评估 SARS-CoV-2 核衣壳突变对快速诊断检测抗原检测影响的方法。
Methods to evaluate the impact of SARS-CoV-2 nucleocapsid mutations on antigen detection by rapid diagnostic tests.
机构信息
Biologics Discovery, Abbott Laboratories, Abbott Park, IL 60064, USA.
ARDx, Abbott Laboratories, Westbrook, ME 04092, USA.
出版信息
Biotechniques. 2022 Sep;73(3):136-141. doi: 10.2144/btn-2022-0020. Epub 2022 Aug 25.
Mutations in the nucleocapsid of SARS-CoV-2 may interfere with antigen detection by diagnostic tests. We used several methods to evaluate the effect of various SARS-CoV-2 nucleocapsid mutations on the performance of the Panbio™ and BinaxNOW™ lateral flow rapid antigen tests and a prototype high-throughput immunoassay that utilizes Panbio antibodies. Variant detection was also evaluated by immunoblot and BIAcore™ assay. A panel of 23 recombinant nucleocapsid antigens (rAgs) were produced that included mutations found in circulating SARS-CoV-2 variants, including variants of concern. All mutant rAgs were detected by all assays, at a sensitivity equivalent to wild-type control (Wuhan strain). Thus, using a rAg approach, we found that the SARS-CoV-2 nucleocapsid mutations examined do not directly impact antigen detection or antigen assay performance.
SARS-CoV-2 核衣壳的突变可能会干扰诊断检测的抗原检测。我们使用了几种方法来评估各种 SARS-CoV-2 核衣壳突变对 Panbio™和 BinaxNOW™侧向流动快速抗原检测以及利用 Panbio 抗体的原型高通量免疫分析的性能的影响。通过免疫印迹和 BIAcore™测定法也评估了变体检测。产生了一组包含循环 SARS-CoV-2 变体中发现的突变的 23 种重组核衣壳抗原（rAg），包括关注的变体。所有突变 rAg 均被所有检测方法检测到，其敏感性与野生型对照（武汉株）相当。因此，通过使用 rAg 方法，我们发现所检查的 SARS-CoV-2 核衣壳突变不会直接影响抗原检测或抗原检测性能。
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