溴甲酚绿法检测低浓度血清清蛋白的偏差分析和临床诊断应用的局限性
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摘要
目的为推荐临床正确选择适合的血清清蛋白测定方法,评估溴甲酚绿法(BCG)与免疫比浊法在临床常见患者中血清清蛋白检测结果的差异。方法选择血清清蛋白浓度在8.0～60.0 g/L内的样本40例,同时采用BCG法和免疫比浊法检测血清清蛋白,绘制散点图,观察数据分布情况,并计算线性拟合方程。以免疫比浊法为标准,评价BCG法偏差的大小和特征。针对偏差较大的患者类型和常见患者类型,扩大样本观察BCG法的检测偏差。结果两种方法检测血清清蛋白浓度存在线性关系,回归方程为Y=1.2X-7.845 6,r~2=0.982 1。BCG法与免疫比浊法的差值与清蛋白浓度高度负相关(P<0.01,r=-0.854)。清蛋白浓度越低,两者差值越大,与免疫比浊法相比,BCG法评估血清清蛋白水平呈正偏向。肾病综合征患者中,BCG法高估血清清蛋白达4～10 g/L;孕产妇中BCG法高估血清清蛋白达2～5 g/L;新生儿和急性淋巴细胞白血病患者BCG法偏差在±2 g/L内。结论 BCG法检测低浓度血清清蛋白有其局限性。对肾病综合征、孕产妇和低蛋白血症等患者采用免疫比浊法正确评估血清清蛋白浓度,可提高临床的诊断、疗效观察和预后评估等的管理水平。
Objective To recommend a suitable method for the determination of serum albumin in clinical use,the difference between bromocresol green method(BCG) and immunoturbidimetric method was evaluated.Methods Forty samples with serum albumin concentration ranging from 8.0 g/L to 60.0 g/L were selected.BCG method and immunoturbidimetric method were used to detect serum albumin.Scatter plot was drawn to observe the data distribution,and the linear fitting equation was calculated.The magnitude and characteristics of BCG deviation were evaluated by using immuneturbidimetric as standard.For patients with large deviations and common patient types,the deviation of BCG method was further observed by expanding samples.Results There was a linear relationship between serum albumin concentration detected by the two methods,and the regression equation was Y=1.2X-7.845 6,r~2=0.982 1.The difference between BCG method and the immunoturbidimetric method was negatively correlated with the albumin concentration(P<0.01,r=-0.854).The lower the albumin concentration,the greater the difference between the two methods,and BCG overestimated the albuminlevel compared with the immunoturbidimetric method.BCG method overestimated serum albumin by 4～10 g/L in patients with nephrotic syndrome and by 2～5 g/L in pregnant women.Conclusion More attention should be paid to the limitations of BCG method in the detection of serum albumin.For patients with nephrotic syndrome,maternal and hypoalbuminemia,serum albumin concentration should be correctly assessed by immuneturbidimetric method,so as not to mislead the clinical diagnosis,efficacy observation and prognosis evaluation caused by BCG method.
Objective To recommend a suitable method for the determination of serum albumin in clinical use,the difference between bromocresol green method(BCG) and immunoturbidimetric method was evaluated.Methods Forty samples with serum albumin concentration ranging from 8.0 g/L to 60.0 g/L were selected.BCG method and immunoturbidimetric method were used to detect serum albumin.Scatter plot was drawn to observe the data distribution,and the linear fitting equation was calculated.The magnitude and characteristics of BCG deviation were evaluated by using immuneturbidimetric as standard.For patients with large deviations and common patient types,the deviation of BCG method was further observed by expanding samples.Results There was a linear relationship between serum albumin concentration detected by the two methods,and the regression equation was Y=1.2X-7.845 6,r~2=0.982 1.The difference between BCG method and the immunoturbidimetric method was negatively correlated with the albumin concentration(P<0.01,r=-0.854).The lower the albumin concentration,the greater the difference between the two methods,and BCG overestimated the albuminlevel compared with the immunoturbidimetric method.BCG method overestimated serum albumin by 4～10 g/L in patients with nephrotic syndrome and by 2～5 g/L in pregnant women.Conclusion More attention should be paid to the limitations of BCG method in the detection of serum albumin.For patients with nephrotic syndrome,maternal and hypoalbuminemia,serum albumin concentration should be correctly assessed by immuneturbidimetric method,so as not to mislead the clinical diagnosis,efficacy observation and prognosis evaluation caused by BCG method.
引文
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[13] MERLINI G,BLIRUP-JENSEN S,JOHNSON A M,et al.Standardizing plasma protein measurements worldwide:a challenging enterprise[J].Clinical Chemistry and Laboratory Medicine,2010,48(11):1567-1575.
[14] ZEGERS I,KELLER T,SCHREIBER W,et al.Cha-racterization of the new serum protein reference material ERM-DA470k/IFCC:value assignment by immunoassay[J].Clinical Chemistry,2010,56(12):1880-1888.
[15] 尚红,王毓三,申子瑜.全国临床检验操作规程[S].4版.北京:人民卫生出版社,2015:203-204.SHANG Hong,WANG Yusan,SHEN Ziyu.National guide to clinical laboratory procedures[S].4th Edition.Beijing:People’s Medical Publishing House,2015:203-204.
[16] 冯品宁,姚真荣,徐鸿绪,等.免疫透射比浊法与溴甲酚绿染色法测定血清清蛋白浓度1 000例样本方法学比较及偏倚评估[J].中国卫生检验杂志,2017,27(15):2231-2234.FENG Pinning,YAO Zhenrong,XU Hongxu,et al.Determination of serum concentration of serum albumin by turbidimetric immunoassay method and bromocresol green staining method of 1 000 samples:methodological comparison and bias evaluation[J].Chin J Health Lab Tec,2017,27(15):2231-2234.
[17] 忻鼎广,石娟娟,伏春明,等.溴甲酚类试剂在测定肾病综合征和血液透析患者血清清蛋白时的偏差[J].检验医学,2006,3(21):231-233.XIN Dingguang,SHI Juanjuan,FU Chunming,et al.The deviation of serum albumin level determined by bromocresol reagent in nephrotic syndrome and hemodialyzed patients[J].Laboratory Medicine,2006,21(3):231-233.
[18] UCHIDA Y,OKUZUMI Y,FUJISHIRO M,et al.Controversies in the determination of serum albumin concentration in chronic liver diseases[J].The Japanese Journal of Clinical Pathology,2006,54(10):1008-1012.
[2] FANALI G,DI MASI A,TRAZZA V,et al.Human serum albumin:from bench to bedside[J].Molecular Aspects of Medicine,2012,33(3):209-290.
[3] GARCIA-MARTINEZ R,CARACENI P,BERNARDI M,et al.Albumin:pathophysiologic basis of its role in the treatment of cirrhosis and its complications[J].Hepatology,2013,58(5):1836-1846.
[4] SITAR M E,AYDIN S,CAKATAY U.Human serum albumin and its relation with oxidative stress[J].Clinical Laboratory,2013,59(9/10):945-952.
[5] HOLLIDAY M A.Extracellular fluid and its protei-ns:dehydration,shock,and recovery[J].Pediatric Nephrology,1999,13(9):989-995.
[6] CABRERIZO S,CUADRAS D,GOMEZ-BUSTO F,et al.Serum albumin and health in older people:Review and meta analysis[J].Maturitas,2015,81(1):17-27.
[7] ONG C,HAN W M,WONG J J,et al.Nutrition biomarkers and clinical outcomes in critically ill children:A critical appraisal of the literature[J].Clinical Nutrition,2014,33(2):191-197.
[8] HAN Sheng,HUANG Yanming,LI Zhonghua,et al.The prognostic role of preoperative serum albumin levels in glioblastoma patients[J].BMC Cancer,2015,15(1):108.
[9] GOLDWASSER P,FELDMAN J.Association of serum albumin and mortality risk[J].Journal of Clinical Epidemiology,1997,50(6):693-703.
[10] 沈丽娟,孙杰,吴晓,等.老年脓毒症患者血清清蛋白水平与其危重程度及预后的相关性[J].现代检验医学杂志,2017,32(1):131-133,137.SHEN Lijuan,SUN Jie,WU Xiao,et al.Relationship of albumin levels with the prognosis and severity of illness among elderly sepsis patients[J].J Mod Lab Med,2017,32(1):131-133,137.
[11] UENO T,HIRAYAMA S,SUGIHARA M,et al.The bromocresol green assay,but not the modified bromocresol purple assay,overestimates the serum albumin concentration in nephrotic syndrome through reaction with alpha2-macroglobulin[J].Annals of Clinical Biochemistry,2016,53(Pt 1):97-105.
[12] GARCIA MOREIRA V,BERIDZE VAKTAN-GOVA N,MARTINEZ GAGO M D,et al.Overestimation of albumin measured by bromocresol green vs bromocresol purple method:influence of acute-phase globulins[J].Laboratory Medicine,2018,49(4):355-361.
[13] MERLINI G,BLIRUP-JENSEN S,JOHNSON A M,et al.Standardizing plasma protein measurements worldwide:a challenging enterprise[J].Clinical Chemistry and Laboratory Medicine,2010,48(11):1567-1575.
[14] ZEGERS I,KELLER T,SCHREIBER W,et al.Cha-racterization of the new serum protein reference material ERM-DA470k/IFCC:value assignment by immunoassay[J].Clinical Chemistry,2010,56(12):1880-1888.
[15] 尚红,王毓三,申子瑜.全国临床检验操作规程[S].4版.北京:人民卫生出版社,2015:203-204.SHANG Hong,WANG Yusan,SHEN Ziyu.National guide to clinical laboratory procedures[S].4th Edition.Beijing:People’s Medical Publishing House,2015:203-204.
[16] 冯品宁,姚真荣,徐鸿绪,等.免疫透射比浊法与溴甲酚绿染色法测定血清清蛋白浓度1 000例样本方法学比较及偏倚评估[J].中国卫生检验杂志,2017,27(15):2231-2234.FENG Pinning,YAO Zhenrong,XU Hongxu,et al.Determination of serum concentration of serum albumin by turbidimetric immunoassay method and bromocresol green staining method of 1 000 samples:methodological comparison and bias evaluation[J].Chin J Health Lab Tec,2017,27(15):2231-2234.
[17] 忻鼎广,石娟娟,伏春明,等.溴甲酚类试剂在测定肾病综合征和血液透析患者血清清蛋白时的偏差[J].检验医学,2006,3(21):231-233.XIN Dingguang,SHI Juanjuan,FU Chunming,et al.The deviation of serum albumin level determined by bromocresol reagent in nephrotic syndrome and hemodialyzed patients[J].Laboratory Medicine,2006,21(3):231-233.
[18] UCHIDA Y,OKUZUMI Y,FUJISHIRO M,et al.Controversies in the determination of serum albumin concentration in chronic liver diseases[J].The Japanese Journal of Clinical Pathology,2006,54(10):1008-1012.