Title | Performance evaluation of Elecsys SARS-CoV-2 Antigen immunoassay for diagnostic of COVID-19. | ||
Author | Montalvo Villalba, Maria C; Sosa Glaria, Elena; Rodriguez Lay, Licel de Los A; Valdes Ramirez, Odalys; Vallina Garcia, Dayana; Arencibia Garcia, Amely; Martinez Alfonso, Javier; Menes Llerena, Dunia M; Torres Perez, Loida; Resik Aguirre, Sonia R; Guzman Tirado, Maria G | ||
Journal | J Med Virol | Publication Year/Month | 2022-Mar |
PMID | 34676585 | PMCID | PMC8662245 |
Affiliation + expend | 1.Department of Virology, Institute of Tropical Medicine Pedro Kouri, Havana, Cuba. |
One of the challenges for control and prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is the early diagnostic at the point of care. Several tests based on qualitative antigen detection have been developed; one of these is Elecsys SARS-CoV-2 Antigen immunoassay (Roche Diagnostics). In total, 523 nasopharyngeal swabs were randomly selected with the aims to evaluate sensitivity, specificity, cross-reactivity, positive and negative predictive value (PPV, NPV), and agreement of Elecsys SARS-CoV-2 Antigen immunoassay using reverse transcription-polymerase chain reaction (RT-PCR) STAT-NAT(R) coronavirus disease-2019 as reference test. Cross-reactivity was estimated using samples positive by RT-PCR to other respiratory viruses (influenza virus, parainfluenza virus, rhinovirus, coronavirus OC43, and HKU1). The overall sensitivity of Elecsys SARS-CoV-2 Antigen was 89.72% (288/321); specificity was 90.59% (183/202); and cross-reactivity to other respiratory viruses were not detected. Elecsys SARS-CoV-2 Antigen immunoassay showed a high sensitivity in samples with cycle threshold value <30, which ranged from 92.81% to 95.40%, independently of symptoms. PPV and NPV were 93.81% and 84.72%, respectively. The kappa coefficient was 0.79 (95% confidence interval: 0.73-0.84), showing substantial agreement between both tests. The results suggest Elecsys SARS-CoV-2 Antigen immunoassay could be used as an alternative to RT-PCR testing, or in complement with it, to identify infectious individuals and reduce SARS-CoV-2 transmission.