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Updated: Jul 4, 2026
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Simultaneous Detection of Different Antibody Classes in a Multiplexed Serological Test
Published on: July 14, 2023
Prospective study of serologic tests for lyme disease
Allen C Steere1, Gail McHugh, Nitin Damle
1Center for Immunology and Inflammatory Diseases, Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. asteere@partners.org
Summary
Current Lyme disease diagnostic tests show varying sensitivity, especially in early stages. Two-tier testing offers slightly better specificity for diagnosing Lyme disease, particularly in later stages with disseminated infection.
Area of Science:
- Infectious Diseases
- Immunology
- Diagnostic Medicine
Background:
- Established diagnostic methods for Lyme disease include 2-tier sonicate immunoglobulin M (IgM) and immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) and Western blot, or the IgG variable major protein-like sequence-expressed (VlsE) C6 peptide ELISA.
- These widely used serologic tests have not undergone prospective assessment for diagnostic accuracy.
Purpose of the Study:
- To prospectively evaluate the diagnostic performance of 2-tier serologic assays and the C6 peptide ELISA for Lyme disease.
- To compare the sensitivity and specificity of these tests across different disease manifestations and patient groups.
Main Methods:
- Prospective serologic testing of 134 patients with Lyme disease, 89 patients with other illnesses, and 136 healthy controls.
- Utilized 2-tier IgM/IgG ELISA and Western blot, alongside IgG C6 peptide ELISA for Borrelia burgdorferi antibody detection.
Main Results:
- Early Lyme disease (erythema migrans) showed low IgM/IgG seroreactivity (approx. one-third) in acute samples, rising to two-thirds in convalescent samples.
- Seroreactivity was significantly higher in patients with disseminated Lyme disease.
- All patients with neurologic, cardiac, or joint involvement had positive C6 ELISA results; 42/44 had positive IgG 2-tier tests.
Conclusions:
- Both 2-tier testing and C6 peptide ELISA are sensitive for diagnosing Lyme disease, except in early erythema migrans.
- Two-tier testing demonstrated slightly superior specificity compared to C6 peptide ELISA in the evaluated patient cohorts.
