The standard two-tier ELISA/Western Blot diagnostic test misses up to 60% of acute Lyme cases as it can take weeks for the body to develop sufficient measurable antibodies. Direct detection of the Lyme-causing bacteria, Borrelia burgdorferi, would be a definitive diagnostic approach, yet efforts to date have proven to be challenging given the elusive nature of the bacteria.
This project leverages more than ten years of experimentation and optimization by Ibis Biosciences to perfect their technology for the detection of blood-borne pathogens and involves three key components:
- The use of whole blood samples to increase the likelihood of bacterial presence in the sample
- Isothermal amplification and polymerase chain reaction (PCR) technology to enrich the sample and increase the sensitivity of the test
- A mass-spectrometry-based assay to increase the number of detectable targets in the Borrelia genome
The result is a test able to detect the bacteria at extremely low levels and an ability to differentiate active infection from prior exposure and even to genotype the bacteria. The additional information provided by the test may lay the foundation for more targeted treatment plans in response to specific strains of bacteria present.
A previously published study by Ibis showed a Borrelia detection rate of 62% in acute Lyme patients. The goal of the Bay Area Lyme-funded project is to increase the sensitivity to an even greater level, although 62% already beats the current “gold standard” two-tier test for acute Lyme.
Mark Eshoo, PhD, Director of New Technology Development, Ibis Biosciences, Inc. (a division of Abbott Laboratories)
For more information about this or other project funding opportunities, contact our Development Office.