Lyme Antibodies, Modified 2-Tier Testing Profile, Serum/Plasma

TEST: 164226
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CPT: 86618
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Synonyms

  • B. burgdorferi
  • Borrelia burgdorferi
  • Lyme disease
  • MTTT
  • Tickborne Disease

Special Instructions

Specimens are tested using an immunoassay measuring total antibodies to specific borrelial proteins; if reactive, the specimens reflex to separate IgG and IgM immunoassays targeting additional Borrelia burgdorferi proteins.

Expected Turnaround Time

1 - 2 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Documents

For more information, please view the literature below.

Lyme Disease Flyer

Specimen Requirements

Specimen

Serum or plasma

Volume

2.0 mL

Minimum Volume

0.75 mL (Note: This volume does not allow for repeat testing.)

Container

Gel-barrier tube, serum transfer tube, or EDTA plasma, lithium heparin plasma, or plasma transfer tubes

Collection

If tube other than a gel-barrier is used, transfer separated serum or plasma to a labeled plastic transport tube. Do not freeze gel-barrier tube (pour off serum first).

Storage Instructions

Room temperature

Stability Requirements

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x3

Causes for Rejection

Gross hemolysis; gross lipemia; samples containing particulate matter or exhibiting obvious microbial contamination

Test Details

Use

This panel utilizes FDA-cleared assays following the modified 2-tier testing (MTTT) algorithm to aid in the diagnosis of Lyme disease in individuals with clinical signs and symptoms consistent with Lyme disease. Lyme disease should be considered based on the presence of typical signs and symptoms of infection in patients with a history of possible exposure to infected ticks.

Limitations

Screening of the general population should not be performed. The positive predictive value depends on the likelihood of Lyme disease being present. Testing should only be performed on patients with clinical symptoms of Lyme disease or when exposure is suspected.

In general, IgM tests should be disregarded if the patient's symptoms have lasted more than 30 days. If the patient has been sick longer than 30 days, only IgG results should be interpreted.

Potential assay interference due to circulating antibodies in patients with Human Ehrlichiosis (HE) and Tick Borne Relapsing Fever (TBRF), Babesiosis, Parvovirus, and EBV infections has been found. Interpret results from these patients with caution.

Methodology

Chemiluminescent Immunoassay (CLIA)

Reference Interval

Negative

References

Association of Public Health Laboratories. Suggested Reporting Language, Interpretation and Guidance Regarding Lyme Disease Serologic Test Results. Silver Spring, MD: May 2021. Accessed at https://www.aphl.org/aboutAPHL/publications/Documents/ID-2021-Lyme-Disease-Serologic-Testing-Reporting.pdf.
Branda JA, Strle K, Nigrovic LE, et al. Evaluation of Modified 2-Tiered Serodiagnostic Testing Algorithms for Early Lyme Diseases. Clin Infect Dis. 2017 Apr 15;64(8):1074-1080.28329259
FDA clears new indications for existing Lyme Disease tests that may help streamline diagnoses [press release]. Washington, DC: US Food & Drug Administration; July 29, 2019. Accessed at https://www.fda.gov/news-events/press-announcements/fda-clears-new-indications-existing-lyme-disease-tests-may-help-streamline-diagnoses.
Lantos PM, Rumbaugh J, Bockenstedt LK, et al. Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR): 2020 Guidelines for the Prevention, Diagnosis and Treatment of Lyme Disease. Clin Infect Dis. 2021 Jan 23;72(1):e1-e48.33417672
LIAISON® Lyme IgG [package insert]. Stillwater, MN: DiaSorin; 2021.
LIAISON® Lyme IgM [package insert]. Stillwater, MN: DiaSorin; 2021.
LIAISON® Lyme Total Antibody Plus [package insert]. Stillwater, MN: DiaSorin; 2021.
Lipsett SC, Branda JA, Nigrovic LE. Evaluation of the Modified Two-Tiered Testing Method for Diagnosis of Lyme Disease in Children. J Clin Microbiol. 2019 Sep 24;57(10):e00547-19.31413078
Mead P, Petersen J, Hinckley A. Updated CDC Recommendation for Serologic Diagnosis of Lyme Disease. MMWR Morb Mortal Wkly Rep. 2019 Aug 16;68(32):703.31415492

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
164226 Lyme Disease Serology w/Reflex 98205-8 164227 Lyme Total Antibody CIA 83081-0
Reflex Table for Lyme Total Antibody CIA
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 164089 Lyme IgG/IgM 164230 Lyme IgG CIA 16480-6
Reflex Table for Lyme Total Antibody CIA
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 164089 Lyme IgG/IgM 164229 Lyme IgM CIA 40612-4
Reflex Table for Lyme Total Antibody CIA
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 164089 Lyme IgG/IgM 164231 Lyme Interpretation 101358-0

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