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检测血浆D-二聚体的新金标斑点渗滤法试剂盒的临床适用性
引用本文:张莉. 检测血浆D-二聚体的新金标斑点渗滤法试剂盒的临床适用性[J]. 检验医学, 2010, 25(1): 30-32
作者姓名:张莉
作者单位:上海交通大学医学院附属新华医院崇明分院检验科,上海,202150
摘    要:目的比较2种金标斑点渗滤法(DIGFA)试剂盒在测定D-二聚体浓度中的临床适用性。方法同时采用NycoCard公司与国产奥普D-二聚体检测试剂盒(D-DDOT)对234份血浆样本进行测试,比较2种方法的一致性。结果D.DDOT线性范围内相关系数(r)=0.998;总批内、批问变异系数(CV)分别为10.77%和12.81%;总回收率为101.3%。配对,检验、Kappa检验(0.95)及Spearman系数(0.87)均显示D—DDOT与NycoCard检测结果有良好的一致性。结论新的DIGFA D-二聚体检测试剂盒与进口NycoCard试剂盒有良好的一致性,能够满足临床需要。

关 键 词:D-二聚体  金标斑点渗滤法  运用  深静脉血栓  肺栓塞

The clinical applicability of a new DIGFA kit for detecting plasma D-dimer
ZHANG Li. The clinical applicability of a new DIGFA kit for detecting plasma D-dimer[J]. Laboratory Medicine, 2010, 25(1): 30-32
Authors:ZHANG Li
Affiliation:ZHANG Li. (Department of Clinical Laboratory, Chongming Branch of Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 202150, China )
Abstract:Objective To compare the clinical applicability of two dot immunogold filtration assay (DIGFA) kits for detecting D-dimer. Methods The kits from NycoCard and Upper (D-D DOT) were used to detect D-dimer in 234 plasma samples. The concordance was compared. Results The linear range of D-D DOT was 0.998;its within-run and between-run coefficients of variation (CV) were 10.77% and 12.81%;its recovery were 101.3%. The results of McNemar test, Kappa value(0.95) and Spearman coefficient(0.87) indicated that two kits had excellent concordance. Conclusions The D-D DOT DIGFA kit has an excellent concordance to the kit from NycoCard and it can meet the needs of clinical application.
Keywords:D-dimer  Dot immunogold filtration assay  Application  Deep vein thrombosis  Pulmonary embolism
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