[1]汪建军,余艳丽,任超杰.胶乳增强免疫比浊法两种定量试剂检测D-二聚体的评价[J].现代检验医学杂志,2015,30(05):141-142.[doi:10.3969/j.issn.1671-7414.2015.05.044]
　WANG Jian-jun,YU Yan-li,REN Chao-jie.Evaluation of Two Kinds of Quantitative Reagents for Detection of D-Dimer by Latex Enhanced Immune Turbidity[J].Journal of Modern Laboratory Medicine,2015,30(05):141-142.[doi:10.3969/j.issn.1671-7414.2015.05.044]
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胶乳增强免疫比浊法两种定量试剂检测D-二聚体的评价()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第30卷
期数:
2015年05期
页码:
141-142
栏目:
研究简报·实验技术
出版日期:
2015-12-10

文章信息/Info

Title:
Evaluation of Two Kinds of Quantitative Reagents for Detection of D-Dimer by Latex Enhanced Immune Turbidity
作者:
汪建军; 余艳丽; 任超杰
陕西省核工业215医院检验科，陕西咸阳712000
Author(s):
WANG Jian-jun; YU Yan-li; REN Chao-jie
Department of Clinical Laboratory， Nuclear Industry 215 Hospital of Shaanxi Province，Shaanxi Xianyang 712000，China
关键词:
D-二聚体; 胶乳增强免疫比浊法; 准确度; 精密度
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2015.05.044
文献标志码:
A
摘要:
目的应用胶乳增强免疫比浊法对两种定量试剂(西门子，九强)检测D-二聚体(D-D)的准确度、精密度及检测结果的一致性进行评价。方法收集新鲜凝血标本50份，应用两种不同试剂在sysmex CA-7000全自动凝血分析仪进行D-二聚体检测，比较其检测结果的一致性，通过对质控品的测定来比较两种试剂的精密度和准确度。结果准确度通过检测自身质控品和对方质控品进行评价，西门子试剂检测D-二聚体的相对偏差分别为-2.0%和-8.7%，九强试剂检测D-二聚体的相对偏差分别为-2.2%和26%；精密度通过20次室内质控结果进行评价，西门子试剂的检测均值为4.9±0.19 mg/L，CV为3.88%，差异无统计学意义(t=0.117，P>0.05)，九强试剂检测的均值为4.5±0.17 mg/L，CV为3.69%，差异无统计学意义(t=0.132，P>0.05)；检测结果一致性的对比显示：在D-D<0.5　mg/L时，两种定量试剂差异无统计学意义(P>0.05)；在0.5　mg/L0.05)；但在D-D>5　mg/L时，九强试剂显著高于西门子试剂，差异具有统计学意义(P<0.01)。结论两种试剂的精密度良好，准确度在检测对方质控品时结果不令人满意，九强试剂在D-D>5 mg/L时的准确度尚需进一步论证。
Abstract:
ObjectiveTo compare the D-Dimer accuracy and precision and consistency of detection results between the 1 and 2 reagent．MethodsSelected 50 fresh samples，detected D-Dimer with the two reagents on sysmex CA-7000 automated blood coagulation analyzer．Compared the consistency of detection results between them，and detected the accuracy and precision by the control material．ResultsIn order to evaluate the accuracy，detected and analysed its quality control material and other quality control material．The relative deviation were -2% and -8.7% respectively for siemens reagent，and the relative deviation were -2.2% and 26.0% for jiuqiang reagent．The precision was evaluated by 20 internal quality control，the mean of D-Dimer for siemens reagent was 4.9±0.19 mg/L，CV was 3.88%，and the difference was not statistically significant (t=0.117，P>0.05)．The mean of D-Dimer for siemens reagent was 4.5±0.17 mg/L，CV was 3.69%，and the difference was not statistically significant (t=0.132，P>0.05)．The contrast of the detection results showed that the difference was not significant (P>0.05)．When D-D<0.5 mg/L or 0.5 mg/L0.05)．But when D-Dimer>5 mg/L，the result of jiuqiang reagent was higher than siemens reagent，and the difference was obvious significance difference (P<0.01)．ConclusionThe two reagents，precision was good，the accuracy was not satisfied in the detection of each other quality control material．In the range of D-Dimer>5 mg/L，the accuracy of the latter had to be testified．

参考文献/References:

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备注/Memo

备注/Memo:
作者简介：汪建军(1979-)，男，硕士，主管检验师，专业：临床检验，Tel：029-32088143，E-mail：wangjianjun790319@163.com。
更新日期/Last Update: 1900-01-01