Pre-evaluation assessment of serological-based COVID-19 point-of- care lateral flow assays in Kenya

The specificity of the assays was determined using a panel of 50 pre-COVID-19 pandemic serumsamples from June 2019. Sensitivity was determined for each assay using 50 rRT-PCR SARS-CoV-2-positive samples.The antibody tests were considered positive when either IgM, IgG or both line(s) were positive.Diagnostic sensitivity (%) and diagnostic specificity were calculated from true positive results, false negative, falsepositive and true negative results

本研究采用50份2019年6月采集的新冠大流行前血清样本，测定了各检测方法的特异性。针对50份经逆转录实时荧光定量聚合酶链反应（rRT-PCR）检测为严重急性呼吸综合征冠状病毒2（SARS-CoV-2）阳性的样本，测定了各检测方法的灵敏度。当IgM、IgG任意一项检测条带呈阳性，或两项检测条带均呈阳性时，该抗体检测结果判定为阳性。诊断灵敏度（%）与诊断特异性通过真阳性、假阴性、假阳性及真阴性结果计算得到。