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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

Diagnosis of Lyme disease


Specimen Required


Supplies: Aliquot Tube, 5 mL (T465)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: 5-mL aliquot tube (T465)

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.

Seattle Children's Hospital Note:

TAT: 3 - 6 days

Performing Laboratory

Mayo Medical Laboratories in Rochester

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Method Description

The first-tier Lyme disease screening enzyme-linked immunosorbent assay (ELISA) used is the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system (Branchburg, NJ) The Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system is designed to detect IgG- and IgM-class antibodies (not differentiated by the assay in the final result) in human sera to VlsE1 and pepC10 antigens. Diluted test sera are incubated in antigen coated microwells. Any antigen-specific antibody in the sample will bind to the immobilized antigen. The plate is washed to remove unbound antibody and other serum components. Peroxidase conjugated goat antihuman IgG and IgM are added to the wells and the plate is incubated. The conjugate will react with IgG and IgM antibodies immobilized on the plate. The wells are washed to remove unreacted conjugate. The microwells containing immobilized peroxidase conjugate are incubated with peroxidase substrate solution. Hydrolysis of the substrate by peroxidase produces a color change.  After a period of time the reaction is stopped and the color intensity of the solution is measured photometrically. The color intensity of the solution depends upon the antibody concentration in the original test sample.(Package insert: Borrelia VlsE1/pepC10 IgG/IgM Test System, Zeus Scientific, Inc., Branchburg, NJ. Rev. Date 12/18/2017; package insert: Immunetics C6 B burgdorferi (Lyme) ELISA Kit, Immunetics, Inc, Boston, MA 02210-2377, 2013)

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

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

Heat inactivated

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)