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Test Code LAB3269 Lyme Disease Serology, Serum

Additional Codes

LYME

Reporting Name

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

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

Useful For

Diagnosing Lyme disease

 

This test should not be used as a screening procedure for the general population.

 

This test should not be used for treatment monitoring.


Specimen Required


Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Information: Centrifuge and aliquot serum into plastic vial.


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  30 days

Day(s) Performed

Monday through Friday

Seattle Children's Hospital Note:

TAT: 3 - 6 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Method Description

The first-tier Lyme disease screening enzyme-linked immunosorbent assay (ELISA) is the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system. 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 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.(Package insert: Borrelia VlsE1/pepC10 IgG/IgM Test System. Zeus Scientific, Inc; Rev. date 05/2021)

Reference Values

Negative

Reference values apply to all ages.

Test Classification

This test has been cleared, approved, or is exempt by the US 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

Reflex Tests

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

Testing Algorithm

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

Report Available

1 to 4 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Heat inactivated Reject

Forms

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

-General Request (T239)

-Infectious Disease Serology Test Request (T916)

Seattle Children's Hospital Additional Information:

Aliases: Borrelia burgdorferi; B. burgdorferi; Lymes; Lyme C6 Peptide Assay; Tick-borne; Tick; VlsE1/pepC10 Assay