首页|期刊导航|中国输血杂志|2019-2025 年中国国际输血感染预防和控制(CITIC)项目细菌检测室间质量评价结果分析

2019-2025 年中国国际输血感染预防和控制(CITIC)项目细菌检测室间质量评价结果分析OA

Analysis of external quality assessment results of bacteria screening in China International Transfusion Infection Control(CITIC),2019 to 2025

中文摘要英文摘要

目的 掌握全国各类采供血及相关实验室细菌检测能力现状,明确影响检测结果符合性的关键因素.方法 对 2019-2025 年中国国际输血感染预防和控制(CITIC)项目开展的 21 次血液细菌检测 EQA 数据进行汇总分析,研究对象涵盖全国 23 个省级行政区的血液中心、中心血站、公司 3 类实验室,统计参评实验室数量,不同机构、不同自动化血培养设备、不同菌液浓度及不同菌株标本的检测符合率,同时梳理结果填报不规范问题,采用统计学方法进行分析.结果 7 年间参评实验室由 161 家增至 236 家,年均增长率 6.58%,年度符合率为 82.61%-94.92%.3 类参评实验室总实验室符合率均>89.0%(P>0.05),公司实验室符合率呈逐年上升(70.97%~100%)趋势(P<0.05).8 个厂家自动化血培养系统设备符合率(97.98%~100%)无差异(P>0.05),各设备运行性能稳定.标本检测总标本符合率为 98.88%,阴性标本符合率低于阳性标本(97.97%vs 99.14%);阳性标本符合率随浓度升高而上升;低浓度的革兰阴性菌株标本符合率低于革兰阳性菌株标本(93.15%vs 100%).本次共发现 50 项结果填报不规范问题,以时间单位填写错误占比最高(52.0%).结论 全国各类采供血及相关实验室参与规模与整体检测水平逐年提升,各类自动化血培养设备均可满足血液细菌筛查需求.阴性及低浓度阳性标本检测是当前细菌项目 EQA 的薄弱环节,实验室数据填报规范性仍需加强.持续开展室间质评、实施专项培训、规范上报流程,可有效提升全国血液细菌检测同质化水平,保障临床输血安全.

Objective To assess the current status of bacterial detection capabilities in various blood collection and supply and related laboratories across China,and to identify key factors affecting the consistency of test results.Methods A pooled analysis was conducted on data from 21 external quality assessment(EQA)rounds for blood bacterial detection carried out by the China International Transfusion Infection Prevention and Control(CITIC)project from 2019 to 2025.The study covered three types of laboratories-blood centers,central blood stations,and commercial laboratories—across 23 pro-vincial-level administrative regions in China.Statistics were compiled on the number of participating laboratories,and the concordance rates were calculated for different institution types,different automated blood culture systems,different bacteri-al concentrations,and different strains.Non-standard reporting issues were also reviewed,and statistical methods were ap-plied for analysis.Results Over the seven-year period,the number of participating laboratories increased from 161 to 236,with an average annual growth rate of 6.58%,and the annual concordance rates ranged from 82.61%to 94.92%.The over-all laboratory concordance rates for the three types of participating laboratories were all>89.0%(P>0.05),while commer-cial laboratories showed a significant year-by-year increase(70.97%-100%,P<0.05).The concordance rates of automated blood culture systems from eight manufacturers showed no significant differences(97.98%-100%,P>0.05),indicating stable performance across all devices.The overall sample concordance rate was 98.88%,with negative samples showing a lower rate than positive samples(97.97%vs 99.14%);positive sample rates increased with higher concentrations;and low-concentration Gram-negative bacterial samples had a lower concordance rate than Gram-positive ones(93.15%vs 100%).A total of 50 instances of non-standard result reporting were identified,with incorrect time units accounting for the highest proportion(52.0%).Conclusion The participation scale and overall testing proficiency of blood collection and sup-ply and related laboratories nationwide have improved year by year,and all types of automated blood culture devices can meet the requirements for blood bacterial screening.Detection of negative and low-concentration positive samples remains a weak link in current bacterial EQA,and the standardization of laboratory data reporting requires further strengthening.Con-tinuous external quality assessment,targeted training,and standardized reporting procedures can effectively enhance the homogenization level of blood bacterial testing across the country and ensure the safety of clinical transfusion.

杨剑豪;陆贇;陈英姣;徐郁阳;杜祎;胡天彦;章怿;邱颖婕

上海市血液中心,上海 200051上海市血液中心,上海 200051上海市血液中心,上海 200051上海市血液中心,上海 200051上海市血液中心,上海 200051上海市血液中心,上海 200051上海市血液中心,上海 200051上海市血液中心,上海 200051

医药卫生

全血及成分血细菌污染室间质量评价血培养输血安全

whole blood and blood componentsbacterial contaminationexternal quality assessmentblood cultureblood transfusion safety

《中国输血杂志》 2026 (8)

1039-1045,7

10.13303/j.cjbt.issn.1004-549x.2026.08.007

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