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Pedro Augusto Alveshttp://lattes.cnpq.br/6935282825820547Karine Lima LourençoAna Paula Moreira Franco Luizhttp://lattes.cnpq.br/2728068915833031Angélica Barbosa da Cunha2023-03-27T15:18:27Z2023-03-27T15:18:27Z2021-12-14http://hdl.handle.net/1843/512402728068915833031Iniciada em 2019 a COVID-19 é uma doença que tem como agente etiológico o coronavírus SARS-CoV-2 que possui em sua constituição, duas proteínas estruturais principais a Spike (S) e a Nucleoproteína (N) que envolve o ácido ribonucleico (RNA) genômico viral. Assim, os anticorpos produzidos durante a infecção geralmente tem como alvo essas proteínas virais. A técnica padrão-ouro de detecção da doença é a transcrição reversa seguida de reação em cadeia da polimerase quantitativa (RT-qPCR). Porém, outras metodologias mais rápidas e com menor custo, como os testes rápidos estão sendo utilizados no Brasil. Avaliar e garantir a qualidade desses testes é importante para que o diagnóstico laboratorial correto seja aplicado. Assim, o objetivo desse trabalho foi avaliar o desempenho de um teste rápido para detecção de anticorpos anti SARS-CoV-2 por método de comparabilidade com as metodologias ELISA, RT-PCR e imunofluorescência. Utilizando 42 amostras positivas, 30 amostras negativas para anticorpos anti SARS-CoV-2 e 28 de indivíduos vacinados com Coronavac. A performance do kit foi determinada pelos parâmetros de sensibilidade, especificidade, VPP, VPN, repetibilidade, reprodutibilidade e variação de temperatura. Testes estatísticos como índice kappa, teste de McNemar, teste de Mann-Whitney foram aplicados para apontar diferenças significativas, demonstrar proporções similares ou diferentes entre os resultados e determinar o nível de confiabilidade do teste e os gráficos foram gerados pelo software GraphPad PRISM 9. O kit avaliado apresentou 95,23% de sensibilidade e especificidade de 100%. O VPP para o ensaio foi de 100% e o VPN de 93,75%. Além de boa correlação quando comparado aos resultados da imunofluorescência para amostras de vacinados por Coronavac (X² p= 0,125) e (k = 0,510 p = 0,004). O estudo demonstrou bom desempenho do kit para detecção de anticorpos durante a infecção por SARS-CoV-2, que foi de encontro a outros estudos semelhantes, principalmente relacionado à especificidade do teste. Os dados obtidos quanto a amostras de vacinados indicam que há necessidade de avaliar a utilização desses kits em populações altamente vacinadas contra o SARS-CoV-2.Initiated in 2019, COVID-19 is a disease whose etiological agent is the SARS-CoV-2 coronavirus, which has in its constitution, two main structural proteins, Spike (S) and Nucleoprotein (N) that involves ribonucleic acid (RNA) viral genomics. Thus, antibodies produced during infection usually target these viral proteins. The gold standard technique for detecting the disease is reverse transcription followed by quantitative polymerase chain reaction (RT-qPCR). However, other faster and less expensive methodologies, such as rapid tests, are being used in Brazil. Evaluating and ensuring the quality of these tests is important for the correct laboratory diagnosis to be applied. Thus, the objective of this work was to evaluate the performance of a rapid test for the detection of antibodies against SARS-CoV-2 by a comparability method with ELISA, RT-PCR and immunofluorescence methodologies. Using 42 positive samples, 30 negative samples for anti-SARS-CoV-2 antibodies and 28 samples from Coronavac vaccinated individuals. Kit performance was determined by the parameters of sensitivity, specificity, PPV, NPV, repeatability, reproducibility and temperature variation. Statistical tests such as kappa index, McNemar test, Mann-Whitney test were applied to point out significant differences, demonstrate similar or different proportions between the results and determine the level of test reliability and the graphs were generated by the GraphPad PRISM 9 software. The kit evaluated showed a sensitivity of 95.23% and a specificity of 100%. The PPV for the test was 100% and the NPV was 93.75%. In addition to a good correlation when compared to the results of immunofluorescence for samples of vaccinated by Coronavac (X² p= 0.125) and (k = 0.510 p = 0.004). The study demonstrated a good performance of the kit for detecting antibodies during SARS-CoV-2 infection, which was against other similar studies, mainly related to the specificity of the test. The data obtained from samples of vaccinates indicate that there is a need to evaluate the use of these kits in populations highly vaccinated against SARS-CoV-2.porUniversidade Federal de Minas GeraisPrograma de Pós-Graduação em MicrobiologiaUFMGBrasilARQ - DEPARTAMENTO DE ANÁLISE CRÍTICA E HISTÓRICA DA ARQUITETURA E DO URBANISMOhttp://creativecommons.org/licenses/by-nc-nd/3.0/pt/info:eu-repo/semantics/openAccessMicrobiologiaCovid-19Aprovação de teste para diagnósticoTeste rápidoEnsaio de desempenhoCOVID-19Avaliação comparativa do desempenho de um teste rápido na detecção de anticorpos IgG e IgM contra o SARS-CoV-2info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisreponame:Repositório Institucional da UFMGinstname:Universidade Federal de Minas Gerais (UFMG)instacron:UFMGORIGINALAngélica Cunha.pdfAngélica Cunha.pdfapplication/pdf1934378https://repositorio.ufmg.br/bitstream/1843/51240/1/Ang%c3%a9lica%20Cunha.pdf004a09dff5eccff0ed60fec0b6af4860MD51CC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; charset=utf-8811https://repositorio.ufmg.br/bitstream/1843/51240/2/license_rdfcfd6801dba008cb6adbd9838b81582abMD52LICENSElicense.txtlicense.txttext/plain; charset=utf-82118https://repositorio.ufmg.br/bitstream/1843/51240/3/license.txtcda590c95a0b51b4d15f60c9642ca272MD531843/512402023-03-27 12:18:27.505oai:repositorio.ufmg.br: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ório InstitucionalPUBhttps://repositorio.ufmg.br/oaiopendoar:2023-03-27T15:18:27Repositório Institucional da UFMG - Universidade Federal de Minas Gerais (UFMG)false
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