罗氏尿微量清蛋白检测试剂盒性能评价
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摘要
目的评价罗氏第2代尿微量清蛋白(ALBU2)在Cobas 8000C702全自动生化分析仪上的检测性能。方法 (1)精密度评价:以CLIA′88规定的允许误差TEa为依据,要求重复精密度<1/4TEa,中间精密度<1/3TEa;(2)线性范围及可报告范围评价:采用EP6-A方案,并延伸计算平均稀释回收率,以平均稀释回收率在90%~110%,评价临床可报告范围;(3)携带污染评估:评估血清清蛋白对尿量微量清蛋白检测的携带污染,以携带污染率≤0.5%标准判定;(4)方法比对分析:以Siemens BNⅡ为参考系统,将罗氏Cobas 8000C702与BN2结果进行相关性比对分析。结果重复精密度:低浓度CV为1.98%,高浓度CV为1.64%;中间精密度:低浓度CV为4.35%,高浓度CV为1.20%。线性范围验证:测量范围为5.6~413.55mg/L;临床可报告范围:最大稀释倍数为30倍,临床可报告范围为5.6~12 406.5mg/L。携带污染率:血清清蛋白(42.6g/L)对尿液微量清蛋白(6.9mg/L)的携带污染为0.28%。室内比对:标本浓度在200mg/L时,回归直线为Y=0.896 X+5.049,r2=0.994 4,医学决定水平处系统偏移通过;当标本浓度在201~413.55mg/L时,回归直线为Y=0.848 X-10.44,r2=0.917,医学决定水平处系统偏移未通过。结论罗氏ALBU2在Cobas 8000C702平台上检测能满足临床的需求,不同仪器间的比对,在不同浓度范围内有差异,应根据各自仪器的系统建立独立的参考范围。
Objective To evaluate the detection performance of the cobas8000c702 fully automatic biochemical analyzer for detecting the second generation Roche urine trace albumin(ALBU2).Methods(1)The precise evaluation:with the allowable error stipulated by CLIA 88 as the basis,the requirements were the repeat precision<1/4TEa,and intermediate precision<1/3TEa;(2)the linear range and the evaluation of the reportable range:the EP6-A scheme was adopted,and extend to calculate the average recovery rate of dilution,the clinical reportable range was evaluated by the average dilution recovery of 90%-110%;(3)the carry over pollution assessment:the carry over pollution of serum albumin on urine trace albumin detection was evaluated by the judgment standard of carry over pollution rate of 0.5%;(4)the methodological comparative analysis:with SIEMENS BNⅡas the reference system,the Roche Cobas 8000C702 and the BN2 results were performed the correlation contrastive analysis.Results The repeat precision:low concentration CV=1.98%.high concentration CV=1.64%;intermediate precision:low concentration CV=4.35%,high concentration CV=1.20%;the linear range verification:the measurement range 5.6-413.55mg/L;clinical reportable range:in the maximum diluted multiples of 30 times,the clinical reportable range was 5.6-12 406.5mg/L;the carry over pollution rate:serum albumin(42.6g/L)on urine trace albumin(6.9mg/L),the carry over pollution rate was 0.28%;the indoor comparison:in the concentration within 200mg/L,the regression line was Y=0.896 X+5.049,the correlation coefficient r2=0.994 4,the system shift was passed at the medical decision level.When the specimen concentration within 201-413.55mg/L,the regression line was Y=0.848 X-10.44,the correlation coefficient r2=0.917,the system shift was not passed at the medical decision level.Conclusion The detection of the Roche ALBU2 in the Cobas 8000C702 platform can meet the clinical needs,the comparison among different instruments has difference in different concentration ranges,therefore the independent reference ranges should be established according to the each instrument system。
Objective To evaluate the detection performance of the cobas8000c702 fully automatic biochemical analyzer for detecting the second generation Roche urine trace albumin(ALBU2).Methods(1)The precise evaluation:with the allowable error stipulated by CLIA 88 as the basis,the requirements were the repeat precision<1/4TEa,and intermediate precision<1/3TEa;(2)the linear range and the evaluation of the reportable range:the EP6-A scheme was adopted,and extend to calculate the average recovery rate of dilution,the clinical reportable range was evaluated by the average dilution recovery of 90%-110%;(3)the carry over pollution assessment:the carry over pollution of serum albumin on urine trace albumin detection was evaluated by the judgment standard of carry over pollution rate of 0.5%;(4)the methodological comparative analysis:with SIEMENS BNⅡas the reference system,the Roche Cobas 8000C702 and the BN2 results were performed the correlation contrastive analysis.Results The repeat precision:low concentration CV=1.98%.high concentration CV=1.64%;intermediate precision:low concentration CV=4.35%,high concentration CV=1.20%;the linear range verification:the measurement range 5.6-413.55mg/L;clinical reportable range:in the maximum diluted multiples of 30 times,the clinical reportable range was 5.6-12 406.5mg/L;the carry over pollution rate:serum albumin(42.6g/L)on urine trace albumin(6.9mg/L),the carry over pollution rate was 0.28%;the indoor comparison:in the concentration within 200mg/L,the regression line was Y=0.896 X+5.049,the correlation coefficient r2=0.994 4,the system shift was passed at the medical decision level.When the specimen concentration within 201-413.55mg/L,the regression line was Y=0.848 X-10.44,the correlation coefficient r2=0.917,the system shift was not passed at the medical decision level.Conclusion The detection of the Roche ALBU2 in the Cobas 8000C702 platform can meet the clinical needs,the comparison among different instruments has difference in different concentration ranges,therefore the independent reference ranges should be established according to the each instrument system。
引文
[1]谭琳琳,任君,陈修祝,等.尿微量白蛋白检测在糖尿病肾病早期诊断的意义[J].国际检验医学杂志,2009,30(10):1012.
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[5]Peralta CA,Shlipak MG,Judd S,et al.Detection of chronic kidney disease with creatinine,cystatin C,and urine albumin-to-creatinine ratio andassociation with progression to end-stage renal disease and mortality[J].JAMA,2011,15(305):1545-1552.
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[7]刘冬牯.尿微量白蛋白和β2-微球蛋白联合检测在早期糖尿病肾病患者中的应用价值[J].当代医学,2015,21(13):76-77.
[8]徐艳.尿液分析仪检测尿蛋白与尿微量白蛋白测定结果比对分析[J].中外医疗,2013,32(31):182-184.
[9]梅旭,刘政,邱广斌.罗氏Cobas 8000全自动生化分析仪的性能验证[J].国际检验医学杂志,2014,35(16):2235-2236.
[10]解春宝,传良敏,罗江蓉,等.尿微量白蛋白检测试剂盒性能评价[J].临床检验,2015,25(11):1770-1771.
[2]鹿新红,方海荣.570例糖尿病患者尿微量白蛋白测定结果分析[J].中国现代医生,2008,46(23):119-120.
[3]杨可.尿微量白蛋白检测在老年高血压患者早期肾损害中的临床价值[J].中国卫生标准管理,2015,6(3):48-49.
[4]艾民,颜昌福,夏福纯,等.冠心病患者尿微量白蛋白水平与冠状动脉病变程度的相关性研究[J].四川医学,2015,36(10):1379-1381.
[5]Peralta CA,Shlipak MG,Judd S,et al.Detection of chronic kidney disease with creatinine,cystatin C,and urine albumin-to-creatinine ratio andassociation with progression to end-stage renal disease and mortality[J].JAMA,2011,15(305):1545-1552.
[6]Ireland R.Chronic kidney disease:use of urine albumin and cystatin C levels improves risk stratificationin chronic kidney disease[J].Nat Rev Nephrol,2011,7(6):301-304.
[7]刘冬牯.尿微量白蛋白和β2-微球蛋白联合检测在早期糖尿病肾病患者中的应用价值[J].当代医学,2015,21(13):76-77.
[8]徐艳.尿液分析仪检测尿蛋白与尿微量白蛋白测定结果比对分析[J].中外医疗,2013,32(31):182-184.
[9]梅旭,刘政,邱广斌.罗氏Cobas 8000全自动生化分析仪的性能验证[J].国际检验医学杂志,2014,35(16):2235-2236.
[10]解春宝,传良敏,罗江蓉,等.尿微量白蛋白检测试剂盒性能评价[J].临床检验,2015,25(11):1770-1771.