Ordering Recommendation

Serum testing is recommended to diagnose Lyme neuroborreliosis; refer to Borrelia burgdorferi VlsE1/pepC10 Antibodies, Total by ELISA With Reflex to IgM and IgG by ELISA (Modified Two-Tier Testing) (3006053). 
Do not order in the absence of clinical symptoms or without concurrent serum antibody testing. May be used in the workup of suspected acute Lyme neuroborreliosis.

New York DOH Approval Status

Testing is not New York state approved. Specimens from New York clients will be sent out to a New York state-approved laboratory.

Specimen Required

Patient Preparation
Collect

CSF.

Specimen Preparation

Transfer 3 mL CSF to an ARUP Standard Transport Tube. (Min: 2 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Bacterially contaminated, heat-inactivated, hemolyzed, or xanthochromic specimens.

Remarks
Stability

Ambient: 8 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)
New York State Clients: Ambient: 1 week; Refrigerated: 2 weeks; Frozen: 1 month

Methodology

Qualitative Immunoblot

Performed

Sun-Sat

Reported

1-4 days

Reference Interval

Test Number
Components
Reference Interval
  Borrelia burgdorferi Ab, IgM, IB (CSF) Negative
  Borrelia burgdorferi Ab, IgG, IB (CSF) Negative

Interpretive Data

IgG: For this assay, a positive result is reported when any 5 or more of the following 10 bands are present: 18, 23, 28, 30, 39, 41, 45, 58, 66, or 93 kDa. All other banding patterns are reported as negative.

IgM: For this assay, a positive result is reported when any 2 or more of the following bands are present: 23, 39, or 41 kDa. All other banding patterns are reported as negative.

The detection of antibodies to Borrelia burgdorferi in cerebrospinal fluid may indicate central nervous system infection. However, consideration must be given to possible contamination by blood or transfer of serum antibodies across the blood-brain barrier.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

Note

A negative result indicates that the immunoblot evaluation for B. burgdorferi antibody demonstrates no antibodies unique to B. burgdorferi and is, therefore not supportive of Lyme disease.

A positive result indicates that the immunoblot evaluation for Lyme antibody is consistent with the presence of antibody produced by patients in response to infection by B. burgdorferi and suggests the presence of Lyme disease. Although the test has been shown to have a high degree of reliability for diagnostic purposes, laboratory data should always be correlated with clinical findings.

Current CDC recommendations for the serological diagnosis of Lyme disease are to screen with a polyvalent ELISA test and confirm equivocals and positives with immunoblot. Both IgM and IgG immunoblots should be performed on samples obtained less than 4 weeks after appearance of erythema migrans. Only IgG immunoblot is to be performed on samples greater than 4 weeks after disease onset. IgM immunoblot in the chronic stage is not recommended and does not aid in the diagnosis of neuroborreliosis or chronic Lyme disease.

Hotline History

N/A

CPT Codes

86617 x2

Components

Component Test Code* Component Chart Name LOINC
0055258 Borrelia burgdorferi Ab, IgM, IB (CSF) 13203-5
0055259 Borrelia burgdorferi Ab, IgG, IB (CSF) 13202-7
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • Lyme Disease
  • Lyme Disease Antibodies (CSF)
  • Lyme Disease CSF Ab Western Blot
Borrelia burgdorferi Antibodies, IgG and IgM by Immunoblot (CSF)