Core Viewpoint - The company has received a medical device registration certificate for its nucleic acid test kits for human coronaviruses, influenza viruses, and novel coronaviruses, which are essential for accurate diagnosis and treatment of respiratory infections [1][2]. Product Registration Details - The newly certified test kits utilize multiplex fluorescent PCR technology, offering high sensitivity, specificity, and ease of use, capable of accurately identifying three pathogens in as little as 30 minutes [2]. - The product line integrates with the company's existing rapid detection solutions for respiratory infections, allowing for unified sampling and amplification, thus enabling simultaneous detection of various common respiratory pathogens [2]. Impact on the Company - The test kits address the clinical challenges posed by respiratory pathogens, which often present similar symptoms, making accurate diagnosis difficult. The need for efficient and precise testing methods is critical for clinical decision-making [1][2]. - The company aims to enhance its product offerings in respiratory infection diagnostics, contributing to improved treatment levels for infectious diseases and supporting public health efforts against antimicrobial resistance [2].

Product Registration - The company has received a medical device registration certificate from the National Medical Products Administration for its nucleic acid detection kits for human bocavirus (HBoV) and human metapneumovirus (HMPV) [1] Impact on the Company - HBoV and HMPV are common respiratory viruses that can cause acute respiratory infections, particularly dangerous for children under 5 and the elderly [1] - The symptoms of these infections are similar to those of influenza and other respiratory pathogens, necessitating efficient and accurate detection methods for clinical diagnosis and treatment decisions [1] - The newly certified kits utilize multiplex fluorescent PCR technology, allowing for high sensitivity and specificity in detecting both pathogens [2] - The product enhances the company's existing respiratory infection nucleic acid rapid detection solutions, supporting precise medication for clinical use [2] - The company has over 10 years of experience in the respiratory infectious disease diagnostics field, with a product matrix covering more than 60 items [2] - The new product enriches the company's respiratory pathogen nucleic acid detection offerings and supports a flexible and comprehensive diagnostic solution for various medical institutions [2]