In a new study, researchers have developed a rapid test that can detect Lyme disease with similar performance as the standard test in a much shorter time—15 minutes.
The research was conducted by a team at Columbia Engineering.
Some 300,000 people in the U.S. are diagnosed with Lyme disease every year.
Caused by Borrelia burgdorferi and transmitted by the bite of infected Ixodes ticks, the disease if left untreated can cause serious neurologic, cardiac, and/or rheumatologic complications.
Current testing for Lyme disease, called the standard 2-tiered approach or the STT, involves running two 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.
In the study, 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 three biomarkers using a standard enzyme immunoassay, and then mChip-LD, an advanced microfluidic platform developed by Sam 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.
The findings are the first to demonstrate that Lyme disease diagnosis can be carried out in a microfluidic format that can provide rapid quantitative results.
This means that the new 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.
The team believes they will help many people with this single, rapid, multiplexed diagnostic test to identify Lyme disease stage that can be used in doctors’ offices.
One author of the study is Sam Sia, a professor of biomedical engineering at Columbia Engineering.
The study is published in the Journal of Clinical Microbiology.
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