UConn Health study reveals a single-step ELISA approach can streamline Lyme disease testing
SEATTLE, Sept. 17, 2026 /PRNewswire-PRWeb/ -- InBios International Inc., a leading developer and manufacturer of diagnostic tests for emerging infectious diseases and biothreats, in collaboration with UConn Health, has announced the publication of a study demonstrating a streamlined approach to Lyme Disease testing. 'Evaluation of a One-Step Serological Test for Lyme Disease" was published in Journal of Applied Laboratory Medicine in September 2026.
Lyme disease, a vector-borne zoonosis caused by Borrelia species, is classified into early localized and late disseminated infection. Left untreated, infected patients face multisystem pathology involving the joints, heart, and peripheral and central nervous system, making early antibiotic therapy essential. Lyme diagnosis with standard 2-tier test (STTT) and a modified 2-tier test (MTTT) utilize sequential serological assays.
The aim of this study was to evaluate the InBios Lyme Detect™ Multiplex ELISA (RUO) (InBios ELISA), a one-step method that combines screening and confirmatory tests. While a recent publication demonstrated good performance of the InBios ELISA during early stages of Lyme disease, this study aimed to assess assay performance relative to STTT and to characterize IgG and IgM reactivity compared to standard immunoblot (IB). In summary, this study shows 99.2% concordance with STTT and that the InBios ELISA can interpret both screen and confirmatory results in one-step. Overall, these findings demonstrate that this single step multiplex approach, upon future regulatory clearance, has the potential to replace standard two-tier testing algorithms and enable rapid turnaround of patient results to improve diagnosis of Lyme. Anu S. Maharjan, PhD, Director Clinical Chemistry Laboratory UConn Health, added "By consolidating tier-testing steps into a single assay, the one-step ELISA decreases turnaround time by more than two hours."
In addition, James Needham, PhD, InBios International Inc., offered, "The study demonstrates that a single-step multiplex methodology can drastically improve laboratory workflow and diagnostic speed, illustrating the potential for an FDA-cleared version of this assay to ultimately replace traditional tiered testing currently in place today."
About InBios: Since 1996, InBios has been a leader in the development of diagnostic tests for emerging infectious diseases and biothreats. Products are designed for superior performance, efficiency and value. These include many FDA market authorized and CE marked assays for arboviruses, parasitic infections, biothreats, and more. InBios continues to anticipate and serve the growing global public health demand. Products in the pipeline include next generation platforms for tick-borne and respiratory diseases. For more information, visit www.inbios.com.
Media Contact
Wendy Bagnato, InBios International Inc., 1 206-326-5409, [email protected], www.inbios.com
SOURCE InBios International Inc.
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