BEIJING – Researchers from The Hong Kong Polytechnic University (PolyU) have developed a diagnostic system that they claim is the world’s most comprehensive as it can identify 30 to 40 pathogens in one single test within an hour.

The automated multiplex diagnostic system comes with a fully automated machine and a multiplex full-screening panel for point-of-care genetic testing (POCT) of respiratory infectious diseases, including COVID-19, which has infected nearly 60,000 people and killed more than 1,300 as of Feb 13, 2020.

The dozens of pathogens that can be identified also include seasonal influenza viruses, such as influenza A subtypes H1, H2 and H3, avian influenza viruses H5, H7 and H9, human respiratory syncytial virus, SARS-CoV and MERS-CoV. The university has tested the system on all major pathogens that cause infectious respiratory diseases.

PolyU’s researchers used polymerase chain reaction technology as part of the diagnostic system, which enables the device to be fully automated from sample nucleic acid extraction and amplification to signal detection and analysis to achieve point-of-care capability. The system does not require manual interaction across the testing process.

The university said microfluidic and biochemical technologies have been adopted to achieve ultra-sensitive detection and simultaneous differentiation of various pathogens with extremely high specificity.

“The proprietary technology combines multiple innovations in biochemistry, diagnostics, microfluidics and production engineering to achieve extremely high analytical sensitivity and analytical specificity,” Hailey Lai, PolyU’s communications and public affairs officer, as she explained to BioWorld how the system can identify so many pathogens in so little time. She said patent applications have been filed for the technologies.

“The design of primers and probes, biochemical reagents and amplification technology allows for simultaneous, sensitive (down to 5 gene copies) and specific detection of up to 40 pathogens without interference. We also have internal control in our system,” Lai added.

She said the research team is urgently focusing on further developments of the system’s robustness and cost-effectiveness. The team is also moving on in the collaboration with relevant parties for the clinical trials, regulatory approvals, mass scale production, and frontline applications of this POCT system.

Terence Lau Lok-ting, director of Innovation and Technology Development and adjunct professor at the Department of Applied Biology and Chemical Technology at PolyU who leads the research team, said this innovation can substantially reduce the cost of microfluidic cartridge manufacturing, thus making it feasible for wide adoption.

He believes this diagnostic system will be a “practical solution” for the lack of full panel POCT technologies in early and on-site diagnosis and should be able to differentiate between different pathogens at the same time. He added that PolyU’s proprietary technology overcame the limitations of existing technologies by ensuring sensitivity.

“Early and accurate detection of pathogens contributes to effective and efficient disease control and management and prevents the spreading of any contagious pathogens. It benefits patient as well because timely therapy can then be applied to prevent complications,” said Lau of the value of early and on-site diagnosis, which may be realized by this new diagnostic system.

The development of this diagnostic system comes at a time when tens of thousands of people in China, especially in the epicenter of Hubei province, are desperate to be tested for the COVID-19 virus so they can be hospitalized and receive medical care. Patients without a proper diagnosis have reportedly been denied access to public health care due to the high demand for hospital beds.

The COVID-19 virus remains a serious threat and Hubei province has reported 14,000 new cases overnight, due to an observational diagnosis system having been developed and implemented.

Alexander Wai Ping-kong, deputy president and provost designate of PolyU, said it is important that the research community is able to quickly pool their expertise and resources to develop practical solutions in the difficult and challenging times that Hong Kong, China and the global community are encountering.

“The system's versatility and capability will provide for comprehensive monitoring during disease outbreaks or routine surveillance. It will become a crucial technology for ensuring the effective control of infectious diseases, medical diagnosis, and treatment,” said Yuen Kwok-yung, the chair of infectious diseases at the University of Hong Kong’s (HKU) department of microbiology.

Yuen has supported the R&D for this PolyU-HKU partnership over the four years it has taken to develop the diagnostic system. Researchers also conducted tests on clinical samples from the COVID-19 outbreak using the system.

Yuen is currently dedicating his efforts toward developing a vaccine for the coronavirus. The vaccine is based on a nasal spray applied vaccine that he and his team invented.

This new PolyU diagnostic system, developed with the support of HKU, is a continuation of the joint efforts from Hong Kong’s academia and university research institutions.

Last week, researchers at Hong Kong University of Science and Technology claimed to have invented the world’s fastest portable diagnostic device, with detection of the COVID-19 virus performed in just 40 minutes.

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