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Evaluation of Modified Two-Tiered Testing Algorithms for Lyme Disease Laboratory Diagnosis Using Well-Characterized
Adoracion Pegalajar-Jurado1, Martin E Schriefer1, Ryan J Welch2
1Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, Fort Collins, Colorado, USA.
Journal of Clinical Microbiology
|May 11, 2018
Summary
A new modified two-tiered testing (MTTT) algorithm using VlsE and C6 immunoassays shows promise for Lyme disease (LD) diagnosis. This novel approach offers improved accuracy and sensitivity compared to standard methods, aiding in reliable LD detection.
Area of Science:
- Immunology
- Infectious Diseases
- Clinical Diagnostics
Background:
- Standard two-tiered testing (STTT) is the current laboratory standard for Lyme disease (LD) diagnosis.
- STTT has limitations including low early-stage sensitivity and subjective, complex immunoblotting.
- Modified two-tiered testing (MTTT) algorithms aim to improve LD diagnosis by eliminating immunoblotting.
Purpose of the Study:
- To evaluate the performance of a novel VlsE/C6 MTTT algorithm for Lyme disease diagnosis.
- To compare the VlsE/C6 MTTT against other MTTTs and STTTs using well-characterized serum samples.
Main Methods:
- Serum samples from the CDC Lyme Serum Repository were tested.
- Three MTTTs (VlsE/C6, WCS/C6, WCS/VlsE) and three STTTs (VlsE, C6, WCS based) were employed.
- Performance metrics including sensitivity and specificity were assessed for all assays.
Main Results:
- The VlsE/C6 MTTT demonstrated the highest specificity (100%) and lowest sensitivity (75%) among MTTTs tested.
- All evaluated MTTTs showed higher sensitivities and accuracy than STTTs for combined LD groups, except WCS/ViraStripe STTT.
- The VlsE/C6 MTTT achieved significantly higher accuracy than WCS/ViraStripe STTT when testing non-LD samples.
Conclusions:
- The VlsE/C6 MTTT is a viable alternative diagnostic algorithm for Lyme disease.
- This MTTT offers comparable or improved performance over other evaluated MTTTs and STTTs.
- The VlsE/C6 MTTT presents a potentially more accurate and efficient method for LD laboratory diagnosis.
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