某国产纤维蛋白原试剂在 Sysmex CA1500血凝仪的临床性能验证

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2．08～3．92 g/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。

Clinical validation of a domestic fibrinogen reagent on coagulometer Sysmex CA1500

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 preci-sion in two levels of quality control respectively.The reference value range was verified by the reagent A in 165 cases of normal clin-ical samples.The fibrinogen detection results in 200 cases of clinical samples were compared between by the reagent A and the rea-gent D.The significance test and the equivalence test were performed.Results The within-run precision CV of 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 CV of 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 -3.92 g/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 in-terval（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.