Abstract
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.
Highlights
Novel technologies are needed to facilitate large-scale detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) specific antibodies in human blood samples
We adapted a mechanically-induced trapping of molecular interactions (MITOMI)-based [15, 16] 1,024-cell NIA device previously applied to vaccine adjuvant screening [17] and the detection of inflammatory and cancer-related protein biomarkers in serum [18] to the detection of anti–SARSCoV-2 IgG antibodies
Patient samples are initially isolated by actuating the neck valve, and the surface of the assay chamber is patterned with biotinylated bovine serum albumin (BSA-biotin) and neutrAvidin, leaving a circular surface region coated with neutrAvidin beneath the MITOMI button
Summary
Novel technologies are needed to facilitate large-scale detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) 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. Addition, tens to hundreds of thousands of blood samples will need to be tested for each SARS-CoV-2 vaccine phase 3 clinical trial, and large numbers of samples will need to be tested to monitor immune responses after a vaccine has been approved and rolled out Such studies are cumbersome and expensive to perform, as they require large numbers of serum samples obtained by venipuncture and analyzed by highly sensitive and specific immunological assays to classify samples as seropositive or seronegative.
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