Newswise — Seattle, Washington- InBios International Inc., a leading developer and manufacturer of diagnostic tests for emerging infectious diseases and biothreats, is developing a new Lyme diagnostic test. This test, the Lyme Detect™ Multiplex ELISA, is an innovative array-based immunoassay in a traditional ELISA plate format that incorporates an automated software package to analyze, quantify and – using machine learning interpretations – classify specimens. This novel approach is designed to significantly improve workflow and acute stage sensitivity for the diagnosis of Lyme disease.
The test will debut at the ADLM Conference, set for July 27-31 in Chicago. James Needham, PhD, InBios’ Director of Product Development, is set to give a talk called “AI-Powered Lyme Diagnostics: The Future is Multiplexed” about the new diagnostic at 11:30 a.m., Tuesday, July 29, at the conference.
InBios’ test advances beyond the standard two-tiered testing (STTT) and modified two-tiered testing (MTTT) for Lyme disease by combining IgG and IgM antibody detection in a single immunoassay. It simultaneously quantifies responses to a broad panel of B. burgdorferi antigens and uses machine-learning guided analysis to determine the status of the clinical specimen with results in less than two hours. Leveraging microarrays, machine learning and automated interpretation, InBios’ assay significantly expands the amount and quality of data analyzed.
“Current Lyme disease diagnostics are complex,” said Needham. “InBios’ new test simplifies the process, offering faster, more informative results compared to the traditional two-tier method. It streamlines workflow by eliminating the need for sequential testing, which should result in faster turnaround times and reduced cost per patient.”
Pre-clinical and in-house performance testing compared InBios’ assay to the STTT and MTTT algorithms. Initial testing with blinded specimens indicated a statistically significant 30-40% sensitivity improvement for detecting early Lyme erythema migrans specimens when compared to STTT and a 15% improvement compared to MTTT, without compromising specificity. Minimal to no cross-reactivity was observed, even in problematic samples including those positive for rheumatoid factor, syphilis and fibromyalgia.
Lyme disease is the most common vector-borne illness in the U.S., with an estimated 476,000 cases annually, though cases are likely underreported, according to the CDC. Though most prevalent in the Northeast, mid-Atlantic and upper Midwest, cases have been reported in all 50 states and over 80 countries worldwide.
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.
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