摘要
目的建立Axceed 260磁微粒全自动化学发光免疫分析仪检测游离前列腺特异性抗原(f-PSA)的空白限(LoB)、最低检出限(LoD)及定量检出限(LoQ)。方法参照美国临床实验室标准化协会2012年颁发的EP17-A2《临床实验室评价检测能力(第2版)》,将f-PSA的空白样品及系列低浓度样品在Axceed 260磁微粒全自动化学发光免疫分析系统进行检测,根据数据的分布规律,采用相应的统计学方法,确定该方法检测f-PSA的LoB、LoD及LoQ。结果 f-PSA的LoB为0.05ng/mL,LoD为0.16ng/mL,LoQ为0.35ng/mL。结论建立的Axceed 260磁微粒全自动化学发光免疫分析系统f-PSA的LoB、LoD、LoQ,其检测能力符合临床检验要求。
Objective To establish the limit of blank （LoB）,the limit of detection （LoD） and the limit of quantitation （LoQ） for the detection of f-PSA by the Axceed 260 automatic magnetic particles chemiluminescence immunoassay （MCLIA） analyzer system.Methods According to CLSI EP17-A2 protocol,f-PSA blank sample and a series of low concerntration samples were performed by the Axceed 260 MCLIA detection.According to the data distribution,the corresponding statistical method was adopted to establish the MCLIA detection of LoB,LoD and LoQ of f-PSA by the manual operation.Results LoB of f-PSA measured by the manual operation was 0.05 ng/mL,LoD was 0.16 ng/mL and LoQ was 0.35 ng/mL.Conclusion The established LoB,LoQ and LoQ of f-PSA in the clinical laboratory,its detection capability meets the clinical requirements.
出处
《检验医学与临床》
CAS
2017年第14期2097-2099,2102,共4页
Laboratory Medicine and Clinic
关键词
游离前列腺特异性抗原
磁微粒化学发光
空白限
检出限
定量检出限
f-PSA
magnetic particles chemiluminescence immunoassay
limit of blank
limit of detection
limit of quantitation
