As of July 22, 2020, more than 14.7 million infections of SARS-CoV-2, the virus responsible for Coronavirus Disease 2019 (COVID-19), have been confirmed globally. Serological assays are essential for community screening, assessing infection prevalence, aiding identification of infected patients, and enacting appropriate treatment and quarantine protocols in the battle against this rapidly expanding pandemic. Antibody detection by agglutination–PCR (ADAP) is a pure solution phase immunoassay that generates a PCR amplifiable signal when patient antibodies agglutinate DNA-barcoded antigen probes into a dense immune complex. Here, we present an ultrasensitive and high-throughput automated liquid biopsy assay based on the Hamilton Microlab ADAP STAR automated liquid-handling platform, which was developed and validated for the qualitative detection of total antibodies against spike protein 1 (S1) of SARS-CoV-2 that uses as little as 4 µL of serum. To assess the clinical performance of the ADAP assay, 57 PCR-confirmed COVID-19 patients and 223 control patients were tested. The assay showed a sensitivity of 98% (56/57) and a specificity of 99.55% (222/223). Notably, the SARS-CoV-2–negative control patients included individuals with other common coronaviral infections, such as CoV-NL63 and CoV-HKU, which did not cross-react. In addition to high performance, the hands-free automated workstation enabled high-throughput sample processing to reduce screening workload while helping to minimize analyst contact with biohazardous samples. Therefore, the ADAP STAR liquid-handling workstation can be used as a valuable tool to address the COVID-19 global pandemic.

截至 2020 年 7 月 22 日，全球已确认超过 1470 万例 SARS-CoV-2 感染，该病毒是导致 2019 年冠状病毒病 (COVID-19) 的病毒。血清学检测对于社区筛查、评估感染流行率、帮助识别感染患者以及制定适当的治疗和隔离协议以对抗这种迅速蔓延的流行病至关重要。凝集-PCR (ADAP) 抗体检测是一种纯溶液相免疫测定法，当患者抗体将带有 DNA 条形码的抗原探针凝集到致密的免疫复合物中时，它会产生 PCR 可放大信号。在这里，我们提出了一种基于 Hamilton Microlab ADAP STAR 自动化液体处理平台的超灵敏和高通量自动化液体活检分析，它是为定性检测针对 SARS-CoV-2 的刺突蛋白 1 (S1) 的总抗体而开发和验证的，只需 4 µL 血清。为了评估 ADAP 检测的临床表现，对 57 名经 PCR 确认的 COVID-19 患者和 223 名对照患者进行了测试。该测定显示灵敏度为 98% (56/57) 和特异性为 99.55% (222/223)。值得注意的是，SARS-CoV-2 阴性对照患者包括没有交叉反应的其他常见冠状病毒感染的个体，例如 CoV-NL63 和 CoV-HKU。除了高性能之外，免提自动化工作站还支持高通量样品处理，以减少筛选工作量，同时帮助最大限度地减少分析人员与生物危害样品的接触。所以，