• J. Clin. Microbiol. · Dec 2013

    Comparative cost-effectiveness of two-tiered testing strategies for serodiagnosis of lyme disease with noncutaneous manifestations.

    • Gary P Wormser, Andrew Levin, Sandeep Soman, Omosalewa Adenikinju, Michael V Longo, and John A Branda.
    • Division of Infectious Diseases, New York Medical College, Valhalla, New York, USA.
    • J. Clin. Microbiol. 2013 Dec 1; 51 (12): 4045-9.

    AbstractThe mainstay of laboratory diagnosis for Lyme disease is two-tiered serological testing, in which a reactive first-tier enzyme-linked immunosorbent assay (ELISA) or an immunofluorescence assay is supplemented by separate IgM and IgG immunoblots. Recent data suggest that the C6 ELISA can be substituted for immunoblots without a reduction in either sensitivity or specificity. In this study, the costs of 4 different two-tiered testing strategies for Lyme disease were compared using the median charges for these tests at 6 commercial diagnostic laboratories in 2012. The study found that a whole-cell sonicate ELISA followed by the C6 ELISA was the most cost-effective two-tiered testing strategy for Lyme disease with acute-phase serum samples. We conclude that the C6 ELISA can substitute for immunoblots in the two-tiered testing protocol for Lyme disease without a loss of sensitivity or specificity and is less expensive.

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