中国输血杂志2024，Vol.37Issue(8)：908-913,6.DOI:10.13303/j.cjbt.issn.1004-549x.2024.08.011
核酸单反应性质量控制多规则的建立
Establishment of a multi-rule quality control mechanism for blood nucleic acid screening results based on Poisson distribution
摘要
Abstract
Objective To establish a quality control mechanism based on the Poisson distribution for monitoring con-tamination in nucleic acid testing(NAT)laboratories.Methods The study collected NAT single-reactivity rates and dis-criminatory test reactivity rates from the Grifols Panther NAT system from 2022 to 2023.The Poisson distribution probability method was used to calculate the daily probability of nucleic acid single reactivity.Sensitivity and specificity of the quality control model were further validated using single-reactivity rates,discriminatory reactivity rates and ROC curve analysis,fol-lowed by proposing corresponding multi-rule quality control strategies.Results Using P=0.05 as the threshold for out-of-control,the Poisson distribution probability quality control model identified 40 out-of-control points with P<0.05.After man-ual verification using discriminatory reactivity rates,20 out-of-control points were confirmed.The sensitivity of determining out-of-control was 60.0%,and the specificity was 95.6%.Due to the high number of out-of-control points,it is recommen-ded to combine discriminatory reactivity rates and employ multi-rule quality control methods for quality monitoring.Under the multi-rule quality control,there were 18 warning points and 2 out-of-control points for NAT single reactivity from 2022 to 2023.Conclusion The multi-rule NAT single-reactivity monitoring mechanism based on the Poisson distribution probability is more suitable for nucleic acid laboratories to monitor and warn of laboratory contamination,thereby enhancing the manage-ment capabilities and detection quality of nucleic acid laboratories.关键词
Poisson分布/核酸检测/实验室污染Key words
Poisson distribution/nucleic acid testing(NAT)/laboratory contamination分类
医药卫生引用本文复制引用
谢君谋,蓝岚茵,杜荣松,黄爱琼,刘旭映,廖芬芳,王淏..核酸单反应性质量控制多规则的建立[J].中国输血杂志,2024,37(8):908-913,6.基金项目
广州市卫生健康科技项目(20231A011074) （20231A011074）
广州市科技计划项目(2023A03J0550) （2023A03J0550）
