SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays

He S. Yang, Sabrina E. Racine-Brzostek, William T. Lee, Danielle Hunt, Jim Yee, Zhengming Chen, Jeffrey Kubiak, Miguel Cantu, Layla Hatem, Elaine Zhong, Danielle D'Ambrosio, Amy Chadburn, Lars Westblade, Marshall Glesby, Massimo Loda, Melissa M. Cushing, Zhen Zhao

Research output: Contribution to journalArticlepeer-review

30 Scopus citations


Background: In the ongoing COVID-19 pandemic, there is an urgent need for comprehensive performance evaluation and clinical utility assessment of serological assays to understand the immune response to SARS-CoV-2. Methods: IgM/IgG and total antibodies against SARS-CoV-2 were measured by a cyclic enhanced fluorescence assay (CEFA) and a microsphere immunoassay (MIA), respectively. Independent performance evaluation included imprecision, reproducibility, specificity and cross-reactivity (CEFA n = 320, MIA n = 364). Clinical utility was evaluated by both methods in 87 patients at initial emergency department visit, 28 during subsequent hospitalizations (106 serial samples), and 145 convalescent patients. Totally 916 patients and 994 samples were evaluated. Results: Agreement of CEFA and MIA was 90.4%-94.5% (Kappa: 0.81–0.89) in 302 samples. CEFA and MIA detected SARS-CoV-2 antibodies in 26.2% and 26.3%, respectively, of ED patients. Detection rates increased over time reaching 100% after 21 days post-symptom onset. Longitudinal antibody kinetic changes by CEFA and MIA measurements correlated well and exhibited three types of seroconversion. Convalescent sera showed a wide range of antibody levels. Conclusion: Rigorously validated CEFA and MIA assays are reliable for detecting antibodies to SARS-CoV-2 and show promising clinical utility when evaluating immune response in hospitalized and convalescent patients, but are not useful for early screening at patient's initial ED visit.

Original languageEnglish (US)
Pages (from-to)117-125
Number of pages9
JournalClinica Chimica Acta
StatePublished - Oct 2020
Externally publishedYes


  • Coronavirus disease 19 (COVID-19)
  • Immunoassay
  • Serology
  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical


Dive into the research topics of 'SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays'. Together they form a unique fingerprint.

Cite this