Ng Elaine, Choi Christopher, Wang Shan X
Department of Materials Science and Engineering, Stanford University, Stanford, CA, USA.
Department of Electrical Engineering, Stanford University, Stanford, CA, USA.
Sens Actuators B Chem. 2023 Jul 15;387:133773. doi: 10.1016/j.snb.2023.133773. Epub 2023 Apr 5.
The COVID-19 pandemic has highlighted the need to monitor important correlates of immunity on a population-wide level. To this end, we have developed a competitive assay to assess neutralizing antibody (NAb) titer on the giant magnetoresistive (GMR) biosensor platform. We compared the clinical performance of our biosensor with established techniques such as Ortho's VITROS Anti-SARS-CoV-2 IgG Quantitative Antibody test. Results obtained between the VITROS test and the GMR assay showed correlation ( = -0.93). We then validated the assay with patient plasma samples that had been tested using focus reduction neutralization testing (FRNT). The results obtained from our GMR assay exhibit a previously identified trend of increased NAb titers 2 weeks post-vaccination. We further evaluated NAb titers 6 months post-vaccination and observed waning neutralizing antibody titers over that time in vaccinated patients. In addition, we calibrated our assay to an arbitrary unit (IU/mL) using World Health Organization (WHO) reference plasma provided by the National Institute of Biological Standards and Control (NIBSC). Our biosensor provides highly specific and sensitive results in serum and plasma with analytical, clinical, and point-of-care (POC) applications due to quick turnaround times on samples and the cost-effectiveness of the platform.
新冠疫情凸显了在全人群层面监测免疫重要相关指标的必要性。为此,我们开发了一种竞争性检测方法,以在巨磁阻(GMR)生物传感器平台上评估中和抗体(NAb)滴度。我们将我们的生物传感器的临床性能与诸如奥瑟诊断公司的VITROS抗SARS-CoV-2 IgG定量抗体检测等既定技术进行了比较。VITROS检测和GMR检测获得的结果显示具有相关性(r = -0.93)。然后,我们用已经使用蚀斑减少中和试验(FRNT)检测过的患者血浆样本验证了该检测方法。我们的GMR检测获得的结果呈现出先前确定的接种疫苗后2周NAb滴度升高的趋势。我们进一步评估了接种疫苗后6个月的NAb滴度,并观察到在这段时间内接种疫苗患者的中和抗体滴度逐渐下降。此外,我们使用由国家生物标准与控制研究所(NIBSC)提供的世界卫生组织(WHO)参考血浆将我们的检测方法校准为任意单位(IU/mL)。由于样本周转时间快且平台具有成本效益,我们的生物传感器在血清和血浆的分析、临床及即时检测(POC)应用中提供了高度特异且灵敏的结果。