Perdomo Sammy A, Ortega Viviana, Jaramillo-Botero Andres, Mancilla Nelson, Mosquera-DeLaCruz Jose Hernando, Valencia Drochss Pettry, Quimbaya Mauricio, Contreras Juan David, Velez Gabriel Esteban, Loaiza Oscar A, Gomez Adriana, de la Roche Jhonattan
Facultad de Ingeniería y CienciasPontificia Universidad Javeriana Cali 760031 Colombia.
Facultad de Ciencias Naturales y ExactasUniversidad del Valle Cali 760032 Colombia.
IEEE Trans Instrum Meas. 2021 Oct 8;70:4007710. doi: 10.1109/TIM.2021.3119147. eCollection 2021.
A critical path to solving the SARS-CoV-2 pandemic, without further socioeconomic impact, is to stop its spread. For this to happen, pre- or asymptomatic individuals infected with the virus need to be detected and isolated opportunely. Unfortunately, there are no current ubiquitous (i.e., ultra-sensitive, cheap, and widely available) rapid testing tools capable of early detection of SARS-CoV-2 infections. In this article, we introduce an accurate, portable, and low-cost medical device and bio-nanosensing electrode dubbed SenSARS and its experimental validation. SenSARS' device measures the electrochemical impedance spectra of a disposable bio-modified screen-printed carbon-based working electrode (SPCE) to the changes in the concentration of SARS-CoV-2 antigen molecules ("S" spike proteins) contained within a sub-microliter fluid sample deposited on its surface. SenSARS offers real-time diagnostics and viral load tracking capabilities. Positive and negative control tests were performed in phosphate-buffered saline (PBS) at different concentrations (between 1 and 50 fg/mL) of SARS-CoV-2(S), Epstein-Barr virus (EBV) glycoprotein gp350, and Influenza H1N1 M1 recombinant viral proteins. We demonstrate that SenSARS is easy to use, with a portable and lightweight (< 200 g) instrument and disposable test electrodes (<U.S. [Formula: see text]5), capable of fast diagnosis (~10 min), with high analytical sensitivity (low limits of detection, LOD = 1.065 fg/mL, and quantitation, LOQ = 3.6 fg/mL) and selectivity to SARS-CoV-2(S) antigens, even in the presence of structural proteins from the other pathogens tested. SenSARS provides a potential path to pervasive rapid diagnostics of SARS-CoV-2 in clinical, point-of-care, and home-care settings, and to breaking the transmission chain of this virus. Medical device compliance testing of SenSARS to EIC-60601 technical standards is underway.
在不造成进一步社会经济影响的情况下，解决新冠疫情的关键途径是阻止病毒传播。要实现这一点，需要及时检测并隔离感染病毒的前期或无症状个体。不幸的是，目前尚无能够早期检测新冠病毒感染的普遍适用（即超灵敏、廉价且广泛可用）的快速检测工具。在本文中，我们介绍了一种名为SenSARS的准确、便携且低成本的医疗设备及生物纳米传感电极及其实验验证。SenSARS设备通过测量一次性生物修饰的丝网印刷碳基工作电极（SPCE）的电化学阻抗谱，来检测沉积在其表面的亚微升流体样本中所含新冠病毒抗原分子（“S”刺突蛋白）浓度的变化。SenSARS具备实时诊断和病毒载量追踪能力。在磷酸盐缓冲盐水（PBS）中，针对不同浓度（1至50 fg/mL）的新冠病毒（S）、爱泼斯坦 - 巴尔病毒（EBV）糖蛋白gp350和甲型H1N1流感病毒M1重组病毒蛋白进行了阳性和阴性对照测试。我们证明，SenSARS易于使用，其仪器便携且重量轻（<200克），测试电极一次性使用（<5美元），能够快速诊断（约10分钟），具有高分析灵敏度（低检测限，LOD = 1.065 fg/mL，定量限，LOQ = 3.6 fg/mL）以及对新冠病毒（S）抗原的选择性，即使在存在其他测试病原体结构蛋白的情况下也是如此。SenSARS为在临床、即时护理和家庭护理环境中广泛开展新冠病毒快速诊断以及切断该病毒传播链提供了一条潜在途径。目前正在对SenSARS进行符合EIC - 60601技术标准的医疗器械合规测试。
