Evaluation of three immunochromatographic tests in COVID-19 serologic diagnosis and their clinical usefulness

Eur J Clin Microbiol Infect Dis. 2021 Apr;40(4):897-900. doi: 10.1007/s10096-020-04040-1. Epub 2020 Oct 20.

Abstract

Results of three rapid immunochromatographic tests (ICTs) were compared with those obtained with two automated immunoassays for evaluation of their usefulness. One hundred fifty-nine patients and 67 healthy volunteers were included. Different assays demonstrate 41-45% of diagnostic sensitivities and 91-98% of specificities, with substantial agreement (89.3-91.2%), but a high percentage of weak positive results (13-22%) was observed with ICTs. ICTs performances were comparable to those of automated immunoassays. ICTs could have a role as screening approach due to their easy usability. Subjective interpretation, significant rate of uncertain results, uncertainty on viral antigens source are undoubtedly drawbacks.

Keywords: CLIA; COVID-19; ELISA; Immunochromatographic; SARS-CoV-2; Serology.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Viral / immunology*
  • COVID-19 / diagnosis*
  • COVID-19 / immunology
  • COVID-19 Nucleic Acid Testing
  • COVID-19 Serological Testing / methods*
  • Child
  • Coronavirus Nucleocapsid Proteins / immunology*
  • Female
  • Humans
  • Immunoassay / methods*
  • Immunoglobulin A / immunology
  • Immunoglobulin G / immunology
  • Male
  • Middle Aged
  • Phosphoproteins / immunology
  • SARS-CoV-2 / immunology
  • Sensitivity and Specificity
  • Spike Glycoprotein, Coronavirus / immunology*
  • Young Adult

Substances

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