[Expert consensus on the standardized clinical application of rapid pathogen nucleic acid testing (2025 edition)].

In recent years, rapid pathogen nucleic acid testing has emerged in clinical settings with development towards to point-of-care testing (POCT), featuring with ease of operation, short detection time, and minimal laboratory space requirements. This is conducive to enhancing the accessibility and timeliness of nucleic acid testing, of great value to identify the pathogen quickly and accurately in clinical settings, and meanwhile, novel issues occurred for the construction and management for clinical gene amplification test laboratory. Therefore, aiming at enhancing standardized application of rapid pathogen nucleic acid testing in clinical laboratory and ensure testing quality, the China Association of Medical Equipment of Genetic Testing, the National Clinical Research Center for Laboratory Medicine, and the Beijing Medical Laboratory Quality Control and Improvement Center jointly developed the expert consensus and formulated 8 recommendations focusing on laboratory environment, reagents and consumable materials, instrument equipment, personnel requirements, specimen collection, transportation and storage, development of standard operating procedures, performance verification, internal quality control, external quality assessment, and result analysis and reporting.