[1]岑伟明,梁宝环,黄明兰,等.应用WS/T 514-2017新标准建立并验证输血前ELISA定性筛查八项的检出限[J].现代检验医学杂志,2018,33(01):141-144.[doi:10.3969/j.issn.1671-7414.2018.01.001]
　CEN Wei-ming,LIANG Bao-huan,HUANG Ming-lan,et al.Establishing and Verifing Detection Limit for the Eight Items before Blood Transfusion with Enzyme-Linked Immunosorbent Assay by the WS/T 514-2017 Industry Standard Documents[J].Journal of Modern Laboratory Medicine,2018,33(01):141-144.[doi:10.3969/j.issn.1671-7414.2018.01.001]
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应用WS/T 514-2017新标准建立并验证输血前ELISA定性筛查八项的检出限()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第33卷
期数:
2018年01期
页码:
141-144
栏目:
研究简报·实验技术
出版日期:
2018-02-05

文章信息/Info

Title:
Establishing and Verifing Detection Limit for the Eight Items before Blood Transfusion with Enzyme-Linked Immunosorbent Assay by the WS/T 514-2017 Industry Standard Documents
文章编号:
1671-7414(2018)01-141-04
作者:
岑伟明; 梁宝环; 黄明兰; 黄媛萍; 梁越媚; 方凤媚; 隋 洪
东莞康华医院,广东东莞 523080
Author(s):
CEN Wei-ming; LIANG Bao-huan; HUANG Ming-lan; HUANG Yuan-ping; LIANG Yue-mei;  FANG Feng-mei; SUI Hong
Dongguan Kanghua Hospital,Guangdong Dongguan 523080,China
关键词:
酶联免疫吸附试验;  概率单位方案;  检出限
分类号:
R457.1
DOI:
10.3969/j.issn.1671-7414.2018.01.001
文献标志码:
A
摘要:
目的 根据医院等级评定及ISO15189:2012的要求,对输血前酶联免疫法定性筛查八项的检出限进行评价。方法 根据2017年新出台的卫生行业标准WS/T 514-2017:《临床检验方法检出能力的确立和验证》中的概率单位方案建立输血前八项项目的检出限(limit of detection,LoD):在同一套检测系统中,使用2个试剂批号,每个批号连续4天,每天对5个评估浓度值标本重复检测5次,计算对应的命中率,将命中率转化为概率单位,与对应浓度值制作回归模型,将命中率为95%对应的概率单位1.645代入方程式中,所得的浓度值即为LoD估计值; 对上述检出限估计值进行验证,连续3天检测对2个LoD声明浓度附近的标本(由标准物质稀释所得)重复检测4次,计算≥LoD声明的阳性结果百分比,≥临界值87%,则验证成功。结果 各个项目的LoD估计值为:乙型肝炎表面抗原0.100 IU/ml,乙型肝炎表面抗体9.642 mIU/ml,乙型肝炎e抗原0.666 NCU/ml,乙型肝炎e抗体3.700 NCU/ml,乙型肝炎核心抗体0.786 IU/ml,丙型肝炎病毒抗体0.506 NCU/ml,梅毒螺旋体特异性抗体2.236 mIU/ml,人类免疫缺陷病毒0.135 NCU/ml。检出限估计值验证通过。结论 验证项目在该实验室的检测方法及检测系统中的检出限满足要求。
Abstract:
Abstract:Objective To evaluate the limit of detection ofeight enzyme-linked immunosorbent assay(ELISA)according to hospital grade assessment and ISO15189:2012.Methods According to the newhealth industry standard WS/T 514-2017:“Establishment and verification of detection capability for clinical laboratory measurement procedures”,the limit of detection(LoD)was established,in the sameset of detection system,using tworeagent lot,each lot for 5 consecutive days 4 consecutive days to assess the value of the concentration of five specimens were detected repeatedly,calculatedthe corresponding hit rate,then transform into probability units,and the corresponding concentration value production regression model,the hit rate of 95% corresponds to the probability unit 1.645 substituted into the equation,the resulting concentration value was LoD estimates.The detection limit values were tested for 3 consecutive days of detection of two LoD concentrations near the declared concentration of the sample(diluted by the standard material)was detected 4 times repeatedly to calculate the positive result was greater than or equalto the percentage of LoD statement,greater than or equal to the critical valueof 87%,then verified success.Results HBsAg:0.100 IU/ml,HBsAb:9.642 mIU/ml,HBeAg:0.666 NCU/ml,HBeAb:3.700 NCU/ml,HBcAb:0.786 IU /ml,HCV:0.506 NCU/ml,TP:2.236 mIU/ml and HIV:0.135 NCU/ml.The detectionlimit estimates were passed.Conclusion The verification limit of the verification project in the testing method and detection system of the laboratory meet the requirements Objective.

参考文献/References:

[1] 中国合格评审国家认可委员会.CNAS-CL39:2012《医学实验室质量和能力认可准则在临床免疫学定性检验领域的应用说明》[S].北京:CNAS-CL39,2013. China National Accreditation Service for Conformity Assessment.Guidance on the application of accreditation criteria for the medical laboratory quality and competence in the field of clinical immunology[S].Beijing:CNAS-CL39,2013.
[2] 任立明.浅谈输血感染和输血安全[J].中国卫生产业,2017,14(12):28-29. Ren LM.Talk about blood transfusion and safety of blood transfusion[J].China Health Industry,2017,14(12):28-29.
[3] 孙桂香,吴月清.1 026例输血前患者血HBsAg,抗HCV,抗HIV和梅毒抗体检测结果分析[J].标记免疫分析与临床,2015,22(1):18-19. Sun GX,Wu YQ.Analysis of infectious disease test results before transfusion among 1 026 patients[J].Labeled Immunoassays and Clinical Medicine,2015,22(1):18-19.
[4] Clinical and Laboratory Standards Institute.Evaluation of detection capability for clinical laboratory measurement procedure; approved guideline-secondedition[S].Wayne:PA,CLSI EP17-A2,2012.
[5] 谭丽娜,杨泽华,赵克斌.酶联免疫法检测血清乙型肝炎表面抗原的空白限、检出限及定量限的建立与评价[J].中国药物与临床,2013,13(2),144-146. Tan LN,Yang ZH,Zhao KB.The establishment and evaluation of limitof blank,limit of detection and limit of quantitation for detection of serum hepatitis B surface antigens by enzyme-linked immunosorbent assay[J].Chinese Remedies & Clinics,2013,13(2):144-146.
[6] Moretti M,Pieretti B,Sisti D,et al.Analytical performance and clinical decision limit of a new release for cardiac troponin I assay[J].Ann Clin Biochem,2015,52(Pt 1):169-72.
[7] 郭绪晓,柏淑美,张春来,等.基于EP-17 A2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].现代医学检验杂志,2015,30(1):78-81. Guo XX,Bai SM,Zhang CL,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-17 A2[J].Journal of Modern Laboratory Medicine,2015,30(1):78-81.
[8] 中华人民共和国国际卫生和计划生育委员会.WS/T 514-2017.临床检验方法检出能力的确立和验证[S].北京:中国标准出版社,2017:8-9. National Health and Family Planning Commission of the People's Republic of China.WS/T 514-2017.Establishment and verification of detection capability for clinical laboratory measurement procedures[S].Beijing:Standards Press of China,2017:8-9.
[9] 康凤凤,王 薇,王治国.临床实验室检测方法空白限、检出限和定量限评价新方法[J].中国卫生统计,2014,31(5):901-904. Kang FF,Wang W,Wang ZG.The new way evaluation of limit of blank,limit of detection and limit of quantitation in the clinical laboratory[J].Chinese Journal of Health Statistics,2014,31(5):901-904.
[10] 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.The methodology evaluation guide in clinical laboratory[M].Beijing:People's Medical Publishing House,2008:142-167. 收稿日期:2017-10-31 修回日期:2017-12-19

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备注/Memo

备注/Memo:
作者简介:岑伟明(1986-),男,本科,主管技师,研究方向:临床免疫学,E-mail:cwm_1234@qq.com。 通讯作者:隋 洪(1968-),女,主任技师,E-mail:13924929876@139.com。
更新日期/Last Update: 2018-02-07