不同试剂盒检测SARS-CoV抗体的方法学评价

The evaluation of ELISA and protein chip assays in the diagnosis of coronavirus-associated SARS

目的 :通过对ELISA方法和蛋白芯片法测定SARS CoV抗体的方法学比较 ,探讨不同SARS试剂盒在辅助诊断非典型肺炎的临床应用价值。方法 :同时用两种ELISA试剂盒检测 135名SARS康复患者及 5 0 0名健康献血者的SARS CoV抗体 ,并随机选取 4 8例小汤山医院确诊SARS康复期患者血清采用蛋白芯片法进行SARS多抗原蛋白测定。结果 :重复性实验 ,两种ELISA试剂盒的批内变异系数分别为 6 .0 6 %、10 .5 % ;批间变异系数分别为 6 .5 7%、11.3%。相关性实验结果显示两试剂盒有良好的相关性 (R2 =0 .94 5 6 ) ,且无显著性差异 (P >0 .0 5 )。4 8例SARS康复患者血清用ELISA方法测定 34例为阳性 ,用蛋白芯片法 35例阳性 ,阳性率分别为 70 .83%、70 .83%、72 .9%。结论 :ELISA方法具有较好的重复性 ,两ELISA试剂盒之间有很好的相关 ;相比之下 ,蛋白芯片法灵敏度较高 。

Objective:To evaluate the methods of different ELISA-assays and the protein chip assays for measurement of serum SARS-CoV antibody and to study the clinical significance of serum antibody against SARS-CoV. Methods:Convalescent sera from 135 clinically confirmed SARS patients, and 500 sera of healthy population have been measured by two ELISA methods and 48 cases have been analyzed by multiple antigens protein chip technique. Results:the repeatability of two ELISA methods were 6.06%、10.5%(coefficient of variability within run ) and 6.56%、11.3%( coefficient of variability between days) respectively, Correlation coefficient of two ELISA methods was 0.9456, The positive rates of specific IgG against SARS virus were 70.83%、70.83%and72.9%respectively which were tested by 48 confirmed SARS cases. Conclusion:ELISA method and protein chip assay can be used to assistdiagnosis of SARS patients. The sensitivity of protein chip assay is better than ELISA methods. [