中国输血杂志2026，Vol.39Issue(4)：423-429,7.DOI:10.13303/j.cjbt.issn.1004-549x.2026.04.002
2024年度全国血站实验室核酸检测混样拆分错项数据分析
Data analysis of resolution discrepancies in minipool nucleic acid testing:A 2024 national study of Chinese blood stations
摘要
Abstract
Objective To investigate the incidence,characteristics,and influencing factors of resolution discrepancies within the minipool(MP)testing model across Chinese blood station laboratories in 2024.Methods A nationwide,multi-center,cross-sectional study was conducted,including 334 blood station laboratories that reported nucleic acid reactive data among enzyme immunoassay non-reactive samples.Of these,296 laboratories adopted the pool resolution model,with a total of 12 536 273 samples tested.Systematic analysis was performed on resolution data,focusing on the MP-NAT reactivity rate,the pool resolution concordance rate,and the resolution discrepancy rate.Subgroup analyses were conducted based on reagent types,viral targets,and Ct values.Potential causes were further explored through laboratory surveys and re-exami-nation of raw amplification curves.Results In 2024,the national average MP-NAT reactivity rate was 0.15%.The overall pool resolution concordance rate was 57.86%,which showed a gradual decline as Ct values increased across all reagents.The national average resolution discrepancy rate was 0.081‱(102/12 536 273),with 17.91%(53/296)of laboratories re-porting at least one discrepancy.Nine reagent types were associated with these events,exhibiting reagent-specific patterns.For Reagent A2,the predominant discrepancy was HBV reactive pools resolving as HIV(36.36%);for Reagent D1,HBV pools frequently resolved as HCV(38.89%);and for Reagent E,the most common pattern was HIV pools resolving as HBV(48.00%).These resolution discrepancies were strongly associated with high Ct values:the median pool Ct for HBV excee-ded 38,while those for HCV and HIV both exceeded 40.Investigations across 16 laboratories revealed that most discrepant samples exhibited"tailing"amplification curves,with some cases linked to cross-contamination or reagent batch-specific is-sues.Conclusion While the incidence of resolution discrepancies in the MP-NAT model remains low in China,variations exist across different reagents and laboratories.These discrepancies are closely associated with low viral load,reagent per-formance,and laboratory operational practices.关键词
献血者/血液筛查/核酸检测/混样拆分Key words
blood donors/blood Screening/nucleic acid testing/pool resolution分类
医药卫生引用本文复制引用
闫颖,何清,郑伟,马洁,常乐,姬慧敏,孙慧珍,王露楠..2024年度全国血站实验室核酸检测混样拆分错项数据分析[J].中国输血杂志,2026,39(4):423-429,7.基金项目
中国医学科学院医学与健康科技创新工程项目(2021-I2M-1-060) （2021-I2M-1-060）
