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.

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Performed

Sun-Sat

Reported

1-4 days

New York DOH Approval Status

Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.

Specimen Required

Patient Preparation
Collect

CSF.

Specimen Preparation

Transfer 3 mL CSF to an ARUP Standard Transport Tube. (Min: 0.5 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)

Reference Interval

0.99 LIV or less Negative - Antibody to B. burgdorferi not detected.
1.00-1.20 LIV Equivocal - Repeat testing in 10-14 days may be helpful.
1.21 LIV or greater Positive - Probable presence of antibody to B. burgdorferi detected.

Interpretive Data

The detection of antibodies to B. 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.

Current CDC recommendations for the serologic diagnosis of Lyme disease are to screen with a polyvalent ELISA test and confirm equivocal and positive results with immunoblot.  Both IgM and IgG immunoblots should be performed on samples less than 4 weeks after appearance of erythema migrans.  Only IgG immunoblot should be performed on samples greater than 4 weeks after the disease onset.  IgM immunoblot in the chronic stage is not recommended and does not aid in the diagnosis of neuroborreliosis or chronic Lyme disease.  Please submit requests for appropriate immunoblot testing within 10 days.

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

Modified FDA

Note

Once this test is performed, if:
a) Negative - no further testing is done.
b) Positive or equivocal - Immunoblot testing will be performed on the original sample upon receiving a request. Sample will be held for 30 days only.

Hotline History

N/A

CPT Codes

86618

Components

Component Test Code* Component Chart Name LOINC
0099483 Borrelia burgdorferi Abs, ELISA, CSF 6318-0
* 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 Antibodies, Total
  • Lyme Disease
  • Lyme Disease Ab CSF, ELISA
Borrelia burgdorferi Antibodies, Total by ELISA, CSF