Performance of Elecsys anti-SARS CoV-2 (Roche) and VIDAS anti-SARS CoV-2 (biomérieux) for SARS-CoV-2 nucleocapsid and spike protein antibody detection

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Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the novel viral pathogen that causes coronavirus disease 2019 (COVID-19) in humans, has spread worldwide since its identification in late 2019. The pandemic produced an accelerated development of new serological techniques for diagnosis....

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Autores principales: Alfaro, J, Riberi, MI, Hernandez Toledo , MG, Cid, MP, Tenaglia, MM, Konigheim, BS, Aguilar, JJ, Blanco, S, Spinsanti, L, Díaz, LA, Rivarola , E, Beranek , M, Gallego , SV, Isa , MB
Formato: Artículo revista
Publicado: Universidad Nacional Córdoba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología 2021
Materias:
performance
diagnosis
antibody detection
anticuerpos
diagnóstico
desempeño
Acceso en línea:https://revistas.unc.edu.ar/index.php/med/article/view/35033
Aporte de:
Revista de la Facultad de Ciencias Médicas de Córdoba de Universidad Nacional de Córdoba
id I10-R327-article-35033
record_format ojs
institution Universidad Nacional de Córdoba
institution_str I-10
repository_str R-327
container_title_str Revista de la Facultad de Ciencias Médicas de Córdoba
format Artículo revista
topic performance
diagnosis
antibody detection
anticuerpos
diagnóstico
desempeño
spellingShingle performance
diagnosis
antibody detection
anticuerpos
diagnóstico
desempeño
Alfaro, J
Riberi, MI
Hernandez Toledo , MG
Cid, MP
Tenaglia, MM
Konigheim, BS
Aguilar, JJ
Blanco, S
Spinsanti, L
Díaz, LA
Rivarola , E
Beranek , M
Gallego , SV
Isa , MB
Performance of Elecsys anti-SARS CoV-2 (Roche) and VIDAS anti-SARS CoV-2 (biomérieux) for SARS-CoV-2 nucleocapsid and spike protein antibody detection
topic_facet performance
diagnosis
antibody detection
anticuerpos
diagnóstico
desempeño
author Alfaro, J
Riberi, MI
Hernandez Toledo , MG
Cid, MP
Tenaglia, MM
Konigheim, BS
Aguilar, JJ
Blanco, S
Spinsanti, L
Díaz, LA
Rivarola , E
Beranek , M
Gallego , SV
Isa , MB
author_facet Alfaro, J
Riberi, MI
Hernandez Toledo , MG
Cid, MP
Tenaglia, MM
Konigheim, BS
Aguilar, JJ
Blanco, S
Spinsanti, L
Díaz, LA
Rivarola , E
Beranek , M
Gallego , SV
Isa , MB
author_sort Alfaro, J
title Performance of Elecsys anti-SARS CoV-2 (Roche) and VIDAS anti-SARS CoV-2 (biomérieux) for SARS-CoV-2 nucleocapsid and spike protein antibody detection
title_short Performance of Elecsys anti-SARS CoV-2 (Roche) and VIDAS anti-SARS CoV-2 (biomérieux) for SARS-CoV-2 nucleocapsid and spike protein antibody detection
title_full Performance of Elecsys anti-SARS CoV-2 (Roche) and VIDAS anti-SARS CoV-2 (biomérieux) for SARS-CoV-2 nucleocapsid and spike protein antibody detection
title_fullStr Performance of Elecsys anti-SARS CoV-2 (Roche) and VIDAS anti-SARS CoV-2 (biomérieux) for SARS-CoV-2 nucleocapsid and spike protein antibody detection
title_full_unstemmed Performance of Elecsys anti-SARS CoV-2 (Roche) and VIDAS anti-SARS CoV-2 (biomérieux) for SARS-CoV-2 nucleocapsid and spike protein antibody detection
title_sort performance of elecsys anti-sars cov-2 (roche) and vidas anti-sars cov-2 (biomérieux) for sars-cov-2 nucleocapsid and spike protein antibody detection
description Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the novel viral pathogen that causes coronavirus disease 2019 (COVID-19) in humans, has spread worldwide since its identification in late 2019. The pandemic produced an accelerated development of new serological techniques for diagnosis. Herein, we evaluated two commercial assays for serological diagnosis of SARS-CoV-2 infection: Elecsys Anti-SARS CoV-2 (Roche), for nucleocapsid total antibody detection and VIDAS Anti- SARS CoV-2 (bioMérieux), for spike protein IgG antibody detection. The Elecsys Anti-SARS CoV-2 assay was performed on a Cobas e411 analyzer (Roche Diagnostics) and conducted according to the manufacturer’s instructions. Results are expressed as (cut-off index, negative COI <1 or positive COI ≥1) for anti-SARS CoV-2 total antibodies. The VIDAS SARS-CoV-2 IgG assay was performed on a VIDAS analyzer (bioMérieux) and conducted according to the manufacturer’s instructions. Results are interpreted as negative (index <1) or positive (index ≥1). Sensitivity was assessed using a panel of 92 plasma samples from recovered COVID-19 patients who were positive for RT-PCR and positive for neutralizing antibodies by PRNT and/or positive for IgG antibodies by indirect immunofluorescence assay (IFA). Specificity was determined studying 71 plasma samples collected during year 2018, prior to the COVID-19 pandemic. Categorical variables were compared using Fisher’s exact test (CI 95%). Additionally, concordance between the two commercial assays was analyzed using Cohen's kappa coefficient (κ). Sensitivity: 97.83% and 98.91% for Roche and bioMérieux assays, respectively, specificity: 98.59% (Roche) and 97.18% (bioMérieux), positive predictive value (PPV): 98.90% (Roche) and 97.85% (bioMérieux), and negative predictive value: (NPV) 97.22% (Roche) and 98.57% (bioMérieux). Additionally, Cohen's kappa coefficient demonstrated high concordance (k=0.950) between Elecsys Anti-SARS CoV-2 and VIDAS Anti-SARS CoV-2. In conclusion, these results evidenced a very good performance for both, the nucleocapsid antibody assay (Elecsys Anti-SARS CoV-2; Roche) and the spike protein antibody assay (VIDAS Anti-SARS CoV-2; bioMérieux), being both platforms equally adequate for indirect diagnosis of SARS-CoV-2 infection through total antibodies and IgG antibody detection, respectively.
publisher Universidad Nacional Córdoba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología
publishDate 2021
url https://revistas.unc.edu.ar/index.php/med/article/view/35033
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first_indexed 2024-09-03T21:03:01Z
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spelling I10-R327-article-350332024-04-15T16:19:09Z Performance of Elecsys anti-SARS CoV-2 (Roche) and VIDAS anti-SARS CoV-2 (biomérieux) for SARS-CoV-2 nucleocapsid and spike protein antibody detection Desempeño clínico de Elecsys anti-SARS CoV-2 (Roche) y VIDAS anti-SARS CoV-2 (bioMérieux) para la detección de anticuerpos de nucleocápside y proteína de espícula del SARS-CoV-2 Alfaro, J Riberi, MI Hernandez Toledo , MG Cid, MP Tenaglia, MM Konigheim, BS Aguilar, JJ Blanco, S Spinsanti, L Díaz, LA Rivarola , E Beranek , M Gallego , SV Isa , MB performance diagnosis antibody detection anticuerpos diagnóstico desempeño Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the novel viral pathogen that causes coronavirus disease 2019 (COVID-19) in humans, has spread worldwide since its identification in late 2019. The pandemic produced an accelerated development of new serological techniques for diagnosis. Herein, we evaluated two commercial assays for serological diagnosis of SARS-CoV-2 infection: Elecsys Anti-SARS CoV-2 (Roche), for nucleocapsid total antibody detection and VIDAS Anti- SARS CoV-2 (bioMérieux), for spike protein IgG antibody detection. The Elecsys Anti-SARS CoV-2 assay was performed on a Cobas e411 analyzer (Roche Diagnostics) and conducted according to the manufacturer’s instructions. Results are expressed as (cut-off index, negative COI <1 or positive COI ≥1) for anti-SARS CoV-2 total antibodies. The VIDAS SARS-CoV-2 IgG assay was performed on a VIDAS analyzer (bioMérieux) and conducted according to the manufacturer’s instructions. Results are interpreted as negative (index <1) or positive (index ≥1). Sensitivity was assessed using a panel of 92 plasma samples from recovered COVID-19 patients who were positive for RT-PCR and positive for neutralizing antibodies by PRNT and/or positive for IgG antibodies by indirect immunofluorescence assay (IFA). Specificity was determined studying 71 plasma samples collected during year 2018, prior to the COVID-19 pandemic. Categorical variables were compared using Fisher’s exact test (CI 95%). Additionally, concordance between the two commercial assays was analyzed using Cohen's kappa coefficient (κ). Sensitivity: 97.83% and 98.91% for Roche and bioMérieux assays, respectively, specificity: 98.59% (Roche) and 97.18% (bioMérieux), positive predictive value (PPV): 98.90% (Roche) and 97.85% (bioMérieux), and negative predictive value: (NPV) 97.22% (Roche) and 98.57% (bioMérieux). Additionally, Cohen's kappa coefficient demonstrated high concordance (k=0.950) between Elecsys Anti-SARS CoV-2 and VIDAS Anti-SARS CoV-2. In conclusion, these results evidenced a very good performance for both, the nucleocapsid antibody assay (Elecsys Anti-SARS CoV-2; Roche) and the spike protein antibody assay (VIDAS Anti-SARS CoV-2; bioMérieux), being both platforms equally adequate for indirect diagnosis of SARS-CoV-2 infection through total antibodies and IgG antibody detection, respectively. El nuevo coronavirus SARS-CoV-2 fue identificado en el 2019, causa el síndrome respiratorio agudo (Covid-19) provocando miles de infecciones a nivel mundial. La pandemia produjo un desarrollo acelerado de nuevas técnicas serológicas para el diagnóstico. Evaluar el desempeño clínico de dos ensayos comerciales automatizados usados para el diagnóstico serológico de la infección por SARS-CoV-2, Elecsys Anti-SARS CoV-2 (Roche) para detectar anticuerpos totales contra la nucleocápside y VIDAS Anti-SARS CoV-2 (bioMérieux) para anticuerpos contra la proteína de espícula tipo IgG. Se realizó la detección de anticuerpos totales en muestras de plasma con Elecsys Anti-Sars-Cov-2 en Cobas E411(Roche). El valor de corte para resultados negativos fue coi < 1 y para valores positivos se consideró coi ≥1. El análisis de las muestras para determinar anticuerpos contra la espícula tipo IgG se realizó con el reactivo 9-COG  en Vidas (bioMerieux). El índice de corte para valores negativos fue vt < 1 y para valores positivos vt ≥ 1. La sensibilidad se evaluó en un panel de 92 muestras de personas con Covid-19 recuperados que fueron positivos para RT-PCR, para anticuerpos neutralizantes por PRNT y / o para anticuerpos IgG por ensayo de inmunofluorescencia indirecta (IFA). La especificidad se determinó mediante 71 muestras  recolectadas durante el año 2018. Los resultados del desempeño fueron analizados con test de Fisher (IC 95%) y se usó el índice de kappa de Cohen para determinar la concordancia entre ambos métodos. La sensibilidad fue del 97,83% y del 98,91% para los ensayos de Roche y bioMerieux, respectivamente. Además, encontramos especificidad 98,59% (Roche) y 97,18% (bioMerieux), valor predictivo positivo (VPP) 98,90% (Roche) 97,85% (bioMerieux) y valor predictivo negativo (VPN) 97,22% (Roche) y 98,57% (bioMerieux). Se analizó el coeficiente kappa de Cohen, mostrando una alta concordancia (k = 0,950) entre Roche y bioMerieux.  Los resultados evidenciaron un muy buen desempeño clínico, para el ensayo de anticuerpos de nucleocápside (Roche) y para el ensayo de anticuerpos de proteínas de espícula (bioMerieux), siendo ambas plataformas igualmente adecuadas para el diagnóstico indirecto de la infección por SARS-CoV-2 mediante la detección de anticuerpos totales y anticuerpos IgG, respectivamente. Universidad Nacional Córdoba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología 2021-10-12 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion texto texto texto https://revistas.unc.edu.ar/index.php/med/article/view/35033 Revista de la Facultad de Ciencias Médicas de Córdoba.; Vol. 78 No. Suplemento (2021): Suplemento JIC XXII Revista de la Facultad de Ciencias Médicas de Córdoba; Vol. 78 Núm. Suplemento (2021): Suplemento JIC XXII Revista da Faculdade de Ciências Médicas de Córdoba; v. 78 n. Suplemento (2021): Suplemento JIC XXII 1853-0605 0014-6722 http://creativecommons.org/licenses/by-nc/4.0

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