| [Abstract] Objective Understand the current update in the analytical performance of multiplex nucleic acid detection kits for pathogenic microorganisms in China, especially the basic situation of detection limit, and provide a reference to users of related enterprises and medical institutions. Methods?The analytical performance of the multiplex nucleic acid detection kits of 10 different detection technology principles has been evaluated, according to the in vitro diagnostic reagent industry standard of “Multiplex Nucleic Acid Detection Kit for Infection of Microorganisms (YY/T 1725-2020)” and “National Reference Panel for Multiplex Nucleic Acid Assay for Identification of Infection of 34 Microorganisms (370026-201801)”. It includes positive coincidence rate, negative coincidence rate, repeatability and limit of detection (LOD). Besides, the evaluation results were summarized and analyzed according to the quality standard of the national reference panel. Results?The 10 kits included 4 respiratory infection kits, 3 central nervous system infection kits, and 3 bloodstream infection kits, and the detection range or pathogenic microorganism spectrum covered 8 Gram-positive bacteria, 14 Gram-negative bacteria, and 10 fungi and atypical pathogens. The positive coincidence rate, negative coincidence rate, repeatability, and LOD of each kit were all in line with the quality standard of the national reference panel. Furthermore, the 6 pathogens with high distribution and frequency in each kit were Streptococcus pneumoniae (median detection limit 5 × 102 CFU/ml), Staphylococcus aureus (median detection limit 3 × 103 CFU/ml), Haemophilus influenzae (median detection limit 1 × 103 CFU/ml), Pseudomonas aeruginosa (median detection limit 5 × 104 CFU/ml), Acinetobacter baumannii (median detection limit 3 × 106 CFU/ml) and Escherichia coli (median detection limit 5 × 104 CFU/ml). Conclusions?The multiplex nucleic acid detection kits for pathogenic microorganisms have high accuracy, specificity, and repeatability, which have entered the registration stage of in vitro diagnostics in China. Meanwhile, the relevant research and development enterprises should pay attention to combining clinical needs and design a reasonable kit pathogen spectrum and optimize LOD performance. |