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Comprehensive Study of the IBMP ELISA IgA/IgM/IgG COVID-19 Kit for SARS-CoV-2 Antibody Detection

2024; Multidisciplinary Digital Publishing Institute; Volume: 14; Issue: 14 Linguagem: Inglês

10.3390/diagnostics14141514

2075-4418

Sibelle B. Mattar, Paola Alejandra Fiorani Celedón, Leonardo Maia Leony, Larissa de Carvalho Medrado Vasconcelos, Daniel Dias Sampaio, Fabrício Klerynton Marchini, Luís Gustavo Morello, Vanessa H. Lin, Sandra Crestani, Aquiles Assunção Camelier, André Costa Meireles, André Luiz Freitas de Oliveira, Antônio Carlos Bandeira, Yasmin Santos Freitas Macêdo, Alan Oliveira Duarte, Tycha Bianca Sabaini Pavan, Isadora Cristina de Siqueira, Fred Luciano Neves Santos,

Biosensors and Analytical Detection

COVID-19 laboratory diagnosis primarily relies on molecular tests, highly sensitive during early infection stages with high viral loads. As the disease progresses, sensitivity decreases, requiring antibody detection. Since the beginning of the pandemic, serological tests have been developed and made available in Brazil, but their diagnostic performance varies. This study evaluated the IBMP ELISA IgA/IgM/IgG COVID-19 kit performance in detecting SARS-CoV-2 antibodies. A total of 90 samples, including 64 from COVID-19 patients and 26 pre-pandemic donors, were assessed based on time post symptom onset (0–7, 8–14, and 15–21 days). The kit showed 61% sensitivity, 100% specificity, and 72% accuracy overall. Sensitivity varied with time, being 25%, 57%, and 96% for 0–7, 8–14, and 15–21 days, respectively. Similar variations were noted in other commercial tests. The Gold ELISA COVID-19 (IgG/IgM) had sensitivities of 31%, 71%, and 100%, while the Anti-SARS-CoV-2 NCP ELISA (IgG) and Anti-SARS-CoV-2 NCP ELISA (IgM) showed varying sensitivities. The IBMP ELISA kit displayed high diagnostic capability, especially as the disease progressed, complementing COVID-19 diagnosis. Reproducibility assessment revealed minimal systematic and analytical errors. In conclusion, the IBMP ELISA IgA/IgM/IgG COVID-19 kit is a robust tool for detecting anti-SARS-CoV-2 antibodies, increasing in efficacy over the disease course, and minimizing false negatives in RT-PCR COVID-19 diagnosis.