tetano
Editor, Senior Moderator
J Immunol Methods
. 2023 May 6;113486.
doi: 10.1016/j.jim.2023.113486. Online ahead of print. Anti-N SARS-CoV-2 assays for evaluation of natural viral infection
Aurelia Gaeta[SUP] 1 [/SUP], Antonio Angeloni[SUP] 2 [/SUP], Anna Napoli[SUP] 3 [/SUP], Beatrice Pucci[SUP] 4 [/SUP], Lilia Cinti[SUP] 3 [/SUP], Piergiorgio Roberto[SUP] 3 [/SUP], Flavia Colaiacovo[SUP] 4 [/SUP], Elena Berardelli[SUP] 4 [/SUP], Antonella Farina[SUP] 4 [/SUP], Guido Antonelli[SUP] 3 [/SUP], Emanuela Anastasi[SUP] 4 [/SUP]
Affiliations
Background: The 2019 coronavirus (COVID-19) epidemic, required the development of different diagnostic tests. While reverse transcriptase real-time PCR (RT-PCR) remains the first-line test of choice in acute infection diagnosis, anti-N antibodies serological assays provide a valuable tool to differentiate natural SARS-CoV-2 immunological response from that induced by vaccination, thus the goal of our study was to evaluate three serological tests agreement for these antibodies detection.
Methods: Three anti-N different tests were examined in 74 sera from patients referred or not COVID infection: immunochromatographic rapid test (Panbio™ COVID-19 IgG/IgM Rapid Test Device Abbott, Germany), ELISA kit (NovaLisa® SARS-CoV-2 IgG and IgM NovaTech Immunodiagnostic GmbH, Germany) and ECLIA immunoassay (Elecsys® Anti-SARS-CoV-2 Roche Diagnostics, Manheim, Germany).
Results: Qualitative comparison of the three analytical methods revealed a moderate agreement between ECLIA immunoassay and immunochromatographic rapid test (Cohen kappa coefficient κ = 0.564). Correlation analysis indicated weak positive correlation between total Ig (IgT) detected by ECLIA immunoassay and IgG by ELISA test (p < 0.0001), the analysis of ECLIA IgT and IgM ELISA detected, showed no statistical correlation.
Conclusion: Comparison between of three analytical systems available for anti-N SARS-CoV-2 IgG and IgM antibodies showed a general agreement when compared to detect total and G class immunoglobulins, while doubtful or discordant results have been highlighted for IgT and IgM class. Anyway, all the tests examined provide reliable results to assess the serological status of SARS-CoV-2 infected patients.
Keywords: Anti SARS-CoV-2; COVID-19; ECLIA; ELISA; Immunochromatography.
. 2023 May 6;113486.
doi: 10.1016/j.jim.2023.113486. Online ahead of print. Anti-N SARS-CoV-2 assays for evaluation of natural viral infection
Aurelia Gaeta[SUP] 1 [/SUP], Antonio Angeloni[SUP] 2 [/SUP], Anna Napoli[SUP] 3 [/SUP], Beatrice Pucci[SUP] 4 [/SUP], Lilia Cinti[SUP] 3 [/SUP], Piergiorgio Roberto[SUP] 3 [/SUP], Flavia Colaiacovo[SUP] 4 [/SUP], Elena Berardelli[SUP] 4 [/SUP], Antonella Farina[SUP] 4 [/SUP], Guido Antonelli[SUP] 3 [/SUP], Emanuela Anastasi[SUP] 4 [/SUP]
Affiliations
- PMID: 37156408
- DOI: 10.1016/j.jim.2023.113486
Background: The 2019 coronavirus (COVID-19) epidemic, required the development of different diagnostic tests. While reverse transcriptase real-time PCR (RT-PCR) remains the first-line test of choice in acute infection diagnosis, anti-N antibodies serological assays provide a valuable tool to differentiate natural SARS-CoV-2 immunological response from that induced by vaccination, thus the goal of our study was to evaluate three serological tests agreement for these antibodies detection.
Methods: Three anti-N different tests were examined in 74 sera from patients referred or not COVID infection: immunochromatographic rapid test (Panbio™ COVID-19 IgG/IgM Rapid Test Device Abbott, Germany), ELISA kit (NovaLisa® SARS-CoV-2 IgG and IgM NovaTech Immunodiagnostic GmbH, Germany) and ECLIA immunoassay (Elecsys® Anti-SARS-CoV-2 Roche Diagnostics, Manheim, Germany).
Results: Qualitative comparison of the three analytical methods revealed a moderate agreement between ECLIA immunoassay and immunochromatographic rapid test (Cohen kappa coefficient κ = 0.564). Correlation analysis indicated weak positive correlation between total Ig (IgT) detected by ECLIA immunoassay and IgG by ELISA test (p < 0.0001), the analysis of ECLIA IgT and IgM ELISA detected, showed no statistical correlation.
Conclusion: Comparison between of three analytical systems available for anti-N SARS-CoV-2 IgG and IgM antibodies showed a general agreement when compared to detect total and G class immunoglobulins, while doubtful or discordant results have been highlighted for IgT and IgM class. Anyway, all the tests examined provide reliable results to assess the serological status of SARS-CoV-2 infected patients.
Keywords: Anti SARS-CoV-2; COVID-19; ECLIA; ELISA; Immunochromatography.