AI Article Synopsis
- The Quidel Sofia 2 Lyme test is a new rapid test for Lyme disease, evaluated against the established ELISA method.
- In a study comparing the Sofia 2 test to the Zeus VlsE1/pepC10 IgG/IgM test, researchers found a high overall agreement of 89.9%.
- When following up with an immunoblot test, the agreement increased to 98.9%, indicating that Sofia 2 reliably works in the two-tiered testing process.
Article 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.
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| http://dx.doi.org/10.1093/ajcp/aqad007 | DOI Listing |
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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.
Am J Clin Pathol
July 2023
Department of Pathology, Division of Clinical Laboratories and Molecular Medicine, Massachusetts General Hospital, Boston, MA, USA.
Article Synopsis
- The Quidel Sofia 2 Lyme test is a new rapid test for Lyme disease, evaluated against the established ELISA method.
- In a study comparing the Sofia 2 test to the Zeus VlsE1/pepC10 IgG/IgM test, researchers found a high overall agreement of 89.9%.
- When following up with an immunoblot test, the agreement increased to 98.9%, indicating that Sofia 2 reliably works in the two-tiered testing process.
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