Aiding in the diagnosis of neuroinvasive Lyme disease or neuroborreliosis due to Borrelia species associated with Lyme disease (eg, B burgdorferi, B garinii, B afzelli)
Spinal fluid (CSF)
- Do not submit CSF from the first vial due to the possibility of blood contamination, which will cause specimen rejection.
Gold serum separator (SST) tube:
Following centrifucation of the SST tube, rubberband the CSF vial and SST tubes together.
Sterile vial and Gold serum separator (SST) tube
Once the serum is transferred to a Screw cap transfer vial/tube (Mayo T465), rubberband the CSF and serum transfer vials together.
|CSF||Refrigerated (preferred)||11 days|
|Serum||Refrigerated (preferred)||11 days|
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, B afzelii, B 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 (TMB/H2O2), 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.(Package insert: Antibodies of the IgG class against Borrelia in cerebrospinal fluid, Euroimmun Ag, Seekamp 31, 23560 Luebeck, Germany 06/15/2015)
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.
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.