A comparative review of immunoassays for COVID-19 detection

Expert Rev Clin Immunol. 2021 Jun;17(6):573-599. doi: 10.1080/1744666X.2021.1908886.

Abstract

Introduction: The gold standard for diagnosis of coronavirus disease 2019 (COVID-19) is detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription polymerase chain reaction (RT-PCR), which is expensive, time-consuming and may result in false-negative results. Serological tests can be employed for RT-PCR negative patients, contact tracing, determining the probability of protection against re-infection, and seroepidemiological studies.Areas covered: The main methodologies of serology-based tests for the detection of SARS-CoV-2 including enzyme-linked immunosorbent assays (ELISAs), chemiluminescent immunoassays (CLIAs) and lateral flow immunoassays (LFIAs) were reviewed and their diagnostic performances were compared. Herein, a literature review on the databases of PubMed, Scopus and Google Scholar between January 1, 2020 and June 30, 2020 based on the main serological methods for COVID-19 detection with the focus on comparative experiments was performed. The review was updated on December 31, 2020.Expert opinion: Serology testing could be considered as a part of diagnostic panel two-week post symptom onset. Higher sensitivity for serology-based tests could be achieved by determining combined IgG/IgM titers. Furthermore, higher sensitive serological test detecting neutralization antibody could be developed by targeting spike (S) antigen. It was also demonstrated that the sensitivity of ELISA/CLIA-based methods are higher than LFIA devices.

Keywords: CLIA; COVID-19; ELISA; LFIA; SARS-CoV-2; serology.

Publication types

  • Review

MeSH terms

  • Antibodies, Neutralizing / blood*
  • Antibodies, Viral / blood*
  • Biomarkers / blood
  • COVID-19 / diagnosis*
  • COVID-19 / immunology
  • COVID-19 / virology
  • COVID-19 Serological Testing*
  • Enzyme-Linked Immunosorbent Assay
  • Host-Pathogen Interactions
  • Humans
  • Immunoglobulin G / blood*
  • Immunoglobulin M / blood*
  • Luminescent Measurements
  • Predictive Value of Tests
  • Reproducibility of Results
  • SARS-CoV-2 / immunology*

Substances

  • Antibodies, Neutralizing
  • Antibodies, Viral
  • Biomarkers
  • Immunoglobulin G
  • Immunoglobulin M