Semiquantitative Enzyme-Linked Immunosorbent Assay
Lyme disease is one of the most common tickborne diseases in the United States. Infection is often accompanied by a characteristic erythema migrans (EM) rash, which alongside the appropriate history of tick exposure, can be used to issue a clinical diagnosis. Although laboratory testing is not always necessary for diagnosis, it is recommended for individuals with atypical presentations or specific neurologic symptoms. When testing is indicated, the CDC recommends two-tiered serologic testing.
For additional information, refer to the ARUP Consult Tickborne Diseases topic or Lyme Disease - Modified Two-Tiered Testing Algorithm.
Test Interpretation
Reference Range
- Negative: ≤0.90 IV
- Equivocal: 0.91-1.09 IV
- Positive: ≥1.10 IV
Results
Testing Tier | Result | Interpretation |
---|---|---|
Tier 1: VlsE1/pepC10 antibodies by ELISA |
Negative |
Antibodies to Borrelia burgdorferi were not detected. Test will not reflex to tier 2. If suspicion of recent infection (≤14 days) remains, consider testing a new specimen after 7-14 days. |
Positive/equivocal |
Antibodies to B. burgdorferi were detected. Test will reflex to tier 2. |
|
Tier 2: Reflex to IgM and IgG antibodies by ELISA |
Negative IgM and IgG |
Antibodies to B. burgdorferi were not detected. If suspicion of recent infection (≤14 days) remains, consider testing a new specimen after 7-14 days. |
Equivocal IgM and IgG |
If tier 1 results were positive, an equivocal tier 2 result supports a diagnosis of Lyme disease. If both tier 1 and tier 2 results are equivocal, consider testing a new specimen after 7-14 days. |
|
Positive IgM only |
IgM antibodies to B. burgdorferi were detected, suggesting an acute or recent infection. IgM antibody results should only be considered to suggest recent or acute infection for specimens drawn ≤30 days from symptom onset. |
|
Positive IgG only |
IgG antibodies to B. burgdorferi were detected, suggesting a recent or past infection. |
|
Positive IgM and IgG |
IgM and IgG antibodies to B. burgdorferi were detected, suggesting a recent or past infection. |
|
ELISA, enzyme-linked immunosorbent assay; Ig, immunoglobulin |
Limitations
- Serologic testing is not useful to assess treatment response.
- IgM antibody results should only be considered for specimens drawn within 30 days of symptom onset.
References
-
33483734
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;72(1):1-8.
-
CDC - tickborne diseases of the United States 6th ed
Centers for Disease Control and Prevention. Tickborne diseases of the United States: a reference manual for healthcare providers. 6th edition, 2022. Last reviewed Aug 2022; accessed Jun 2023.
Preferred reflex test to diagnose Lyme disease in symptomatic individuals. Reflex pattern follows the modified two-tier testing (MTTT) approach; a positive or equivocal screen is confirmed by immunoassay.