首页> 中文期刊> 《国际检验医学杂志》 >颗粒增强透射比浊法测定胱抑素C方法学评价

颗粒增强透射比浊法测定胱抑素C方法学评价

         

摘要

目的:用颗粒增强透射比浊法(PETIA)测定血清中胱抑素C(CysC)水平,评价该法用于检测血清中CysC水平的可行性。方法用PETIA检测试剂盒在Cobas 8000全自动生化分析仪上测定血清CysC水平,对方法的不精密度、灵敏度、线性范围等进行评价,并与CysC颗粒增强散射比浊法检测结果进行相关性分析,同时对其参考区间进行验证。结果低值样本和高值样本的批内不精密度 CV分别为3.67%,1.15%,批间不精密度 CV分别为4.08%,1.53%;准确度的测定偏差仅为-1.25%;此试剂盒检测CysC灵敏度为0.07 mg/L ;CysC浓度在0.2~8.0 mg/L范围内检测线性良好;与西门子德灵颗粒增强散射比浊法(PENIA )比较有良好的相关性Y=0.9458 X+0.0486,r2=0.9913,r=0.9956,40例健康体检者样本的检测值仅有2例在厂家提供的参考区间之外,90%以上的观测值在待验证区间之内。结论颗粒增强透射比浊法用于定量检测人血清CysC水平,具有简便易行、快捷价廉、准确可靠的优点,适用于在日常临床检测中推广应用。%Objective To evaluate methodologically particle‐enhanced turbidimetric immunoassay (PETIA ) for determining quantitatively Cystatin C .Methods Cystatin C was determined quantitatively with PETIA by Cobas 8000 automatic biochemical analyzer ,and imprecision ,veracity ,sensitivity ,linearity range of the method were investigated .The correlation of fresh serum sam‐ple results between PENIA and PETIA was analyzed .The reference interval was verified .Results The within‐run CV imprecision of samples with low and high concentration of adiponectin was 3 .67% and 1 .15% respectively ,the between‐run CV imprecision of samples with low and high concectration of adiponectin was 4 .08% and 1 .53% respectively .The accuracy of the measurement devi‐ation was only -1 .25% .The sensitivity was 0 .07 mg/L .When the adiponectin concentration was between 0 .2 -8 .0 mg/L ,the method showed good linearity .A strong correlation between PETIA and PENIA was confirmed (Y = 0 .945 8X+ 0 .048 6 ,r2 =0 .991 3 ,r=0 .995 6) .Among 40 cases of healthy physical examination sample ,2 cases were with cystatin C level out of the refer‐ence range supplied by reagent kit .The values that were more than 90% in validation interval .Conclusion The PETIA assay is a convenient ,rapid ,cheap ,accurate and reliable method for quantitating the human serum concentration of adiponectin .This assay is suitable for clinical routine analysis .

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