摘要
目的采用两种方法评估冰冻人血清孕酮标准物质在临床常用检测系统中的互换性,为基质标准物质的互换性评价提供参考。方法收集30单人份新鲜血清样品,其孕酮浓度覆盖常规检测范围,分别采用参考方法和3个临床常规系统进行检测。随后采用最小二乘法回归(OLS回归)和国际临床化学与检验医学联合会推荐的偏倚差值法,对两浓度标准物质在3个常规检测系统中的互换性进行分析。结果OLS回归分析结果显示,两浓度标准物质在3个常规系统中均具有良好互换性。而偏倚差值法显示,低浓度标准物质在罗氏和西门子的偏倚与临床允许偏倚范围部分重叠,互换性无法判定。其余标准物质在3系统间互换性良好。结论OLS回归方法和IFCC推荐的偏倚差值法基于不同的评价原理建立互换性评估模型,各有优缺点,在实际应用中可结合采用。
Objective To evaluate the commutability of serum-based reference material for progesterone using two independent methods.Methods Thirty individual fresh serum samples were collected for the analysis,with progesterone concentrations covering the routine testing range.The clinical samples and reference material were measured by the reference measurement procedure and three clinical systems.Subsequently,the commutability of the reference material was assessed through ordinary least squares(OLS)regression analysis and the difference in bias method recommended by International Federation of Clinical Chemistry and Laboratory Medicine(IFCC).Results The OLS method indicated that both reference materials were commutable in all three routine systems.The difference in bias method revealed that the Level 1 reference material partially overlapped with the acceptable bias range in the Roche and Siemens systems,indicating their commutability could not be determined.Reference material of Level 2 was commutable across all platforms.Conclusion The commutability of progesterone reference materials is evaluated by OLS regression method and difference in bias method,which are based on different principles,each with its own advantages and disadvantages.These two methods can be applied in combination in clinical practice.
作者
黄飞
陈慕萱
王建兵
张乔轩
严君
展敏
黄迪
张鹏伟
黄宪章
韩丽乔
HUANG Fei;CHEN Muxuan;WANG Jianbing;ZHANG Qiaoxuan;YAN Jun;ZHAN Min;HUANG Di;ZHANG Pengwei;HUANG Xianzhang;HAN Liqiao(Department of Laboratory Medicine,The Second Affiliated Hospital of Guangzhou University of Chinese Medicine(Guangdong Provincial Hospital of Chinese Medicine),Guangzhou 510120,China;Second Clinical Medical College,Guangzhou University of Chinese Medicine,Guangzhou 510405,China)
出处
《标记免疫分析与临床》
2025年第10期2160-2165,2200,共7页
Labeled Immunoassays and Clinical Medicine
基金
国家科技重大专项2024年度“四大慢病重大专项”(编号:2024ZD0533000,2024ZD0533002)
广东省中医院中医药科学技术研究专项资助(编号:YN2022QN16)。
关键词
孕酮
标准物质
互换性
最小二乘法
IFCC-偏倚差值法
临床实验室
Progesterone
Reference material
Commutability
Ordinary least squares
IFCC-recommended difference in bias method
Clinical laboratory
