Portable Molecular POC System Rules Out UTIs in Just 35 Minutes

There are over 400 million UTI cases globally each year, of which around 90% are in women. Fast and accurate UTI diagnosis is crucial for effective treatment and for preventing complications. The gold standard for UTI diagnosis is still considered to be laboratory culture. This is despite lab culture tests taking at least 24 hours to provide a result because of the need to transport the sample to a lab and the time taken to incubate the sample. Waiting for culture results can lead to delays in determining the best course of action and prescribing inappropriate or unnecessary antibiotics.

The other most common approach to UTI testing is the use of dipsticks. These are cheap to buy and simple to use, but have a maximum sensitivity of around 74%. There is a need for faster, more accurate, and inexpensive UTI diagnostics to improve the way patients are treated and reduce the volume of antibiotic prescriptions issued. Now, a portable diagnostic device that delivers lab-accurate results for UTIs in around half an hour to guide real-time clinical decision-making at the point-of-care.

The Lodestar DX UTI rapid molecular diagnostic platform from Llusern Scientific (Cardiff, UK) is based on isothermal LAMP technology (not PCR) without the need for DNA extraction or centralized lab infrastructure. This low-cost, portable, easy-to-use testing system offers up to 97% accuracy in detecting the presence of clinically relevant levels of UTI-causing bacteria. With industry-leading sensitivity and specificity, Lodestar DX empowers clinicians to diagnose and treat specific microbial infections with precision in a single visit, thereby improving patient outcomes.

As well as providing guidance on the best treatment option based on the specific microbial infection, Lodestar DX also provides a clear ‘rule-out’ decision where antibiotics are not necessary, helping to reduce antimicrobial resistance through antibiotic stewardship. Llusern Scientific has been awarded ISO 13485 certification for its Lodestar DX testing system, marking a crucial regulatory step for marketing its medical device globally.

“Not only does our Lodestar UTI testing system help a clinician decide whether or not to prescribe an antibiotic, but it will also identify the bacterial cause of the UTI,” said co-founder and CEO, Dr. Emma Hayhurst. “This enables clinicians to quickly target the right bug with the right treatment to save lives. Now that we have ISO 13485 certification, our next goal is to achieve IVDR certification to further expand the market potential for our innovative molecular diagnostic globally.”

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