tetano
Editor, Senior Moderator
J Med Virol
. 2021 Sep 15.
doi: 10.1002/jmv.27338. Online ahead of print.
Evaluation of the correlation between the Access SARS-CoV-2 IgM and IgG II antibody tests with the SARS-CoV-2 surrogate virus neutralization test
Yutaro Kitagawa[SUP] 1 [/SUP], Kazuo Imai[SUP] 2 3 [/SUP], Masaru Matsuoka[SUP] 1 [/SUP], Ai Fukada[SUP] 1 [/SUP], Katsumi Kubota[SUP] 1 [/SUP], Momoko Sato[SUP] 1 [/SUP], Tomohito Takada[SUP] 1 [/SUP], Sakiko Noguchi[SUP] 1 [/SUP], Norihito Tarumoto[SUP] 2 [/SUP], Shigefumi Maesaki[SUP] 2 [/SUP], Shinichi Takeuchi[SUP] 1 [/SUP], Takuya Maeda[SUP] 1 [/SUP]
Affiliations
Abstract
Fully automated immunoassays for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies that are strongly correlated with neutralization antibodies (nAbs) are clinically important because they enable assessment of humoral immunity after infection and vaccination. Access SARS-CoV-2 IgM and IgG II antibody tests are semi-quantitative, fully automated immunoassays that detect anti-receptor-binding domain (RBD) antibodies and might reflect nAb levels in coronavirus disease 2019 (COVID-19). However, no studies have investigated the clinical utility of these tests in association with nAbs to date. To evaluate the clinical utility of Access SARS-CoV-2 IgM and IgG II antibody tests and their correlation with the SARS-CoV-2 surrogate virus neutralization test (sVNT) that measures nAbs in patients with COVID-19. We analyzed 54 convalescent serum samples from COVID-19 patients and 89 serum samples from non-COVID-19 patients. The presence of anti-RBD antibodies was detected by Access SARS-CoV-2 IgM and IgG II antibody tests, while nAbs were measured by sVNT. The sensitivity and specificity of sVNT were 94.4% and 98.9%, respectively. There were strong positive correlations between the inhibition values of sVNT and the results of the Access SARS-CoV-2 IgM (R = 0.95, R[SUP]2[/SUP] = 0.90, p < 0.001) and IgG II antibody tests (R = 0.96, R[SUP]2[/SUP] = 0.92, p < 0.001). In terms of the presence of nAbs, the sensitivity and specificity were 98.1% and 98.9% in the IgM assay, and 100.0% and 100.0% in the IgG II assay, respectively. The Access SARS-CoV-2 IgM and IgG II antibody tests showed high sensitivity and specificity for the detection of nAbs in COVID-19 patients and might be alternatives for measuring nAbs. This article is protected by copyright. All rights reserved.
Keywords: COVID-19; IgG; IgM; SARS-CoV-2; neutralization antibody.
. 2021 Sep 15.
doi: 10.1002/jmv.27338. Online ahead of print.
Evaluation of the correlation between the Access SARS-CoV-2 IgM and IgG II antibody tests with the SARS-CoV-2 surrogate virus neutralization test
Yutaro Kitagawa[SUP] 1 [/SUP], Kazuo Imai[SUP] 2 3 [/SUP], Masaru Matsuoka[SUP] 1 [/SUP], Ai Fukada[SUP] 1 [/SUP], Katsumi Kubota[SUP] 1 [/SUP], Momoko Sato[SUP] 1 [/SUP], Tomohito Takada[SUP] 1 [/SUP], Sakiko Noguchi[SUP] 1 [/SUP], Norihito Tarumoto[SUP] 2 [/SUP], Shigefumi Maesaki[SUP] 2 [/SUP], Shinichi Takeuchi[SUP] 1 [/SUP], Takuya Maeda[SUP] 1 [/SUP]
Affiliations
- PMID: 34524695
- DOI: 10.1002/jmv.27338
Abstract
Fully automated immunoassays for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies that are strongly correlated with neutralization antibodies (nAbs) are clinically important because they enable assessment of humoral immunity after infection and vaccination. Access SARS-CoV-2 IgM and IgG II antibody tests are semi-quantitative, fully automated immunoassays that detect anti-receptor-binding domain (RBD) antibodies and might reflect nAb levels in coronavirus disease 2019 (COVID-19). However, no studies have investigated the clinical utility of these tests in association with nAbs to date. To evaluate the clinical utility of Access SARS-CoV-2 IgM and IgG II antibody tests and their correlation with the SARS-CoV-2 surrogate virus neutralization test (sVNT) that measures nAbs in patients with COVID-19. We analyzed 54 convalescent serum samples from COVID-19 patients and 89 serum samples from non-COVID-19 patients. The presence of anti-RBD antibodies was detected by Access SARS-CoV-2 IgM and IgG II antibody tests, while nAbs were measured by sVNT. The sensitivity and specificity of sVNT were 94.4% and 98.9%, respectively. There were strong positive correlations between the inhibition values of sVNT and the results of the Access SARS-CoV-2 IgM (R = 0.95, R[SUP]2[/SUP] = 0.90, p < 0.001) and IgG II antibody tests (R = 0.96, R[SUP]2[/SUP] = 0.92, p < 0.001). In terms of the presence of nAbs, the sensitivity and specificity were 98.1% and 98.9% in the IgM assay, and 100.0% and 100.0% in the IgG II assay, respectively. The Access SARS-CoV-2 IgM and IgG II antibody tests showed high sensitivity and specificity for the detection of nAbs in COVID-19 patients and might be alternatives for measuring nAbs. This article is protected by copyright. All rights reserved.
Keywords: COVID-19; IgG; IgM; SARS-CoV-2; neutralization antibody.