Technical performance of a lateral flow immunoassay for detection of anti-SARS-CoV-2 IgG in the outpatient follow-up of non-severe cases and at different times after vaccination: comparison with enzyme and chemiluminescent immunoassays

Autor: Barreira, Gabriel Acca, Santos, Emilly Henrique dos, Pereira, Maria Fernanda Bádue, Rodrigues, Karen Alessandra, Rocha, Mussya Cisotto, Kanunfre, Kelly Aparecida, Marques, Heloisa Helena de Sousa, Okay, Thelma Suely, 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
Rok vydání: 2022
Předmět:
Zdroj: Revista do Instituto de Medicina Tropical de São Paulo, Volume: 64, Article number: e49, Published: 13 JUL 2022
Revista do Instituto de Medicina Tropical de São Paulo; Vol. 64 (2022); e49
Revista do Instituto de Medicina Tropical de São Paulo; v. 64 (2022); e49
Revista do Instituto de Medicina Tropical de São Paulo
Instituto de Medicina Tropical (IMT)
instacron:IMT
ISSN: 1678-9946
0036-4665
DOI: 10.1590/s1678-9946202264049
Popis: 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.
Databáze: OpenAIRE
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