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 B garinii or B 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

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 ELYME is positive or equivocal, then ELYMI 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, B garinii and B afzelii are more prevalent in Europe and regions of Asia. These spirochetes are transmitted to humans through the bite of Ixodes species ticks, primarily I ricinus and to a lesser extent I 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 postonset of symptoms. An IgM-class antibody response usually peaks between 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 ELISA is used to screen all specimens and those with positive or equivocal 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 our ability to detect antibodies to the European Borrelia species, immunoblots 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

IgM:

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 B 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 B afzelii and B 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.

 

IgG:

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

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 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 B afzelii or B 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. 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 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.

 

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.

Supportive Data

 

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