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Lyme Antibodies, Modified 2-Tier Testing Profile, Serum/Plasma
CPT:
86618
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
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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