BS-800M型全自动生化分析仪的临床分析性能评价

目的对迈瑞公司BS-800M型全自动生化分析仪(以下简称BS-800M型分析仪)进行分析性能评价。方法按美国临床和实验室标准化协会(CLSI)相关文件的方法,对BS-800M型分析仪检测12个常规项目的精密度、线性范围、稀释倍数、干扰试验、携带污染等性能进行验证,并与贝克曼公司AU5431型分析仪进行方法学比对。结果BS-800M型分析仪清蛋白(ALB)、肌酐(Cr)、三酰甘油(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、总胆固醇(TC)、载脂蛋白A1(ApoA1)、丙氨酸氨基转移酶(ALT)、总胆红素(TBIL)、尿酸(UA)、尿素(UREA)、葡萄糖(GLU)检测批内检测变异系数均小于允许总误差的1/4,批间检测变异系数小于允许总误差的1/3。线性试验显示,ALB、ALT、GLU等10个项目的最适方程均为一阶线性方程,各项目在临床常见浓度范围内线性良好。除ApoA1外,其他11个项目测定结果与AU5431型分析仪具有良好的一致性。TBIL、TG、血红蛋白(Hb)3种干扰物终浓度分别为427.5mol/L、22.60mmol/L、5.0g/L时,对12个项目测定结果的干扰在临床可接受范围内。12个项目的携带污染率为0.16%~1.43%。高浓度标本经相应倍数稀释后,TG、ALT、UA、UREA、GLU测定结果的相对偏差满足临床需求。结论迈瑞公司BS-800M型分析仪的分析性能能够满足临床应用的要求,适合中小型临床实验室日常使用。

Evaluation of clinical analysis capability of BS-800M automatic biochemical analyzer

Objective To evaluate the clinical analysis capability of BS-800M automatic biochemical analyzer of Mindray compa-ny .Methods According to Clinic and Laboratory Standards Institute(CLSI) guidelines ,precision ,linear range ,dilution ratio ,inter-ference test and carry-over of 12 clinical indicators were analyzed ,and compared with AU5431 automatic biochemical analyzer of Bekman company .Results The within-run precision of the 12 items(ALB ,Cr ,TG ,TBIL ,UA ,UREA ,GLU ,HDL-C ,TC ,ApoA1 , ALT ) of BS-800M analyzer was less than the 1/4 of allowed total error ,and the between-run precision was less than the 1/3 of al-lowed total error .Linear test showed that the optimal equation of the ten items were the first order equation ,and all items were with fine linearity within clinical common concentration range .Except ApoA1 ,the detected results of the other 11 indicators were in good consistency with AU5431 analyzer .When the final concentration of the three interferents ,including total bilirubin ,triacylglycerol , hemoglobin ,were 427 .5 μmol/L ,22 .60 mmol/L and 5 .0 g/Lrespectively ,the interference of the 12 items were clinically accepta-ble .The carry-over rates of the 12 items were 0 .16% - 1 .43% .After dilution of clinical samples ,the relative deviation of alanine aminotransferase ,uric acid ,urea ,glucose and triacylglycerol could fulfill the clinical criteria .Conclusion Clinical analysis capability of BS-800M automatic biochemical analyzer could meet the requirements of clinical applications ,and might be suitable for small and medium sized clinical laboratories .