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Test Code LAB6700 Lyme Central Nervous System Infection IgG with Antibody Index Reflex, Serum and Spinal Fluid

Additional Codes

SQ: LNBABM

MAYO: LNBAB


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.


Secondary ID

63502

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

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
CSF contaminated with blood Reject

Reference Values

Negative

 

Reference values apply to all ages.

Method Description

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, 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.(Unpublished Mayo method)

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.