Borrelia burgdorferi Antibodies, Total by ELISA (Change effective as of 11/14/22: Refer to 0050267)

0050216
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Negative
Positive

Ordering Recommendation

First-line serologic screening test for suspected Lyme disease. Positive or equivocal results must be confirmed by immunoblot.

Mnemonic

LYME EIA

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Performed

Sun-Sat

Reported

1-2 days

New York DOH Approval Status

This test is New York DOH approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 2 mL serum to an ARUP Standard Transport Tube. (Min: 0.15 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Bacterially contaminated, heat-inactivated, hemolyzed, icteric, lipemic, or turbid specimens.

Remarks
Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)

Reference Interval

0.99 LIV or less Negative - Antibody to B. burgdorferi not detected.
1.00-1.20 LIV Equivocal - Repeat testing in 10-14 days may be helpful.
1.21 LIV or greater Positive - Probable presence of antibody to B. burgdorferi detected.

Interpretive Data



Compliance Category

FDA

Note

Once this test is performed, if:
a) Negative - no further testing is done;
b) Positive or equivocal - immunoblot testing will be performed on the original sample upon receiving a request. Sample will be held for 30 days only.

Current CDC recommendations for the serologic diagnosis of Lyme disease are to screen with a polyvalent ELISA test and confirm equivocal and positive results with Immunoblot.  Both IgM and IgG Immunoblots should be performed on specimens less than 4 weeks after appearance of erythema migrans.  Only IgG Immunoblot should be performed on specimens greater than 4 weeks after the disease onset.  IgM Immunoblot in the chronic stage is not recommended and does not aid in the diagnosis of neuroborreliosis or chronic Lyme disease.  Please submit requests for appropriate Immunoblot testing within 10 days.

Hotline History

N/A

CPT Codes

86618

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Components

Component Test Code* Component Chart Name LOINC
0050216 Borrelia burgdorferi Abs, Total by ELISA 34148-7
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • Lyme Antibodies Detection
  • Lyme Disease
  • Lyme Disease Ab ELISA
Borrelia burgdorferi Antibodies, Total by ELISA (Change effective as of 11/14/22: Refer to 0050267)