From the Departments of Pathology (Garcia-Beltran, Miller, Kirkpatrick, Nixon, Astudillo, Yang, Murali, Dighe, Lennerz, Thierauf, Iafrate), Massachusetts General Hospital, Boston.
Garcia-Beltran and Miller contributed equally to this work.
Arch Pathol Lab Med. 2021 Apr 1;145(4):415-418. doi: 10.5858/arpa.2020-0713-SA.
The rapid worldwide spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has propelled the rapid development of serologic tests that can detect anti-SARS-CoV-2 antibodies. These have been used for studying the prevalence and spread of infection in different populations, and helping establish a recent diagnosis of coronavirus disease 2019 (COVID-19), and will likely be used to confirm humoral immunity after infection or vaccination. However, nearly all lab-based high-throughput SARS-CoV-2 serologic assays require a serum sample from venous blood draw, limiting their applications and scalability. Here, we present a method that enables large-scale SARS-CoV-2 serologic studies by combining self or office collection of fingerprick blood with a volumetric absorptive microsampling device (Mitra, Neoteryx LLC) with a high-throughput electrochemiluminescence-based SARS-CoV-2 total antibody assay (Roche Elecsys, Roche Diagnostics Inc) that is emergency use authorization approved for use on serum samples and widely used by clinical laboratories around the world. We found that the Roche Elecsys assay has a high dynamic range that allows for accurate detection of SARS-CoV-2 antibodies in serum samples diluted 1:20 as well as contrived dried blood extracts. Extracts of dried blood from Mitra devices acquired in a community seroprevalence study showed near identical sensitivity and specificity in detection of SARS-CoV-2 antibodies compared with neat sera using predefined thresholds for each specimen type. Overall, this study affirms the use of Mitra dried blood collection device with the Roche Elecsys SARS-CoV-2 total antibody assay for remote or at-home testing as well as large-scale community seroprevalence studies.
严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)感染在全球迅速传播,推动了血清学检测方法的快速发展,这些方法可用于检测抗 SARS-CoV-2 抗体。这些方法已被用于研究不同人群中感染的流行和传播情况,并有助于建立对 2019 年冠状病毒病(COVID-19)的近期诊断,并且可能用于确认感染或接种疫苗后的体液免疫。然而,几乎所有基于实验室的高通量 SARS-CoV-2 血清学检测都需要静脉采血的血清样本,限制了它们的应用和扩展性。在这里,我们提出了一种方法,通过将自采或在诊所采集的指血与带有高通量基于电化学发光的 SARS-CoV-2 总抗体检测(罗氏 Elecsys,罗氏诊断公司)的容积式吸收微采样装置(Mitra,Neoteryx 有限责任公司)相结合,实现了大规模 SARS-CoV-2 血清学研究,该检测已获得血清样本的紧急使用授权,并被世界各地的临床实验室广泛使用。我们发现,罗氏 Elecsys 检测法具有很宽的动态范围,允许在血清样本稀释 1:20 以及人为的干血提取物中准确检测 SARS-CoV-2 抗体。在社区血清流行率研究中采集的 Mitra 设备中的干血提取物在检测 SARS-CoV-2 抗体时的敏感性和特异性与使用预定义阈值的新鲜血清几乎相同。总体而言,这项研究证实了使用 Mitra 干血采集装置与罗氏 Elecsys SARS-CoV-2 总抗体检测法进行远程或家庭检测以及大规模社区血清流行率研究。