摘要
目的验证由日本积水（SEKISUI）医疗株式会社生产的FDP检测试剂盒在STAGO STA-R全自动血凝分析仪上的分析性能。方法参照美国临床实验室标准化研究所（CLSI）系列文件和其他相关文献的实验方案,对FDP试剂盒应用在STAGO STA-R全自动血凝分析仪上检测FDP的精密度、检测限、线性范围、准确度、临床可报告范围和参考范围等性能进行验证,并与试剂说明书提供的质量性能进行比较。结果 FDP批内不精密度小于5.0%;批间不精密度小于10.0%,检测限为0.44mg/L小于说明书提供的检测限,符合要求。FDP的线性方程为：Y=1.003 X＋0.675,r2=0.995,检测范围为0.44-150.00mg/L。干扰试验：在总胆红素小于220μmol/L,血红蛋白小于4.0g/L,三酰甘油小于7.5mmol/L的情况下,对FDP测定结果影响不明显,其相对偏差均小于10%。参考范围区间：20例健康者的FDP的检测结果均在厂商的生物参考区间范围内。结论日本积水医疗株式会社生产的纤维蛋白（原）降解产物（FDP）试剂盒应用在STAGO STA-R全自动血凝分析仪上,主要性能指标符合要求。
Objective To verify the analytical performance of fibrin/fibrinogen degradation products（FDP）detection on STAGO STA-R automatic coagulation analyzer by using the FDP kits made in Sekisui Medical CO.,LTD.Methods In this study,the validations of FDP′s precision,detection limit,linear range,accuracy,the clinical allowable range and reference range were according to a series of files of American clinical laboratory standardization institute（CLSI）and other relevant experimental documents and compared with its quality performance which showed in kit introductions.Results Precision：The within-run coefficients of variations（CV）were less than 5.0%,between-run coefficients of variations were less than 10.0%.The detection limit of FDP was 0.44mg/L.It was less than that in the kit introductions,the detection 1imit meets the requirement.The linear equation of FDP was Y=1.003 X＋0.675,r2=0.995,its 1inear range was 0.44-150.00mg/L.Interference test：there was no obvious interference observed when the concentration of total bilirubin 〈220μmol/L,hemoglobin〈4.0g/L and triglyceride〈7.5 mmol/L in the sample.The relative deviation was〈10%.Reference range：the measured results of FDP in 20 normal individuals were a11 in the reference interval of producers.Conclusion The main performance index of FDP kits made in Sekisui Medical CO,LTD is comply with the requirements on STAGO STA-R automatic coagulation analyzer.
出处
《国际检验医学杂志》
CAS
2015年第14期2040-2042,共3页
International Journal of Laboratory Medicine
