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Point-of-Care MDx System Enables Simple, Fast and Accurate Diagnosis in Near Patient Setting

By LabMedica International staff writers
Posted on 22 Mar 2023

Image: The STANDARD M10 Point-of-Care MDx system (Photo courtesy of SD Biosensor)

In the healthcare industry, time is critical. Patients and their loved ones depend on physicians to make rapid and accurate diagnoses, and decisions that can save lives. There's no margin for error and no time to waste. That's where Molecular Diagnostic (MDx) solutions come in. These cutting-edge solutions facilitate the quick and accurate detection of microbial pathogens and provide insights into a patient's genes by combining lab testing with the precision of molecular biology. MDx technologies can effectively perform DNA-level detective work, utilizing millions – or even billions – of replicated copies to gain a more detailed understanding of DNA strands. The resulting insights offer physicians the crucial information they need to make informed diagnostic and therapeutic decisions. Now, an automated point of care MDx system enables rapid, effortless and accurate molecular diagnostic testing of infectious diseases, drug resistance, and genetic testing from human specimens.

The STANDARD M10 from SD Biosensor (Gyeonggi-do, Korea) is a random access and scalable solution that can be utilized for both qualitative as well as quantitative measurement of biomarkers from human samples, like blood, urine, and nasal mucus in a laboratory or POCT environment. The system automatically extracts and amplifies nucleic acids (DNA and RNA) for molecular diagnostics and analyzes the data from amplification in real time. STANDARD M10 is a modular and scalable system, with customized throughput that consists of the STANDARD M10 console (user interface), STANDARD M10 module (cartridge analysis function), and ready-to-use kits. One console can be connected to 1-8 modules, and each module can be used individually, enabling random access testing of patient samples.

The STANDARD M10 combines RT-PCR and isothermal amplification (LAMP) technology in one system, making it a versatile and flexible solution that is suitable for any healthcare settings. It offers multiplex capability, with up to 11 targets + internal control, while providing automated result interpretation and amplification curves. Featuring an intuitive and simple touch screen user interface, the system delivers fast and reliable results in 20-60 minutes with minimal hands-on time of less than three minutes.

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