Real-world evaluation of a novel technology for quantitative simultaneous antibody detection against multiple SARS-CoV-2 antigens in a cohort of patients presenting with COVID-19 syndrome

Analyst. 2020 Aug 21;145(16):5638-5646. doi: 10.1039/d0an01066a. Epub 2020 Jul 8.

Abstract

An evaluation of a rapid portable gold-nanotechnology measuring SARS-CoV-2 IgM, IgA and IgG antibody concentrations against spike 1 (S1), spike 2 (S) and nucleocapsid (N) was conducted using serum samples from 74 patients tested for SARS-CoV-2 RNA on admission to hospital, and 47 historical control patients from March 2019. 59 patients were RNA(+) and 15 were RNA(-). A serum (±) classification was derived for all three antigens and a quantitative serological profile was obtained. Serum(+) was identified in 30% (95% CI 11-48) of initially RNA(-) patients, in 36% (95% CI 17-54) of RNA(+) patients before 10 days, 77% (95% CI 67-87) between 10 and 20 days and 95% (95% CI 86-100) after 21 days. The patient-level diagnostic accuracy relative to RNA(±) after 10 days displayed 88% sensitivity (95% CI 75-95) and 75% specificity (95% CI 22-99), although specificity compared with historical controls was 100% (95%CI 91-100). This study provides robust support for further evaluation and validation of this novel technology in a clinical setting and highlights challenges inherent in assessment of serological tests for an emerging disease such as COVID-19.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Viral / analysis*
  • Antibodies, Viral / immunology
  • Betacoronavirus / immunology*
  • COVID-19
  • COVID-19 Testing
  • Clinical Laboratory Techniques
  • Cohort Studies
  • Coronavirus Infections / blood
  • Coronavirus Infections / diagnosis*
  • Coronavirus Nucleocapsid Proteins
  • False Negative Reactions
  • Female
  • Gold / chemistry
  • Humans
  • Immunoglobulin A / analysis
  • Immunoglobulin A / immunology
  • Immunoglobulin G / analysis
  • Immunoglobulin G / immunology
  • Immunoglobulin M / analysis
  • Immunoglobulin M / immunology
  • Male
  • Metal Nanoparticles / chemistry
  • Middle Aged
  • Nucleocapsid Proteins / immunology
  • Pandemics
  • Phosphoproteins
  • Pneumonia, Viral / blood
  • Pneumonia, Viral / diagnosis*
  • SARS-CoV-2
  • Sensitivity and Specificity
  • Serologic Tests / methods*
  • Spike Glycoprotein, Coronavirus / immunology
  • Young Adult

Substances

  • Antibodies, Viral
  • Coronavirus Nucleocapsid Proteins
  • Immunoglobulin A
  • Immunoglobulin G
  • Immunoglobulin M
  • Nucleocapsid Proteins
  • Phosphoproteins
  • Spike Glycoprotein, Coronavirus
  • nucleocapsid phosphoprotein, SARS-CoV-2
  • spike protein, SARS-CoV-2
  • Gold