UConn Health and InBios Develop One-Step Lyme Disease Test

UConn Health and InBios International Inc. have collaborated to develop a streamlined method for diagnosing Lyme disease, according to a study published in the Journal of Applied Laboratory Medicine. The new one-step serological test, called the InBios Lyme Detect™ Multiplex ELISA, aims to simplify the diagnostic process and reduce the time it takes to get results.

Lyme disease, a vector-borne illness caused by Borrelia species, can lead to serious complications if left untreated. Early diagnosis and treatment are crucial to prevent joint, heart, and nervous system issues. Traditionally, Lyme disease is diagnosed using a two-tier testing approach: a screening test followed by a confirmatory test. However, this process can be time-consuming and complex.

The InBios Lyme Detect™ Multiplex ELISA combines both the screening and confirmatory steps into a single test. The study evaluated the performance of this one-step method against the standard two-tier testing approach (STTT) and a modified two-tier testing approach (MTTT). The results showed that the InBios ELISA achieved 99.2% concordance with the standard two-tier testing, indicating a high level of accuracy.

Anu S. Maharjan, PhD, Director of the Clinical Chemistry Laboratory at UConn Health, explained, "By consolidating the tier-testing steps into a single assay, the one-step ELISA decreases turnaround time by more than two hours. This improvement in diagnostic speed is significant for patient care and public health."

James Needham, PhD, from InBios International Inc., added, "The study demonstrates that a single-step multiplex methodology can drastically improve laboratory workflow and diagnostic speed. This approach has the potential to replace traditional tiered testing and enable faster diagnosis of Lyme disease."

InBios International Inc., founded in 1996, has been a leader in developing diagnostic tests for emerging infectious diseases and biothreats. The company's products are designed for superior performance, efficiency, and value. The InBios Lyme Detect™ Multiplex ELISA is part of the company's ongoing efforts to address the growing global public health demand for accurate and rapid diagnostic tools.

The study's findings suggest that the InBios Lyme Detect™ Multiplex ELISA could significantly enhance the efficiency of Lyme disease testing, potentially leading to earlier and more accurate diagnoses. With future regulatory clearance, this single-step approach could replace the current two-tier testing algorithms and improve patient outcomes by reducing the time to treatment.