[1]刘振玲.常规凝血项目测量不确定度的评定[J].医学信息,2020,33(03):165-167.[doi:10.3969/j.issn.1006-1959.2020.03.055]
 LIU Zhen-ling.Evaluation of Uncertainty in Measurement of Routine Coagulation Items[J].Medical Information,2020,33(03):165-167.[doi:10.3969/j.issn.1006-1959.2020.03.055]
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常规凝血项目测量不确定度的评定()

医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
33卷
期数:
2020年03期
页码:
165-167
栏目:
诊疗技术
出版日期:
2020-02-01

文章信息/Info

Title:
Evaluation of Uncertainty in Measurement of Routine Coagulation Items
文章编号:
1006-1959(2020)03-0165-03
作者:
刘振玲
(天津市蓟州区人民医院检验科,天津 301900)
Author(s):
LIU Zhen-ling
(Department of Clinical Laboratory,Jizhou District People’s Hospital,Tianjin 301900,China)
关键词:
不确定度凝血项目能力验证数据
Keywords:
UncertaintyCoagulation itemsProficiency testing data
分类号:
R446.11
DOI:
10.3969/j.issn.1006-1959.2020.03.055
文献标志码:
A
摘要:
目的 评定常规凝血项目测量不确定度,探讨利用室内质控(IQC)及能力验证数据评定测量不确定度方法的可行性。方法 参照CNAS-TRL-001文件,收集2017年9月~2018年8月3个水平的IQC数据和2016~2018年卫生部临检中心组织的6次能力验证数据,采用“自上而下”的评定方法,评定凝血酶原时间(PT)、国际标准化比值(INR)、部分凝血活酶时间(APTT)、血浆纤维蛋白原浓度(FIB)的相对扩展不确定度。结果 各项目的不确定度从水平1到水平3依次为:PT(11.02;11.91;13.10)、INR(13.94;14.67;16.26)、APPT(12.22;13.97;13.24)、FIB(16.17;15.76;15.48)。结论 采用IQC及能力验证数据评定常规凝血项目的不确定度符合CLIA,88目标测量不确定度的要求,是一种简便易行的评定方法,具有良好的应用价值。
Abstract:
Objective To evaluate the measurement uncertainty of conventional coagulation items, and to explore the feasibility of evaluating measurement uncertainty using indoor quality control (IQC) and proficiency testing data.Methods With reference to the CNAS-TRL-001 document, collect three levels of IQC data from September 2017 to August 2018 and six capacity verification data organized by the Clinical Inspection Center of the Ministry of Health from 2016 to 2018. Evaluation method, to assess the relative extended uncertainty of prothrombin time (PT), international standardized ratio (INR), partial thromboplastin time (APTT), and plasma fibrinogen concentration (FIB).Results The uncertainty of each item from level 1 to level 3 is: PT (11.02; 11.91; 13.10), INR (13.94; 14.67; 16.26), APPT (12.22; 13.97; 13.24), FIB (16.17; 15.76; 15.48).Conclusion The IQC and proficiency testing data are used to evaluate the uncertainty of conventional coagulation items in line with the requirements of CLIA, 88 target measurement uncertainty. It is a simple and easy evaluation method with good application value.

参考文献/References:

[1]黄福达,张秀明,傅强,等.血常规项目测量不确定度评定[J].国际检验医学杂志,2015,36(22):3232-3237. [2]中国合格评定国家认可委员会.CNAS-TRL-001:2012医学实验室-测量不确定度的评定与表达[S].北京:中国合格评定国家认可委员会,2015. [3]严能兵,吕辉,李俊枫,等.医学实验室常规凝血检验项目测量不确定度的评定[J].国际检验医学杂志,2014(8):997-998,1000. [4]王蔚,秦妍妍,尹弘毅,等.采用室间质评数据建立常规凝血项目的目标测量不确定度[J].中华检验医学杂志,2017,40(12):942-946. [5]中国合格评定国家认可委员会.CNAS-CL01-G003 测量不确定度的要求[S].北京:中国合格评定国家认可委员会,2018. [6]Tan A,Koh S,Bertoletti A.Immune response in hopatitis B virus infection[J].Cold Spring Harb Perspect Med,2015,15(8):a021428. [7]尚红,王毓三,申子瑜.全国临床检验操作规程[M].4版.北京:人民卫生出版社,2014.

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更新日期/Last Update: 2020-02-01