Abstract
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® 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 κ 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.
Keywords: SARS-CoV-2 antigen tests; cross reactivity; immunoassay; sensitivity; specificity.
【저자키워드】 immunoassay, sensitivity, specificity., Cross reactivity, SARS-CoV-2 antigen tests, 【초록키워드】 SARS-CoV-2, coronavirus, Influenza, point of care, Infection, diagnostic, complement, Influenza virus, severe acute respiratory syndrome Coronavirus, RT-PCR, Symptoms, Predictive value, Antigen, cross-reactivity, respiratory viruses, Nasopharyngeal swab, immunoassay, polymerase chain reaction, specificity, SARS-CoV-2 transmission, rhinovirus, nasopharyngeal swabs, reverse transcription, cross, antigen tests, SARS-CoV-2 antigen, parainfluenza virus, antigen detection, OC43, HKU1, Cross reactivity, Reverse transcription-polymerase chain reaction, STAT, Cycle threshold value, Other respiratory viruses, Negative predictive value, Chain Reaction, acute respiratory syndrome, reference test, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, RT-PCR testing, alternative, 95% confidence interval, individual, positive, Roche Diagnostics, aims, Elecsys, Randomly, selected, identify, evaluate, reduce, other respiratory virus, ranged, Elecsy, NPV, PPV, 【제목키워드】 COVID-19, SARS-CoV-2, diagnostic, performance, Elecsy,