血清SCC在非配套免疫检测系统中的性能验证

目的验证上海透景公司生产的化学发光法血清鳞状上皮细胞癌相关抗原(SCC)定量测定试剂盒在非配套免疫检测系统中的性能,并初步评价其临床应用价值。方法参考CLSI EP15-A2及EP9-A2方案,在雅培全自动免疫分析仪i2000SR上验证上海透景化学发光法SCC定量测定试剂盒,主要评价试剂盒的精密度、正确度、线性范围和生物参考区间。采用上海透景公司提供的多项肿瘤标志物质控品进行精密度的评价;同时,收集雅培化学发光法SCC检测结果均匀分布在测量范围内的冻存血清标本进行比对试验和线性范围的评价。另外,选取120例表观健康体检人员的新鲜血清标本进行生物参考区间的评价。将所得的结果与厂家提供的数值进行比较,判断其是否一致。结果测定多项肿瘤标志物质控品,血清SCC低值和高值质控品实验室内CV分别为5.37%和4.02%,均小于厂家提供的数值(≤10%),精密度验证通过。40例标本进行比对试验时,透景与雅培试剂盒SCC检测结果相关性良好,说明二者之间具有一致性。线性范围验证时,血清SCC的线性范围为0.1~70.0 ng/mL,决定系数R^2大于0.995。120例表观健康体检人员的血清SCC检测结果均在厂家提供的参考区间范围之内。结论上海透景化学发光法血清SCC定量测定试剂盒在非配套免疫检测系统(雅培全自动免疫分析仪i2000SR)中具有良好的精密度,与雅培化学发光法SCC试剂盒的检测结果和线性范围一致,可初步满足临床需要。

A Performance Verification of SCC in the Non-matching Immunoassay System

Objective To validate the analytical performance of Toujing chemiluminescent immunoassay for the determination of serum SCC on an unmatched immunoassay system.Methods Based on the protocol provided by CLSI EP 15-A2 and EP9-A2,the precision,trueness,linear range and reference intervals of Toujing SCC kits were evaluated on an automatic immune analytic system Abbott i2000SR.Two levels of control materials provided by Toujing were used as precision verification samples.Comparison test and linear range verification were carried out with the frozen sera,the SCC results of which were distributed uniformly in the measuring range of Abbott.Additionally,120 apparent healthy cases were selected from the physical examination and the serum SCC of them was detected to validate the biological reference intervals.All the results were compared with manufacturer’s claimed results.If the evaluated results were less than the claimed results,the claimed range would be verifiable.Results The within-laboratory CVs of low and high level control of SCC were 5.37%and 4.02%respectively.All of the estimated CVs were less than the claimed CVs,suggesting that the manufacturer’s claims were verifiable.The Toujing results of SCC from 40 frozen sera were well correlated with the results of Abbott.The linearity intervals of serum SCC were 0.1-70.0 ng/mL.Squares of all the correlation coefficients of SCC was more than 0.995.The detection results of SCC from 120 apparent healthy cases were in the reference intervals of the manufacturer’s claim.Conclusion The performance for precision,trueness and linear range of SCC are reliable.All the performance indexes are in accordance with the quality standards and are met with the requirements of clinical testing.