胶乳免疫比浊法tPSA、fPSA诊断试剂盒临床应用评价  

An Evaluation of Clinical Application of tPSA and fPSA DiagnosticKits with Latex Turbidimetric Immunoassay

作　　者：黄利思[1] 孙龙乔子 罗美群 段朝晖[1] HUANG Lisi;SUN Longqiaozi;LUO Meiqun;DUAN Chaohui(Department of Clinical Laboratory,Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University,Guangzhou,510120,China)

机构地区：[1]中山大学孙逸仙纪念医院检验科,广东广州510120

出　　处：《标记免疫分析与临床》2022年第10期1741-1746,共6页Labeled Immunoassays and Clinical Medicine

基　　金：国家重点研发计划项目(编号:2021YFC2009300,2021YFC2009302)。

摘　　要：目的评估胶乳免疫比浊法总前列腺特异性抗原(total prostate specific antigen,tPSA)、游离前列腺特异性抗原(free PSA,fPSA)测定试剂盒的正确度、精密度、线性范围、抗干扰和方法一致性等性能指标,从而评价其临床应用价值。方法参照WST 420-2013《临床实验室对商品定量试剂盒分析性能的验证》、CNAS-GL037:2019《临床化学定量检验程序性能验证指南》以及NCCLS EP7-A2等文件,对北京九强金斯尔tPSA、fPSA测定试剂盒进行性能验证,并与对应罗氏电化学发光法进行方法学比对。结果tPSA、fPSA诊断试剂盒测定其企业参考品的偏差均小于±7%;且tPSA、fPSA在原装配套质控品靶值附近的测量重复性精密度和中间精密度的变异系数(CV)均在±5%范围内;在线性范围验证试验中,tPSA、fPSA实测值与线性预期值的相对偏差均小于±10%,且线性回归分析提示其决定系数(R^(2))分别为0.9977、0.9994。抗干扰试验:当直接胆红素(DBIL)≤18.9mg/dL,血红蛋白(Hb)≤490mg/dL,三酰甘油(TG)≤5700mg/dL时,tPSA测定结果的相对偏差均小于±3%;当DBIL≤40mg/dL,Hb≤500mg/dL,TG≤600mg/dL时,fPSA检测结果偏差均小于±5%。此外,与罗氏电化学发光法进行比对,其相关性回归分析结果为:tPSA,Y=0.8455 X+1.010,R^(2)=0.9984;fPSA,Y=0.8917 X+0.7426,R^(2)=0.9654。结论金斯尔tPSA、fPSA试剂盒的各项性能指标均能够达到行业标准和厂家声明的要求,且与罗氏电化学发光法检测结果一致性较好,有望进一步推进tPSA、fPSA国产体外诊断试剂盒的临床应用。Objective To evaluate the accuracy,precision,linearity,anti-interference,and methodology comparison of total prostate specific antigen(tPSA),free PSA(fPSA)diagnostic kits detected by latex turbidimetric immunoassay.Methods According to WST 420-2013 document(verification of analytical performance of quantitative kits by clinical laboratory),CNAS-GL037:2019 document(guidance on the verification of quantitative measurement procedures used in the clinical chemistry)and the profile of NCCLS EP7-A2,performance verifications of tPSA,fPSA diagnostic kits produced by Beijing Jiuqiang Gcell were conducted.Furthermore,a methodology comparison with Roche electrochemical luminescence immunoassay was performed.Results The deviations of tPSA,fPSA diagnostic kits evaluated by enterprise reference materials were less than±7%.Moreover,the repetitive precision and intermediate precision CV of tPSA and fPSA were within±5%using the quality control materials produced by the manufacturer.For the analysis of linearity,the deviations between measured results and predicted values of tPSA and fPSA were less than±10%,and regression analysis revealed that correlation coefficient R^(2) were 0.9977 and 0.9994,respectively.For the anti-interference experiment,when direct bilirubin(DBIL)≤18.9 mg/dL,hemoglobin(Hb)≤490 mg/dL,triglyceride(TG)≤5700 mg/dL,the deviations of tPSA were less than±3%;when DBIL≤40 mg/dL,Hb≤500 mg/dL,TG≤600 mg/dL,the deviations of fPSA were less than±5%.Additionally,in comparison with Roche electrochemical luminescence immunoassay,the correlation regression equations were as following:tPSA,Y=0.8455 X+1.010,R^(2)=0.9984;fPSA,Y=0.8917 X+0.7426,R^(2)=0.9654.Conclusion The tPSA and fPSA diagnostic kits can meet the demand of industry standard and the manufacturer’s instructions,and have a good correlation with Roche kits.Our study may help promote the clinical application of tPSA,fPSA indigenous diagnostic kits.

关 键 词：总前列腺特异性抗原 游离前列腺特异性抗原 胶乳免疫比浊法 性能评价 方法学比对 

分 类 号：R392-33[医药卫生—免疫学]