摘要
目的对电化学发光法检测鳞状上皮细胞癌抗原(SCCA)进行性能验证。方法依据美国临床实验室标准化委员会系列文件,对电化学发光法检测SCCA的精密度、正确度、线性范围、参考区间及可报告范围进行验证和评价。结果电化学发光法检测SCCA高、低值质控血清批内变异系数(CV)分别为1.20%和2.19%,批间CV分别为2.72%和5.43%,均小于厂家声明的不精密度;正确度验证试验中高、低值质控血清相对偏差分别为0.98%和3.68%,均<1/2允许总误差;线性回归方程和判定系数为Y=1.020 3X-0.277 9,r^2=0.998 5,线性范围为0.142~58.120ng/mL;20例健康体检者检测结果均在厂家提供的参考区间内,可报告范围上限为944.000ng/mL。结论电化学发光法检测SCCA的验证指标均达到规定要求,可用于临床检测。
Objective To verify the performance of electrochemiluminescence in the detection of squamous cell carcinoma antigen(SCCA).Methods Precision,accuracy,linear range,reference range and reducible range of electrochemiluminescence for SCCA were verified and evaluated according to the NCCLS series of documents.Results The within-assay coefficient of variation(CV)of high and low value quality control products by electrochemiluminescence in detecting SCCA were 1.20% and 2.19% respectively,and inter-assay of CV were 2.72% and 5.43% respectively,which were all lower than imprecision that manufacturer′s stated.In the test of accuracy verification,the relative deviation of the high and low value quality control serum were 0.98% and 3.68% respectively,both were lower than 1/2 of the total allowable error(TEa).The linear regression equation and the determination coefficient were Y=1.020 3 X-0.277 9,r^2=0.998 5,and the linear range was 0.142-58.120 ng/mL.The test results of 20 healthy subjects were all within the reference range provided by the manufacturer.The upper limit of the reportable range was 944.000 ng/mL.Conclusion Electrochemiluminescence technique can be used in clinical detection of SCCA.
作者
杜秀环
陶耕
DU Xiuhuan;TAO Geng(Department of Clinical Laboratory,Second Affiliated Hospital of Fujian Medical University,Quanzhou,Fujian 362000,China)
出处
《检验医学与临床》
CAS
2020年第2期186-188,191,共4页
Laboratory Medicine and Clinic
关键词
电化学发光法
鳞状上皮细胞癌抗原
性能验证
electrochemiluminescence
squamous epithelial cell carcinoma antigens
performance validation
