tetano
Editor, Senior Moderator
Pract Lab Med
. 2021 May;25:e00222.
doi: 10.1016/j.plabm.2021.e00222. Epub 2021 Apr 20.
Comparison of virus neutralization activity and results of 10 different anti-SARS-CoV-2 serological tests in COVID-19 recovered plasma donors
Zs?fia Szab?[SUP] 1 [/SUP], Tam?s Szab?[SUP] 1 2 [/SUP], Korn?lia Bod?[SUP] 3 [/SUP], G?bor Kemenesi[SUP] 4 5 [/SUP], Fanni F?ldes[SUP] 4 5 [/SUP], Katalin Krist?f[SUP] 1 [/SUP], Eszter Barab?s[SUP] 1 [/SUP], Barna V?s?rhelyi[SUP] 1 [/SUP], Zolt?n Proh?szka[SUP] 6 [/SUP], Eszter Fodor[SUP] 7 [/SUP], Ferenc Jakab[SUP] 4 5 [/SUP], Timea Berki[SUP] 3 [/SUP], Zsombor Lacza[SUP] 7 [/SUP]
Affiliations
Abstract
Serological testing is a tool to predict protection against later infection. This potential heavily relies on antibody levels showing acceptable agreement with gold standard virus neutralization tests. The aim of our study was to investigate diagnostic value of the available serological tests in terms of predicting virus neutralizing activity of serum samples drawn 5-7 weeks after onset of symptoms from 101 donors with a history of COVID-19. Immune responses against Receptor Binding Domain (RBD), Spike1 and 2 proteins and Nucleocapsid antigens were measured by various ELISA tests. Neutralizing antibody activity in serum samples was assessed by a cell-based virus neutralization test. Spearman correlation coefficients between serological and neutralization results ranged from 0.41 to 0.91 indicating moderate to strong correlation between ELISA test results and virus neutralization. The sensitivity and specificity of ELISA tests in the prediction of neutralization were 35-100% and 35-90% respectively. No clear cut off levels can be established that would reliably indicate neutralization activity. For some tests, however, a value below which the sample is not expected to neutralize can be established. Our data suggests that several of the ELISA kits tested may be suitable for epidemiological surveys 1-2 months after the infection, estimating whether a person may have recently exposed to the virus. Sensitivities considerably superseding specificity at the cut-off values proposed by the manufacturers suggest greater potential in the identification of insufficient antibody responses than in confirming protection. Nevertheless, the former might be important in assessing response to vaccination and characterizing therapeutic plasma preparations.
Keywords: AUC, area under the curve; Antibody response; COVID-19; COVID-19, coronavirus disease 2019; Correlate of protection; ECDC, European Centre for Disease Prevention and Control; NAbs, neutralizing antibodies; NC, Nucleocapsid; Neutralization; OD, optical density; ROC, receiver operating characteristic; S1, Spike protein 1; S2, Spike protein 2; SARS-CoV-2; SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2; Serological test; VNT, virus neutralization test.
. 2021 May;25:e00222.
doi: 10.1016/j.plabm.2021.e00222. Epub 2021 Apr 20.
Comparison of virus neutralization activity and results of 10 different anti-SARS-CoV-2 serological tests in COVID-19 recovered plasma donors
Zs?fia Szab?[SUP] 1 [/SUP], Tam?s Szab?[SUP] 1 2 [/SUP], Korn?lia Bod?[SUP] 3 [/SUP], G?bor Kemenesi[SUP] 4 5 [/SUP], Fanni F?ldes[SUP] 4 5 [/SUP], Katalin Krist?f[SUP] 1 [/SUP], Eszter Barab?s[SUP] 1 [/SUP], Barna V?s?rhelyi[SUP] 1 [/SUP], Zolt?n Proh?szka[SUP] 6 [/SUP], Eszter Fodor[SUP] 7 [/SUP], Ferenc Jakab[SUP] 4 5 [/SUP], Timea Berki[SUP] 3 [/SUP], Zsombor Lacza[SUP] 7 [/SUP]
Affiliations
- PMID: 33898689
- PMCID: PMC8056825
- DOI: 10.1016/j.plabm.2021.e00222
Abstract
Serological testing is a tool to predict protection against later infection. This potential heavily relies on antibody levels showing acceptable agreement with gold standard virus neutralization tests. The aim of our study was to investigate diagnostic value of the available serological tests in terms of predicting virus neutralizing activity of serum samples drawn 5-7 weeks after onset of symptoms from 101 donors with a history of COVID-19. Immune responses against Receptor Binding Domain (RBD), Spike1 and 2 proteins and Nucleocapsid antigens were measured by various ELISA tests. Neutralizing antibody activity in serum samples was assessed by a cell-based virus neutralization test. Spearman correlation coefficients between serological and neutralization results ranged from 0.41 to 0.91 indicating moderate to strong correlation between ELISA test results and virus neutralization. The sensitivity and specificity of ELISA tests in the prediction of neutralization were 35-100% and 35-90% respectively. No clear cut off levels can be established that would reliably indicate neutralization activity. For some tests, however, a value below which the sample is not expected to neutralize can be established. Our data suggests that several of the ELISA kits tested may be suitable for epidemiological surveys 1-2 months after the infection, estimating whether a person may have recently exposed to the virus. Sensitivities considerably superseding specificity at the cut-off values proposed by the manufacturers suggest greater potential in the identification of insufficient antibody responses than in confirming protection. Nevertheless, the former might be important in assessing response to vaccination and characterizing therapeutic plasma preparations.
Keywords: AUC, area under the curve; Antibody response; COVID-19; COVID-19, coronavirus disease 2019; Correlate of protection; ECDC, European Centre for Disease Prevention and Control; NAbs, neutralizing antibodies; NC, Nucleocapsid; Neutralization; OD, optical density; ROC, receiver operating characteristic; S1, Spike protein 1; S2, Spike protein 2; SARS-CoV-2; SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2; Serological test; VNT, virus neutralization test.