In 2014, the CDC published an article (1) describing a new two-tiered testing algorithm based on use of two EIA tests. This modified algorithm would serve as an alternate to the standard two-tiered EIA + lmmunoblot testing (STTT) algorithm. Following this CDC discussion, the US FDA accepted the proposed testing option and published guidelines (2) for this modified two tiered testing (MTTT) algorithm.
Gold Standard Diagnostics now offers a solution for this new Lyme testing algorithm, which complements our existing market leading Lyme test portfolio. With the addition of the B. burgdorferi lgG/IgM VlsE-OspC EIA test, you can choose which tests and algorithms best meet the needs of your laboratory and your clients.
An example of the MTTT workflow using GSD EIA Lyme kits is shown below.
GSD Lyme IgG/IgM EIA, IgG EIA, and IgM EIA screens are FDA cleared as qualitative presumptive (first tier) tests for Lyme disease, and are optimized for both superior sensitivity and specificity. These simple, easy-to-use kits include ready-to-use controls and a fast protocol which can be easily automated.
Includes antigens from B. burgdorferi strains B31 and 2591.
Contains VIsE immunogenic lipoprotein.
Kit includes ready to use controls for ease of use.
Simple procedure is easy to automate.
Lyme IgG/IgM EIA, IgG EIA, and IgM EIA screens are FDA Cleared and can be easily automated.
GSD offers four Lyme ELISA kits that can work with laboratory preferences to determine the best workflow. A separate B. burgdorferi lgG/IgM VlsE-OspC recombinant ELISA is available to be used with any of the ELISA assays listed below. All GSD Lyme ELISA assays are FDA cleared and easily automatable on any open EIA/ELISA processors.
Call your GSD representative for additional information and pricing.
References
1. Molins CR, Sexton C, Young JW, eta/. Collection and characterization of samples for establishment of a serum repository for Lyme disease diagnostic test development and evaluation.
2. Center for Disease Control and Prevention, Morbidity and Mortality Report MMWR, Updated CDC Recommendation for Serologic Diagnosis of
Lyme Disease, Weekly I August 16, 2019 I 68(32);703.
