Diagnosing Lyme Disease in Just 15 Minutes

Single multiplexed assays could replace the standard 2-tiered (STT) algorithm recommended for the laboratory diagnosis of Lyme disease, reported a team at Columbia Engineering.

This rapid microfluidic test can detect Lyme disease with similar performance as the STT but in just 15 minutes.

‘This means that our test could easily be used directly in a doctor’s office, obviating having to send the samples out to a laboratory that needs at least a couple of hours, if not days, to get test results,’ said these researchers in a press release.

If left untreated, Lyme disease can cause serious neurologic, cardiac, and rheumatologic complications. 

This innovative study was published in the Journal of Clinical Microbiology on October 11, 2019, which is very important since about 300,000 people in the USA are diagnosed with Lyme disease every year.

Furthermore, recent estimates suggest that Lyme disease is underreported and that the true incidence is likely 10 times higher.

Lyme disease is caused by Borrelia burgdorferi and transmitted by the bite of infected Ixodes ticks.

Current testing for Lyme disease involves running 2 complex assays (ELISA and western blot) to detect antibodies against the bacterium and requires experienced personnel in a lab, and a few hours to carry out and interpret.

“Our findings are the first to demonstrate that Lyme disease diagnosis can be carried out in a microfluidic format that can provide rapid quantitative results,” said Samual Sia, a professor of biomedical engineering at Columbia.

Sia’s group worked in collaboration with Maria Gomes-Solecki from Immuno Technologies, which found a combination of 3 proteins that identified antibodies specific to the B. burgdorferi bacterium in the serum, and OPKO Health, which provided microfluidic cassettes.

The researchers evaluated 142 samples, including patients with early Lyme disease, healthy individuals from areas where Lyme disease is endemic, and those with Lyme arthritis. 

They first screened a set of known diagnostic Lyme disease biomarkers for their ability to detect Lyme disease infection. 

They then tested the top 3 biomarkers using a standard enzyme immunoassay, and then mChip-LD, an advanced microfluidic platform developed by Sia, to test the samples.

When tested against additional samples of serum from people with Lyme disease, the multiplexed set of biomarkers was more sensitive than standard Lyme disease tests, while also exhibiting high specificity. 

The team found that it was better at picking up signs of Lyme disease infection in early-stage samples—possibly because it was able to detect antibodies that peak in the first weeks after someone is infected with Lyme disease.

When the test was run on Sia’s mChip-LD platform, it worked very well, showing strong potential for the development of a point-of-care test for Lyme disease. 

“While the assay will require more refinement and testing before it can be approved for widespread use as a test for Lyme disease, our results are very exciting,” says one of the study’s lead authors, Siddarth Arumugam, who is a Ph.D. student in Sia’s lab. 

“It will help so many people if we can develop a single, rapid, multiplexed diagnostic test to identify Lyme disease stage that can be used in doctors’ offices.”

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Sia and Gomes-Solecki are planning a more thorough clinical validation study to see whether the performance of the Lyme microfluidic platform holds up.

Columbia Engineering, based in New York City, is one of the top engineering schools in the U.S. and one of the oldest in the nation.

Lyme Disease news published by Precision Vaccinations