Assessment of Residual-Serum SARS-CoV-2-N-Antigen Testing for Hospital Surveillance in Germany
Journal of Medical Virology, cilt.98, sa.7, 2026 (SCI-Expanded, Scopus)
- Yayın Türü: Makale / Tam Makale
- Cilt numarası: 98 Sayı: 7
- Basım Tarihi: 2026
- Doi Numarası: 10.1002/jmv.71055
- Dergi Adı: Journal of Medical Virology
- Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, CAB Abstracts, Chemical Abstracts Core, EMBASE, MEDLINE, Biomedical Reference Collection: Corporate Edition (EBSCO), Health Research Premium Collection (ProQuest)
- Anahtar Kelimeler: COVID-19, ELISA, hospital surveillance, nucleocapsid antigen, residual serum, SARS-CoV-2
- Acıbadem Mehmet Ali Aydınlar Üniversitesi Adresli: Evet
Özet
Routine SARS-CoV-2 surveillance in hospitals is crucial for preventing in-hospital transmission, especially among elderly and multimorbid patients. While RT-PCR testing is sensitive, it is resource-intensive, and rapid antigen tests lack sensitivity. This study evaluates the diagnostic performance and utility of serum N-antigen ELISA for detecting active SARS-CoV-2 infection in hospitalized patients during the Omicron period. A prospective, non-interventional diagnostic accuracy study was conducted at a tertiary-care university hospital in Germany from 6 January to 8 February 2023. Residual serum samples were tested for N-antigen using a commercial ELISA and compared with RT-PCR results from respiratory swabs. Diagnostic latency, sensitivity, specificity, and predictive values were calculated at the sample and patient levels. Among 2030 inpatients (12,558 patient-days), 610 were screened by ELISA. Sensitivity and specificity were 60.6% and 99.9%, respectively, increasing to 89.6% and 99.9% for samples with ≥ 104 genome equivalents/mL. Early infection showed higher sensitivity (78.6%) compared to late infection (25.5%). In a paired same-cohort PCR-only scenario, the combined PCR plus available serum N-antigen workflow reduced unknown-risk time by 243 patient-days, corresponding to 1.94 fewer unknown-risk days per 100 cohort patient-days (95% bootstrap CI, 1.38–2.57). Residual-serum SARS-CoV-2 N-antigen testing offers high specificity and early-phase sensitivity, complementing PCR-based hospital surveillance without additional sampling. This approach may enhance the efficient detection of unsuspected infections in routine inpatient care.