用于检测抗SARS-CoV-2抗体的内部酶联免疫吸附测定（ELISA）和两种商业血清学检测方法的比较评估
Comparative evaluation of in-house ELISA and two commercial serological assays for the detection of antibodies against SARS-CoV-2.
作者信息
Gobena Dabesa, Gudina Esayas Kebede, Degfie Tizta Tilahun, Girma Tsinuel, Gebre Getu, Abdissa Alemseged, Tafesse Fikadu G, Gelanew Tesfaye, Mekonnen Zeleke
机构信息
Public Health Emergency Management and Health Research Directorate, Oromia Health Bureau, Addis Ababa, Ethiopia.
School of Medical Laboratory Science, Institute of Health, Jimma University, Jimma, Ethiopia.
出版信息
Sci Rep. 2025 Apr 22;15(1):13853. doi: 10.1038/s41598-025-97050-y.
The in-house ELISA SARS-CoV-2 serological assay, developed by the Armauer Hansen Research Institute (AHRI) in Ethiopia, measures anti-SARS-CoV-2 receptor binding domain (RBD) antibodies. This study aimed to compare the performance of our cost-effective in-house ELISA with two established commercially available SARS-CoV-2 antibody detection assays during the pre-Omicron COVID-19 pandemic. In April 2021, serum samples were collected from 1441 students across 60 schools in Oromia, from 15 hotspot districts and towns. Socio-demographic data were gathered using CSentryCSProDataEntry7.2.1. Performance agreements between AHRI's in-house ELISA and the two commercial assays were analyzed in these serum samples. Statistical analyses, including Cohen's kappa (κ), overall percentage agreement, positive percent agreement (PPA), and negative percent agreement (NPA), were performed using STATA software. Diagnostic parameters were presented with 95% confidence intervals (CI), calculated using the Clopper-Pearson method. The performance comparison of the in-house ELISA showed substantial agreement with the two commercial assays. The overall concordance rate between in-house ELISA and Elecsys CLIA was 80.8% (95% CI 75.0-86.5), while the agreement between in-house ELISA and the Rapid LFA test (IgG + IgM) was 75.8% (95% CI 70.1-81.5). The kappa coefficients were: in-house ELISA vs. Elecsys CLIA (κ = 0.61, 95% CI 0.55-0.67), in-house ELISA vs. Rapid LFA test (IgG + IgM) (κ = 0.52, 95% CI 0.46-0.58), and Elecsys CLIA vs. Rapid LFA test (IgG + IgM) (κ = 0.73, 95% CI 0.67-0.78). The in-house ELISA demonstrated strong agreement with the Elecsys CLIA, showing a PPA of 81.7% and an NPA of 80.1%. Compared to the Rapid LFA test (IgG + IgM), which had a PPA of 83% and an NPA of 70.4%, the in-house ELISA exhibited better overall agreement with Elecsys CLIA. This study's findings indicate substantial agreement between the in-house ELISA and Elecsys. However, only modest agreement was observed between the in-house ELISA and the rapid test (IgG + IgM). Together, these results suggest the utility of the in-house ELISA as a cost-effective tool for sero surveillance studies and monitoring the effect of interventions in resource-poor settings.
由埃塞俄比亚的阿姆奥尔·汉森研究所（AHRI）开发的内部酶联免疫吸附测定法（ELISA）检测抗严重急性呼吸综合征冠状病毒2（SARS-CoV-2）受体结合域（RBD）抗体。本研究旨在比较我们具有成本效益的内部ELISA与两种已建立的商用SARS-CoV-2抗体检测方法在奥密克戎毒株出现之前的新冠疫情期间的性能。2021年4月，从奥罗米亚州60所学校的1441名学生中收集血清样本，这些学校来自15个热点地区和城镇。使用CSentryCSProDataEntry7.2.1收集社会人口统计学数据。在这些血清样本中分析了AHRI的内部ELISA与两种商业检测方法之间的性能一致性。使用STATA软件进行统计分析，包括科恩kappa系数（κ）、总体百分比一致性、阳性百分比一致性（PPA）和阴性百分比一致性（NPA）。诊断参数以95%置信区间（CI）表示，采用克洛普 - 皮尔逊方法计算。内部ELISA的性能比较显示与两种商业检测方法有高度一致性。内部ELISA与电化学发光免疫分析法（Elecsys CLIA）之间的总体一致性率为80.8%（95% CI 75.0 - 86.5），而内部ELISA与快速乳胶凝集试验（IgG + IgM）之间的一致性为75.8%（95% CI 70.1 - 81.5）。kappa系数分别为：内部ELISA与Elecsys CLIA（κ = 0.61，95% CI 0.55 - 0.67），内部ELISA与快速乳胶凝集试验（IgG + IgM）（κ = 0.52，95% CI 0.46 - 0.58），以及Elecsys CLIA与快速乳胶凝集试验（IgG + IgM）（κ = 0.73，95% CI 0.67 - 0.78）。内部ELISA与Elecsys CLIA显示出高度一致性，PPA为81.7%，NPA为80.1%。与PPA为83%、NPA为70.4%的快速乳胶凝集试验（IgG + IgM）相比，内部ELISA与Elecsys CLIA的总体一致性更好。本研究结果表明内部ELISA与Elecsys之间有高度一致性。然而，内部ELISA与快速检测（IgG + IgM）之间仅观察到中等一致性。总之，这些结果表明内部ELISA作为一种具有成本效益的工具，可用于血清学监测研究以及在资源匮乏地区监测干预措施的效果。
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