CAJ | 학술논문

目的：评价手工操作和高通量全自动酶联免疫吸附试验（ELISA）法检测血清乙型肝炎e抗原（HBeAg）的精密度性能。方法参考美国临床和实验室标准协会（CLSI）EP5-A2文件，对稳定的高低浓度的HBeAg实验样品，每天做2批实验，每批对样品做双份检测，共做20 d实验，计算批内不精密度、批间精密度、天间不精密度和总不精密度，并与厂商声称的不精密度比较。结果手工法和全自动ELISA测定高低浓度HBeAg样品的批内不精密度的变异系数为4.6％、3.2％和1.1％、1.9％，天间精密度的变异系数为3.2％、2.0％和1.6％、1.9％，且小于厂商声明的不精密度质量目标。结论手工法和高通量全自动酶联免疫吸附试验法测定血清HBeAg的精密度性能均良好，可满足临床要求。
목적：평개수공조작화고통량전자동매련면역흡부시험（ELISA）법검측혈청을형간염e항원（HBeAg）적정밀도성능。방법삼고미국림상화실험실표준협회（CLSI）EP5-A2문건，대은정적고저농도적HBeAg실험양품，매천주2비실험，매비대양품주쌍빈검측，공주20 d실험，계산비내불정밀도、비간정밀도、천간불정밀도화총불정밀도，병여엄상성칭적불정밀도비교。결과수공법화전자동ELISA측정고저농도HBeAg양품적비내불정밀도적변이계수위4.6％、3.2％화1.1％、1.9％，천간정밀도적변이계수위3.2％、2.0％화1.6％、1.9％，차소우엄상성명적불정밀도질량목표。결론수공법화고통량전자동매련면역흡부시험법측정혈청HBeAg적정밀도성능균량호，가만족림상요구。
Objective To evaluate the precision performance of using manual operating versus high-flux fully automatic enzyme-linked immunosorbent assay (ELISA) on Hepatitis Be antigen (HBeAg). Methods The HBeAg ex-perimental samples with high and low stable concentrations were examined by manual operating and high-flux fully automatic ELISA based on CLSI EP5-A2 document, with two batches of experiments daily for 20 days, and each batch was tested two times. The within-run imprecision, between-run imprecision, between-day precision and total impreci-sion of the assays were calculated and compared with those announced by manufactures. Results For the HBeAg samples with high and low concentrations determined by manual versus fully automatic ELISA, the within-run impre-cision coefficients of variation were 4.6% vs. 3.2% and 1.1% vs. 1.9%, whereas the between-day imprecision coeffi-cients of variation were 3.2% vs. 2.0% and 1.6% vs. 1.9%, and all were less than the imprecision quality goal of the manufacturers. Conclusion The precision performance of using manual and high-flux fully automatic ELISA to de-termine HBeAg is good, which meets the requirements of clinical trials.