摘要
目的:对医疗机构和体外诊断试剂生产企业的从业人员开展体外诊断试剂参考区间影响因素认知调查,为规范体外诊断试剂参考区间的确定提供支持。方法:采用在线调查数据平台软件,对浙江省内的111家体外诊断试剂生产企业及其与全国154家医疗机构体外诊断试剂相关人员进行体外诊断试剂参考区间影响因素认知的在线问卷调查,计算并分析影响体外诊断试剂参考区间中的参考区间来源、参考个体入排标准、参考样本要求、检测条件和数据统计分析5个类型中41个指标的影响程度评分。结果:在线问卷调查共收到有效调查表446份,其中生产企业312份,医疗机构154份。在影响参考区间的5个类型评分中,检测条件分数最高(3.37分),参考区间来源分数最低(2.50分);在41个指标的影响程度评分中,高分数分别为检测条件中分析仪器的精密度和稳定性(3.56分)、参考样本要求中样本储存时间(3.47分)和样本存储条件(3.52分);低分数为参考区间来源中的引用资料(2.39分)和参考个体入排标准中的种族差异(2.53分)。结论:生产企业和技术审评机构在评价体外诊断试剂参考区间确定资料时,应考虑引用资料的适用性、权威性和时效性,优先考虑行业标准。
Objective:To conduct an investigation on the cognition of the influencing factors of the reference interval for the practitioners of medical institutions and manufacturers of in vitro diagnostic reagents,so as to provide support for regulating the determination of the reference intervals of in vitro diagnostic reagents.Methods:An online investigation of the cognition of influencing factors of reference interval was conducted by using the online survey data platform among the related practitioners of in vitro diagnostic reagents in 111 manufacturers of in vitro diagnostic reagents in Zhejiang Province and 154 medical institutions nationwide.The scores of effect degrees of 41 indicators in the origin of reference interval,the standards of inclusion and exclusion of reference individual,the requirement of reference sample,detection condition and statistical analysis of data,which affected the reference interval of in vitro diagnostic reagents,were calculated and analyzed.Results:A total of 446 valid questionnaires were obtained,including 312 questionnaires from manufacturers and 154 questionnaires from medical institutions.In 5 types of scores which affected reference interval,the score of detection condition was the highest(3.37 scores),and the score of the origin of reference interval was the lowest(2.50 scores).In scores of effect degrees of 41 indicators,the high scores were precision and stability(3.56 scores)of analytical instrument in detection condition,the storage time(3.47 scores)and storage condition(3.52 scores)of sample in the requirement of reference sample.In addition,the low scores were cited literature(2.39 scores)in the origin of reference interval and the racial difference(2.53 scores)in standards of inclusion and exclusion of reference individual.Conclusion:Manufacturers and institutions of review and evaluation of technique should consider the applicability,authority and timeliness of cited literature,and give priority to industry standards when they evaluate the determination materials of refer
作者
叶朝付
季聪华
寇艳芹
王宇航
何蕊
YE Chao-fu;JI Cong-hua;KOU Yan-qin(Department of Review and Evaluation,Center for Medical Device Evaluation of Zhejiang Province,Hangzhou 311121,China;不详)
出处
《中国医学装备》
2022年第5期142-145,共4页
China Medical Equipment
基金
浙江省科学技术厅资助项目(2021C35085)“浙江省体外诊断试剂生产企业参考区间一致化建设的对策研究”。
关键词
体外诊断试剂
参考区间
影响因素
来源多样性
In vitro diagnostic reagent
Reference interval
Influence factor
Diversity of sources
