Collect


Blood, Gold

Preferred Draw Volume

2mL

Other Acceptable Containers

Red

Unacceptable Conditions

Gross hemolysis or lipemia

Collection Comments

Do not collect in Orange Tube. Allow Gold tube to sit for 30 minutes to form clot. Spin for 10 minutes at 1100-1300 g in a swing bucket unit or 15 minutes in a fixed angle to separate cells from serum. Refrigerate spun tube. Remember to properly labeltube with patient name, DOB, test and collect date. If collecting in Red, spin, separate and transfer serum to aliquot tube. Send serum refrigerated.

Storage/Transport Temperature

Refrigerated

Stability (from collection to initiation)

After separation from cells: Refrigerated: 6 days; Frozen: indefinitely

Ordering Recommendations

Lyme disease is a bacterial illness transmitted by blacklegged ticks. In the U.S., most cases occur in individuals who reside in or travel to the Northeast and Upper Midwest states though cases may be seen in Indiana. In early infection, 70-80% of patients exhibit a characteristic bulls-eye rash. According to the Infectious Diseases Society of America (IDSA), when this rash is correctly identified, no further work-up is indicated and the patient can be directly diagnosed with Lyme disease without additional testing. However, when the rash is not seen and in later stages of infection, testing for Lyme disease-specific antibodies may aid in the diagnosis. Presently, in accordance with CDC guidance, IU Health offers a two-tier Lyme disease serologic assay. The serum sample collected from the patient is first assessed for presence of Lyme disease-specific antibodies via an enzyme immunoassay (EIA). If this assay result is 'negative', the patient does not have detectable levels of Lyme disease-specific antibodies present in their bloodstream at the time of specimen collection. All Lyme Disease Antibody IgG-POSITIVE and Lyme Disease Antibody IgM-POSITIVE and -EQUIVOCAL specimens will be referred to ARUP Laboratories for confirmatory immunoblot testing. For more information on those tests, please refer to: a. ARUP Laboratories Borrelia burgdorferi Antibody, IgG by Immunoblot: https://ltd.aruplab.com/Tests/Pub/0050255 b. ARUP Laboratories Borrelia burgdorferi Antibody, IgM by Immunoblot: https://ltd.aruplab.com/Tests/Pub/0050253 Unless the EIA is negative, the final determination of whether or not Lyme disease-specific antibodies are present in a sample cannot be made until the IB result is available. This final determination depends on both the EIA and the IB results. Lyme disease serologic testing systems are not designed to produce reliable results if a sample bypasses the EIA and goes directly to the WB. Note that depending on timing of serum sample collection relative to patient symptoms, a specimen may be assessed for IgM and/or IgG antibody isotypes.

Performed

Monday, Wednesday, Friday

Methodology

Enzyme Linked Fluorescent Assay (ELFA)

Reported

1-3 days

Performing Lab

Serology

Synonyms

  • 11364
  • Lyme Antibodies
  • Lyme Disease IgG/M Immunoblot
  • Lyme Disease Acute Rfx Pnl
  • Lyme Disease Serology

Reference Interval

VIDAS® Lyme IgM II (LYM) 
Index < 0.12 Negative No detectable anti-B. burgdorferi IgM antibodies detected.
0.12 < Index <0.32 Equivocal Imprecise detection of anti-B. burgdorferi IgM antibodies.  The specimen should be tested further by an IgM Western Blot for supplementary information. 
Index > 
 0.32		 Positive Presumptive detection of anti-B. burgdorferi IgM antibodies.  The specimen should be tested further by an IgM Western Blot for supplementary information.
VIDAS® Lyme IgG II (LYG) 
Index Result Interpretation
Index < 0.20 NegativeNegative No detectable anti-B. burgdorferi IgM antibodies detected.No detectable anti-B. burgdorferi IgM antibodies detected.No detectable anti-B. burgdorferi IgM antibodies detected.No detectable anti-B. burgdorferi IgM antibodies detected.
Index > 
 0.20		 Positive Presumptive detection of anti-B. burgdorferi IgM antibodies.  The specimen should be tested further by an IgM Western Blot for supplementary information

CPT Codes

86618

LOINC Codes

  NAME LOINC
Result Lyme IgG EIA QN 5062-5
  Lyme IgM EIA QN 5064-1

Test Code (Outreach Synonym)

11364

Catalog Code

8199109105
Collection

Collect


Blood, Gold

Preferred Draw Volume

2mL

Other Acceptable Containers

Red

Unacceptable Conditions

Gross hemolysis or lipemia

Collection Comments

Do not collect in Orange Tube. Allow Gold tube to sit for 30 minutes to form clot. Spin for 10 minutes at 1100-1300 g in a swing bucket unit or 15 minutes in a fixed angle to separate cells from serum. Refrigerate spun tube. Remember to properly labeltube with patient name, DOB, test and collect date. If collecting in Red, spin, separate and transfer serum to aliquot tube. Send serum refrigerated.

Storage/Transport Temperature

Refrigerated

Stability (from collection to initiation)

After separation from cells: Refrigerated: 6 days; Frozen: indefinitely
Ordering

Ordering Recommendations

Lyme disease is a bacterial illness transmitted by blacklegged ticks. In the U.S., most cases occur in individuals who reside in or travel to the Northeast and Upper Midwest states though cases may be seen in Indiana. In early infection, 70-80% of patients exhibit a characteristic bulls-eye rash. According to the Infectious Diseases Society of America (IDSA), when this rash is correctly identified, no further work-up is indicated and the patient can be directly diagnosed with Lyme disease without additional testing. However, when the rash is not seen and in later stages of infection, testing for Lyme disease-specific antibodies may aid in the diagnosis. Presently, in accordance with CDC guidance, IU Health offers a two-tier Lyme disease serologic assay. The serum sample collected from the patient is first assessed for presence of Lyme disease-specific antibodies via an enzyme immunoassay (EIA). If this assay result is 'negative', the patient does not have detectable levels of Lyme disease-specific antibodies present in their bloodstream at the time of specimen collection. All Lyme Disease Antibody IgG-POSITIVE and Lyme Disease Antibody IgM-POSITIVE and -EQUIVOCAL specimens will be referred to ARUP Laboratories for confirmatory immunoblot testing. For more information on those tests, please refer to: a. ARUP Laboratories Borrelia burgdorferi Antibody, IgG by Immunoblot: https://ltd.aruplab.com/Tests/Pub/0050255 b. ARUP Laboratories Borrelia burgdorferi Antibody, IgM by Immunoblot: https://ltd.aruplab.com/Tests/Pub/0050253 Unless the EIA is negative, the final determination of whether or not Lyme disease-specific antibodies are present in a sample cannot be made until the IB result is available. This final determination depends on both the EIA and the IB results. Lyme disease serologic testing systems are not designed to produce reliable results if a sample bypasses the EIA and goes directly to the WB. Note that depending on timing of serum sample collection relative to patient symptoms, a specimen may be assessed for IgM and/or IgG antibody isotypes.

Performed

Monday, Wednesday, Friday

Methodology

Enzyme Linked Fluorescent Assay (ELFA)

Reported

1-3 days

Performing Lab

Serology

Synonyms

  • 11364
  • Lyme Antibodies
  • Lyme Disease IgG/M Immunoblot
  • Lyme Disease Acute Rfx Pnl
  • Lyme Disease Serology
Result Interpretation

Reference Interval

VIDAS® Lyme IgM II (LYM) 
Index < 0.12 Negative No detectable anti-B. burgdorferi IgM antibodies detected.
0.12 < Index <0.32 Equivocal Imprecise detection of anti-B. burgdorferi IgM antibodies.  The specimen should be tested further by an IgM Western Blot for supplementary information. 
Index > 
 0.32		 Positive Presumptive detection of anti-B. burgdorferi IgM antibodies.  The specimen should be tested further by an IgM Western Blot for supplementary information.
VIDAS® Lyme IgG II (LYG) 
Index Result Interpretation
Index < 0.20 NegativeNegative No detectable anti-B. burgdorferi IgM antibodies detected.No detectable anti-B. burgdorferi IgM antibodies detected.No detectable anti-B. burgdorferi IgM antibodies detected.No detectable anti-B. burgdorferi IgM antibodies detected.
Index > 
 0.20		 Positive Presumptive detection of anti-B. burgdorferi IgM antibodies.  The specimen should be tested further by an IgM Western Blot for supplementary information
Additional Information

CPT Codes

86618

LOINC Codes

  NAME LOINC
Result Lyme IgG EIA QN 5062-5
  Lyme IgM EIA QN 5064-1

Test Code (Outreach Synonym)

11364

Catalog Code

8199109105

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