RT info:eu-repo/semantics/article
T1 An Evaluation of Serological Tests to Determine Postvaccinal Immunity to SARS-CoV-2 by mRNA Vaccines
A1 Iglesias García, Graciela
A1 Díaz Rodríguez, Ángel
A1 Díaz Fernández, Beatriz
A1 Cuello Estrada, Carmela
A1 García Ferreiro, Tania
A1 Crespo García, Noelia
A1 Seco Calvo, Jesús Ángel
A2 Fisioterapia
K1 Fisioterapia
K1 Automated immunoassays
K1 COVID-19
K1 Llateral flow immunoassays
K1 Performance
K1 SARS-CoV-2
K1 ELISA immunoassays
K1 CLIA immunoassays
AB [EN] Background: The duration of the protective efficacy of vaccines against SARS-CoV-2 is unknown. Thus, an evaluation of the clinical performance of available tests is required. Objectives: To evaluate the clinical performance of LFIA immunoassay compared to ELIA and CLIA immunoassays available in Europe for the detection of IgG antibodies generated by mRNA vaccines against SARS-CoV-2. Methods: Two automated immunoassays (the EUROIMMUN anti-SARS-CoV-2 IgG S1 ELISA and the LIAISON de Diasorin anti-SARS-CoV-2 IgG S1/S2 test) and a lateral flow immunoassay (the Livzon LFIA anti-SARS-CoV-2 IgG S test) were tested. We analyzed 300 samples distributed in three groups: 100 subjects aged over 18 years and under 45 years, 100 subjects aged between 45 and 65 years, and 100 subjects aged over 65 years. The samples were collected before vaccination; at 21 days; and then at 1, 2, 3, and 6 months after vaccination. The sensitivity, specificity, positive predictive value, negative predictive value, positive probability quotient, negative probability quotient, and concordance (kappa index) were calculated for each serological test. Results: The maximum sensitivity values for IgG were 98.7%, 98.1%, and 97.8% for the EUROIMMUN ELISA, Abbott CLIA, and Livzon LFIA tests, respectively, and the maximum specificity values for IgG were 99.4%, 99.9%%, and 98.4% for the ELISA, CLIA, and LFIA tests, respectively, at the third month after vaccination, representing a decrease in the antibody levels after the sixth month. The best agreement was observed between the ELISA and CLIA tests at 100% (k = 1.00). The agreement between the ELIA, CLIA, and LFIA tests was 99% (k = 0.964) at the second and third month after vaccination. Seroconversion was faster and more durable in the younger age groups. Conclusion: Our study examined the equivalent and homogeneous clinical performance for IgG of three immunoassays after vaccination and found LFIA to be the most cost-effective, reliable, and accurate for routine use in population seroconversion and seroprevalence studies.
PB MDPI
LK https://hdl.handle.net/10612/19415
UL https://hdl.handle.net/10612/19415
NO Iglesias García, G., Díaz Rodríguez, Á., Díaz Fernández, B., Cuello Estrada, C., García Ferreiro, T., Crespo García, N., Seco-Calvo, J.(2022) An Evaluation of Serological Tests to Determine Postvaccinal Immunity to SARS-CoV-2 by mRNA Vaccines. Journal of Clinical Medicine 11(24), 7534; https://doi.org/10.3390/jcm11247534
DS BULERIA. Repositorio Institucional de la Universidad de León
RD 30-jun-2024