Comparison of the Elecsys® Anti-SARS-CoV-2 immunoassay with the EDI™ enzyme linked immunosorbent assays for the detection of SARS-CoV-2 antibodies in human plasma

Clin Chim Acta. 2020 Oct;509:18-21. doi: 10.1016/j.cca.2020.05.049. Epub 2020 May 30.

Abstract

Background: Here, we report on a head-to-head comparison of the fully-automated Elecsys® Anti-SARS-CoV-2 immunoassay with the EDITM enzyme linked immunosorbent assays (ELISA) for the detection of SARS-CoV-2 antibodies in human plasma.

Methods: SARS-CoV-2 antibodies were measured with the Elecsys® assay and the EDITM ELISAs (IgM and IgG) in 64 SARS-CoV-2 RT-PCR confirmed COVID-19 patients with serial blood samples (n = 104) collected at different time points from symptom onset. Blood samples from 200 healthy blood donors and 256 intensive care unit (ICU) patients collected before the COVID-19 outbreak were also used.

Results: In COVID-19 patients, the percentage of positive results rose with time from symptom onset, peaking to positivity rates after 15-22 days of 100% for the Elecsys® assay, of 94% for the EDITM IgM-ELISA and of 100% for the EDITM IgG ELISA. In the 104 blood samples, the agreement between positive/negative classifications of the Elecsys® assay and the EDITM ELISAs (IgM or IgG) was 90%. The false positivity rates in the healthy blood donors and the ICU patients were < 1% for the Elecsys® assay and < 3% for the EDITM ELISAs.

Conclusions: Our results indicate a high sensitivity and specificity for the Elecsys® assay and an acceptable agreement with the EDITM ELISAs.

Keywords: Antibody testing; COVID-19; ECLIA; SARS-CoV-2; Serological test.

Publication types

  • Comparative Study

MeSH terms

  • Antibodies, Viral / blood*
  • Betacoronavirus* / isolation & purification
  • COVID-19
  • Clinical Laboratory Techniques / methods*
  • Clinical Laboratory Techniques / standards*
  • Coronavirus Infections / blood*
  • Coronavirus Infections / diagnosis*
  • Enzyme-Linked Immunosorbent Assay / methods
  • Enzyme-Linked Immunosorbent Assay / standards
  • Female
  • Humans
  • Immunoassay / methods
  • Immunoassay / standards
  • Male
  • Pandemics
  • Pneumonia, Viral / blood*
  • Pneumonia, Viral / diagnosis*
  • SARS-CoV-2
  • Serologic Tests / methods
  • Serologic Tests / standards

Substances

  • Antibodies, Viral