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Test Code LYME Lyme Disease Serology, Serum

Reporting Name

Lyme Disease Serology, S
Seattle Children's Hospital Note:

Clinical System Name: Lyme Disease Ab - Reflex to WB IgG/IgM

Useful For

Diagnosing Lyme disease

 

As a sensitive screening (enzyme-linked immunosorbent assay) test for Lyme disease


Specimen Required


Container/Tube: 

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL


Seattle Children's Hospital Note:

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

Specimen Type

Serum

Specimen Minimum Volume

0.4 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 10 days
  Frozen  14 days

Day(s) and Time(s) Performed

Monday through Friday; 10 a.m.

Performing Laboratory

Mayo Medical Laboratories in Rochester

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Method Description

The C6 Borrelia burgdorferi (Lyme) assay is based on a synthetic peptide antigen (C6 peptide) in microwell enzyme-linked immunosorbent assay (ELISA) format. The antigen is derived from the VisE protein of B burgdorferi. In the assay procedure, diluted serum specimens are added to and incubated in wells of an antigen-coated microwell plate. Antibodies specific to the C6 peptide in the serum specimen are bound by the immobilized antigen, and unbound antibodies are removed by wash steps. The bound antibodies are detected by addition of a horseradish peroxidase-conjugated (HRP) goat antihuman IgG/IgM conjugate. After removal of excess conjugate by further wash steps, a chromogenic peroxidase substrate containing tetramethylbenzidine is added. A blue-green product is produced in wells where antibodies have been bound to the antigen. The color development reaction is quenched by addition of dilute sulfuric acid, after which optical absorbance at 45 nm is measured in each well using an ELISA plate reader.(Package insert: Immunetics C6 Borrelia burgdorferi [Lyme] ELISA Kit. Immunetics, Boston, MA, 2006; Liang FT, Steere AC, Marques AR, et al: Sensitive and specific serodiagnosis of Lyme disease by enzyme-linked immunosorbent assay with a peptide based on an immunodominant conserved region of Borrelia burgdorferi VisE. J Clin Microbiol 1999;37[12]:3990-3996)

Reference Values

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

86618-Lyme disease serology

86617 x 2-Lyme disease confirmation (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
LYME Lyme Disease Serology, S 20449-5

 

Result ID Test Result Name Result LOINC Value
LYME Lyme Disease Serology, S 20449-5

Testing Algorithm

If Lyme disease serology is positive, then Lyme disease antibody confirmation (by Western blot) will be performed at an additional charge.

 

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

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

NA

Other

NA

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
LYWB Lyme Disease Ab, Immunoblot, S Yes No

Forms

If not ordering electronically, complete, print, and send a General Request Form (T239) with the specimen (http://www.mayomedicallaboratories.com/it-mmfiles/general-request-form.pdf)