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目的研究溴甲酚绿染色法检测血清白蛋白浓度非特异性反应物质的影响,为尚在使用此方法学的实验室提供参考依据。方法依据美国临床和实验室标准协会(CLSI)标准化文件EP9-A2,收集患者血清样本1 000份,分别用免疫透射比浊法与溴甲酚绿染色法进行双份测定。以CLIA’88规定的总允许误差(ALB±10%)的1/2作为方法学比较系统误差的允许限值,进行偏倚的评估。结果 2种方法测定血清白蛋白浓度存在偏差,在医学决定水平20 g/L、25 g/L、30 g/L、35 g/L、52 g/L时,染色法相对偏倚分别为23.25%、13.96%、7.77%、3.31%、-5.37%;根据EP9-A2预期偏倚在95%可信限内。结论溴甲酚绿染色法检测血清白蛋白浓度由于受球蛋白和转铁蛋白等非特异性反应物质影响,正常值以下检测结果偏高,浓度越低,偏差越大。对实验室结果产生误导,必须引起实验室和临床的重大关注。
OBJECTIVE To study the effect of bromocresol green staining on the nonspecific reaction of serum albumin concentration and to provide a reference for the laboratories still using this method. Methods According to the CLSI standardization document EP9-A2, 1000 samples of patients’ serum samples were collected and determined by immunoturbidimetry and bromocresol green staining respectively. The bias was evaluated using a factor of two of the total allowable error (ALB ± 10%) defined by CLIA’88 as the allowable limit for systematic comparison of systematic errors. Results The serum albumin concentrations were deviated by the two methods. The relative bias of staining was 23.25% at the medical decision level of 20 g / L, 25 g / L, 30 g / L, 35 g / L and 52 g / , 13.96%, 7.77%, 3.31%, -5.37%; expected bias within 95% confidence limits according to EP9-A2. Conclusion Bromocresol green staining method for the determination of serum albumin concentration of globulin and transferrin and other non-specific reaction substances, the normal value of the following test results were higher, the lower the concentration, the greater the deviation. Misleading the results of the laboratory must lead to major laboratory and clinical attention.