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Review
. 2022 Aug 8;33(2):159-165.
eCollection 2022 Aug.

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

Riberi María Inés  1 , Hernandez Toledo Marina Gabriela  1 , Cid Mariana Paula  2   3 , Tenaglia María Magdalena  1 , Alfaro Jimena  1 , Konigheim Brenda Salome  4   3 , Aguilar Juan Javier  4 , Blanco Sebastián  4 , Spinsanti Lorena  4 , Díaz Luis Adrián  4   3 , Rivarola Elisa  4 , Beranek Mauricio  4   3 , Bottiglieri Marina Tersita  1 , Gallego Sandra Verónica  4   3 , Isa María Beatriz  1   4
Affiliations
Review

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

Riberi María Inés et al. EJIFCC. .

Abstract

Introduction: 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.

Methods: We evaluated two commercial assays for serological diagnosis of SARS-CoV-2 infection, approved by the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) in Argentina: Elecsys Anti-SARS-CoV-2; Roche for nucleocapsid total antibody detection, and VIDAS Anti-SARS-CoV-2 bioMérieux for spike protein IgG antibody detection. 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 plaque reduction neutralization test (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. Assays were evaluated as stand-alone tests.

Results: Sensitivity was 97.8% and 98.9% for the Roche and bioMérieux assays, respectively, specificity: 98.5% (Roche) and 97.1% (bioMérieux), positive predictive value (PPV): 98.9% (Roche) and 97.8% (bioMérieux), and negative predictive value: (NPV) 97.2% (Roche) and 98.5% (bioMérieux). Additionally, Cohen's kappa coefficient demonstrated high concordance (k=0.950) between Roche and bioMérieux.

Discussion: In conclusion, our results evidenced a very good performance for the nucleocapsid antibody assay (Roche) and the spike protein antibody assay (bioMérieux), thus both platforms are equally adequate for indirect diagnosis of SARS-CoV-2 infection through total antibodies and IgG antibody detection, respectively.

Keywords: COVID-19; SARS-CoV-2 infection; antibody detection; diagnosis.

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Conflict of interest statement

We thank Dr. Rogelio Pizzi, Dean of the Facultad de Ciencias Médicas, Universidad Nacional de Córdoba and Dr. Silvia Nates, Director of the Instituto de Virología Dr. J. M. Vanella (FCM-UNC) for their assistance in the development of this investigation. Personal and financial conflicts of interest The authors declare that there are not competing interest.

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