【摘要】 目的某国产纤维蛋白原凝固法-Clauss法试剂在日本Sysmex CA1500血凝仪上的临床性能验证。方法国产纤维蛋白原试剂为A试剂,德国西门子Dade Thrombin Reagent试剂为D试剂,均采用Clauss法,分别测试两个水平质控品的批内精密度、批间精密度;165例正常临床样本用A试剂进行参考值范围验证;用A试剂和D试剂的200例临床样本纤维蛋白原结果比对,进行显著性检验和等效性检验。结果 A试剂和D试剂两个水平质控的批内精密度CV分别为4.28%、6.98%和3.45%、5.22%,A试剂和D试剂两个水平质控的批间精密度CV分别为6.23%、10.34%和6.20%、9.89%,差异均无统计学意义(P>0.05);A试剂参考值范围为2.08~3.92g/L;A试剂和D试剂临床样本的纤维蛋白原结果比对,差异有统计学意义(P=0.025);但是,两组试剂结果均数之差的90%双侧可信区间(90%CI:-0.09,0.15)位于等效区间(-0.27,0.27)内。结论国产纤维蛋白原凝固法-Clauss法试剂结果可靠,适用于日本Sysmex CA1500血凝仪,和德国西门子Dade试剂临床应用等效。更多还原

【Abstract】 Objective To validate the clinical performance of a domestic fibrinogen reagent by freezing method(Clauss method)on the coagulometer Japan Sysmex CA1500.Methods The domestic fibrinogen reagent as the reagent A and the Germany Siemens Dade thrombin reagent as the reagent D,the Clauss method was adopted to measure the within-run precision and between-run precision in two levels of quality control respectively.The reference value range was verified by the reagent A in 165cases of normal clinical samples.The fibrinogen detection results in 200cases of clinical samples were compared between by the reagent A and the reagent D.The significance test and the equivalence test were performed.Results The within-run precision CVof the reagent A and D in two levels of quality control were 4.28%,6.98%and 3.45%,5.22%respectively,the between-run precision CVof the reagent A and D in two levels of quality control were 6.23%,10.34% and 6.20%,9.89%respectively,the differences had no statistical significance(P>0.05).The reference value range of the reagent A was 2.08-3.92g/L.The fibrinogen detection results of the clinical samples by the reagent A and D had the statistically significant differences(P=0.025).But the 90%bilateral confidence interval(90%CI:-0.09,0.15)of the difference in the mean detection results by these two reagents located in the equivalent interval(-0.27,0.27).Conclusion The domestic fibrinogen reagent for Clauss method has reliable detection results and is suitable for the coagulometer Japan Sysmex CA1500,which is equivalent to the clinical application of Germany Siemens Dade thrombin reagent.更多还原