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


Ordering Guidance


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


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

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

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. Centrifuge and aliquot serum into a plastic vial.

3. Label as serum.

4. Band specimens together.


Useful For

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)

 

Profile Information

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

Test ID Reporting Name Available Separately Always Performed
LNBAI Lyme CNS Infection IgG, Ab Index No No

Testing Algorithm

This test begins with IgG screening of the spinal fluid 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:

-Lyme Neuroborreliosis Diagnostic Algorithm

-Acute Tick-Bourne Disease Testing Algorithm

-Meningitis/Encephalitis Panel Algorithm

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Lyme CNS Infection IgG w/ AI Reflex

Specimen Type

CSF
Serum

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
CSF Refrigerated (preferred) 11 days
  Frozen  35 days
Serum Refrigerated (preferred) 11 days
  Frozen  35 days

Reference Values

Negative

 

Reference values apply to all ages.

Interpretation

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.

Clinical Reference

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

Day(s) Performed

Monday, Wednesday, Friday

Report Available

Same day/1 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

CPT Code Information

86618

86618 x2 - if applicable

82040 - if applicable

82042- if applicable

82784 x2 - if applicable

LOINC Code Information

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
LNB1 Lyme CNS Infection IgG, CSF 92813-5
LNBAS Lyme CNS Infection IgG, S 92814-3
LNB2 Lyme CNS Infection IgG Interp 69048-7

Forms

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