连苯三酚红法测定尿液及脑脊液蛋白的再认识

Pyrogallol Red Method for Determination of Urine and Cerebrospinal Fluid Protein and Know Again

目的评估连苯三酚红法测定尿蛋白和脑脊液蛋白的分析性能。方法采用不精密度、回收率、空白限(LoB)、检出限(LoD)、功能灵敏度(FS)、分析测量范围(AMR)、临床可报告范围(CRR)进行评估;分析与磺基水杨酸定性法的关系。结果蛋白浓度在0.17～1.5g·L-1时,总变异系数(CV)<5%;平均回收率为98.6%;LoB、LoD和FS分别为0.01、0.02和0.04g·L-1;AMR为0.01～2.00g·L-1;CRR为0.04～40.0g·L-1。与磺基水杨酸定性结果比较显示:"-～+"的样本与定量结果无差异,"++～++++"的高值样本与定量结果有差异。结论连苯三酚红法的不精密度、回收率符合要求,建立的LoD、FS、最大稀释度和CRR可为临床提供更好的质量保证;但AMR比较窄,超出线性范围时,根据蛋白定性的结果决定待检标本是否需要进行预稀释处理。

Objective To evaluate the pyrogallol red method for the determination of urinary protein and cerebrospinal fluid protein. Methods The not precision, recovery rate, limit of blank （LOB）, limit of detection （LoD）, the functional sensitivity （FS）, analytical measurement range （AMR） and clinical reportable range （CRR） were used to assess its performance; its relationship with the sulfosalicylic acid qualitative method was analyzed. Results When the protein concentration was 0.17-1.5 g·L^-1 , the total coefficient of variation （CV） was less than 5%, average recovery rate was 98.6%, and LoB, LoD, and FS were respectively 0.01, 0.02 and 0.04 g·L^-1. When AMR was 0.01-2.00 g·L^-1, the CRR was 0.04-40.0 g·L^-1 Compared with qualitative results of sulfosalicylic acid, there was no difference between ＂-～＋＂ samples and quantitative results while differences were observed between ＂＋＋～＋＋＋＋＂ high-value samples and quantitative results. Conclusion The imprecision and recovery rate of pyrogallol red method are in accordance with the requirements, and the established LoD, FS, the maximum dilution rate and CRR can offer better quality assurance for clinical application; however, as AMR is quite narrow, when out of linear range, whether specimens need treatment of pre-dilution are based on the protein qualitative results.