Assessment of an in-house IgG ELISA targeting SARS-CoV-2 RBD: Applications in infected and vaccinated individuals

The study evoluated an in-house Spike Receptor Binding Domain Enzyme-Linked Immunosorbent Assay (RBD-IgG-ELISA) for detecting SARS-CoV-2 IgG antibodies in infected and vaccinated individuals. The assay demonstrated a sensitivity of 91%, specificity of 99.25%, and accuracy of 95.13%. Precision and re...

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Bibliographic Details
Published in:	Journal of immunological methods Vol. 530; p. 113683
Main Authors:	da Costa, Hernan Hermes Monteiro, Silva, Valeria Oliveira, Amorim, Gustavo Carvalho, Guereschi, Marcia Grando, Sergio, Luciana Marciano, Gomes, Carlos Henrique Rodrigues, Hong, Marisa Ailin, de Oliveira, Elaine Lopes, Brígido, Luis Fernando de Macedo, Lindoso, Jose Angelo Lauletta, Prudencio, Carlos Roberto
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 01-07-2024
Subjects:	diagnosis Enzyme-Linked Immunosorbent Assay Epidemiology SARS-CoV-2 Vaccines validation study diagnosis SARS-CoV-2 validation study Vaccines Enzyme-Linked Immunosorbent Assay Epidemiology
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Summary:	The study evoluated an in-house Spike Receptor Binding Domain Enzyme-Linked Immunosorbent Assay (RBD-IgG-ELISA) for detecting SARS-CoV-2 IgG antibodies in infected and vaccinated individuals. The assay demonstrated a sensitivity of 91%, specificity of 99.25%, and accuracy of 95.13%. Precision and reproducibility were highly consistent. The RBD-IgG-ELISA was able to detect 96.25% of Polymerase chain reaction (PCR) confirmed cases for SARS-CoV-2 infection, demonstrating positive and negative predictive values of 99,18% and 91,69%, respectively. In an epidemiological survey, ELISA, lateral flow immunochromatographic assay (LFIA), and electrochemiluminescence immunoassay (ECLIA) exhibited diagnostic sensitivities of 68.29%, 63.41%, and 70.73%, respectively, along with specificities of 82.93%, 80.49%, and 80.49%, respectively. Agreement between RBD-IgG-ELISA/PCR was moderate (k index 0.512). However, good agreement between different assays (RBD-IgG-ELISA/LFIA k index 0.875, RBD-IgG-ELISA/ECLIA k index 0.901). Test performance on individuals' samples were inferior due to seroconversion time and chronicity. The IgG-RBD-ELISA assay demonstrated its effectiveness in monitoring antibody levels among healthcare professionals, revealing significant differences both before and after the administration of the third vaccine dose, with heightened protection levels observed following the third dose in five Coronavirus disease (COVID-19) vaccine regimens. In conclusion, the RBD-IgG-ELISA exhibits high reproducibility, specificity, and sensitivity, making it a suitable assay validated for serosurveillance and for obtaining information about COVID-19 infections or vaccinations. •SARS-CoV-2 infection and vaccination typically induce a strong humoral immune response.•RBD-IgG-ELISA exhibits high sensitivity and specificity among controlled settings.•False negatives from the test can be directly linked to the timing of antibody production.•Understanding the IgG antibodies profiles is essential to guide COVID-19 vaccine boosting strategies.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0022-1759 1872-7905 1872-7905
DOI:	10.1016/j.jim.2024.113683