Low-Cost Near-Patient Diagnostic Platform Rapidly Diagnoses STIs

Every day, over one million sexually transmitted infections (STIs) are acquired worldwide. Rapid diagnosis and appropriate antibiotic treatment are crucial to control their spread. Timely testing is necessary to break the transmission chain, enabling patients to receive a diagnosis and begin treatment during the same clinic visit. Although current tests can be used with limited training, they have not yet achieved the target of delivering results within 20 minutes from sample collection. A new, low-cost, near-patient diagnostic platform now promises to detect infections faster than any commercial alternative.

This platform, being developed by Linear Diagnostics (Birmingham, UK), a spin-out from the University of Birmingham, uses Exponential Amplification (EXPAR) technology, which detects bacterial DNA through a rapid signal amplification process. Originally developed and tested during the COVID-19 pandemic at the University, the platform has now demonstrated the ability to detect bacterial STIs, urinary tract infections, and viral infections such as SARS-CoV-2 in as little as five minutes. Recently, the company has focused its efforts on STIs—especially Neisseria gonorrhoeae and Chlamydia trachomatis—given the growing threat posed by multidrug-resistant strains of the former.

Linear is currently refining the cartridge and reader components of the platform and working to validate its performance. By reviewing clinical guidelines and engaging with healthcare providers, patients, and the public, the team aims to understand how best to design and implement the platform to improve patient outcomes. The research will also explore unmet clinical needs, evaluate current diagnostic practices, and determine the most effective stage for introducing this technology in the patient care pathway. Additionally, the researchers will analyze the diagnostic accuracy of the test using data from the innovation lab and assess whether the technology offers cost-effectiveness for the NHS through health economic modelling.

“The most difficult criteria to achieve in diagnostic testing is combining rapidity with accuracy,” said Dr. Jean-Louis Duprey, Head of Research and Development at Linear Diagnostics. “While rapid lateral flow meets the ideal timeframe of 20 minutes to diagnosis, it struggles to meet market requirements for high sensitivity and specificity. And while Nucleic Acid Amplification Tests deliver high accuracy, samples are sent to laboratories for analysis, meaning the waiting time for results may be days. We are developing a near patient device that will overcome this conundrum.”

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