tetano
Editor, Senior Moderator
J Clin Virol
. 2021 Nov 4;145:105024.
doi: 10.1016/j.jcv.2021.105024. Online ahead of print.
Development of a rapid point-of-care test that measures neutralizing antibodies to SARS-CoV-2
Douglas F Lake[SUP] 1 [/SUP], Alexa J Roeder[SUP] 2 [/SUP], Erin Kaleta[SUP] 3 [/SUP], Paniz Jasbi[SUP] 4 [/SUP], Kirsten Pfeffer[SUP] 2 [/SUP], Calvin Koelbela[SUP] 2 [/SUP], Sivakumar Periasamy[SUP] 5 [/SUP], Natalia Kuzmina[SUP] 5 [/SUP], Alexander Bukreyev[SUP] 6 [/SUP], Thomas E Grys[SUP] 3 [/SUP], Liang Wu[SUP] 7 [/SUP], John R Mills[SUP] 7 [/SUP], Kathrine McAulay[SUP] 3 [/SUP], Maria Gonzalez-Moa[SUP] 8 [/SUP], Alim Seit-Nebi[SUP] 8 [/SUP], Sergei Svarovsky[SUP] 8 [/SUP]
Affiliations
Abstract
Background: 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).
Methods: 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.
Results: 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.
Conclusions: 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.
Keywords: ACE2; Covid-19; Lateral flow assay; Neutralizing antibodies; RBD; Sars-cov-2.
. 2021 Nov 4;145:105024.
doi: 10.1016/j.jcv.2021.105024. Online ahead of print.
Development of a rapid point-of-care test that measures neutralizing antibodies to SARS-CoV-2
Douglas F Lake[SUP] 1 [/SUP], Alexa J Roeder[SUP] 2 [/SUP], Erin Kaleta[SUP] 3 [/SUP], Paniz Jasbi[SUP] 4 [/SUP], Kirsten Pfeffer[SUP] 2 [/SUP], Calvin Koelbela[SUP] 2 [/SUP], Sivakumar Periasamy[SUP] 5 [/SUP], Natalia Kuzmina[SUP] 5 [/SUP], Alexander Bukreyev[SUP] 6 [/SUP], Thomas E Grys[SUP] 3 [/SUP], Liang Wu[SUP] 7 [/SUP], John R Mills[SUP] 7 [/SUP], Kathrine McAulay[SUP] 3 [/SUP], Maria Gonzalez-Moa[SUP] 8 [/SUP], Alim Seit-Nebi[SUP] 8 [/SUP], Sergei Svarovsky[SUP] 8 [/SUP]
Affiliations
- PMID: 34781240
- DOI: 10.1016/j.jcv.2021.105024
Abstract
Background: 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).
Methods: 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.
Results: 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.
Conclusions: 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.
Keywords: ACE2; Covid-19; Lateral flow assay; Neutralizing antibodies; RBD; Sars-cov-2.