Test Id : ELYMI

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.

For more information see Acute Tick-Borne Disease Testing Algorithm.

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.

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

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

Pediatric: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.

• Acute Tick-Borne Disease Testing Algorithm

0.2 mL

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.

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.

For more information see Acute Tick-Borne Disease Testing Algorithm.

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, both of which are 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, 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 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 immunoblot assays 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.

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

Immunoglobulin M:

The interpretation of IgM immunoblots for Lyme disease caused by Borrelia species endemic to Europe differs from the interpretive criteria for IgM immunoblot tests 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 immunoblot tests 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.

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.

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 Aug;57(3):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 VlsE. J Clin Microbiol. 1999 Dec;37(12):3990-3996

• Acute Tick-Borne Disease Testing Algorithm

The European Borrelia IgM and IgG immunoblot tests 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.(Unpublished Mayo method)

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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.

86617 x 2

Sample Reports

Normal and Abnormal sample reports are provided as references for report appearance.

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