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Published on: July 14, 2023
Serological testing for Lyme disease: current assays, diagnostic performance, and challenges
1Department of Pathology, Microbiology and Immunology, Vanderbilt Health, Nashville, Tennessee, USA.
Journal of Clinical Microbiology
|July 20, 2026
Summary
Diagnosing Lyme disease, a common tick-borne illness, is improving with modified two-tiered testing (MTTT) showing higher sensitivity for early infection detection. However, limitations in identifying early-stage disease and differentiating active from past infections remain challenges for Lyme disease diagnosis.
Area of Science:
- Infectious Diseases
- Microbiology
- Immunology
Background:
- Lyme disease is a prevalent vector-borne infection in the Northern Hemisphere.
- Current laboratory diagnosis relies heavily on serologic testing due to low sensitivity of direct detection methods.
- Standard two-tiered testing (STTT) is the established algorithm for Lyme disease serological diagnosis.
Purpose of the Study:
- To evaluate the diagnostic performance of the modified two-tiered testing (MTTT) algorithm for Lyme disease.
- To compare the sensitivity of MTTT against STTT, particularly for early Lyme disease samples.
- To discuss the persistent challenges in Lyme disease serologic assays and diagnostic accuracy.
Main Methods:
- Analysis of early Lyme disease samples using the modified two-tiered testing (MTTT) algorithm.
- Comparison of MTTT sensitivity with the standard two-tiered testing (STTT) algorithm.
- Review of current serologic assays and diagnostic algorithms for Lyme disease.
Main Results:
- The modified two-tiered testing (MTTT) algorithm demonstrated increased sensitivity compared to STTT for early Lyme disease samples.
- Despite improved sensitivity, MTTT still faces limitations in detecting very early infections.
- The inability to differentiate between active and past Lyme disease infections persists.
Conclusions:
- The MTTT algorithm offers enhanced sensitivity for early Lyme disease detection but does not fully resolve diagnostic limitations.
- Further advancements are needed to improve sensitivity in the earliest stages of infection.
- Addressing the challenge of distinguishing active from past infections is crucial for effective clinical decision-making in Lyme disease management.
