Test Catalog

Test Id : SLYME

Lyme Antibody Modified 2-Tier with Reflex, Serum

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

Diagnosis of Lyme disease

 

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

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
TLYME Lyme IgM/IgG, WCS, EIA, S Yes No

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

If the Lyme antibody result is positive or equivocal, then confirmation by whole cell sonicate 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

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 Ab Modified 2-Tier w/Reflex, S

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

SLYME

B. burgdorferi

Borrelia burgdorferi

Lyme C10 Peptide Assay

Tick-borne

VlsE1/pepC10 Assay

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

If the Lyme antibody result is positive or equivocal, then confirmation by whole cell sonicate 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

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

Supplies: Aliquot Tube, 5 mL (T465)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: 5-mL aliquot tube

Specimen Volume: 0.6 mL

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

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

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

Diagnosis of Lyme disease

 

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.

If the Lyme antibody result is positive or equivocal, then confirmation by whole cell sonicate 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, 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 (ACA), 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 are 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

Negative:

Negative for antibodies to the Borrelia (Borreliella) species causing Lyme disease. Negative results may occur in patients who have been recently infected (< or =14 days).  If recent infection is suspected, repeat testing on a new sample collected in 7 to 14 days is recommended.

 

Equivocal: 

Not diagnostic. Supplemental testing in accordance with the modified 2-tiered testing algorithm for Lyme disease has been ordered by reflex.

 

Positive: 

Not diagnostic. Supplemental testing in accordance with the modified 2-tiered testing algorithm for Lyme disease has been ordered by reflex.

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

A negative result does not exclude the possibility of infection with Lyme disease causing Borrelia species. Patients in the early stages of Lyme disease and those who have been treated with antibiotics may not exhibit detectable antibody titers. Patients with clinical history, signs, or symptoms suggestive of Lyme disease should be retested in 2 to 4 weeks in the event that the initial test result is negative.

 

A positive result is not definitive evidence of infection with Borrelia burgdorferi. It is possible that other disease conditions may produce artifactual reactivity in the assay (eg, infectious mononucleosis, syphilis). All samples with equivocal or positive results should be tested using a second tier method, including either immunoblot testing or enzyme immunoassay (EIA) methods for IgM- and IgG-class antibodies in accordance with Centers for Disease Control and Prevention and the Association of State and Territorial Public Health Laboratory Directors (CDC/ASTPHLD) recommendations.

 

Patients infected with other members of the B burgdorferi sensu lato complex, including Borrelia garinii, Borrelia afzelii, and Borrelia mayonii will be detected by this assay; however, they cannot be differentiated.

 

This test should not be performed as a screening procedure for the general population. The predictive value of a positive or negative result depends on the prevalence of analyte (antibodies present to VlsE1 and pepC10 antigens) in a given population. Testing should only be performed when clinical evidence suggests the diagnosis of Borrelia infection or related etiological conditions observed by the physician.

 

Lyme serology should not be used for treatment monitoring as IgG can remain for years post-resolution of infection. Instead, monitoring resolution of symptoms in response to treatment is recommended.

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;54(5):1191-1196. doi: 10.1128/JCM.03394-15. 

2. Dattwyler RJ: Lyme borreliosis: an overview of clinical manifestations. Lab Med. 1990;21:290-292

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

4. 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

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 first-tier Lyme disease screening enzyme-linked immunosorbent assay (ELISA) used is the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system. The Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system is designed to detect IgG- and IgM-class antibodies (not differentiated by the assay in the final result) in human sera to VlsE1 and pepC10 antigens. Diluted test sera 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. Peroxidase conjugated goat antihuman IgG and IgM are added to the wells and the plate is incubated. The conjugate will react with IgG and IgM antibodies immobilized on the plate. The wells are washed to remove unreacted conjugate. 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 test sample.(Package insert: Borrelia VlsE1/pepC10 IgG/IgM Test System. Zeus Scientific, Inc; Rev 05/21/2021)

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 to 4 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 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 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.

86618

86617 x 2-Lyme IgM/IgG, WCS, EIA S (if appropriate)

LOINC® Information

Test Id Test Order Name Order LOINC Value
SLYME Lyme Ab Modified 2-Tier w/Reflex, S 83081-0
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
SLYME Lyme Ab Modified 2-Tier w/Reflex, S 83081-0

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