中国输血杂志2025，Vol.38Issue(2)：251-256,6.DOI:10.13303/j.cjbt.issn.1004-549x.2025.02.015
血站核酸混检模式质量指标监测及应用评价
Quality index monitoring and application evaluation of nucleic acid pooling detection mode in blood stations
董菲 1柳杨 1董国良 1翟玮玮 1刘炜民 1李雪梅1
作者信息
- 1. 潍坊市中心血站,山东 潍坊 261041
- 折叠
摘要
Abstract
Objective To explore the influencing factors of quality monitoring index on the nucleic acid pooling detec-tion mode and continuously improve the detection quality of nucleic acid laboratory.Methods The quality monitoring indi-cators(NAT reactive rate,NAT resolution reactive rate,NAT invalid batch rate,NAT invalid result rate,equipment failure rate)and causes of invalidity in our laboratory from January 1,2020 to December 31,2022 were retrospectively analyzed.The quality monitoring indicators of the laboratory during 2020 to 2022 were compared longitudinally.The quality monitoring indicators of the laboratory in 2022 were compared horizontally with the overall level in Shandong for the same period to find the differences.Results From 2020 to 2022,a total of 218 686 samples were detected,the NAT reactive rate was 0.15‰(32 samples in total),the resolution reactive rate was 39.02%,the invalid batch rate was 1.06%,the invalid result rate was 1.18%,and the equipment failure rate was 3.58%.There were no differences in the NAT reactive rate,NAT resolu-tion reactive rate and NAT invalid batch rate among different years(P>0.05),but there were differences in the invalid re-sult rate(P<0.05).Equipment failure was the main cause of invalid results(56.53%).Compared with other laboratories in Shandong,there were differences in the NAT reactive rate and invalid result rate(P<0.05).There were differences in the reaction rate,resolution rate and invalid result rate among different reagents(P<0.05).Compared with other two labo-ratories using the same manufacturer's reagent,there were differences in the reactive rate and invalid result rate(P<0.05),but no difference in the resolution rate and invalid batch rate(P>0.05).Conclusion Establishing quality indexes for process control and regular analysis can timely detect potential risks in laboratory operation.The use of quality indicators to implement self-comparison and inter-laboratory comparison can help the laboratory systematically and scientifically evaluate its own operating status and formulate corresponding quality management strategies,thereby improving the laboratory's tes-ting capacity and ensure the safety of blood use.关键词
核酸检测/混样检测/质量监测指标/自身比对/横向比对Key words
nucleic acid testing(NAT)/pooling NAT/quality monitoring index/self-comparison/horizontal compari-son分类
临床医学引用本文复制引用
董菲,柳杨,董国良,翟玮玮,刘炜民,李雪梅..血站核酸混检模式质量指标监测及应用评价[J].中国输血杂志,2025,38(2):251-256,6.
