Revista: | Revista do Instituto de Medicina Tropical de Sao Paulo |
Base de datos: | |
Número de sistema: | 000547871 |
ISSN: | 0036-4665 |
Autores: | Barreira, Gabriel Acca1 Santos, Emilly Henrique dos1 Pereira, Maria Fernanda Bádue1 Rodrigues, Karen Alessandra1 Rocha, Mussya Cisotto1 Kanunfre, Kelly Aparecida1 Marques, Heloisa Helena de Sousa1 Okay, Thelma Suely1 Eisencraft, Adriana Pasmanik Rossi Junior, Alfio Fante, Alice Lima Cora, Aline Pivetta Costa Reis, Amelia Gorete A. de Ferrer, Ana Paula Scoleze Andrade, Anarella Penha Meirelles de Watanabe, Andreia Gonçalves, Angelina Maria Freire Waetge, Aurora Rosaria Pagliara Silva, Camila Altenfelder Ceneviva, Carina Lazari, Carolina dos Santos Abellan, Deipara Monteiro Sabino, Ester Cerdeira Bianchini, Fabíola Roberta Marim Alcantara, Flávio Ferraz de Paes Ramos, Gabriel Frizzo Leal, Gabriela Nunes Rodriguez, Isadora Souza Pinho, João Renato Rebello Carneiro, Jorge David Avaizoglou Paz, Jose Albino Ferreira, Juliana Carvalho Ferranti, Juliana Ferreira Ferreira, Juliana de Oliveira Achili Framil, Juliana Valéria de Souza Silva, Katia Regina da Bastos, Karina Lucio de Medeiros Galleti, Karine Vusberg Cristofani, Lilian Maria Suzuki, Lisa Campos, Lucia Maria Arruda Perondi, Maria Beatriz de Moliterno Diniz, Maria de Fatima Rodrigues Fonseca, Maria Fernanda Mota Cordon, Mariana Nutti de Almeida Pissolato, Mariana Peres, Marina Silva Garanito, Marlene Pereira Imamura, Marta Dorna, Mayra de Barros Luglio, Michele Aikawa, Nadia Emi Degaspare, Natalia Viu Sakita, Neusa Keico Udsen, Nicole Lee Scudeller, Paula Gobi Gaiolla, Paula Vieira de Vincenzi Severini, Rafael da Silva Giannasi Rodrigues, Regina Maria Toma, Ricardo Katsuya Paula, Ricardo Iunis Citrangulo de Palmeira, Patricia Forsait, Silvana Farhat, Sylvia Costa Lima Sakano, Tânia Miyuki Shimoda Koch, Vera Hermina Kalika Cobello Junior, Vilson |
Instituciones: | 1Universidade de São Paulo, Faculdade de Medicina, São Paulo, São Paulo. Brasil 2Faculdade Israelita de Ciências da Saúde Albert Einstein, São Paulo, São Paulo. Brasil |
Año: | 2022 |
Volumen: | 64 |
País: | Brasil |
Idioma: | Inglés |
Resumen en inglés | This study assessed the technical performance of a rapid lateral flow immunochromatographic assay (LFIA) for the detection of anti-SARS-CoV-2 IgG and compared LFIA results with chemiluminescent immunoassay (CLIA) results and an in-house enzyme immunoassay (EIA). To this end, a total of 216 whole blood or serum samples from three groups were analyzed: the first group was composed of 68 true negative cases corresponding to blood bank donors, healthy young volunteers, and eight pediatric patients diagnosed with other coronavirus infections. The serum samples from these participants were obtained and stored in a pre-COVID-19 period, thus they were not expected to have COVID-19. In the second group of true positive cases, we chose to replace natural cases of COVID-19 by 96 participants who were expected to have produced anti-SARS-CoV-2 IgG antibodies 30-60 days after the vaccine booster dose. The serum samples were collected on the same day that LFIA were tested either by EIA or CLIA. The third study group was composed of 52 participants (12 adults and 40 children) who did or did not have anti-SARS-CoV-2 IgG antibodies due to specific clinical scenarios. The 12 adults had been vaccinated more than seven months before LFIA testing, and the 40 children had non-severe COVID-19 diagnosed using RT-PCR during the acute phase of infection. They were referred for outpatient follow-up and during this period the serum samples were collected and tested by CLIA and LFIA. All tests were performed by the same healthcare operator and there was no variation of LFIA results when tests were performed on finger prick whole blood or serum samples, so that results were grouped for analysis. LFIA’s sensitivity in detecting anti-SARS-CoV-2 IgG antibodies was 90%, specificity 97.6%, efficiency 93%, PPV 98.3%, NPV 86.6%, and likelihood ratio for a positive or a negative result were 37.5 and 0.01 respectively. There was a good agreement (Kappa index of 0.677) between LFIA results and serological (EIA or CLIA) results. In conclusion, LFIA analyzed in this study showed a good technical performance and agreement with reference serological assays (EIA or CLIA), therefore it can be recommended for use in the outpatient follow-up of non-severe cases of COVID-19 and to assess anti-SARS-CoV-2 IgG antibody production induced by vaccination and the antibodies decrease over time. However, LFIAs should be confirmed by using reference serological assays whenever possible. |
Keyword: | COVID-19, SARS-CoV-2, Laboratory diagnosis, Rapid test, Lateral Flow Immunoassay, Enzyme Immunoassay |
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