A comparative review of immunoassays for COVID-19 detection

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/CLIAbased methods are higher than LFIA devices.

Micro/nanotechnology-inspired rapid diagnosis of respiratory infectious diseases

“…In addition, it showed that endothelial microparticles present in the blood could be utilized as biomarkers for better management of respiratory infectious diseases. Another study by Boukli et al evaluated the chemiluminescent microparticle immunoassay (CLMIA) for the detection of IgG anti-SARS-COV-2 antibodies [ 161 ]. This study shows the effectiveness of the CLMIA alinity I SARS CoV-2 IgG assay over the Liaison SARS-CoV-2 assay to detect the antigen of the virus.…”

“…Several studies also showed the clinical application of CLMIA for SARS-CoV-2 infection diagnosis [ 161 , 162 ]. These types of microparticles were developed on the basis of recombinant spike for detecting IgM and total antibodies (Ab) against SARS-COV-2 in human serum.…”

Towards Internationally standardised humoral Immune Correlates of Protection from SARS-CoV-2 infection and COVID-19 disease

“…One of the factors that have precluded the derivation of well-defined humoral CoP in general, and to COVID-19 disease in particular, is the diverse number of quantitative antibody assays available and the different units used to quantify the antibody levels of clinical samples. Measuring nAb against SARS-CoV-2 is typically done by virus neutralisation tests such as plaque reduction neutralisation test (PRNT), infectious centre assays or micro-neutralisation tests 19–23 . These are performed with live SARS-CoV-2 or with pseudotyped viruses (typically lentivirus or vesicular stomatitis virus) displaying SARS-CoV-2 Spike protein in their envelope.…”

Qualification of ELISA and neutralization methodologies to measure SARS-CoV-2 humoral immunity using human clinical samples

“…Indeed, many ELISAs have been developed against SARS-CoV-2 19,20 , including those that characterize seroconversion in response to infection and quantify the magnitude of the humoral response 9 . However, few are clinically qualified using trimeric SARS-CoV-2 spike antigen as our studies report.…”