Indrati Agnes Rengga, Horian Erinca, Dewi Nina Susana, Suraya Nida, Tiara Marita Restie, Djauhari Hofiya, Alisjahbana Bachti
Departement of Clinical Pathology, Hasan Sadikin Hospital, Faculty of Medicine, Universitas Padjadjaran, Bandung 40161, West Java, Indonesia.
Research Center for Care and Control of Infectious Disease, Universitas Padjadjaran, Bandung 40161, West Java, Indonesia.
Diagnostics (Basel). 2024 Aug 14;14(16):1776. doi: 10.3390/diagnostics14161776.
COVID-19 infection in high-risk populations is fatal and has a poor prognosis, necessitating a test to determine the protectiveness of immune response. Antibody testing is necessary to determine the body's immune response to COVID-19 infection and also vaccination strategies. Among the various methods available, the chemiluminescent immunoassay (CLIA) test is more widely used and accessible to determine antibody levels. This study aimed to determine the protection level of S-RBD SARS-CoV-2 IgG using CLIA compared to the Surrogate Virus Neutralization Test (SVNT). The population of this study comprised all healthcare professionals who experienced S-RBD SARS-CoV-2 IgG antibody level examinations. S-RBD SARS-CoV-2 IgG antibody levels were examined using CLIA and SVNT. The cut-off was determined using a receiver operating characteristic (ROC) curve, and area under the curve (AUC) measurements were evaluated. The result showed a strong positive correlation between S-RBD SARS-CoV-2 IgG CLIA and SVNT, with a value of r = 0.933 and < 0.001. The value ≥ 37.29 BAU/mL was determined as the cut-off based on SVNT 30% inhibition level with sensitivity, specificity, and positive and negative predictive values of 96.5%, 90.9%, 96.5%, and 90.9%, respectively. A titer of antibodies greater than or equal to 37.29 BAU/mL with CLIA showed the presence of protective antibodies compared to SVNT.
高危人群感染新型冠状病毒肺炎（COVID-19）具有致命性且预后较差，因此需要进行检测以确定免疫反应的保护性。抗体检测对于确定机体对COVID-19感染的免疫反应以及疫苗接种策略都很有必要。在现有的各种方法中，化学发光免疫分析法（CLIA）检测在确定抗体水平方面应用更为广泛且易于操作。本研究旨在通过CLIA检测与替代病毒中和试验（SVNT）比较，确定严重急性呼吸综合征冠状病毒2（SARS-CoV-2）刺突蛋白受体结合域（S-RBD）IgG的保护水平。本研究的对象包括所有接受过S-RBD SARS-CoV-2 IgG抗体水平检测的医护人员。使用CLIA和SVNT检测S-RBD SARS-CoV-2 IgG抗体水平。通过绘制受试者工作特征（ROC）曲线确定临界值，并评估曲线下面积（AUC）测量值。结果显示，S-RBD SARS-CoV-2 IgG CLIA与SVNT之间呈强正相关，r值为0.933，P<0.001。基于SVNT 30%抑制水平，将≥37.29 BAU/mL的值确定为临界值，其敏感性、特异性、阳性预测值和阴性预测值分别为96.5%、90.9%、96.5%和90.9%。与SVNT相比，CLIA检测抗体滴度大于或等于37.29 BAU/mL表明存在保护性抗体。
