In Vitro Diagnostic Industry in China - POCT VI

8. Molecular POCT Technology

Molecular diagnosis is performed at the gene level with nucleic acids as the object for detection, with high sensitivity and accuracy. However, traditional nucleic acid detection processes are complex to operate and take a long time. Further, it needs to be partitioned independently in clinical laboratories to establish a standard molecular diagnostic laboratory, which is costly. As the technology has developed and clinical needs have been promoted, fully automatic and integrated molecular detection POCT platforms, based on a “sample in – result out” paradigm has emerged. Since 2020, molecular diagnostic POCT has received significant attention. Related products are mainly based on polymerase chain reaction (PCR), isothermal amplification, and other technologies that integrate complex nucleic acid detection steps into a system, greatly simplifying the process to hasten nucleic acid detection. For example, the US Food and Drug Administration (FDA) has approved the first CRISPR-based COVID-19 detection kit, which provides results in approximately 1 h, greatly shortening the detection time and improving the detection efficiency. Therefore, with the advantages of rapidity and convenience, molecular POCT has great application potential in screening, auxiliary diagnosis, and treatment guidance of infectious diseases, tumors, and other diseases.

9. POCT Mass Spectrometry Technology

Mass spectrometric analysis first ionizes substances, separates them according to the mass-to-charge ratio (m/z) of ions, and then measures the intensities of various ion peaks to achieve the purpose of analysis. Mass spectrometry is very suitable for qualitative and quantitative analyses of substances and it is one of the most powerful tools for the identification of pure substances. At present, most mass spectrometers used in China are large, expensive, and difficult to upgrade and maintain. In addition, the entire process, from sample pretreatment to mass spectrometric determination, is completed in the laboratory, which means that it cannot be used for clinical bedside detection. To meet the needs of mobile detection, on-site rapid detection, and cost reduction, the development of portable miniaturized mass spectrometers with on-site analysis and emergency detection capabilities has become a hot topic in the field of mass spectrometry. Multiple layers of filter paper have been used for liquid chromatography with LC-MS/MS to separate hormones and biological matrices, and mass spectrometry has been used for qualitative and quantitative analysis of three hormones: testosterone (T), androsterone (ADT), and androstenedione (4-AD). The multilayer PS-MS established by this method realizes rapid, simple, and reliable quantitative analysis of various hormones and provides a broad prospect for clinical analysis of small molecules in different biological samples.

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