一种全自动生化分析仪血清质量指数的性能验证  

The Performance Validation of Serum Quality Index of a Biochemical Analyzer

作　　者：邵燕[1] 孙璟[1] 马婷[1] 刘功文 李少青 尹显艳 陶世萍 于洪远[1] SHAO Yan;SUN Jing;MA Ting;LIU Gongwen;LI Shaoqing;YIN Xianyan;TAO Shiping;YU Hongyuan(Laboratory Department,Beijing Aerospace General Hospital,Beijing 100076,China)

机构地区：[1]北京航天总医院检验科,北京100076

出　　处：《标记免疫分析与临床》2025年第1期174-179,211,共7页Labeled Immunoassays and Clinical Medicine

基　　金：国家重点研发计划“国家质量基础的共性技术研究与应用”(编号:ZLJC1706-1-1)。

摘　　要：目的 验证雅培C16000生化分析仪上血清溶血指数(hemolytic index, HI)、黄疸指数(icteric index, II)及乳糜指数(lipemic index, LI)的检测性能是否满足临床需求。方法 参考CNAS-GL037、CNAS-GL038文件方法对本院血清HI、II和LI检测的符合性、精密度与产生物质的相关性及检测方法局限性等性能进行验证。选取本院1周内肉眼可见具有不同程度溶血、黄疸、乳糜的血清标本各49、33、71份,在本院和某三甲医院雅培C16000生化分析仪上同时检测HI、II和LI各1次,并按照厂家给定的判读标准得出半定量结果,采用0~4+表示,计算两家实验室检测结果的总符合率。分别选取1份正常和1份具有一定程度溶血、黄疸及乳糜的血清标本在雅培C16000生化分析上检测HI、II和LI,每份样本测量5批,每批重复4次,计算批内CV和总CV。采用基础血清将高浓度溶血、黄疸、乳糜干扰物进行系列浓度稀释,在雅培C16000生化分析上分别检测HI、II、LI、总胆红素(TBil)和三酰甘油(TG)浓度,在迈瑞5390血液分析仪上检测血红蛋白(HB)浓度。分别以HB、TBil和TG浓度为X轴,HI、II和LI为Y轴做线性回归分析,若R^(2)>0.95,则HI和HB浓度、II和TBil浓度、LI与TG浓度之间具有线性相关关系。采用基础血清将高浓度溶血、黄疸、乳糜干扰物进行系列浓度稀释,在雅培C16000生化分析上分别检测HI、II和LI,分析HI、II和LI之间的相互影响。结果 本院和某三甲医院雅培C16000生化分析仪上检测HI、II和LI结果的一致率分别为98.0%、97.0%和97.2%,比对通过。正常和具有一定程度溶血、黄疸及乳糜的异常血清标本HI、II和LI检测批内CV均小于2.5%,总CV均小于5.0%,符合实验室预期用途。溶血指数HI与HB浓度的线性回归方程为Y=1.0241X+1.0661,R^(2)=0.9986;黄疸指数II与TBil浓度的线性回归方程为Y=0.5446X+37.847,R^(2)=0.9876;乳糜指数LI与TG浓度的线性回归方程为Y=0.6276X-1.0053,R^(2)=0.9998,Objective To validate whether the detection performance of serum hemolytic index(HI), icteric index(II)and lipemic index(LI) on Abbott C16000 biochemical analyzer can meet clinical needs. Methods We validated the compliance, precision, correlation with the producing substances, and limitations of detection methods of serum HI, II, and LI index in our hospital. 49, 33, and 71 serum samples with varying degrees of hemolysis, icterus and chyle visible to naked eyes within one week were selected from our hospital. HI, II and LI were simultaneously tested once on the Abbott C16000 biochemical analyzer in our hospital and a tertiary hospital. Semi-quantitative results were obtained according to the manufacturer's interpretation standards, represented by 0-4+ and the total conformity rate of the two laboratory test results was calculated. We selected one normal and one serum sample with a certain degree of hemolysis, icterus and chyle, then detected HI, II and LI on Abbott C16000 biochemical analysis, with 5 batches of each sample, 4 times for each batch and calculated intra batch CV and total CV. High concentrations of hemolysis, icterus and chyle interferents were diluted in a series of concentrations using basic serum. HI, II, LI. Total bilirubin(TBil) and triglyceride(TG) concentration of above solutions were detected on Abbott C16000 biochemical analysis and hemoglobin(HB) concentration was detected on Mindray 5390 blood analyzer. Linear regression analysis was performed with HB, TBil and TG concentrations as the X-axis and HI, II and LI as the Y-axis.R^(2)>0.95 was considered as a linear correlation between HI and HB concentrations, between II and TBil concentrations, between LI and TG concentrations. We used basic serum to dilute high concentrations of hemolysis, icterus and chyle interferents in a series of concentrations and detected HI, II and LI on Abbott C16000 biochemical analysis and analyzed the mutual influence between HI, II and LI. Results The consistency rates of HI, II, and LI results detected on Abb

关 键 词：血清质量指数 性能验证 溶血 黄疸 乳糜 

分 类 号：R-331[医药卫生]