Two serological approaches for detection of antibodies to SARS-CoV-2 in different scenarios: a screening tool and a point-of-care test

Diagn Microbiol Infect Dis. 2020 Dec;98(4):115167. doi: 10.1016/j.diagmicrobio.2020.115167. Epub 2020 Aug 11.

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has infected more than 8 million people worldwide, becoming a pandemic. Detecting antibodies against SARS-CoV-2 is of utmost importance and a good indicator of exposure and circulation of the virus within the general population. Two serological tools based on a double recognition assay [enzyme-linked immunosorbent assay (DR-ELISA) and lateral flow assay (DR-LFA)] to detect total antibodies to SARS-CoV-2 have been developed based on the recombinant nucleocapsid protein. A total of 1065 serum samples, including positive for COVID-19 and negative samples from healthy donors or infected with other respiratory pathogens, were analyzed. The results showed values of sensitivity between 91.2% and 100%, and specificity of 100% and 98.2% for DR-LFA and DR-ELISA, respectively. No cross-reactivity against seasonal coronavirus (HCoV-NL63, HCoV-229E, HCoV-HKU1, HCoV-OC43) was found. These results demonstrate the importance of serology as a complementary tool to polymerase chain reaction for follow-up of recovered patients and identification of asymptomatic individuals.

Keywords: COVID-19; Diagnosis; ELISA; LFA; SARS-CoV-2; Serology.

MeSH terms

  • Antibodies, Viral / blood*
  • Betacoronavirus / immunology
  • COVID-19
  • COVID-19 Testing
  • Clinical Laboratory Techniques / methods*
  • Common Cold / diagnosis
  • Common Cold / virology
  • Coronavirus Infections / diagnosis*
  • Enzyme-Linked Immunosorbent Assay / methods
  • Female
  • Humans
  • Immunoassay / methods*
  • Male
  • Mass Screening / methods*
  • Nucleocapsid Proteins / immunology
  • Pandemics
  • Pneumonia, Viral / diagnosis*
  • Point-of-Care Testing*
  • SARS-CoV-2
  • Sensitivity and Specificity

Substances

  • Antibodies, Viral
  • Nucleocapsid Proteins