Test Catalog

Test Id : TLYME

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Lyme IgM and IgG, Whole Cell Sonicate, ELISA, Serum

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Overview

Test Catalog

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

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.

Highlights

Lyme disease serology positive results by the modified 2-tier testing algorithm are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease.

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

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 IgM/IgG, WCS, EIA, S

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

TLYME

B. burgdorferi

Borrelia burgdorferi

Borrelia burgdorferi whole cell antigen

Lymes

Tick-borne

Tick

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

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

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

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

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.

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

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.5 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 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

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.

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

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, 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.

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

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

Tier 1

Tier 2

IgM result

Tier 2

IgG result

Interpretation

Positive/equivocal

Negative

Negative

Negative for antibodies to the Borrelia (Borreliella) species causing Lyme disease. Antibodies detected by the first-tier test were not confirmed. Negative results may occur in recently infected (< or =14 days) patients. If recent infection is suspected, repeat testing on a new sample collected in 7 to 14 days is recommended.

Positive/equivocal

Positive/equivocal

Negative

IgM-class antibodies to the Borrelia (Borreliella) species causing Lyme disease were detected, suggesting acute or recent infection.

 

IgM enzyme immunoassay (EIA) results should only be considered as indicative of recent infections in patients presenting within 30 days of symptom onset. Consideration of IgM EIA results in patients with symptoms lasting more than 30 days is discouraged due to the risk of false-positive IgM results and/or prolonged IgM seropositivity following disease resolution. If both first and second tier IgM results are equivocal consider repeat testing in 7 to 14 days if clinically warranted.

Positive/equivocal

Negative

Positive/equivocal

IgG-class antibodies to the Borrelia (Borreliella) species causing Lyme disease were detected, suggesting infection in the recent or remote past. IgG-class antibodies may remain detectable for months to years following resolution of infection. Results should not be used to monitor or establish adequate response to therapy. Response to therapy is confirmed through resolution of clinical symptoms; additional laboratory testing should not be performed.

Positive/equivocal

Positive/equivocal

Positive/equivocal

IgM and IgG-class antibodies to the Borrelia (Borreliella) species causing Lyme disease were detected, suggesting infection in the recent or remote past. Antibodies may remain detectable for months to years following resolution of infection. Results should not be used to monitor or establish adequate response to therapy. Response to therapy is confirmed through resolution of clinical symptoms; additional laboratory testing should not be performed.

If both first and second tests are equivocal consider repeat testing in 7 to 14 days if clinically warranted.

 

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."

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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.

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

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

Method Description
Describes how the test is performed and provides a method-specific reference

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)

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.

Tuesday, 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 5 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 account representative. 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.

86617 x 2

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
TLYME Lyme IgM/IgG, WCS, EIA, S 34942-3
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
LYMEM Lyme Ab, IgM, S 40612-4
LYMEG Lyme Ab, IgG, S 16480-6
LYMEI Lyme Ab Interpretation 46248-1

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