基于EP-17A2的胶体金法检测粪便隐血的空白限、检出限及定量限的建立及评价  

Establishment and Evaluation of Blank Limit, Detection Limint and Quantitation Limit of Fecal Occult Blood Tests with Colloidal Gold Method Based on the Document of EP-17A2

作　　者：郭绪晓[1] 柏淑美[1] 张春来[1] 袁长金[1] 李金星[1] 

机构地区：[1]山东中医药大学附属医院检验科,济南250011

出　　处：《现代检验医学杂志》2015年第1期78-81,共4页Journal of Modern Laboratory Medicine

摘　　要：目的：参考美国临床实验室标准化委员会（CLSI）发布的《临床实验室检验程序检测能力评价指南（第二版）》（EP-17A2）文件，探讨粪便隐血（FOB）胶体金法检测能力，建立该实验室的空白限（LOB）、检出限（LOD）及定量限（LOQ），减少弱阳性标本漏检率，并为胶体金法的检测限提供定量评价方法。方法使用人游离血红蛋白（f-Hb）ELISA试剂盒检测新鲜全血制备的系列低浓度的血红蛋白溶液，制定校准曲线，将粪便隐血的空白样本及一系列的血红蛋白低浓度样本使用胶体金试纸条进行检测，利用 Nato Checker710对显色带进行定量检测，并对定量结果进行统计分析，建立胶体金法检测粪便隐血的空白限、检出限及定量限。结果空白限为99.01 ng／ml，检出限为340.48 ng／ml，定量限为354.9 ng／ml。结论参考CLSI EP17-A2文件建立的检测限比常规方法建立的检测限科学合理，优于肉眼判断结果，更能满足临床实验室的质量要求和临床早期诊疗的需求；为提高实验室质量管理水平，每批次粪便隐血应根据此方法建立检测限，以及应用于其它项目胶体金法检出限的建立。Objective To explore colloidal gold method used to detect fecal occult blood tests（FOB）detection capability and establish the laboratory standard operation of detecting FOB limit of blank（LOB）,limit of detection （LOD）and quantification limit （LOQ）according to the CLSI document《Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures;Approved Guideline-Second Edition》（EP17-A2）,in order to reduce the false negative rate of the weakly positive samples,and to provide a way of quantitative detection for qualitative detection of colloidal gold method.Methods Detected series of solution of hemoglobin made of dissolved fresh whole blood with the ELISA kit of human free hemoglobin,and established the standard curve of detection of FOB with colloidal gold method.Detected the blank samples and a series of low concentration samples with the colloidal gold test strip of FOB and measured the color bands by the Nato Checker710.The quantitative results obtained were statistically analysised by SPSS 19.0 and calculated blank limit,detection limit and quantification limit.Results The LOB,LOD and LOD were 99.01,340.48 and 354.9 ng/ml according to the methods in CLSI EP1 7-A2 ducument.Conclusion The detection limits established by CLSI EP1 7-A2 document was more scientific in judgement positive or negative to FOB than which used naked eye and can meet the clinical laboratory and clinical doctor requirement better.Clinical laboratories should be strictly in detection limits of reagents in order to ensure their effectiveness,and should be generaly to other tests based on colloidal gold method.

关 键 词：胶体金法 粪便隐血 空白限 检出限 定量限 

分 类 号：R446.133[医药卫生—诊断学]