Test Catalog

Test Id : STICK

Tick-Borne Antibodies, Modified 2-Tier, ELISA, Serum

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

Evaluation of the most common tick-borne diseases found in the United States, including Lyme disease, human monocytic and granulocytic ehrlichiosis, and babesiosis using the modified 2-tier testing algorithm approach

 

Evaluation of patients with a history of, or suspected, tick exposure who are presenting with fever, myalgia, headache, nausea, and other nonspecific symptoms

 

Sero-epidemiological surveys of the prevalence of the infection in certain populations

 

Diagnosis of Lyme disease

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
ANAP Anaplasma phagocytophilum Ab, IgG,S Yes Yes
EHRC Ehrlichia Chaffeensis (HME) Ab, IgG Yes Yes
BABG Babesia microti IgG Ab, S Yes Yes
SLYME Lyme Ab Modified 2-Tier w/Reflex, S Yes Yes

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 Lyme disease antibody confirmation 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

ANAP, EHRC, BABG: Immunofluorescence Assay (IFA)

SLYME: 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

Tick-Borne Abs w/ Lyme MTTTA, S

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

STICK

Anaplasma phagocytophilum

Ehrlichia chaffeensis

Babesia microti

Borrelia burgdorferi

HME (Human Monocytotropic Ehrlichiosis)

HGA (Human Granulocytic Anaplasmosis)

Lyme Disease

Spirochetes

Tick-Borne Diseases

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 Lyme disease antibody confirmation 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

Ordering Guidance

During the acute phase of an Anaplasma phagocytophilum or Ehrlichia chaffeensis infection, serologic tests are often nonreactive, polymerase chain reaction (PCR) testing is available to aid in the diagnosis of these cases; see EHRL / Ehrlichia/Anaplasma, Molecular Detection, PCR, Blood.

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: 1.35 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

0.9 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 specimen 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 14 days

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

Evaluation of the most common tick-borne diseases found in the United States, including Lyme disease, human monocytic and granulocytic ehrlichiosis, and babesiosis using the modified 2-tier testing algorithm approach

 

Evaluation of patients with a history of, or suspected, tick exposure who are presenting with fever, myalgia, headache, nausea, and other nonspecific symptoms

 

Sero-epidemiological surveys of the prevalence of the infection in certain populations

 

Diagnosis of Lyme disease

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 Lyme disease antibody confirmation 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

In North America, ticks are the primary vectors of infectious diseases.(1) Worldwide, ticks rank second only to mosquitoes in disease transmission. In the United States, tick-borne diseases include Lyme disease, Rocky Mountain spotted fever, human monocytic and granulocytic ehrlichiosis, babesiosis, tularemia, relapsing fever, and Colorado tick fever.

 

Symptoms of the various tick-vectored diseases range from mild to life-threatening and significantly overlap. Early symptoms, which include fever, aches, and malaise, do not aid in distinguishing the various diseases. Because early treatment can minimize or eliminate the risk of severe disease, early detection is essential, yet patients may not have developed distinctive symptoms to help in the differential diagnosis. A tick-borne panel can assist in identifying the pathogen, allowing treatment to be initiated.

 

For information on the specific diseases, see the individual test IDs.

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.

Anaplasma phagocytophilum ANTIBODY, IgG

<1:64

Reference values apply to all ages.

 

Ehrlichia chaffeensis (HME) ANTIBODY, IgG

<1:64

Reference values apply to all ages.

 

Babesia microti IgG ANTIBODIES

<1:64

Reference values apply to all ages.

 

LYME ANTIBODY

Negative

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

Anaplasma phagocytophilum:

A positive immunofluorescence assay (titer > or =1:64) suggests current or previous infection. In general, the higher the titer, the more likely the patient has an active infection. Four-fold rises in titer also indicate active infection.

 

Previous episodes of ehrlichiosis may produce a positive serology although antibody levels decline significantly during the year following infection.

 

Ehrlichia chaffeensis:

A positive immunofluorescence assay (titer > or =1:64) suggests current or previous infection. In general, the higher the titer, the more likely the patient has an active infection. Four-fold rises in titer also indicate active infection.

 

Previous episodes of ehrlichiosis may produce a positive serology although antibody levels decline significantly during the year following infection.

 

Babesia microti:

A positive result of an indirect fluorescent antibody test (titer > or =1:64) suggests current or previous infection with Babesia microti. In general, the higher the titer, the more likely it is that the patient has an active infection. Patients with documented infections have usually had titers ranging from 1:320 to 1:2560.

 

Lyme disease:

Negative:

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

 

Equivocal or Positive:

Not diagnostic. Supplemental testing in accordance with the modified two-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

Anaplasma phagocytophilum:

Serology for IgG may be negative during the acute phase of infection (<7 days post-symptom onset), during which time detection using targeted nucleic acid amplification testing (eg, polymerase chain reaction: PCR) is recommended.

 

Detectable IgG-class antibodies typically appear within 7 to 10 days post-symptom onset.

 

IgG-class antibodies may remain detectable to months to years following prior infection. Therefore, a single time point-positive titer needs to be interpreted alongside other findings to differentiate recent versus past infection.

 

Other members of the Ehrlichia genus (eg, Ehrlichia ewingii) may not be detected by this assay.

 

Ehrlichia chaffeensis:

Serology for IgG may be negative during the acute phase of infection (<7 days post symptom onset), during which time detection using targeted nucleic acid amplification testing (eg, PCR) is recommended.

 

Detectable IgG-class antibodies typically appear within 7 to 10 days post symptom onset.

 

IgG-class antibodies may remain detectable for months to years following prior infection. Therefore, a single time point-positive titer needs to be interpreted alongside other findings to differentiate recent versus past infection.

 

Other members of the Ehrlichia genus (eg, E ewingii) may not be detected by this assay.

 

Babesia microti:

Previous episodes of babesiosis may produce a positive serologic result.

 

In selected cases, documentation of infection may be attempted by animal inoculation or PCR methods (LBAB / Babesia species, Molecular Detection, PCR, Blood)

 

Performance characteristics have not been established for the following specimen characteristics:

-Lipemic

-Hemolyzed

 

Lyme disease:

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 equivocal or positive results should be supplemented immunoblot testing 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 B garinii, B afzelii, and B 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. Centers for Disease Control and Prevention (CDC). Tick-borne diseases of the United States: A Reference Manual for Health Care Providers. 5th ed. CDC; 2018. Available at www.cdc.gov/ticks/tickbornediseases/index.html

2. Mathieu ME, Wilson BB: Ticks (including tick paralysis). In: Mandell GL, Bennett JE, Dolin R, eds: Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. Vol 1. 5th ed. Churchill Livingston; 2000:2980-2983

3. 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. 

4. Dattwyler RJ: Lyme borreliosis: an overview of clinical manifestations. Lab Med. 1990;21:290-292. doi: 10.3390/healthcare6030104.

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

6. 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

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

Anaplasma phagocytophilum:

The patient's serum is diluted and is placed in microscopic slide wells that have been coated with A phagocytophilum-infected cells. After incubation, the slides are washed and a fluorescein-isothiocyanate conjugate is added to each well. The slides are then read using a fluorescence microscope and significant fluorescent staining of intracellular organisms constitutes a positive reaction.(Dumler JS, Asanovich KM, Bakken JS, Richter P, Kimsey R, Madigan JEl: Serologic cross-reactions among Ehrlichia equi, Ehrlichia phagcoytophilia, and human granulocytic ehrlichia. J Clin Microbiol. 1995;33:1098-1103; Pancholi P, Kolbert CP, Mitchell PD, et al: Ixodes dammini as a potential vector of human granulocytic ehrlichiosis. J Infect Dis. 1995;172:1007-1012; Dawson JE, Fishbein DB, Eng TR, Redus MA, Green NR: Diagnosis of human ehrlichiosis with the indirect fluorescent antibody test: kinetics and specificity. J Infect Dis. 1990;162:91-95; package insert: Anaplasma phagocytophila IFA IgG. DiaSorin Molecular; 8/12/2016)

 

Ehrlichia chaffeensis:

The patient's serum is diluted and is placed in microscopic slide wells that have been coated with E chaffeenis-infected cells. After incubation, the slides are washed and a fluorescein-isothiocyanate conjugate is added to each well. The slides are then read using a fluorescence microscope and significant fluorescent staining of intracellular organisms constitutes a positive reaction.(Dumler JS, Asanovich KM, Bakken JS, Richter P, Kimsey R, Madigan JE: Serologic cross-reactions among Ehrlichia equi, Ehrlichia phagcoytophilia, and human granulocytic ehrlichia. J Clin Microbiol. 1995;33:1098-1103; Pancholi P, Kolbert CP, Mitchell PD, et al: Ixodes dammini as a potential vector of human granulocytic ehrlichiosis. J Infect Dis. 1995;172:1007-1012; Dawson JE, Fishbein DB, Eng TR, Redus MA, Green NRet: Diagnosis of human ehrlichiosis with the indirect fluorescent antibody test: kinetics and specificity. J Infect Dis. 1990;162:91-95; package insert: Ehrlichia chaffeensis IFA IgG. DiaSorin Molecular; 8/12/2016)

 

Babesia microti:

This immunofluorescence assay (IFA) detects antibodies against Babesia microti. The patient's serum is diluted and is placed in microscopic slide wells that have been coated with B microti-infected red blood cells from Syrian hamsters. After incubation, the slides are washed and a fluorescein-isothiocyanate conjugate is added to each well. The slides are then read using a fluorescence microscope and significant fluorescent staining of intraerythrocytic organisms constitutes a positive reaction.(Krause PJ, Telford SR III, Ryan R, et al: Diagnosis of babesiosis: Evaluation of a serologic test for the detection of Babesia microti antibody. J Infect Dis. 1994;169:923-926; package insert: Babesia IFA IgG. DiaSorin Molecular; 8/12/2016)

 

Lyme disease:

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. Date 05/25/2021)

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.

2 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.

See Individual Test IDs

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

86666 x 2

86753

86617 x 2 (if appropriate)

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