Establishment of national reference material for Vibrio flurialis nucleic acid detection reagent
Objective To develop a national reference panel for Vibrio flurialis nucleic acid detection reagent and establish the quality standard. Methods The positive and negative clinical samples were collected and screened to establish a national reference panel for Vibrio flurialis nucleic acid detection. Various re-agents were invited to coordinate the calibration of the panel ,and the stability and uniformity were further investigated. Results The national reference panel consists of 20 samples,including 8 positives(P1～P8),10 negatives(N1～N10),1 detection limit and 1 repeatability sample. The concentration of L was determined to be 1 × 108 CFU/mL using the colony counting method. The quality standard for the national reference panel is that the positive coincidence rate should be 8/8 and the negative coincidence rate should be 10/10. The precision requirement is that the variation coefficient(CV,％)of the Ct values for the two concentration levels should not exceed 5.0％. The detection limit requires that L when diluted at a ratio of 1:104 or higher,should still test positive for Vibrio flurialis nucleic acid. After conducting a random sampling test,it was found that the panel met the requirements for uniformity. The stability of the reference product was not affected when stored at 2-8℃,or at room temperature for 7 days. Conclusion A national reference panel for Vibrio flurialis nucleic acid detection reagents has been established. This panel can be used to ensure the quality control and evaluate the effectiveness of relevant qualitative detection reagents.
万方数据
维普
