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- Title
Evaluation of the Rapid Quidel Sofia 2 Lyme Immunoassay as a First-Tier Test in a Two-Tier Testing Algorithm for Lyme Disease: Comparison to the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM Assay Followed by Immunoblot.
- Authors
Lewandrowski, Elizabeth Lee; Branda, John A; Lewandrowski, Kent; Turbett, Sarah
- Abstract
Objectives Two-tiered serologic testing for Lyme disease is usually performed using an enzyme-linked immunosorbent assay (ELISA) as the first-tier test. The Quidel Sofia 2 Lyme test is a relatively new lateral flow method to provide more rapid turnaround time. We evaluated its performance in comparison to an established ELISA method. The test can be performed on demand rather than batching assays in a central laboratory. Methods We compared the Sofia 2 assay to the Zeus VlsE1/pepC10 IgG/IgM test in a standard two-tiered testing algorithm. Results Comparison of the Sofia 2 to the Zeus VlsE1/pepC10 IgG/IgM showed an overall agreement of 89.9% (κ statistic of 0.750, indicating "substantial agreement"). When the tests were followed by immunoblot in a two-tier algorithm, the agreement was 98.9% (κ statistic of 0.973, indicating "almost perfect" agreement). Conclusions The Sofia 2 Lyme test performs well when compared with the Zeus VlsE1/pepC10 IgG/IgM in a two-tiered testing algorithm.
- Subjects
SOFIA (Bulgaria); LYME disease; IMMUNOGLOBULIN G; IMMUNOASSAY; ENZYME-linked immunosorbent assay; BORRELIA; IMMUNOGLOBULIN M; IMMUNOGLOBULINS
- Publication
American Journal of Clinical Pathology, 2023, Vol 160, Issue 1, p58
- ISSN
0002-9173
- Publication type
Article
- DOI
10.1093/ajcp/aqad007