胶乳免疫比浊法检测总前列腺特异性抗原性能评价及其与电化学免疫发光法的一致性评价

A Method Comparison of LTIA and ECLI in Measuring Total PSA

目的对胶乳免疫比浊法(比对方法)检测总前列腺特异性抗原(total prostate specific antigen,tPSA)做性能验证,比较其与电化学免疫发光法(参比方法)检测结果的一致性。方法依据CNAS-GL037文件对比对方法检测PSA进行准确度、精密度、线性区间的验证;收集2021年5月至8月解放军总医院第二医学中心剩余血清样本225例,分别由比对方法及参比方法检测总PSA,并对检测结果进行一致性评价。用Passing-Bablok回归、一致性相关系数(CCC)、Bland-Altman图分析2种检测方法的一致性和偏差。结果比对方法检测国家标准物质4个浓度偏倚均在±5%以内,低于厂家声明的15%;重复性和实验室内精密度(CV)不超过2%;临床高低值样本验证1.20~98.12μg/L区间符合临床线性要求。比对方法与参比方法的相关性(r=0.994)、一致性(CCC=0.989)均较好;两种方法检测总PSA平均偏差为-0.617μg/L(-4.36%)。结论比对方法检测总PSA正确度、精密度、线性区间验证均符合要求,比对方法与参比方法检测总PSA具有较好的相关性和一致性。

Objective To study the performance of Latex turbidimetric immunoassay(LTIA,comparison method)detecting total prostate specific antigen(PSA),and to evaluate the measurement agreement of LIT with Electro-Chemiluminescence Immunoassay(ECLI,reference method).Methods LIT measurement’s accuracy,precision and linear interval were obtained according to CNAS-GL037.225 residual serum samples were collected from May to August,2021 and total PSA was detected by these two methods.Passing-Bablok regression,concordance correlation coefficient(CCC)and Bland Altman plots were used to analyze the consistency and bias.Results The bias of LIT measuring national reference materials was within±5%,lower than 15%declared by the manufacturer;The repeatability and in laboratory precision(CV)were lower than 2%,and a linear interval between 1.20 and 98.12μg/L passed the validation.The studied method and the reference method showed a good correlation(r=0.994),consistency(CCC=0.989)with an average deviation of-0.617μg/L(-4.36%).Conclusion The studied method shows an accuracy,precision and linear interval which can meet the requirements and also shows a good correlation and consistency with the reference method.