Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak

Abstract

We developed a chemiluminescence immunoassay method based on the recombinant nucleocapsid antigen and assessed its performance for the clinical diagnosis of severe acute respiratory syndrome coronavirus (SARS-CoV)-2 infections by detecting SARS-CoV-2-specific IgM and IgG antibodies in patients. Full-length recombinant nucleocapsid antigen and tosyl magnetic beads were used to develop the chemiluminescence immunoassay approach. Plasmas from 29 healthy cohorts, 51 tuberculosis patients, and 79 confirmed SARS-CoV-2 patients were employed to evaluate the chemiluminescence immunoassay method performance for the clinical diagnosis of SARS-CoV-2 infections. A commercial ELISA kit (Darui Biotech, China) using the same nucleocapsid antigen was used for the in-parallel comparison with our chemiluminescence immunoassay method. The IgM and IgG manner of testing in the chemiluminescence immunoassay method showed a sensitivity and specificity of 60.76% (95% CI 49.1 to 71.6) and 92.25% (95% CI 83.4 to 97.2) and 82.28% (95% CI 72.1 to 90.0) and 97.5% (95% CI 91.3 to 99.7), respectively. Higher sensitivity and specificity were observed in the chemiluminescence immunoassay method compared with the Darui Biotech ELISA kit. The developed high sensitivity and specificity chemiluminescence immunoassay IgG testing method combined with the RT-PCR approach can improve the clinical diagnosis for SARS-CoV-2 infections and thus contribute to the control of COVID-19 expansion.

Ultrasensitive high-resolution profiling of early seroconversion in patients with COVID-19

“…Many serological enzyme-linked immunosorbent assays (ELISAs) have been developed recently to detect anti-SARS-CoV-2 antibodies. However, these assays have important limitations 4,8,[10][11][12][13][14][15][16][17][18][19] .…”

Metastatic pulmonary dissemination as differential diagnosis of COVID-19 disease

“…6 Initial positive rapid antibody test was considered false-positive. [7][8][9][10][11][12] On the other hand, chest CT has been proposed as a diagnostic criterion by the National Health Commission of China in Hubei with the benefit of advancing proper treatment and isolation measures due to the delays of microbiological testing. Also, some studies have suggested that chest CT may have higher sensitivity for diagnosis of COVID-19 than RT-PCR, and may have a role as the first step in diagnosis and follow-up to clinical response.…”

SARS-CoV-2 pandemic: a review of molecular diagnostic tools including sample collection and commercial response with associated advantages and limitations

“…Antibodies are proteins generated by the immune system in response to an infection. The level of antibody response can vary with age, gender, and presence of comorbidities [123,124]. Immunoglobulin G, M, and A (IgG, IgM, and IgA) are being used as potential markers for COVID-19.…”

“…Analysis of sequencing data from clinical samples (using Illumina sequencer) unveiled undetected community transmission of COVID-19 in the state of Washington [72] Analysis of sequencing data from clinical samples (using Illumina sequencer) unveiled multiple routes of introduction of COVID-19 into the state of California [73] Amplicon-based targeted sequencing from clinical samples (using Nanopore sequencer) unveiled multiple routes of introduction of COVID-19 into the Netherlands [102] Platforms and global consortiums utilizing genomic data to track real-time spread and evolution of pathogens including COVID-19 [84,103,104] immunoassay (CLIA) [123][124][125], and enzyme-linked immunosorbent assay (ELISA) [126,[133][134][135][136]. Pan et al [137] and Li et al [130] reported the detection of SARS-CoV-2 antibodies from whole blood.…”