Sensitivity of the Elecsys Nucleocapsid Assay for the Detection of Preceding SARS-CoV-2 Infections

Abstract Nucleocapsid serological assay sensitivity to identify severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections among vaccinees and for Omicron cases is unclear. In this prospective study, the Elecsys nucleocapsid assay was 89% sensitive in identifying SARS-CoV-2 infections 14–607 days pre–blood collection. Sensitivity was similar when comparing by vaccination status, and in Omicron (vs pre-Omicron) cases.

[1]  P. Demers,et al.  A Prospective Observational Cohort Comparison of SARS-CoV-2 Seroprevalence Between Paramedics and Matched Blood Donors in Canada During the COVID-19 Pandemic , 2022, Annals of Emergency Medicine.

[2]  P. Demers,et al.  Evaluation of the Performance of a Multiplexed Serological Assay in the Detection of SARS-CoV-2 Infections in a Predominantly Vaccinated Population , 2022, Microbiology spectrum.

[3]  H. Woo,et al.  Omicron: A Heavily Mutated SARS-CoV-2 Variant Exhibits Stronger Binding to ACE2 and Potently Escapes Approved COVID-19 Therapeutic Antibodies , 2022, Frontiers in Immunology.

[4]  S. Ghedira,et al.  Comparative study of six SARS-CoV-2 serology assays: Diagnostic performance and antibody dynamics in a cohort of hospitalized patients for moderate to critical COVID-19 , 2022, International journal of immunopathology and pharmacology.

[5]  C. Bergin,et al.  Serological markers of SARS-CoV-2 infection; anti-nucleocapsid antibody positivity may not be the ideal marker of natural infection in vaccinated individuals , 2021, Journal of Infection.

[6]  R. D. Nerenz,et al.  A comparison of SARS-CoV-2 nucleocapsid and spike antibody detection using three commercially available automated immunoassays , 2021, Clinical Biochemistry.

[7]  J. Dunne,et al.  SARS-CoV-2 Antibody Testing in Health Care Workers: A Comparison of the Clinical Performance of Three Commercially Available Antibody Assays , 2021, medRxiv.

[8]  P. Glasziou,et al.  Estimating the extent of asymptomatic COVID-19 and its potential for community transmission: Systematic review and meta-analysis. , 2020, Journal of the Association of Medical Microbiology and Infectious Disease Canada = Journal officiel de l'Association pour la microbiologie medicale et l'infectiologie Canada.

[9]  P. Bieniasz,et al.  Longitudinal Serological Analysis and Neutralizing Antibody Levels in Coronavirus Disease 2019 Convalescent Patients , 2020, The Journal of Infectious Diseases.

[10]  G. Rodger,et al.  Performance characteristics of five immunoassays for SARS-CoV-2: a head-to-head benchmark comparison , 2020, The Lancet Infectious Diseases.

[11]  Aashish Manglik,et al.  Test performance evaluation of SARS-CoV-2 serological assays , 2020, Nature Biotechnology.