tetano
Editor, Senior Moderator
Jpn J Infect Dis
. 2021 Dec 28.
doi: 10.7883/yoken.JJID.2021.273. Online ahead of print.
Evaluation of a Lateral Flow Immunoassay COVIDTECH [SUP]®[/SUP] SARS-CoV-2 IgM/IgG Antibody Rapid Test
Julien Exinger[SUP] 1 [/SUP], Cédric Hartard[SUP] 2 [/SUP], Fanny Lafferrière[SUP] 1 [/SUP], Christelle Fenninger[SUP] 1 [/SUP], Loic J Charbonnière[SUP] 3 [/SUP], Hélène Jeulin[SUP] 2 [/SUP]
Affiliations
Abstract
The new epidemic coronavirus SARS-CoV-2 is responsible for severe respiratory illness (i.e. COVID-19). RT-PCR on respiratory samples is the gold standard in COVID-19 diagnosis, while serological tests may contribute to detect post-infection and post-vaccination immunity, and permit seroprevalence studies. The lateral flow immunoassay (LFIA) COVIDTECH[SUP]®[/SUP] SARS-CoV-2 IgM/IgG Antibody Rapid Test that detects anti-SARS-CoV-2 IgM and IgG using a S-protein recombinant antigen has been independently evaluated in two laboratories. The specificity evaluated on 65 pre-pandemic samples reached 100% for IgM/IgG. Analyzing samples from patients with RT-PCR-confirmed infection, IgM/IgG antibodies were detected in 18/26 (69%) and 58/58 (100%) samples before day 13[SUP]th[/SUP] and from the 14[SUP]th[/SUP] day post-symptom onset respectively. Before the 14[SUP]th[/SUP] post-symptom onset, the COVIDTECH test was less sensitive than another LFIA method (BioSynex BSS IgM/IgG) and a chemiluminescent Immunoassay (LIAISON[SUP]®[/SUP] SARS-CoV-2 TrimericS IgG assay). Overall, this LFIA method is suitable for SARS-CoV-2 serological diagnosis, when the patient is > 14[SUP]th[/SUP] day after onset of symptoms.
Keywords: COVID-19; SARS-CoV-2; immunoassay; serology.
. 2021 Dec 28.
doi: 10.7883/yoken.JJID.2021.273. Online ahead of print.
Evaluation of a Lateral Flow Immunoassay COVIDTECH [SUP]®[/SUP] SARS-CoV-2 IgM/IgG Antibody Rapid Test
Julien Exinger[SUP] 1 [/SUP], Cédric Hartard[SUP] 2 [/SUP], Fanny Lafferrière[SUP] 1 [/SUP], Christelle Fenninger[SUP] 1 [/SUP], Loic J Charbonnière[SUP] 3 [/SUP], Hélène Jeulin[SUP] 2 [/SUP]
Affiliations
- PMID: 34980703
- DOI: 10.7883/yoken.JJID.2021.273
Abstract
The new epidemic coronavirus SARS-CoV-2 is responsible for severe respiratory illness (i.e. COVID-19). RT-PCR on respiratory samples is the gold standard in COVID-19 diagnosis, while serological tests may contribute to detect post-infection and post-vaccination immunity, and permit seroprevalence studies. The lateral flow immunoassay (LFIA) COVIDTECH[SUP]®[/SUP] SARS-CoV-2 IgM/IgG Antibody Rapid Test that detects anti-SARS-CoV-2 IgM and IgG using a S-protein recombinant antigen has been independently evaluated in two laboratories. The specificity evaluated on 65 pre-pandemic samples reached 100% for IgM/IgG. Analyzing samples from patients with RT-PCR-confirmed infection, IgM/IgG antibodies were detected in 18/26 (69%) and 58/58 (100%) samples before day 13[SUP]th[/SUP] and from the 14[SUP]th[/SUP] day post-symptom onset respectively. Before the 14[SUP]th[/SUP] post-symptom onset, the COVIDTECH test was less sensitive than another LFIA method (BioSynex BSS IgM/IgG) and a chemiluminescent Immunoassay (LIAISON[SUP]®[/SUP] SARS-CoV-2 TrimericS IgG assay). Overall, this LFIA method is suitable for SARS-CoV-2 serological diagnosis, when the patient is > 14[SUP]th[/SUP] day after onset of symptoms.
Keywords: COVID-19; SARS-CoV-2; immunoassay; serology.