| [Abstract] Objective To develop reference panel of hantavirus nucleic acid detection reagents and formulate quality standards. Methods?The samples of hantavirus positive and negative clinical strains were collected, and the simulated samples of hantavirus RNA phage were developed. The nucleic acid sequences were identified by Metagenome sequencing and real-time fluorescence quantitative polymerase chain reactiontechnology. Appropriate samples were selected to form a reference panel thus calibrating by different reagents. The quality standards of hantavirus nucleic acid detection reagents reference panel were determined according to the collaborative calibration results, then evaluated its stability. Results?The reference panel consisted of 20 samples, including 5 positive reference materials (PC01～PC05), 11 negative reference materials (NC01～NC11), 2 precision reference materials (R01, R02) and 2 limit of detection (LOD) reference materials (S01, S05). After 1:10 gradient dilution, the LOD reference materials test results required that S02, S03 should be positive for Hantaan type of hantavirus, S06, S07 should be positive for Seoul type of hantavirus, and the rest of the samples were not mandatory. The stability evaluation results showed that the reference materials performance were not affected by 24 hours at 25℃ or repeated freezing and thawing for 3 times. Conclusions?The reference panel for hantavirus nucleic acids detection were developed and the corresponding quality standards were formulated. They can be applied to the quality evaluation of related qualitative detection reagents. |