Test Id : TLYME

For more information see Acute Tick-Borne Disease Testing Algorithm

This test should only be ordered on specimens that have tested positive or equivocal by a first tier Lyme disease antibody test.

Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.6 mL

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

• Acute Tickborne Disease Testing Algorithm

If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.

0.5 mL

Supplemental testing for samples with positive or equivocal first-tier test results for antibodies to Lyme disease causing Borrelia species

This test should not be used as a screening procedure for the general population.

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, 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 LD 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 either the standard or modified 2-tiered serologic testing algorithm (STTTA or MTTTA, respectively). For the STTTA, see LYME / Lyme Disease Serology, Serum.

The MTTTA starts with an initial enzyme immunoassay (EIA) screen for detection of total antibodies against the Borrelia Vlse/pepC10 proteins. Samples that screen positive or equivocal by this first tier EIA are subsequently reflexed for supplemental assessment using 2 separate EIAs for detection of IgM and IgG antibodies against B burgdorferi whole cell sonicate material.

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.

Negative

Reference values apply to all ages.

For specimens that did not have first tier testing performed at Mayo Clinic Laboratories, the results will also include the comment: "Interpretation assumes first tier Lyme disease causing Borrelia species antibody test was performed and resulted as positive or equivocal."

The modified 2-tiered serologic testing (MTTT) study was conducted using the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System as the first-tier assay and the ZEUS ELISA Borrelia burgdorferi IgM and IgG Test System as the second-tier assay with testing performed in that order. The performance characteristics of the device are not established for changing the order of testing or for substituting other enzyme immunoassay (EIA) in the MTTT (2-EIA) procedure.

Sera from patients with other spirochetal diseases (syphilis, yaws, pinta, leptospirosis, and relapsing fever), or infectious mononucleosis and systemic lupus erythematosus may give false-positive results. In cases where false-positive reactions are observed, extensive clinical epidemiologic, and laboratory workups should be carried out to determine the specific diagnosis. False-positive sera from syphilis patients can be identified by running a rapid plasma reagin and a treponemal antibody assay on such specimens. True B burgdorferi disease-positive sera will be negative in these assays.

False-negative results may be obtained if serum specimens are collected too early after onset of disease before antibody levels have reached significant levels. Also, early antibiotic therapy may abort an antibody response to the spirochete.

Interpret all data in conjunction with clinical symptoms of disease, epidemiologic data, exposure in endemic areas, and results of other laboratory tests.

Do not perform screening of the general population. The positive predictive value depends on the pretest likelihood of infection. Only perform testing when clinical symptoms are present, or exposure is suspected.

The performance characteristics of the ZEUS ELISA B burgdorferi IgM and IgG Test Systems are not established with specimens from individuals vaccinated with B burgdorferi antigens.

Rheumatoid factor may cause false-positive results with the B burgdorferi IgM Test System.

1. Theel ES: The past, present and (possible) future of serologic testing for Lyme disease. J Clin Microbiol. 2016 May;54(5):1191-1196. doi: 10.1128/JCM.03394-15

2. Dattwyler RJ: Lyme borreliosis: an overview of clinical manifestations. Lab Med. 1990 May;21(5):290-292. doi: 10.1093/labmed/21.5.290

3. Schwan TG, Burgdorfer W, Rosa PA: Borrelia. In: Murray PR, ed: Manual of Clinical Microbiology. 7th ed. ASM Press; 1999:746-758

4. Centers for Disease Control and Prevention (CDC): 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

This enzyme-linked immunosorbent assay is designed to detect IgM and IgG class antibodies to Borrelia burgdorferi in human sera. The sensitized wells of plastic microwell strips are prepared by passive adsorption with B burgdorferi whole cell antigen. The test procedure involves 3 incubations steps. First, test sera (properly diluted) 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. Second, peroxidase conjugated goat anti-human IgM (mu chain specific) and IgG (Fc chain specific) is added to the wells, and the plate is incubated. The conjugate will react with IgM and IgG antibody immobilized on the solid phase in the first step. The wells are washed to remove unreacted conjugate. Third, 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 sample.(Package insert: B burgdorferi IgM or IgG Test System. ZEUS Scientific, Inc; Rev Date 01/27/2020)

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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.

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