Sysmex CS-5100全自动血凝仪检测纤维蛋白(原)降解产物性能评价

Performance evaluation of Sysmex CS-5100 automatic coagulometer for detecting fibrinogen degradation product

目的：通过免疫比浊法评价Sysmex CS-5100全自动血凝仪检测纤维蛋白（原）降解产物（FDP）的性能。方法：随机选择门诊及住院患者60份血样,参照仪器选用Sysmex CA-1500全自动血凝仪,依据CLSI系列文件,对FDP检测的批内、批间精密度,分析测量范围,临床可报告范围等性能指标进行评估,并采用血红蛋白（Hb）、胆红素（TBi L）、甘油三酯（TG）、胆固醇（TC）4种干扰物进行干扰实验。结果：批内和批间变异系数（cofficient of variation,CV）值均小于15%;Sysmex CS-5100与Sysmex CA-1500全自动血凝仪具有良好的线性关系（P=0.103,r=0.986）;FDP的测量线性范围在0-80 mg/L之间,最适稀释倍数为1∶8,临床可报告范围为2.0-640 mg/L;4种干扰物质影响度均小于±10%。结论：Sysmex CS-5100全自动血凝仪检测FDP各项性能均达到要求,能够保证检验质量。

Objective To evaluate Sysmex CS-5100 automatic coagulometer for detection of fibrinogen degradation product（FDP） by immunoturbidimetry. Methods Totally 60 blood samples of the outpatient and inpatient were randomly selected and detected with Sysmex CS-5100 automatic coagulometer for the between-run precision, within-run precision, measurement range, clinical reportable range and etc of FDP based on CLSI series of documents. Four interferents were involved in the interference test such as hemoglobin, bilirubin, triglyceride and cholesterol, and Sysmex CA-1500 coagulometer was used for reference. Results The within-run and between-run CV values were both less than 15%. Sysmex CS-5100 automatic coagulometer gained high linear correlation with Sysmex CA-1500 automatic coagulometer（P =0.103,r =0.986）. The measurement range of Sysmex CS-5100 automatic coagulometer was between 0 and 80 mg/L, and the optimal dilution ratio was1∶ 8. The clinical reportable range was between 2.0 and 640 mg/L, and the influencing degrees of the four interferents were all restrained in the range from-10% to ＋10%. Conclusion Sysmex CS-5100 automatic coagulometer can be used for FDP detection.