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Test Code Lyme Ab WB Lyme Disease Antibody, Immunoblot, Serum

Reporting Name

Lyme Disease Ab, Immunoblot, S
Seattle Children's Hospital Note:

Clinical System Name: Lyme Disease Ab, Western Blot

Useful For

Aids in the diagnosis of systemic Lyme disease


Specimen Required


Container/Tube: 

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.75 mL


Seattle Children's Hospital Note:

Collect 1.0 mL whole blood in a Red or Gold top.

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 14 days
  Frozen  30 days

Day(s) and Time(s) Performed

Monday through Friday; 9 a.m.

Saturday, Sunday; Varies

Seattle Children's Hospital Note:

TAT: 3 - 5 days

Performing Laboratory

Mayo Medical Laboratories in Rochester

Method Name

Immunoblot Microarray

Method Description

The Viramed Biotech AG Borrelia B31 ViraChip IgM and IgG are protein microarray assays, and can be considered modified solid-phase enzyme linked immunosorbent assays (ELISAs). Highly purified antigens from the Borrelia burgdorferi B31 strain, including the 93 kD, 66 kD, 58 kD, 45 kD, 41 kD, 39 kD, 30 kD, 28 kD, 23 kD, and 18 kD proteins, are bound to the solid phase nitrocellulose membrane in triplicate. The positions of these antigen "spots" are well defined and are reliably identifiable using customized software. Each microarray also has "spots" for a negative control, serum controls, conjugate controls, and 6 calibrators. One microarray is fixed to the bottom of a well in a standard 96-well microtiter plate.

 

For each test to be performed, the diluted patient serum is added to each microarray (note: the B burgdoreri IgG and IgM microarrays are in separate wells). If specific antibodies recognizing a B burgdorferi antigen are present, they will bind to the specific antigens on the microarray. After incubation the microarray is washed to remove unbound antibodies. Alkaline-phosphatase antihuman IgG or antihuman IgM (conjugate) is then added to the well and incubated. If antibodies are present, the conjugate will bind to those respective antibodies, and after a washing step to remove unbound conjugate, substrate solution is added. If the antibody/conjugate complex is present, the substrate will undergo precipitation and color change. After an incubation period, the reaction is stopped and the presence of precipitated substrate is visualized at specific locations on the microarray. The presence of a colored precipitation at various locations on the microarray is an indirect measurement of B burgdorferi specific antibodies in the patient specimen. Visualized spots from the reaction are compared for intensity with the integrated calibrator controls for evaluation.(Package inserts: Borrelia B31 ViraChip IgM and Borrelia B31 ViraChip IgG, July 2016, VIRAMED Biotech AG, Planegg, Germany)

Reference Values

IgG: Negative

IgM: Negative

Test Classification

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86617 x 2

LOINC Code Information

Test ID Test Order Name Order LOINC Value
LYWB Lyme Disease Ab, Immunoblot, S In Process

 

Result ID Test Result Name Result LOINC Value
5744 IgG Immunoblot 6320-6
2992 IgG Band(s) 13502-0
23931 IgM Immunoblot 6321-4
23932 IgM Band(s) 13503-8
6241 Interpretation 12781-1

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross reject

Other

Heat-inactivated specimen

Testing Algorithm

See Acute Tick-Borne Disease Testing Algorithm in Special Instructions.

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

General Request Form (T239) (http://www.mayomedicallaboratories.com/it-mmfiles/general-request-form.pdf)

Microbiology Test Request Form (T244) (http://www.mayomedicallaboratories.com/it-mmfiles/microbiology_test_request_form.pdf)