Department of Pharmaceutical Sciences School of Pharmacy and Pharmaceutical Sciences Binghamton University, Johnson City, NY, 13790, USA.
Talanta. 2021 Mar 1;224:121883. doi: 10.1016/j.talanta.2020.121883. Epub 2020 Nov 10.
The COVID-19 pandemic has had a devastating impact worldwide and has brought clinical assays both for acute diagnosis and prior exposure determination to the forefront. Serological testing intended for point-of-care or laboratory use can be used to determine more accurate individual and population assessments of prior exposure to SARS-CoV-2; improve our understanding of the degree to which immunity is conveyed to subsequent exposures; and quantify immune response to future vaccines. In response to this pandemic, initially more than 90 companies deployed serology assays to the U.S. market, many of which made overstated claims for their accuracy, regulatory approval status, and utility for intended purpose. The U.S. Food and Drug Administration subsequently instituted an Emergency Use Authorization (EUA) procedure requiring that manufacturers submit validation data, but allowing newly developed serological tests to be marketed without the usual approval process during this crisis. Although this rapid deployment was intended to benefit public health, the incomplete understanding of immune response to the virus and lack of assay vetting resulted in quality issues with some of these tests, and thus many were withdrawn after submission. Common assay platforms include lateral flow assays which can serve an important niche of low cost, rapid turnaround, and increased accessibility whereas established laboratory-based platforms based on ELISAs and chemiluminescence expand existing technologies to SARS-CoV-2 and can provide throughput and quantification capabilities. While most of the currently EUA assays rely on these well-established platforms, despite their apparent technical simplicity, there are numerous practical challenges both for manufacturers in developing and for end-users in running and interpreting such assays. Within are discussed technical challenges to serology development for SARS-CoV-2, with an emphasis on lateral flow assay technology.
COVID-19 大流行在全球范围内造成了毁灭性的影响，将用于急性诊断和既往暴露检测的临床检测方法推到了前沿。用于即时护理或实验室使用的血清学检测可用于更准确地评估个体和人群对 SARS-CoV-2 的既往暴露情况；增进我们对免疫在多大程度上传递给后续暴露的理解；并定量评估对未来疫苗的免疫反应。针对这一大流行，最初有超过 90 家公司向美国市场推出了血清学检测方法，其中许多夸大了其准确性、监管批准状态和预期用途的实用性。美国食品和药物管理局随后制定了紧急使用授权 (EUA) 程序，要求制造商提交验证数据，但允许在这一危机期间，未经通常的批准程序，即可将新开发的血清学检测方法推向市场。尽管这种快速部署旨在造福公共卫生，但由于对病毒免疫反应的不完全了解以及缺乏检测验证，导致其中一些检测方法出现质量问题，因此许多检测方法在提交后被撤回。常见的检测平台包括侧向流动检测法，该检测法可以作为低成本、快速周转和提高可及性的重要选择，而基于 ELISA 和化学发光的既定实验室平台则将现有的技术扩展到 SARS-CoV-2，并可提供通量和定量能力。虽然目前大多数 EUA 检测方法都依赖于这些成熟的平台，但尽管它们的技术看似简单，制造商在开发和最终用户在运行和解释这些检测方面都面临着许多实际挑战。本文讨论了 SARS-CoV-2 血清学检测开发所面临的技术挑战，重点是侧向流动检测技术。
