[1]郭绪晓,柏淑美,张春来,等.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[J].现代检验医学杂志,2015,30(01):78-81.[doi:10.3969/j.issn.1671-7414.2015.01.021]
　GUO Xu-xiao,BAI Shu-mei,ZHANG Chun-lai,et al.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[J].Journal of Modern Laboratory Medicine,2015,30(01):78-81.[doi:10.3969/j.issn.1671-7414.2015.01.021]
点击复制

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()
分享到：

《现代检验医学杂志》[ISSN:/CN:]

卷:
第30卷
期数:
2015年01期
页码:
78-81
栏目:
论著
出版日期:
2015-01-30

文章信息/Info

Title:
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
文章编号:
1671-7414(2015)01-078-04
作者:
郭绪晓; 柏淑美; 张春来; 袁长金; 李金星
山东中医药大学附属医院检验科,济南 250011
Author(s):
GUO Xu-xiao; BAI Shu-mei; ZHANG Chun-lai; YUAN Chang-jin; LI Jin-xing
Department of Clinical Laboratory,Affiliated Hospital of Shandong Traditional Medical University,Jinan 250011,China
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
DOI:
10.3969/j.issn.1671-7414.2015.01.021
文献标志码:
A
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99.01ng/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。
Abstract:
Objective To explore colloidal gold method usedto detect fecal occult blood tests(FOB)detection capability and establish thelaboratory 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 freshwhole blood with the ELISA kit of human free hemoglobin,and established the standard curve of detection of FOB with colloidal gold method.Detected the blanksamples 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 themethods in CLSI EP17-A2 ducument.Conclusion The detection limits established by CLSI EP17-A2 document was more scientific in judgementpositive or negative to FOB than which used naked eye and can meet the clinicallaboratory and clinical doctor requirement better.Clinical laboratories shouldbe strictly in detection limits of reagents in order to ensure their effectiveness,and should be generaly to other tests based on colloidal gold method.

参考文献/References:

[1] 刘成玉,罗春丽.临床检验基础[M].5版.北京:人民卫生出版社,2012:198-199. Liu CY,Luo CL.Basic clinical laboratory medicine[M].5th Edition.Beijing:People's Medical Publishing House,2012:198-199.
[2] Lucidarme O,Cadi M,Berger G,et al.Cost-effectiveness modeling of colorectal cancer:computed tomography vs colonography colonoscopy or fecal occultblood tests[J].Eur J Radiol,2011,81(7):1413-1419.
[3] Clinical Laboratory Standards Institute.Evaluation of detection capability for clinical laboratory measurement procedures; Approved guideline-second edition[M].Wayne:PA CLSI Document EP17-A2,2012.
[4] Chiang CH,Jeng JE,Wang WM,et al.A comparative study of three fecal occult blood tests in upper gastrointestinal bleeding[J].Kaohsiung J Med Sci,2006,22(5):223-228.
[5] 芦宏凯,韩呈武,刘海霞.两种便潜血检测方法的评价与应用[J].现代检验医学杂志,2011,26(1):114-116. Lu HK,Han CW,Liu HX.Evaluations and applica tions on two kinds detection methods of fecal occult blood[J].Journal of Modern Laboratory Medicine,2011,26(1):114-116.
[6] 周 强,王忠英,谢彩修,等.模拟消化道出血时大便潜血试验金标法的研究[J].检验医学与临床,2010,7(24):2689-2691. Zhou Q,Wang ZY,Xie CX,et al.Research on colloidal gold method of fecaloccult blood testing in simulating gastrointestinal hemorrhage[J].LaboratoryMedicine and Clinic,2010,7(24):2689-2691.
[7] 杨有业,张秀明.临床检验方法学评价[M].北京:人民卫生出版社,2008:142-167. Yang YY,Zhang XM.Clinical testing methodology[M].Beijing:People's Medical PublishingHouse,2008:142-167.
[8] Linnet K,Kondratovich M.Partly nonparametricapproach for determining the limit of detection[J].Clin Chem,2004,50(4):732-740.

相似文献/References:

[1]童　伟,陈登奕,陈俊文,等.2019-nCoV 总抗体两种免疫学检测方法的应用评价[J].现代检验医学杂志,2020,35(02):80.[doi:10.3969/j.issn.1671-7414.2020.02.023]
　TONG Wei,CHEN Deng-yi,CHEN Jun-wen,et al.Application Evaluation of Two Immunological Detection Methodsof 2019-nCoV Specific Antibodies[J].Journal of Modern Laboratory Medicine,2020,35(01):80.[doi:10.3969/j.issn.1671-7414.2020.02.023]
[2]王　丹,于海立,张露方,等.国产新型冠状病毒抗体胶体金法检测试剂盒在低流行区应用的诊断效果评价[J].现代检验医学杂志,2021,36(03):103.[doi:10.3969/j.issn.1671-7414.2021.03.024]
　WANG Dan,YU Hai-li,ZHANG Lu-fang,et al.Evaluation of Two Different Domestic Colloidal Gold Assay Kit forNew Coronavirus Antibody in Low Endemic Areas[J].Journal of Modern Laboratory Medicine,2021,36(01):103.[doi:10.3969/j.issn.1671-7414.2021.03.024]
[3]尚佳文,徐文娜,许南松,等.mCIM 和碳青霉烯酶抑制剂增强试验检测CRE 和CRPA 产酶表型的方法学评价[J].现代检验医学杂志,2023,38(03):165.[doi:10.3969/j.issn.1671-7414.2023.03.030]
　SHANG Jia-wen,XU Wen-na,XU Nan-song,et al.Methodological Evaluation of mCIM and Carbapenemase Inhibitor-enhancing Assays to Detect CRE and CRPA Enzyme Producing Phenotypes[J].Journal of Modern Laboratory Medicine,2023,38(01):165.[doi:10.3969/j.issn.1671-7414.2023.03.030]

备注/Memo

备注/Memo:

作者简介:郭绪晓(1977-),男,硕士,主管技师,主要研究方向为定量定性检测项目的性能评价和质量控制,Tel:13793188381,E-mail:guoxuxiao180@163.com。
通讯作者:柏淑美,Tel:0531-68616500。
更新日期/Last Update: 2015-01-30