A new Lyme disease diagnostic

PORTOLA VALLEY, Calif.—Bay Area Lyme Foundation (BAL) has announced an article published in the Journal of Clinical Microbiology that reports on a potential new diagnostic, mChip-Ld. This diagnostic can be performed in 15 minutes in a physician’s office, offers efficacy improvements over the two-tier test (the current gold standard diagnostic) and may be able to identify a patient’s Lyme disease stage.

The research study, which was funded by the National Institutes of Health (NIH), was made possible in part by blood samples provided by Bay Area Lyme Foundation’s Lyme Disease Biobank (LDB). LDB is supported by donations from multiple sources, including the Steven & Alexandra Cohen Foundation.

“Our research toward developing rapid diagnostic assays for Lyme disease is impossible to carry out without having access to laboratory confirmed physician-characterized blood samples,” said study author Maria Gomes-Solecki, DVM, associate professor at the University of Tennessee Health Science Center. “In the past, a limited set of well-characterized Lyme disease samples could be obtained from the CDC. The BAL Lyme Disease Biobank provides another much-needed option in that regard.”

The Lyme Disease Biobank has more than 800 blood, urine and tissue samples from 800 participants, with each participant’s sample divided into as many as 50 smaller aliquots that facilitate research of Lyme disease and other tick-borne infections. The LDB is currently supporting more than a dozen studies related to identifying novel diagnostics and treatments and to gain a better understanding of tick-borne diseases.

“While research in Lyme disease lags far behind most other diseases of the same magnitude, we are encouraged by the growing focus on Lyme and the increasing ability of the Lyme Disease Biobank to offer the tools researchers need to do their work. As there is a great need for a rapid point-of-care diagnostic test for Lyme disease and the current gold standard diagnostic misses about half of all cases of early Lyme disease, our hope is that this critical research will one day help to improve care, and outcomes, for future Lyme patients,” noted Liz Horn, Ph.D., principal investigator, Lyme Disease Biobank.

A collaborative effort led by Gomes-Solecki and Sam Sia, Ph.D., professor of biomedical engineering at Columbia Engineering, the study explores the mChip-Ld, a rapid lab-on-a-chip point of care blood test that utilizes microfluidics technology for the diagnosis of Lyme disease. Similar to the first tier (ELISA) test, the mChip-Ld test works by evaluating antibodies. As part of this study, the team developed a new algorithm that helps improve diagnostic performance of the assay.

“We selected three antigens (3Ag) to include in the mChip-Ld: VlsE and a proprietary synthetic 33-mer peptide (PepVF) to capture sensitivity in all disease stages, and OspC for early Lyme disease,” the article abstract states. “With specificity set at 95%, the sensitivity of mChip-Ld ranged between 80% (95% CI: 56% to 94%) and 85% (95% CI: 74% to 96%) for two panels of early Lyme disease, and was 100% (95% CI: 83% to 100%) for Lyme arthritis; the STT algorithm detected the same two panels of early Lyme disease with a sensitivity of 48.5% and 75%, Lyme arthritis with a sensitivity of 100%, with a specificity of 97.5% to 100%.”

When comparing the mChip-Ld to the standard two-tier (STT) test, researchers observed a marked increase in sensitivity without loss of specificity, and also found that more antigens became positive as Lyme disease progressed from early to late stages.

“The mChip-Ld platform outperforms the STT algorithm on sensitivity. These results open the door for the development of a single, rapid, multiplexed diagnostic test for point-of-care use that can be designed to identify Lyme disease stage,” the abstract concludes.