- Grebe, Eduard;
- Stone, Mars;
- Spencer, Bryan;
- Akinseye, Akintunde;
- Wright, David;
- Di Germanio, Clara;
- Bruhn, Roberta;
- Zurita, Karla;
- Contestable, Paul;
- Green, Valerie;
- Lanteri, Marion;
- Saa, Paula;
- Biggerstaff, Brad;
- Coughlin, Melissa;
- Kleinman, Steve;
- Custer, Brian;
- Jones, Jefferson;
- Busch, Michael
Nucleocapsid antibody assays can be used to estimate SARS-CoV-2 infection prevalence in regions implementing spike-based COVID-19 vaccines. However, poor sensitivity of nucleocapsid antibody assays in detecting infection after vaccination has been reported. We derived a lower cutoff for identifying previous infections in a large blood donor cohort (N = 142,599) by using the Ortho VITROS Anti-SARS-CoV-2 Total-N Antibody assay, improving sensitivity while maintaining specificity >98%. We validated sensitivity in samples donated after self-reported swab-confirmed infections diagnoses. Sensitivity for first infections in unvaccinated donors was 98.1% (95% CI 98.0-98.2) and for infection after vaccination was 95.6% (95% CI 95.6-95.7) based on the standard cutoff. Regression analysis showed sensitivity was reduced in the Delta compared with Omicron period, in older donors, in asymptomatic infections, <30 days after infection, and for infection after vaccination. The standard Ortho N antibody threshold demonstrated good sensitivity, which was modestly improved with the revised cutoff.