaws, pinta, relapsing fever, or leptospirosis), influenza, autoimmune disorders, multiple sclerosis, or amyotrophic lateral sclerosis.

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

1. Branda JA, Strle F, Strle K, Sikand N, Ferraro MJ, Steere AC: 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, Johnson BJ, Miller JN, Philipp MT: 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 European Borrelia IgM and IgG immunoblots are based on an enzyme-immunoassay in a microarray format, carrying highly purified, specific native antigens from Borrelia afzelii (Pko strain) and Borrelia burgdorferi sensu stricto, as well as recombinant VlsE at defined position on a solid-phase nitrocellulose membrane in triplicate. The positions of these antigen "spots" are well defined and are reliably identifiable using customized software. Each microarray also has spots for a negative control, serum controls, conjugate controls, and 6 calibrators.

 

One microarray is fixed at the bottom of each well in a standard microtiter plate (MTP). For each test to be performed, the diluted patient serum is added to each microarray (note: the Borrelia IgM and IgG microarrays are in separate wells). If specific antibodies recognizing a Borrelia antigen are present, they will bind to the specific antigens on the microarray. After incubation the microarray is washed to remove unbound antibodies. Alkaline-phosphatase-antihuman IgG or antihuman IgM (conjugate) is then added to the well and incubated. If antibodies are present, the conjugate will bind to those respective antibodies, and, after a washing step to remove unbound conjugate, substrate solution is added. If the antibody/conjugate complex is present, the substrate will undergo precipitation and color change. After an incubation period, the reaction is stopped and the presence of precipitated substrate is visualized at specific locations on the microarray. The presence of a colored precipitation at various locations on the microarray is an indirect measurement of Borrelia specific antibodies in the patient specimen. Visualized spots from the reaction are compared for intensity with the integrated calibrator controls for evaluation. The IgM-analyte spots serve to detect antibodies against p41, p39, OspC, Osp17, and VlsE. The IgG-analyte spots serve to detect antibodies against p83, p58, p43, p39, p30, p21, OspC, DbpA/Osp17, p14, and VlsE.(Package insert: Borrelia ViraChip IgM and IgG Test kits. ViraMed; 07/2018)

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 day

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 was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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.

86617 x 2

LOINC® Information

Test Id Test Order Name Order LOINC Value
ELYMI Lyme Disease European Immunoblot, S 87274-7
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
48569 Euro Lyme IgG Immunoblot Result 87275-4
48570 Euro Lyme IgG Band(s) Detected 87276-2
48571 Euro Lyme IgM Immunoblot Result 87277-0
48572 Euro Lyme IgM Band(s) Detected 87278-8
48573 Euro Lyme Interpretation 69048-7

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