摘要
目的探讨全自动ELISA系统检测HBs Ag、HBs Ab、HBe Ag、HBe Ab、Hbc Ab(HBV-M)是否在重复性、准确度等方面优于手工法和半自动法,为其更好地在临床实验室开展工作提供进一步的数据和基础。方法用以上各项指标的弱阳性质控品,分别做手工法、半自动法和全自动法的批内和批间重复性试验。另用三种方法分别检测临床血清标本,每项810人份。定性结果不完全一致的标本,HBs Ag用中和法做确证试验,其余四项用化学发光法作为参考方法进行验证。结果批内与批间重复性比较,全自动法的CV小于手工法和半自动法。三种方法检测临床标本,定性结果两两比较,均显示一致性非常好(k>0.8,P<0.05);进行卡方检验,除HBc Ab的半自动法阳性率显著高于全自动法(P<0.0125)外,其余项目三种方法两两比较,均无显著性差异(P>0.0125)。经过确证/参考试验验证,全自动法、半自动法、及手工法不完全一致的标本,HBs Ag17份,符合个数分别为15、9和4;HBs Ab 24份,符合个数分别为17、13、7;HBe Ag 9份,符合个数分别为7、2、5;HBe Ab 34份,符合个数分别为19、16、19;HBc Ab 36份,符合个数分别为28、15、19。结论 1全自动法比半自动法和手工法具有更好的重复性。2三种方法有非常好的一致性,均能较好的诊断乙型肝炎。3全自动法ELISA检测HBV-M比半自动法和手工法准确度更高,可进一步提高这些项目的检验质量。
Objective To investigate whether automatic ELISA system is superior to semi-automatic ELISA and manual ELISA for detecting HBsAg, HBsAb, HBeAg, HBeAb, HbcAb （ HBV- M ） in terms of precision and accuracy, and to provide further data and foundation on ELISA detection of HBV-M for clinical laboratory. Methods Within-run and between-run repetitive experiments were performed with each weakly positive quality control standard of the above indexes through manual method, semi-automatic method and high-throughput automatic method respectively. In addition, clinical serum samples were detected by manual method, semi- automatic method and high-throughput automatic method. Each test items contained 810 serum samples. For the samples whose qualitative results were not completely consistent, the neutralization was used as a confirmatory test for HBsAg and CLIA was regarded as the reference method to confirm the rest four indexes. Results Comparison of within- run and between- run repeatability, it was found that the CV obtained by automatic method was smaller than that by manual method and semi-automatic method. Paired comparison of qualitative results of serum samples indicated that any two methods had good consistency （ k 〉 0.8, P 〈 0.05 ）. According to Chi-square test, there was no difference in qualitative results between any two methods（ P 〉 0. 0125 ）, except that the semi- automatic method had higher positive rate than automatic method （ P 〈 0. 0125 ） in HBcAb. Thenumbers of samples which were not completely consistent in the three methods for HBsAg, HBsAb, HBeAg, HBeAb and HBcAb were 17,24,9,34 and 36 respectively. Conclusion Automatic method showed better stability than semi-automatic method and manual method. Tree methods have relatively good consistency, and all of them can be used for better diagnosis of HBV. Automatic method has higher accuracy than semi- automatic method and manual method in ELISA HBV-M tests and can further improve the quality of the analysis.
出处
《标记免疫分析与临床》
CAS
2016年第1期78-82,共5页
Labeled Immunoassays and Clinical Medicine
基金
卫生部医药卫生科技发展研究中心(28-1-2)
