Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, 615 North Wolfe Street, Room W7033B Baltimore, MD, 21205 USA; Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, 615 North Wolfe Street, Room W7033B Baltimore, MD, 21205 USA.
J Clin Virol. 2021 Dec;145:104997. doi: 10.1016/j.jcv.2021.104997. Epub 2021 Oct 9.
Oral fluid (hereafter saliva) offers a non-invasive sampling method for detection of SARS-CoV-2 antibodies. However, data comparing performance of salivary tests against commercially-available serologic and neutralizing antibody (nAb) assays are lacking. This study compared the performance of a laboratory-developed multiplex salivary SARS-CoV-2 IgG assay targeting antibodies to nucleocapsid (N), receptor binding domain (RBD) and spike (S) antigens to three commercially-available SARS-CoV-2 serologic enzyme immunoassays (EIAs) (Ortho Vitros, Euroimmun, and BioRad) and nAb. Paired saliva and plasma samples were collected from 101 eligible COVID-19 convalescent plasma (CCP) donors >14 days since PCR+ confirmed diagnosis. Concordance was evaluated using positive (PPA) and negative (NPA) percent agreement, and Cohen's kappa coefficient. The range between salivary and plasma EIAs for SARS-CoV-2-specific N was PPA: 54.4-92.1% and NPA: 69.2-91.7%, for RBD was PPA: 89.9-100% and NPA: 50.0-84.6%, and for S was PPA: 50.6-96.6% and NPA: 50.0-100%. Compared to a plasma nAb assay, the multiplex salivary assay PPA ranged from 62.3% (N) and 98.6% (RBD) and NPA ranged from 18.8% (RBD) to 96.9% (S). Combinations of N, RBD, and S and a summary algorithmic index of all three (N/RBD/S) in saliva produced ranges of PPA: 87.6-98.9% and NPA: 50-91.7% with the three EIAs and ranges of PPA: 88.4-98.6% and NPA: 21.9-34.4% with the nAb assay. A multiplex salivary SARS-CoV-2 IgG assay demonstrated variable, but comparable performance to three commercially-available plasma EIAs and a nAb assay, and may be a viable alternative to assist in monitoring population-based seroprevalence and vaccine antibody response.
唾液(以下简称 saliva)提供了一种非侵入性的采样方法,用于检测 SARS-CoV-2 抗体。然而,缺乏比较唾液检测与市售血清学和中和抗体(nAb)检测性能的数据。本研究比较了实验室开发的针对核衣壳(N)、受体结合域(RBD)和刺突(S)抗原的多重唾液 SARS-CoV-2 IgG 检测与三种市售 SARS-CoV-2 血清学酶免疫分析(EIA)(Ortho Vitros、Euroimmun 和 BioRad)和 nAb 的性能。从 101 名符合条件的 COVID-19 恢复期血浆(CCP)供体中采集了配对的唾液和血浆样本,这些供体在 PCR+确诊后 >14 天。使用阳性(PPA)和阴性(NPA)百分比一致性和 Cohen's kappa 系数评估一致性。唾液和血浆 EIA 之间 SARS-CoV-2 特异性 N 的范围为 PPA:54.4-92.1%和 NPA:69.2-91.7%,RBD 为 PPA:89.9-100%和 NPA:50.0-84.6%,S 为 PPA:50.6-96.6%和 NPA:50.0-100%。与血浆 nAb 检测相比,多重唾液检测的 PPA 范围为 62.3%(N)和 98.6%(RBD),NPA 范围为 18.8%(RBD)至 96.9%(S)。唾液中 N、RBD 和 S 的组合以及这三种的汇总算法指标(N/RBD/S)产生了与三种 EIA 的 PPA 范围:87.6-98.9%和 NPA:50-91.7%,与 nAb 检测的 PPA 范围:88.4-98.6%和 NPA:21.9-34.4%。多重唾液 SARS-CoV-2 IgG 检测与三种市售血浆 EIA 和 nAb 检测的性能存在差异,但具有可比性,可能是一种可行的替代方法,有助于监测基于人群的血清流行率和疫苗抗体反应。