Replication Data for: Comparative performance of the InBios SCoV-2 DetectTM IgG ELISA and the in-house KWTRP ELISA in detecting SARS-CoV-2 spike IgG antibodies in Kenyan populations

This is a replication dataset for the manuscript titled \"Comparative performance of the InBios SCoV-2 DetectTM IgG ELISA and the in-house KWTRP ELISA in detecting SARS-CoV-2 spike IgG antibodies in Kenyan populations.\" The SARS-CoV-2 seroprevalence estimates have been carried out by institutions under the Kenya Multi-Site Sero-surveillance (KEMIS) collaboration using both the InBios SCoV-2 DetectTM IgG ELISA and in house KWTRP ELISA. For the comparability of data collected using both tests by KEMIS participating sites, we conducted a direct comparison of these assays. We directly used pre-pandemic serum/plasma collected in 2018 from 454 blood donors and 173 malaria cross-sectional survey participants designated gold standard negatives. As gold standard positives, we assayed serum/plasma from 159 SARS-CoV-2 PCR-positive patients and 166 vaccination-confirmed participants.We obtained ODs(Optical density) from the samples' reactivity to SARS-CoV-2 antigen on both ELISA assays. We then expressed the OD into a ratio using the control samples. The ratios from both assays were then used to determine specificity, sensitivity, and prevalence. Pairwise comparisons between the InBios and KWTRP was done and assays’ reproducibility was assesed by examining the raw ODs and coefficient of variation (CV) for the negative, positive and cut-off controls.

本数据集为论文《InBios SCoV-2 DetectTM IgG酶联免疫吸附试验（Enzyme-Linked Immunosorbent Assay，ELISA）与KWTRP自制酶联免疫吸附试验检测肯尼亚人群中严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）刺突免疫球蛋白G（Immunoglobulin G，IgG）抗体的性能对比》的复现数据集。肯尼亚多站点血清监测合作项目（Kenya Multi-Site Sero-surveillance, KEMIS）的下属机构，已同时采用InBios SCoV-2 DetectTM IgG ELISA与KWTRP自制ELISA，完成了SARS-CoV-2血清阳性率估算。为确保KEMIS各参与站点采用两种检测方法所获数据的可比性，本研究对这两种检测方法开展了直接对比。本研究以2018年收集的大流行前血清/血浆样本作为金标准阴性对照：包括454名献血者样本，以及173名参与疟疾横断面调查的受试者样本；同时以159例SARS-CoV-2聚合酶链式反应（Polymerase Chain Reaction，PCR）阳性患者的血清/血浆样本、166例经疫苗接种证实的受试者血清/血浆样本作为金标准阳性对照。我们检测了所有样本在两种ELISA检测中与SARS-CoV-2抗原反应的光密度（Optical Density，OD）值，随后以对照样本为基准将OD值转换为比值；基于两种检测方法得到的比值，我们计算了特异性、灵敏度及血清阳性率。本研究完成了InBios与KWTRP两种检测方法的两两对比，并通过分析阴性、阳性及临界值对照的原始OD值与变异系数（Coefficient of Variation，CV），评估了两种检测方法的重复性。