An Evaluation of Serological Tests to Determine Postvaccinal Immunity to SARS-CoV-2 by mRNA Vaccines
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 Euro...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-12-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/11/24/7534 |
| _version_ | 1797456982154674176 |
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| author | Graciela Iglesias García Ángel Díaz Rodríguez Beatriz Díaz Fernández Carmela Cuello Estrada Tania García Ferreiro Noelia Crespo García Jesús Seco-Calvo |
| author_facet | Graciela Iglesias García Ángel Díaz Rodríguez Beatriz Díaz Fernández Carmela Cuello Estrada Tania García Ferreiro Noelia Crespo García Jesús Seco-Calvo |
| author_sort | Graciela Iglesias García |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T16:15:35Z |
| format | Article |
| id | doaj.art-275a9bd4d6254f6c911fa38bda573ae6 |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-09T16:15:35Z |
| publishDate | 2022-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-275a9bd4d6254f6c911fa38bda573ae62023-11-24T15:47:16ZengMDPI AGJournal of Clinical Medicine2077-03832022-12-011124753410.3390/jcm11247534An Evaluation of Serological Tests to Determine Postvaccinal Immunity to SARS-CoV-2 by mRNA VaccinesGraciela Iglesias García0Ángel Díaz Rodríguez1Beatriz Díaz Fernández2Carmela Cuello Estrada3Tania García Ferreiro4Noelia Crespo García5Jesús Seco-Calvo6Institute of Biomedicine (IBIOMED), Campus of Vegazana, University of Leon, 24071 Leon, SpainInstitute of Biomedicine (IBIOMED), Campus of Vegazana, University of Leon, 24071 Leon, SpainArturo Eyries Center, Puerto Rico Street 1, 47014 Valladolid, SpainBembibre Health Center, University of Leon, Carbajal Street 1, 24300 Bembibre, SpainBembibre Health Center, University of Leon, Carbajal Street 1, 24300 Bembibre, SpainBembibre Health Center, University of Leon, Carbajal Street 1, 24300 Bembibre, SpainPhysiotherapy Department, Institute of Biomedicine (IBIOMED), Campus of Vegazana, University of Leon, 24071 Leon, SpainBackground: 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.https://www.mdpi.com/2077-0383/11/24/7534automated immunoassaysCOVID-19lateral flow immunoassaysperformanceSARS-CoV-2ELISA immunoassays |
| spellingShingle | Graciela Iglesias García Ángel Díaz Rodríguez Beatriz Díaz Fernández Carmela Cuello Estrada Tania García Ferreiro Noelia Crespo García Jesús Seco-Calvo An Evaluation of Serological Tests to Determine Postvaccinal Immunity to SARS-CoV-2 by mRNA Vaccines Journal of Clinical Medicine automated immunoassays COVID-19 lateral flow immunoassays performance SARS-CoV-2 ELISA immunoassays |
| title | An Evaluation of Serological Tests to Determine Postvaccinal Immunity to SARS-CoV-2 by mRNA Vaccines |
| title_full | An Evaluation of Serological Tests to Determine Postvaccinal Immunity to SARS-CoV-2 by mRNA Vaccines |
| title_fullStr | An Evaluation of Serological Tests to Determine Postvaccinal Immunity to SARS-CoV-2 by mRNA Vaccines |
| title_full_unstemmed | An Evaluation of Serological Tests to Determine Postvaccinal Immunity to SARS-CoV-2 by mRNA Vaccines |
| title_short | An Evaluation of Serological Tests to Determine Postvaccinal Immunity to SARS-CoV-2 by mRNA Vaccines |
| title_sort | evaluation of serological tests to determine postvaccinal immunity to sars cov 2 by mrna vaccines |
| topic | automated immunoassays COVID-19 lateral flow immunoassays performance SARS-CoV-2 ELISA immunoassays |
| url | https://www.mdpi.com/2077-0383/11/24/7534 |
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