Comparative assessment of homemade ELISA and lateral flow assay (LFA)in the rapid, specific and sensitive detection of SARS-CoV-2 anti-nucleocapsid protein in sera of Egyptian patients

Theodor Bilharz Research Institute

Bibliographic Information

Authors: El-Shershaby A.; Hussein N.; Ali E.; El-Hakim A.; Tabll A.; Shaheen M.; Ali I.; Elshall M.; Shahein Y.

Journal: Journal of Immunoassay and Immunochemistry

Publisher: Taylor and Francis Ltd.

Publication Date: 15 June 2023

Volume / Issue: Volume 44 / Issue 4

Pages: 338–359

ISSN: 15321819

DOI: 10.1080/15321819.2023.2224865

Scopus: View on Scopus

PubMed: 37319429

Document Type: Article

Authors and Affiliations

El-Shershaby A., Molecular Biology Department, Biotechnology Research Institute, National Research Centre, Cairo, Egypt; Hussein N., Molecular Biology Department, Biotechnology Research Institute, National Research Centre, Cairo, Egypt; Ali E., Molecular Biology Department, Biotechnology Research Institute, National Research Centre, Cairo, Egypt; El-Hakim A., Molecular Biology Department, Biotechnology Research Institute, National Research Centre, Cairo, Egypt; Tabll A., Microbial Biotechnology Department, Biotechnology Research Institute, National Research Centre, Cairo, Egypt, Immunology Department, Egypt Center for Research and Regenerative Medicine (ECRRM), Cairo, Egypt; Shaheen M., Environmental Virology Laboratory, Water Pollution Research Department, Environmental and Climate Change Research Institute, National Research Centre, Cairo, Egypt; Ali I., Parasitology Department, Theodor Bilharz Research Institute, Giza, Egypt; Elshall M., Parasitology Department, Theodor Bilharz Research Institute, Giza, Egypt; Shahein Y., Molecular Biology Department, Biotechnology Research Institute, National Research Centre, Cairo, Egypt

Abstract

Several diagnostic measures have been employed to precisely detect the SARS-CoV-2 viral infection using viral antigens, nucleic acids, and other serological approaches. The sensitivity and specificity of the serological tests remain a challenging need. Here, we describe the detection of human anti-SARS-CoV-2 IgG and IgM antibodies qualitatively through two optimized in-house ELISA and lateral flow immunoassay. Both approaches are based on the prokaryotic expression of 50 kDa SARS-CoV-2 recombinant nucleocapsid protein. This SARS-CoV-2rN-6×His was used either to coat ELISA plates or to be conjugated to gold nanoparticles followed by colorimetric detection of bound human IgG or IgM. In the LFA, we show the optimization of nanoparticle size, protein-binding capacity, membrane treatment, and finally testing the potential capacity of using either the optimized ELISA or LFA in detecting antibodies raised against viral infection. Assessment of both methods was carried out using human sera-positive and negative SARS-CoV-2 antibodies. The ELISA and LFA tests showed 86%, 96.5% sensitivity, 92%, 93.75% specificity, 97%, 98.2% PPV, and 64%, 88.2% NPV, respectively. In conclusion, both approaches were able to successfully detect human antibodies against SARS-CoV-2 nucleocapsid protein. The importance of both protocols cannot be overstated in the detection and diagnosis of viral infections, especially in developing countries. © 2023 Taylor & Francis.

Keywords

Diagnosis; ELISA; Lateral flow assay (LFA); Nucleocapsid; SARS-CoV-2; Antibodies, Viral; COVID-19; Egypt; Enzyme-Linked Immunosorbent Assay; Gold; Humans; Immunoglobulin G; Immunoglobulin M; Metal Nanoparticles; Sensitivity and Specificity; coronavirus nucleocapsid protein; glass fiber; gold nanoparticle; polyethylene; polypropylene; pyroxylin; recombinant protein; SARS-CoV-2 antibody; metal nanoparticle; virus antibody; Article; colorimetry; controlled study; coronavirus disease 2019; COVID-19 serological testing; developing country; diagnostic accuracy; Egyptian; enzyme linked immunosorbent assay; Escherichia coli; false negative result; false positive result; human; intermethod comparison; lateral flow immunochromatography; membrane; nonhuman; particle size; predictive value; protein binding; protein expression; qualitative analysis; serum; Severe acute respiratory syndrome coronavirus 2; virus nucleocapsid; procedures

Citation Information

Scopus Citations: 4

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