Evaluation of a Sequential Enzyme Immunoassay Testing Algorithm for Lyme Disease Demonstrates Lack of Test Independence but High Diagnostic Specificity

Authors

Gary P. Wormser, New York Medical CollegeFollow
Claudia R. Molins
Andrew Levin
Susan C. Lipsett
Lise E. Nigrovic
Martin E. Schriefer
John A. Branda

DOI

10.1016/j.diagmicrobio.2018.02.006

Journal Title

Diagnostic Microbiology and Infectious Disease

First Page

217

Last Page

219

Document Type

Article

Publication Date

July 2018

Department

Medicine

Abstract

To diagnose Lyme disease, a two-tier testing algorithm is used in which supplemental IgM and IgG immunoblots to detect antibody to Borrelia burgdorferi are reflexively performed if a first-tier assay, such as a whole-cell sonicate-based enzyme immunoassay (WCS EIA), is reactive. Recent data suggest that equal specificity is found by substituting the C6 peptide EIA for immunoblots. In this study using 3956 control sera, we demonstrated that although this two-tier testing algorithm does significantly improve diagnostic specificity compared with each of the EIAs individually, the WCS EIA and the C6 peptide EIA are not independent tests. Therefore, when the C6 peptide EIA is used as the second-tier test, it should be regarded as a supplemental rather than a confirmatory test.

Recommended Citation

Wormser, G., Molins, C., Levin, A., Lipsett, S., Nigrovic, L., Schriefer, M., & Branda, J. (2018). Evaluation of a Sequential Enzyme Immunoassay Testing Algorithm for Lyme Disease Demonstrates Lack of Test Independence but High Diagnostic Specificity. Diagnostic Microbiology and Infectious Disease, 91 (3), 217-219. https://doi.org/10.1016/j.diagmicrobio.2018.02.006