Test Catalog

Test Id : LNBAB

Lyme Central Nervous System Infection IgG with Antibody Index Reflex, Serum and Spinal Fluid

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

Aiding in the diagnosis of neuroinvasive Lyme disease or neuroborreliosis due to Borrelia species associated with Lyme disease (eg, Borrelia burgdorferi, Borrelia garinii, Borrelia afzelli)

 

Highlights

This test should be ordered in patients with suspected neuroinvasive Lyme disease.

 

Although a small percentage of patients with neuroinvasive Lyme disease may be seronegative, it is recommended that all patients test by the Lyme Antibody Index assay also have standard 2-tiered testing for Lyme disease performed on serum.

 

This test compares the level of IgG antibodies to Lyme disease-causing Borrelia species in spinal fluid (CSF) and serum. The level of anti-Borrelia species IgG is normalized to total IgG and albumin in CSF and serum.

 

This test can help identify whether the presence of IgG to Borrelia species in the CSF is due to true intrathecal antibody synthesis, suggesting neuroinvasive Lyme disease, versus antibody presence due to passive diffusion through the blood-brain barrier or possibly, due to blood contamination of the CSF as a result of a traumatic lumbar puncture.

 

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
LNBAC Lyme CNS Infection IgG Screen, CSF No Yes
LNBAS Lyme CNS Infection IgG, S No No

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
LNBAI Lyme CNS Infection IgG, Ab Index No No

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

This test begins with IgG screening of the spinal fluid (CSF) specimen. If the screen is negative, no additional testing will be performed.

 

If the screen is positive, the paired CSF and serum specimens will be used to establish the antibody index. In order to establish the antibody index, the paired serum and CSF samples (collected within 24 hours of each other) are tested on the same run using quantitative assays to determine levels for the following analytes:

1. Anti-Borrelia species IgG levels in CSF and serum

2. Total IgG in CSF and serum

3. Albumin in CSF and serum

 

These additional tests are necessary in order to normalize the level of anti-Borrelia antibodies to total IgG and albumin in the CSF and establish the antibody index ratio of anti-Borrelia antibodies in CSF-to-serum. This testing is performed at an additional charge.

 

The following algorithms are available in Special Instructions:

-Lyme Neuroborreliosis Diagnostic Algorithm

-Acute Tick-Bourne Disease Testing Algorithm

-Meningitis/Encephalitis Panel Algorithm

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 CNS Infection IgG w/ AI Reflex

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

Neuroinvasive Lyme Disease

Neuroborreliosis

Lyme Disease in the Central Nervous System

Lyme CNS Disease

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

This test begins with IgG screening of the spinal fluid (CSF) specimen. If the screen is negative, no additional testing will be performed.

 

If the screen is positive, the paired CSF and serum specimens will be used to establish the antibody index. In order to establish the antibody index, the paired serum and CSF samples (collected within 24 hours of each other) are tested on the same run using quantitative assays to determine levels for the following analytes:

1. Anti-Borrelia species IgG levels in CSF and serum

2. Total IgG in CSF and serum

3. Albumin in CSF and serum

 

These additional tests are necessary in order to normalize the level of anti-Borrelia antibodies to total IgG and albumin in the CSF and establish the antibody index ratio of anti-Borrelia antibodies in CSF-to-serum. This testing is performed at an additional charge.

 

The following algorithms are available in Special Instructions:

-Lyme Neuroborreliosis Diagnostic Algorithm

-Acute Tick-Bourne Disease Testing Algorithm

-Meningitis/Encephalitis Panel Algorithm

Specimen Type
Describes the specimen type validated for testing

CSF

Serum

Ordering Guidance

This test is preferred for diagnosis of neuroinvasive Lyme disease over testing of spinal fluid (CSF) by immunoblot for IgM and IgG class antibodies to Borrelia species associated with Lyme disease. This test is recommended because it can help distinguish true intrathecal synthesis of antibodies to Lyme disease in the CSF, indicating neuroinvasive infection, versus antibody presence due to passive diffusion through the blood-brain barrier or possibly, due to blood contamination of the CSF as a result of a traumatic lumbar puncture.

 

For Lyme testing on serum, order LYME / Lyme Disease Serology, Serum.

Additional Testing Requirements

Although a small percentage of patients with neuroinvasive Lyme disease may be seronegative, it is recommended that all patients tested by this assay also have standard 2-tiered testing for Lyme disease performed (LYME / Lyme Disease Serology, Serum).

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

Both spinal fluid (CSF) and serum are required for this test. CSF and serum must be collected within 24 hours (maximum) of each other.

 

Specimen Type: Spinal fluid

Container/Tube: Sterile vial

Specimen Volume:  1.2 mL

Collection Instructions:

1. A spinal fluid (CSF) sample of  1.2 mL needs to be collected within 24 hours of the serum specimen, preferably at the same time.

2. Label vial as spinal fluid or CSF.

3. CSF aliquot should be from the second, third, or fourth CSF vial collected during the lumbar puncture.

- Do not submit CSF from the first vial due to the possibility of blood contamination, which will cause specimen rejection.

4. Band specimens together.

 

Specimen Type: Serum

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume:  1.2 mL

Collection Instructions:

1. A serum sample of 1.2 mL needs to be collected within 24 hours of the spinal fluid specimen, preferably at the same time.

2. Label as serum.

3. Band specimens together.

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

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
CSF contaminated with blood 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
CSF Refrigerated (preferred) 11 days
Frozen 35 days
Serum Refrigerated (preferred) 11 days
Frozen 35 days

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

Aiding in the diagnosis of neuroinvasive Lyme disease or neuroborreliosis due to Borrelia species associated with Lyme disease (eg, Borrelia burgdorferi, Borrelia garinii, Borrelia afzelli)

 

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

This test begins with IgG screening of the spinal fluid (CSF) specimen. If the screen is negative, no additional testing will be performed.

 

If the screen is positive, the paired CSF and serum specimens will be used to establish the antibody index. In order to establish the antibody index, the paired serum and CSF samples (collected within 24 hours of each other) are tested on the same run using quantitative assays to determine levels for the following analytes:

1. Anti-Borrelia species IgG levels in CSF and serum

2. Total IgG in CSF and serum

3. Albumin in CSF and serum

 

These additional tests are necessary in order to normalize the level of anti-Borrelia antibodies to total IgG and albumin in the CSF and establish the antibody index ratio of anti-Borrelia antibodies in CSF-to-serum. This testing is performed at an additional charge.

 

The following algorithms are available in Special Instructions:

-Lyme Neuroborreliosis Diagnostic Algorithm

-Acute Tick-Bourne Disease Testing Algorithm

-Meningitis/Encephalitis Panel Algorithm

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Lyme disease is a multisystem and multistage tick-transmitted infection caused by spirochetal bacteria in the Borrelia burgdorferi sensu lato (Bbsl) complex. Nearly all human infections are caused by 3 Bbsl species; B burgdorferi sensu stricto (hereafter referred to as B burgdorferi) is the primary cause of Lyme disease in North America, while Borrelia afzelii and Borrelia garinii are the primary causes of Lyme disease in Europe and parts of Asia.

 

Lyme disease is the most commonly reported tick-borne infection in North America and Europe, causing an estimated 300,000 cases in the United States each year and 85,000 cases in Europe. The clinical features of Lyme disease are broad and may be confused with various immune and inflammatory disorders. The classic presenting sign of early localized Lyme disease caused by B burgdorferi is erythema migrans (EM), which occurs in approximately 80% of individuals. Other early signs and symptoms include malaise, headache, fever, lymphadenopathy, and myalgia. Arthritis, cardiac disease, and neurological disease may be later stage manifestations.

 

Neuroinvasive Lyme disease (NLD) can affect either the peripheral or central nervous system, with patients classically presenting with the triad of lymphocytic meningitis, cranial neuropathy (especially facial nerve palsy) and radiculoneuritis, which can affect the motor or sensory nerves, or both. These symptoms can occur in any combination or alone. Some patients may present with Bannwarth syndrome, which includes painful radiculoneuritis with variable motor weakness.

 

NLD should be considered in individuals presenting with appropriate symptoms who have had exposure to ticks in a Lyme endemic region of the United States, Europe or Asia. Patients meeting these criteria should be evaluated for the presence of anti-Bbsl antibodies in serum using the standard 2-tiered testing algorithm (LYME / Lyme Disease Serology, Serum) as recommended by the Centers for Disease Control and Prevention. Briefly, the LYME test includes testing of serum specimens by an anti-Bbsl antibody enzyme-linked immunosorbent assay (ELISA), followed by supplemental testing of all reactive samples using an immunoblot or western blot for detection of IgM- and IgG-class antibodies to Bbsl. Notably, the majority of patients with NLD will be seropositive in serum. Therefore, it is recommended that all patients tested by this assay also have LYME / Lyme Disease Serology, Serum performed. Results from these assays, alongside appropriate exposure history and clinical presentation, may be used to establish a diagnosis of NLD.

 

Spinal fluid (CSF) should not be tested for the presence of antibodies to Bbsl using the current 2-tiered testing algorithm as there are no interpretive criteria for assessment of anti-Bbsl IgM and IgG immunoblot banding patterns in CSF. Additionally, while the presence of antibodies to Bbsl in CSF may be due to true intrathecal antibody synthesis, thus indicating central nervous system (CNS) infection, antibodies may alternatively be present as a result of passive diffusion through the blood-brain barrier or due to blood contamination of CSF during a traumatic lumbar puncture.

 

The Lyme CNS infection antibody index (AI) is performed as a reflex and quantitatively measures the level of anti-Bbsl antibodies in CSF and serum, ideally collected within 24 hours of each other, and normalizes those levels to total IgG and albumin in both specimen sources. A positive Lyme CNS AI indicates true intrathecal antibody synthesis of antibodies to Bbsl, which alongside clinical and exposure history can be used to establish a diagnosis of NLD.

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:

No antibodies to Lyme disease causing Borrelia species detected in spinal fluid. A negative result in a patient with appropriate exposure history and symptoms consistent with neuroinvasive Lyme disease should not be used to exclude infection. Testing for antibodies to Lyme disease-causing Borrelia species in serum should be performed.

 

Reactive:

Supplemental testing to determine a Lyme central nervous system antibody index has been ordered. Diagnosis of neuroinvasive Lyme disease should not be established solely based on a reactive screening result.

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

A single negative result should not be used to exclude the diagnosis of neuroinvasive Lyme disease in a patient with appropriate exposure history and symptoms suggestive of infection. Testing of serum samples using the Centers for Disease Control and Prevention (CDC) recommended standard 2-tiered testing algorithm should be performed (LYME / Lyme Disease Serology, Serum).

 

False-negative results may be acquired in patients tested soon after infection, prior to the development of a detectable level of antibodies in the spinal fluid.

 

False-reactive results may occur in patients with syphilis or Leptospira infections. Patient management decisions should not be made on a single reactive result.

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

1. Wormser GP, Dattwyler RJ, Shapiro ED, et al: The clinical assessment, treatment, and prevention of lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2006 Nov 1;43(9):1089-1134

2. Halperin JJ, Shapiro ED, Logigian E, et al: Practice parameter: treatment of nervous system Lyme disease (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2007 Jul 3;69(1):91-102

3. Halperin JJ: Neuroborreliosis: J Neurol. 2017;264(6):1292-1297

4. Theel ES: The Past, present and (possible) future of serologic testing for Lyme disease. J Clin Microbiol. 2016;54(5):1191-1196

5. Theel ES, Aguero-Rosenfeld ME, Pritt B, Adem PV, Wormser GP: Limitations and confusing aspects of diagnostic testing for neurologic Lyme disease in the United States. J Clin Microbiol. 2019 Jan 2;57(1): e01406-18. doi: 10.1128/JCM.01406-18

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 test kit contains microtiter strips with break-off reagent wells coated with a mix of Bb sl antigens (whole antigen extracts of Borrelia burgdorferi sensu stricto, Borrelia afzelii, Borrelia garinii and recombinant VlsE of B burgdorferi sensu stricto). In the first reaction step, diluted patient samples are incubated in the wells. In the case of positive samples, Borrelia-specific-IgG antibodies will bind to the antigens. To detect the bound antibodies, a second incubation is carried out using an enzyme-labelled antihuman IgG (enzyme conjugate), followed by a third incubation using chromogen/substrate (TMB/H2O2), which catalyzes a color reaction that is then measured for optical density (OD) using spectrophotometry. The obtained OD values of the paired patient serum and spinal fluid samples are compared against a 6-level calibration curve to quantitatively determine the relative anti-Borrelia IgG antibody titers.(Package insert: Antibodies of the IgG class against Borrelia in cerebrospinal fluid. Euroimmun Ag; 06/15/2015)

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, Wednesday, 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 was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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-Lyme spinal fluid

86618 x 2-Lyme, Serum and spinal fluid if applicable for Antibody Index

82040-Albumin, serum if applicable for Antibody Index

82042-Albumin, spinal fluid if applicable for Antibody Index

82784 x 2-IgG, serum and spinal fluid if applicable for Antibody Index

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
LNBAB Lyme CNS Infection IgG w/ AI Reflex 92815-0
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.
LNB1 Lyme CNS Infection IgG, CSF 92813-5
LNB2 Lyme CNS Infection IgG Interp 69048-7
LNBAS Lyme CNS Infection IgG, S 92814-3

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