Institute of Bioengineering, School of Engineering, École Polytechnique Fédérale de Lausanne, 1015 Lausanne, Switzerland.
Division of Laboratory Medicine, Department of Diagnostics, Geneva University Hospitals and Geneva University, 1205 Geneva, Switzerland.
Proc Natl Acad Sci U S A. 2021 May 4;118(18). doi: 10.1073/pnas.2025289118.
Novel technologies are needed to facilitate large-scale detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific antibodies in human blood samples. Such technologies are essential to support seroprevalence studies and vaccine clinical trials, and to monitor quality and duration of immunity. We developed a microfluidic nanoimmunoassay (NIA) for the detection of anti-SARS-CoV-2 IgG antibodies in 1,024 samples per device. The method achieved a specificity of 100% and a sensitivity of 98% based on the analysis of 289 human serum samples. To eliminate the need for venipuncture, we developed low-cost, ultralow-volume whole blood sampling methods based on two commercial devices and repurposed a blood glucose test strip. The glucose test strip permits the collection, shipment, and analysis of 0.6 μL of whole blood easily obtainable from a simple finger prick. The NIA platform achieves high throughput, high sensitivity, and specificity based on the analysis of 289 human serum samples, and negligible reagent consumption. We furthermore demonstrate the possibility to combine NIA with decentralized and simple approaches to blood sample collection. We expect this technology to be applicable to current and future SARS-CoV-2 related serological studies and to protein biomarker analysis in general.
需要新的技术来促进在人血样本中大规模检测严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 特异性抗体。这些技术对于支持血清流行率研究和疫苗临床试验以及监测免疫的质量和持续时间至关重要。我们开发了一种用于检测 1024 个样本中抗 SARS-CoV-2 IgG 抗体的微流控纳米免疫分析 (NIA) 技术。该方法基于对 289 个人血清样本的分析,实现了 100%的特异性和 98%的灵敏度。为了消除静脉穿刺的需要,我们开发了基于两种商业设备的低成本、超低体积全血采样方法,并重新利用了血糖测试条。血糖测试条允许从简单的指尖轻松采集、运输和分析 0.6 μL 的全血。该 NIA 平台在分析 289 个人血清样本时实现了高通量、高灵敏度和特异性,并且试剂消耗极少。我们还展示了将 NIA 与分散和简单的血液样本采集方法相结合的可能性。我们预计这项技术将适用于当前和未来与 SARS-CoV-2 相关的血清学研究以及一般的蛋白质生物标志物分析。