Use in conjunction with positive serologic testing for the workup of suspected acute Lyme neuroborreliosis. Do not order in the absence of clinical symptoms.
Transfer 3 mL CSF to an ARUP Standard Transport Tube. (Min: 2 mL)
Contaminated, heat-inactivated, or hemolyzed specimens.
Ambient: 8 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)
Effective August 15, 2011
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.
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
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.
|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|
- Lyme Disease
- Lyme Disease Antibodies (CSF)
- Lyme Disease CSF Ab Western Blot