全自动酶联免疫吸附法检测血清丙型肝炎抗体精密度评价

Evaluation on precision of serum hepatitis C antibodies determined by automatic ELISA

目的评价全自动酶联免疫吸附法检测血清丙型肝炎抗体的精密度性能。方法参照美国临床与实验室标准化协会(CLSI)EP5-A2文件,选用2个浓度(高值和低值)的实验样本,每个样本每天批内重复测定2次,每天2批,持续20 d,计算其批内不精密度(CV_(批内))、天间不精密度(CV_(天间))和总不精密度(CV_总)。结果 HCV-Ab低值(L)精密度的CV_(批内)、CV_(天间)、CV_总分别为3.4%、2.8%、5.9%;HCV-Ab高值(H)精密度的CV_(批内)、CV_(天间)、CV_总分别为3.2%、1.9%、3.8%。全自动酶联免疫吸附法检测血清丙型肝炎抗体的CV_(批内)均<1/4EA(5%),CV_(天间)均<1/3EA(6.7%),CV_总均<厂家声明值(15%)。结论全自动酶联免疫吸附法测定血清丙型肝炎抗体精密度符合实验室质量要求。

Objective To evaluate the precision of serum hepatitis C antibodies determined by the automatic enzyme-linked immunosorbent assay（ELISA）. Methods According to the EP5-A2 document of American Clinical and Laboratory Standards Institute（CLSI）, the experimental samples of two concentrations（high value and low value）were included in the study. Each sample within each batch was measured repeatedly twice daily, 2 batches a day, for continuous 20 days. The within-run imprecision（CV within-run）, between-day imprecision（CV between-day） and total imprecision（CV total） were calculated. Results The CV within-run, CV between-day and CV total imprecision of HCV-Ab low value（L） was 3.4%, 2.8% and 5.9%, respectively. The CV within-run, CV between-day and CV total imprecision of HCV-Ab high value（H） was 3.2%, 1.9% and 3.8%, respectively. The automatic ELISA was used to deter-mine serum hepatitis C antibodies and showed that CV within-run imprecision was less than 1/4EA（5%）, CV betweenday imprecision was less than 1/3EA（6.7%） and CV total imprecision was less than the total value declared by the manufacturer（15%）. Conclusion Using automatic ELISA to determine the precision of serum hepatitis C virus antibodies meets the laboratory quality requirements.