目的：验证日本积水（Sekisui）医疗株式会生产的FDP试剂盒在日本Sysmex公司CS5100全自动凝血分析仪检测FDP的分析性能。方法：参照临床和实验室标准协会（Clinical and Laboratory Standars Institute，CLSI）及其他相关文献，检测FDP检测系统的精密度、准确性、分析测量范围、可报告范围、样本针的携带污染、抗干扰能力和参考范围，并与试剂说明书的质量性能进行比较。结果：FDP批内变异系数<5%；批间变异系数<5%。FDP的线性方程为Y=0.9853X+1.4031，r2=0.9993，r2>0.975，在2.5~120μg/mL范围内，FDP结果呈线性。检测高值标本时稀释倍数不宜超过8倍，以保证结果的准确性。抗干扰实验：在游离型胆红素和结合型胆红素<20.0 mg/dL，溶血血红蛋白<500 mg/dL，乳糜浊度<3000 CM的情况下，对FDP的检测影响均不明显，相对偏差均<10%。参考区间验证：检测20个健康体检者的FDP值结果均在厂商提供的生物参考区间FDP<5.0μg/mL范围内。结论：日本积水公司生产的FDP试剂盒及标准品和质控品在Sysmex CS5100全自动凝血分析仪上检测FDP系统主要分析性能验证结果与厂家提供的分析性能一致，符合质量目标的要求。%Objective:To verify the Japanese Sekisui medical strains will produce FDP kit in Japan Sysmex CS5100 Automatic Coagulation Analyzer to detect FDP analysis performance.Method:According to clinical and laboratory standards institute and other relevant documents,the FDP system precision,accuracy,measurement range,reportable range,sample carryover needle,the anti-interference ability and the reference range were detected,and quality performance and kit were compared.Result:The within-run coefficients of variations(CV) were less than 5.0%,between-run coefficients of variations(CV)were less than 5.0%.The linear equation of FDP was Y=0.9853X+1.4031,r2=0.9993,r2>0.975,its linear was 2.5-120μg/mL.It was not more than 8 times to detect high value samples to ensure the accuracy of the results.Interference test:there was no obvious interference observed when the concentration of free bilirubin or conjugated bilirubin<20.0 mg/dL,hemoglobin<500 mg/dL, and turbidity chyle<3000 CM in the sample.The relative deviation was<10%.Reference range:the measured results of FDP in 20 normal individuals were all in the reference interval of producers.Conclusion:The main performance index of the reagent for the FDP made in Japanese Sekisui on sysmex CS5100 automatic coagulation analyzer consistent with the analysis of the manufacturer’s performance,and meet the requirements of quality objectives.
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