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

The clinical applicability of a new DIGFA kit for detecting plasma D-dimer

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-D DOT)对234份血浆样本进行测试,比较2种方法的一致性。结果D-D DOT线性范围内相关系数(r)=0.998;总批内、批间变异系数(CV)分别为10.77%和12.81%;总回收率为101.3%。配对χ2检验、Kappa检验(0.95)及Spearman系数(0.87)均显示D-D DOT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。

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.