3种肌酐测定方法的分析性能评价
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摘要
目的系统评价亚胺水解酶法(简称紫外酶法)、肌氨酸氧化酶法(简称氧化酶法)及苦味酸法测定肌酐的分析性能。方法按美国临床和实验室标准化协会EP5-A2、EP6-A、EP9-A2、EP7-A2等文件要求,采用罗氏Cobas c702全自动生化分析仪对3种肌酐测定方法的精密度、线性范围、可报告范围、方法学比对、药物干扰、试剂稳定性等性能指标进行评价。结果紫外酶法、氧化酶法及苦味酸法的批内精密度和批间精密度分别小于1/4允许总误差(TEa)和1/3TEa。紫外酶法、氧化酶法及苦味酸法的线性范围分别为4～2 017、8～1 966、3～1 310μmol/L;可报告范围分别为4～20 160、8～51 900、3～10 080μmol/L。3种方法具有良好的相关性(R2>0.99)。羟苯磺酸钙≥5.24μg/mL、酚磺乙胺≥0.016g/L时氧化酶法存在负干扰;其他2种方法在药物的最大剂量下不受干扰。苦味酸法在不定标的情况下待机在控时间只有2d,随后检测结果逐日明显下降,而其他2种方法稳定性较好。结论紫外酶法是3种肌酐测定方法中最为可靠的方法。
Objective To evaluate the results of plasma creatinine determined by imide Hydrolase method(hereinafter referred to as UV enzymatic method),sarcosine oxidase enzymatic method and Jaffémethod on biochemical Analyzer Cobas 8000 c702.Methods According to the American clinical and laboratory Standards Institute(CLSI)guidelines EP5-A2,EP6-A,C28-A2,EP9-A2,EP7-A2 and other documents,the precisions,linear ranges,reportable ranges,methodological comparisons,drug interferences,reagents stability of three methods for determination of creatinine were evaluated.Results The within-run precision and between-run precision of three methods were less than 1/4 TEa and 1/3 Tea,respectively.The linear ranges of UV enzymatic method,sarcosine oxidase enzymatic method and Jaffémethod were 4-2 017μmol/L,8-1 966.5μmol/L,and3-1 310.5μmol/L respectively,and their reportable ranges were as follows:4-20 160μmol/L,8-51 900μmol/L and 3-10 080μmol/L.The methodological comparison shows that these three above-mentioned methods correlate to each other very well with a correlation coefficient of more than 0.99.However,in interference test,we found that the sarcosine oxidase enzymatic method of creatinine quantification could be affected significantly by the negative interference of the presence of 5.24μg/mL calcium dobesilate or 0.016 g/L etamsylate,but there were no marked difference in the other two methods even under the maximum dose.In the stability of reagent within the instrument after open,the reagents of Jaffémethod without calibration could maintain stability only two days and show obvious decreasing trend,but the reagents were more stable in the other two methods.Conclusion Based on the above data,we presented the view that UV enzyme method is the most reliable in these three above-mentioned methods of detecting creatinine.
Objective To evaluate the results of plasma creatinine determined by imide Hydrolase method(hereinafter referred to as UV enzymatic method),sarcosine oxidase enzymatic method and Jaffémethod on biochemical Analyzer Cobas 8000 c702.Methods According to the American clinical and laboratory Standards Institute(CLSI)guidelines EP5-A2,EP6-A,C28-A2,EP9-A2,EP7-A2 and other documents,the precisions,linear ranges,reportable ranges,methodological comparisons,drug interferences,reagents stability of three methods for determination of creatinine were evaluated.Results The within-run precision and between-run precision of three methods were less than 1/4 TEa and 1/3 Tea,respectively.The linear ranges of UV enzymatic method,sarcosine oxidase enzymatic method and Jaffémethod were 4-2 017μmol/L,8-1 966.5μmol/L,and3-1 310.5μmol/L respectively,and their reportable ranges were as follows:4-20 160μmol/L,8-51 900μmol/L and 3-10 080μmol/L.The methodological comparison shows that these three above-mentioned methods correlate to each other very well with a correlation coefficient of more than 0.99.However,in interference test,we found that the sarcosine oxidase enzymatic method of creatinine quantification could be affected significantly by the negative interference of the presence of 5.24μg/mL calcium dobesilate or 0.016 g/L etamsylate,but there were no marked difference in the other two methods even under the maximum dose.In the stability of reagent within the instrument after open,the reagents of Jaffémethod without calibration could maintain stability only two days and show obvious decreasing trend,but the reagents were more stable in the other two methods.Conclusion Based on the above data,we presented the view that UV enzyme method is the most reliable in these three above-mentioned methods of detecting creatinine.
引文
[1]陈文彬,潘祥林.诊断学[M].8版.北京:人民卫生出版社,2013:342-343.
[2] WEYKAMP C,KUYPERS A,BAKKEREN D,et al.Creatinine,Jaffe,and glucose:another inconvenient truth[J].Clin Chem Lab Med,2015,53(12):e347-349.
[3] LIPPI G,BROCCO G,FRANCHINI M,et al.Comparison of serum creatinine,uric acid,albumin and glucose in male professional endurance athletes compared with healthy controls[J].Clin Chem Lab Med,2004,42(6):644-647.
[4] GREENBERG N,ROBERTS W L,BACHMANN L M,et al.Specificity characteristics of 7commercial creatinine measurement procedures by enzymatic and Jaffe method principles[J].Clin Chem,2012,58(2):391-401.
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[7]温冬梅,张秀明,吴剑杨,等.应用CLSI EP5-A2文件评价生化检测系统的精密度性能[J].检验医学与临床,2010,7(19):2096-2098.
[8]黄志宏,付文金,汤慧华,等.多项式线性评价在自建生化检测系统中的初步应用[J].检验医学与临床,2012,9(1):93-96.
[9] DELANAYE P,CAVALIER E,POTTEL H.Serum creatinine:not so simple[J].Nephron,2017,136(4):302-308.
[10]马恺,秦培华.临床实验室分析前影响因素的探讨与对策研究[J].国际检验医学杂志,2011,32(16):1908-1909.
[11]戴莹洁,周勇,陈文举,等.羟苯磺酸钙对肌氨酸氧化酶法和苦味酸法检测肌酐的干扰[J].中国乡村医药,2017,24(15):46-47.
[12]倪莉,王晓欧,林应宝,等.酚磺乙胺对酶法测定血清肌酐的干扰及其纠正方法[J].中国卫生检验杂志,2017,27(14):2009-2011.
[13]程涌江,李丽,陈海鸣.酚磺乙胺对不同方法测定肌酐的干扰[J].检验医学与临床,2011,8(16):1939-1940.
[14]刘芳龙,刘伟.胆红素对血清肌酐测定结果的干扰及原因分析[J].中国医药指南,2014,12(15):230-231.
[15]温勇,玉韦勇.胆红素对肌酐测定的影响[J].吉林医学,2013,34(35):7377-7378.
[16]殷立奎,邓文涛,马华山.胆红素对肌酐测定的影响分析[J].中国医药导报,2008,5(7):90-91.
[17]江俊铮,谢梦禹,张卫,等.维生素C对肌氨酸氧化酶法检测血清肌酐干扰的定量分析[J].中华实用诊断与治疗杂志,2012,26(1):64-66.
[18]汪开华.维生素C对三种常用肌酐测定方法的干扰[J].国际检验医学杂志,2012,33(11):1385-1386.
[19]程海平,廖璞.血清中肌酐的检测方法及其进展[J].检验医学与临床,2009,6(19):1682-1684.
[20]戴新华,方向,全灿,等.血清中肌酐的检测方法及其进展[J].分析测试学报,2007,26(5):763-767.
[2] WEYKAMP C,KUYPERS A,BAKKEREN D,et al.Creatinine,Jaffe,and glucose:another inconvenient truth[J].Clin Chem Lab Med,2015,53(12):e347-349.
[3] LIPPI G,BROCCO G,FRANCHINI M,et al.Comparison of serum creatinine,uric acid,albumin and glucose in male professional endurance athletes compared with healthy controls[J].Clin Chem Lab Med,2004,42(6):644-647.
[4] GREENBERG N,ROBERTS W L,BACHMANN L M,et al.Specificity characteristics of 7commercial creatinine measurement procedures by enzymatic and Jaffe method principles[J].Clin Chem,2012,58(2):391-401.
[5]中华人民共和国卫生部医政司.全国临床检验操作规程[J].3版.南京:东南大学出版社,2006:791-798.
[6]张建平,王治国.肌酐检测的准确性问题研究[J].国际检验医学杂志,2008,29(6):501-503.
[7]温冬梅,张秀明,吴剑杨,等.应用CLSI EP5-A2文件评价生化检测系统的精密度性能[J].检验医学与临床,2010,7(19):2096-2098.
[8]黄志宏,付文金,汤慧华,等.多项式线性评价在自建生化检测系统中的初步应用[J].检验医学与临床,2012,9(1):93-96.
[9] DELANAYE P,CAVALIER E,POTTEL H.Serum creatinine:not so simple[J].Nephron,2017,136(4):302-308.
[10]马恺,秦培华.临床实验室分析前影响因素的探讨与对策研究[J].国际检验医学杂志,2011,32(16):1908-1909.
[11]戴莹洁,周勇,陈文举,等.羟苯磺酸钙对肌氨酸氧化酶法和苦味酸法检测肌酐的干扰[J].中国乡村医药,2017,24(15):46-47.
[12]倪莉,王晓欧,林应宝,等.酚磺乙胺对酶法测定血清肌酐的干扰及其纠正方法[J].中国卫生检验杂志,2017,27(14):2009-2011.
[13]程涌江,李丽,陈海鸣.酚磺乙胺对不同方法测定肌酐的干扰[J].检验医学与临床,2011,8(16):1939-1940.
[14]刘芳龙,刘伟.胆红素对血清肌酐测定结果的干扰及原因分析[J].中国医药指南,2014,12(15):230-231.
[15]温勇,玉韦勇.胆红素对肌酐测定的影响[J].吉林医学,2013,34(35):7377-7378.
[16]殷立奎,邓文涛,马华山.胆红素对肌酐测定的影响分析[J].中国医药导报,2008,5(7):90-91.
[17]江俊铮,谢梦禹,张卫,等.维生素C对肌氨酸氧化酶法检测血清肌酐干扰的定量分析[J].中华实用诊断与治疗杂志,2012,26(1):64-66.
[18]汪开华.维生素C对三种常用肌酐测定方法的干扰[J].国际检验医学杂志,2012,33(11):1385-1386.
[19]程海平,廖璞.血清中肌酐的检测方法及其进展[J].检验医学与临床,2009,6(19):1682-1684.
[20]戴新华,方向,全灿,等.血清中肌酐的检测方法及其进展[J].分析测试学报,2007,26(5):763-767.