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Feature

Portable Intelligent Rapid Molecular Diagnostic System

Point-of-care testing (PoCT) has become increasingly significant because of its easy access and fast analysis, which provide immediate diagnostic information that helps reduce disease transmission. In vitro diagnostic (IVD) devices are common systems used for point-of-care testing because they can accurately detect various diseases, infections, or conditions.

Dr. Peggy Jiang, Senior Researcher of ITRI’s Biomedical Technology and Device Research Laboratories, indicated that the development of molecular diagnostic systems for infectious disease detection has gained much research attention as diagnostic precision and efficiency are crucial in epidemic prevention. There is also an increased emphasis on disease management, rapid diagnosis, and personal health management, accentuating the significance of self-monitoring (home PoC) medical services. According to an industry forecast by Research and Markets, the global IVD market is expected to grow at a rate of 6.3% in the next decade, expanding the business for molecular diagnostic systems to a market size of approximately US$101.8 billion by 2025.

To address the market demand, ITRI developed the Portable Intelligent Rapid Molecular Diagnostic System with a small compact size, weighing only 596 g and holding a maximum of 6 test samples. Aside from an improvement in portability, ITRI’s system uses an innovative heating control methodology that not only fulfills rapid temperature control but also performs both DNA and RNA amplification. According to Dr. Jiang, this approach remarkably shortens the time spent heating and cooling in thermocyclers. Furthermore, by utilizing a unique optical detection module, it can also achieve qualitative or semi-quantitative rapid detections for polymerase chain reaction (PCR) systems within short periods of time.

An example of the system’s applications is influenza testing. The system is first initiated for internal heating. Soon after, the user can put samples of patients’ nasal or oral mucous into the test tubes. Finally, the results can then be obtained from PCR testing within 30 minutes. Because of its strength in accessible, precise, and instant diagnostic services, ITRI’s Portable Intelligent Rapid Molecular Diagnostic System can be applied to non-central labs or agricultural/aquacultural testing, in addition to clinics and local public health centers. The system is certified in China and is currently going through the patent application in the U.S.