tetano
Editor, Senior Moderator
J Med Virol
. 2021 Oct 21.
doi: 10.1002/jmv.27412. Online ahead of print.
Performance evaluation of Elecsys SARS-CoV-2 Antigen immunoassay for diagnostic of COVID-19
María Caridad Montalvo Villalba[SUP] 1 [/SUP], Elena Sosa Glaria[SUP] 1 [/SUP], Licel de Los Ángeles Rodriguez Lay[SUP] 1 [/SUP], Odalys Valdés Ramirez[SUP] 1 [/SUP], Dayana Vallina García[SUP] 1 [/SUP], Amely Arencibia Garcia[SUP] 1 [/SUP], Javier Martinez Alfonso[SUP] 1 [/SUP], Dunia Menes Llerena[SUP] 1 [/SUP], Loida Torres Pérez[SUP] 2 [/SUP], Sonia Resik Aguirre[SUP] 1 [/SUP], Maria Guadalupe Guzmán Tirado[SUP] 1 [/SUP]
Affiliations
Abstract
Introduction: One of challenge for control and prevention of 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).
Methods: 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 RT-PCR STAT-NAT® COVID-19 as reference test. Cross reactivity was estimated using samples positive by RT-PCR to other respiratory virus (Influenza virus, Parainfluenza virus, Rhinovirus, Coronavirus OC43 and HKU1).
Results: 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 virus was 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.
Conclusion: 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. This article is protected by copyright. All rights reserved.
Keywords: SARS-CoV-2 antigen tests; cross reactivity; immunoassay; sensitivity; specificity.
. 2021 Oct 21.
doi: 10.1002/jmv.27412. Online ahead of print.
Performance evaluation of Elecsys SARS-CoV-2 Antigen immunoassay for diagnostic of COVID-19
María Caridad Montalvo Villalba[SUP] 1 [/SUP], Elena Sosa Glaria[SUP] 1 [/SUP], Licel de Los Ángeles Rodriguez Lay[SUP] 1 [/SUP], Odalys Valdés Ramirez[SUP] 1 [/SUP], Dayana Vallina García[SUP] 1 [/SUP], Amely Arencibia Garcia[SUP] 1 [/SUP], Javier Martinez Alfonso[SUP] 1 [/SUP], Dunia Menes Llerena[SUP] 1 [/SUP], Loida Torres Pérez[SUP] 2 [/SUP], Sonia Resik Aguirre[SUP] 1 [/SUP], Maria Guadalupe Guzmán Tirado[SUP] 1 [/SUP]
Affiliations
- PMID: 34676585
- DOI: 10.1002/jmv.27412
Abstract
Introduction: One of challenge for control and prevention of 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).
Methods: 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 RT-PCR STAT-NAT® COVID-19 as reference test. Cross reactivity was estimated using samples positive by RT-PCR to other respiratory virus (Influenza virus, Parainfluenza virus, Rhinovirus, Coronavirus OC43 and HKU1).
Results: 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 virus was 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.
Conclusion: 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. This article is protected by copyright. All rights reserved.
Keywords: SARS-CoV-2 antigen tests; cross reactivity; immunoassay; sensitivity; specificity.