About a million individuals are diagnosed with Lyme disease
each year of which about 350,000 are just in the US alone. But unfortunately, tens of thousands more are often not even diagnosed correctly or are often mistreated for other symptoms despite contracting Lyme Disease
. Access to proper diagnostics is one major issue. Lyme disease
is caused by Borrelia burgdorferi and transmitted by the bite of infected Ixodes ticks and also other tick species. Lyme disease
if left untreated can cause serious neurologic, cardiac, and/or rheumatologic complications.
Present 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. Most hospitals in Asia and places like Middle-East, Africa and South America do not even have easy accessibility to these tests.
Medical researchers led by Dr Sam Sia, professor of biomedical engineering at Columbia University, has developed a rapid microfluidic test that can detect Lyme disease
with similar performance as the STT in a much shorter time 15 minutes and is even cheaper commercially and easy for healthcare staff to use.
Dr Sam Sia commented in an interview with Thailand Medical News "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. 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."
The researchers worked in collaboration with Maria Gomes-Solecki from Immuno Technologies, which found a combination of three proteins that identified antibodies specific to the B. burgdorferi bacterium in the serum, and OPKO Health, which provided microfluidic cassettes.
The medical 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.
Upon 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
Test run on Sia's mChip-LD platform, worked very well, showing strong potential for the development of a point-of-care test for Lyme disease
Dr Siddarth Arumugam, who is a Ph.D. student in Sia's lab and one of the lead authors of the study further commented to Thailand Medical News. "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. 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."
Sia is the co-founder of Claros Diagnostics, whose underlying microfluidics technology is now being commercialized by OPKO Health and was recently approved by the FDA for testing for prostate cancer. He and Gomes-Solecki are now planning a more thorough clinical validation study to see whether the performance of the Lyme microfluidic platform holds up.
Their findings were published in the Journal of Clinical Microbiology
Due to climate changes, many scientists believe that the ticks responsible for these infections are migrating to various newer destinations or even evolving and multiplying in existing destinations and hence Lyme disease
occurrence will start rising.
Reference: Siddarth Arumugam et al, A Multiplexed Serologic Test for Diagnosis of Lyme Disease for Point-of-Care Use, Journal of Clinical Microbiology (2019). DOI: 10.1128/JCM.01142-19