Clinical validation of a domestic fibrinogen reagent on coagulometer Sysmex CA1500 / 国际检验医学杂志

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 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.