Development of a rapid point-of-care test that measures neutralizing antibodies to SARS-CoV-2.
Development of a rapid point-of-care test that measures neutralizing antibodies to SARS-CoV-2.
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DOI：
10.1016/j.jcv.2021.105024
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发表时间：
2021-12
期刊：
影响因子：
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通讯作者：
Svarovsky S
中科院分区：
文献类型：
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作者：
Lake DF;Roeder AJ;Kaleta E;Jasbi P;Pfeffer K;Koelbela C;Periasamy S;Kuzmina N;Bukreyev A;Grys TE;Wu L;Mills JR;McAulay K;Gonzalez-Moa M;Seit-Nebi A;Svarovsky S
接种 COVID-19 疫苗后，大多数接种者都想知道自己是否能够免受感染以及能够持续多久。由于中和抗体与保护作用相关，因此我们开发了一种侧向层析测定 (LFA)，可测量一滴血中中和抗体的水平。 LFA 的原理是中和抗体阻断受体结合域 (RBD) 与血管紧张素转换酶 2 (ACE2) 的结合。使用 SARS-CoV-2 微中和测定评估了 LFA 正确测量 COVID-19 患者血清、血浆或全血中和的能力。我们还确定了 LFA 是否能够区分季节性呼吸道病毒患者和 COVID-19 患者。为了证明 LFA 的有用性，我们在基线以及第一剂和第二剂疫苗接种后对之前感染和未感染的 COVID-19 疫苗接种者进行了测试。 LFA 与 SARS-CoV-2 微中和测定相比，ROC 曲线下面积为 98%。从季节性冠状病毒患者获得的血清在 LFA 中没有显示出中和活性。在接种单剂 mRNA 疫苗后，87% 的先前感染者表现出高水平的中和抗体。然而，如果个体之前没有被感染，只有 24% 的人在接种一剂疫苗后表现出高水平的中和抗体。第二次注射后，先前感染者的中和抗体水平仅高出 8%，但未感染者的中和抗体水平则高出 63% 以上。快速、半定量、高度便携且廉价的中和抗体测试可能有助于监测疫苗诱导的 COVID-19 中和抗体的上升和下降。
After receiving a COVID-19 vaccine, most recipients want to know if they are protected from infection and for how long. Since neutralizing antibodies are a correlate of protection, we developed a lateral flow assay (LFA) that measures levels of neutralizing antibodies from a drop of blood. The LFA is based on the principle that neutralizing antibodies block binding of the receptor-binding domain (RBD) to angiotensin-converting enzyme 2 (ACE2). The ability of the LFA was assessed to correctly measure neutralization of sera, plasma or whole blood from patients with COVID-19 using SARS-CoV-2 microneutralization assays. We also determined if the LFA distinguished patients with seasonal respiratory viruses from patients with COVID-19. To demonstrate the usefulness of the LFA, we tested previously infected and non-infected COVID-19 vaccine recipients at baseline and after first and second vaccine doses. The LFA compared favorably with SARS-CoV-2 microneutralization assays with an area under the ROC curve of 98%. Sera obtained from patients with seasonal coronaviruses did not show neutralizing activity in the LFA. After a single mRNA vaccine dose, 87% of previously infected individuals demonstrated high levels of neutralizing antibodies. However, if individuals were not previously infected, only 24% demonstrated high levels of neutralizing antibodies after one vaccine dose. A second dose boosted neutralizing antibody levels just 8% higher in previously infected individuals, but over 63% higher in non-infected individuals. A rapid, semi-quantitative, highly portable and inexpensive neutralizing antibody test might be useful for monitoring rise and fall in vaccine-induced neutralizing antibodies to COVID-19.