Validação de kit imunocromatográfico rápido para diagnóstico da Hepatite C
Autor(a) principal: | |
---|---|
Data de Publicação: | 2019 |
Tipo de documento: | Dissertação |
Idioma: | por |
Título da fonte: | Repositório Institucional da UFSCAR |
Texto Completo: | https://repositorio.ufscar.br/handle/ufscar/12046 |
Resumo: | Hepatitis C is an infectious disease caused by the Hepatitis C Virus (HCV) and usually asymptomatic in the acute phase. Globally, an estimated 71 million people are infected with HCV and approximately 400,000 deaths happen annually due to complications from the disease, such as cirrhosis and liver cancer. This study aimed to develop and validate a rapid immunochromatographic test for the detection of anti-HCV antibodies, the Imuno-Rápido HCV, by comparing the performance of this product with a second commercially available test (Commercial A) with the same methodology and ELISA methodology (Murex anti-HCV 4.0, DiaSorin) considered gold standard. Tests for validation include repeatability and reproducibility analysis, real-time and accelerated stability analysis, clinical sensitivity and specificity measurements, and positive and negative predictive values. In this study, 383 samples characterized by ELISA methodology were included and, by comparing the results, the clinical sensitivity and specificity parameters, positive and negative predictive values for the immunochromatographic tests Imuno-Rápido HCV and Commercial A were measured. For both immunochromatographic tests, a value of 100% were found for clinical sensitivity and negative predictive value. Clinical specificity values were 99.7% for Imuno-Rápido HCV and 100% for Commercial A test and positive predictive values for these kits were 98.6% and 100%, respectively. Repeatability and reproducibility analyzes showed concordant results in 100% of the tests, and real-time and accelerated stability assessments demonstrated the ability of the kit to maintain its proper functioning over time even under temperature stress, suggesting its ability to maintain stable for at least 18 months. These results corroborate the hypothesis that the Imuno-Rápido HCV has performance similar to commercially available kits that use the same methodology and is able to assist in the diagnosis of HCV infection safely and quickly, combined with easy execution and low cost. |
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Lima, Jéssica Caldeira deThiemann, Otávio Henriquehttp://lattes.cnpq.br/4933022274560322http://lattes.cnpq.br/11794018761056195f9cce49-f135-48b0-99c5-76639a1425e52019-11-21T14:35:58Z2019-11-21T14:35:58Z2019-09-17LIMA, Jéssica Caldeira de. Validação de kit imunocromatográfico rápido para diagnóstico da Hepatite C. 2019. Dissertação (Mestrado em Genética Evolutiva e Biologia Molecular) – Universidade Federal de São Carlos, São Carlos, 2019. Disponível em: https://repositorio.ufscar.br/handle/ufscar/12046.https://repositorio.ufscar.br/handle/ufscar/12046Hepatitis C is an infectious disease caused by the Hepatitis C Virus (HCV) and usually asymptomatic in the acute phase. Globally, an estimated 71 million people are infected with HCV and approximately 400,000 deaths happen annually due to complications from the disease, such as cirrhosis and liver cancer. This study aimed to develop and validate a rapid immunochromatographic test for the detection of anti-HCV antibodies, the Imuno-Rápido HCV, by comparing the performance of this product with a second commercially available test (Commercial A) with the same methodology and ELISA methodology (Murex anti-HCV 4.0, DiaSorin) considered gold standard. Tests for validation include repeatability and reproducibility analysis, real-time and accelerated stability analysis, clinical sensitivity and specificity measurements, and positive and negative predictive values. In this study, 383 samples characterized by ELISA methodology were included and, by comparing the results, the clinical sensitivity and specificity parameters, positive and negative predictive values for the immunochromatographic tests Imuno-Rápido HCV and Commercial A were measured. For both immunochromatographic tests, a value of 100% were found for clinical sensitivity and negative predictive value. Clinical specificity values were 99.7% for Imuno-Rápido HCV and 100% for Commercial A test and positive predictive values for these kits were 98.6% and 100%, respectively. Repeatability and reproducibility analyzes showed concordant results in 100% of the tests, and real-time and accelerated stability assessments demonstrated the ability of the kit to maintain its proper functioning over time even under temperature stress, suggesting its ability to maintain stable for at least 18 months. These results corroborate the hypothesis that the Imuno-Rápido HCV has performance similar to commercially available kits that use the same methodology and is able to assist in the diagnosis of HCV infection safely and quickly, combined with easy execution and low cost.A Hepatite C é uma doença infecciosa causada pelo vírus da Hepatite C (HCV, do inglês Hepatitis C Virus) e geralmente assintomática na fase aguda. Globalmente, estima-se que 71 milhões de pessoas estejam infectadas pelo HCV e aproximadamente 400 mil mortes ocorram anualmente devido a complicações decorrentes da doença, como cirrose e câncer de fígado. Este estudo teve como objetivo o desenvolvimento e a validação de um kit imunocromatográfico rápido para a detecção de anticorpos anti-HCV, o kit Imuno-Rápido HCV, através da comparação de desempenho deste produto com um segundo kit de mesma metodologia disponível no mercado (Comercial A) e metodologia ELISA (Murex anti-HCV 4.0, DiaSorin) considerada padrão ouro. Dentre os testes realizados para a validação do kit estão análise de repetibilidade e reprodutibilidade de resultados, análise de estabilidade em tempo real e estabilidade acelerada, medições dos valores de sensibilidade e especificidade clínicas e valores preditivos positivos e negativos. Foram incluídas neste estudo, 383 amostras caracterizadas por metodologia ELISA e, a partir da comparação dos resultados, foram medidos os parâmetros sensibilidade e especificidade clínicas, valores preditivos positivo e negativo para os kits imunocromatográficos Imuno-Rápido HCV e Comercial A. Para ambos os kits imunocromatográficos rápidos, encontrou-se o valor de sensibilidade e valor preditivo negativo de 100%. Os valores de especificidade clínica foram de 99,7% para o Imuno-Rápido HCV e 100% para o kit Comercial A e os valores preditivos positivos para esses kits foram 98,6% e 100%, respectivamente. As análises de repetibilidade e reprodutibilidade apresentaram resultados concordantes em 100% das execuções e as avaliações de estabilidade em tempo real e acelerada demonstraram a capacidade do kit manter seu bom funcionamento ao longo do tempo mesmo sob estresse de temperatura, sugerindo sua capacidade de manter-se estável por pelo menos 18 meses. Esses resultados corroboram com a hipótese de que o kit Imuno-Rápido HCV possui desempenho similar a kits disponíveis no mercado que utilizam a mesma metodologia e é capaz de auxiliar no diagnóstico da infecção pelo HCV de forma segura e rápida, combinada a uma fácil execução e baixo custo.Não recebi financiamentoporUniversidade Federal de São CarlosCâmpus São CarlosPrograma de Pós-Graduação em Genética Evolutiva e Biologia Molecular - PPGGEvUFSCarAttribution-NonCommercial-NoDerivs 3.0 Brazilhttp://creativecommons.org/licenses/by-nc-nd/3.0/br/info:eu-repo/semantics/openAccessHepatite CDiagnósticoImunocromatografiaValidaçãoPoint of careHepatitis CDiagnosisImmunochromatographyValidationCIENCIAS BIOLOGICAS::BIOQUIMICA::BIOLOGIA MOLECULARCIENCIAS BIOLOGICAS::BIOQUIMICACIENCIAS BIOLOGICAS::IMUNOLOGIAValidação de kit imunocromatográfico rápido para diagnóstico da Hepatite CValidation of rapid immunochromatographic assay for diagnosis of hepatitis Cinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesis600600cc6c7897-1c5e-41af-8e84-9c960b60ad3breponame:Repositório Institucional da UFSCARinstname:Universidade Federal de São Carlos (UFSCAR)instacron:UFSCARCC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; charset=utf-8811https://repositorio.ufscar.br/bitstream/ufscar/12046/3/license_rdfe39d27027a6cc9cb039ad269a5db8e34MD53ORIGINALDissertação_JCL.pdfDissertação_JCL.pdfDissertação Finalapplication/pdf1083565https://repositorio.ufscar.br/bitstream/ufscar/12046/1/Disserta%c3%a7%c3%a3o_JCL.pdf733e4b1c4afe9fcb6bac48e967fb34faMD51Submissao_Tese_140.pdfSubmissao_Tese_140.pdfCarta Comprovanteapplication/pdf503630https://repositorio.ufscar.br/bitstream/ufscar/12046/2/Submissao_Tese_140.pdf40a8d1021ace360ed1503f0a7e79ea4bMD52TEXTDissertação_JCL.pdf.txtDissertação_JCL.pdf.txtExtracted texttext/plain125808https://repositorio.ufscar.br/bitstream/ufscar/12046/4/Disserta%c3%a7%c3%a3o_JCL.pdf.txt8a4169ebf3a016cfa7d0731d06980a2dMD54Submissao_Tese_140.pdf.txtSubmissao_Tese_140.pdf.txtExtracted texttext/plain1https://repositorio.ufscar.br/bitstream/ufscar/12046/6/Submissao_Tese_140.pdf.txt68b329da9893e34099c7d8ad5cb9c940MD56THUMBNAILDissertação_JCL.pdf.jpgDissertação_JCL.pdf.jpgIM Thumbnailimage/jpeg5899https://repositorio.ufscar.br/bitstream/ufscar/12046/5/Disserta%c3%a7%c3%a3o_JCL.pdf.jpgab119918123c95f6180d284c7ab9ec5bMD55Submissao_Tese_140.pdf.jpgSubmissao_Tese_140.pdf.jpgIM Thumbnailimage/jpeg12663https://repositorio.ufscar.br/bitstream/ufscar/12046/7/Submissao_Tese_140.pdf.jpgc949f376f1799220f303858fd539b2fdMD57ufscar/120462023-09-18 18:31:46.479oai:repositorio.ufscar.br:ufscar/12046Repositório InstitucionalPUBhttps://repositorio.ufscar.br/oai/requestopendoar:43222023-09-18T18:31:46Repositório Institucional da UFSCAR - Universidade Federal de São Carlos (UFSCAR)false |
dc.title.por.fl_str_mv |
Validação de kit imunocromatográfico rápido para diagnóstico da Hepatite C |
dc.title.alternative.eng.fl_str_mv |
Validation of rapid immunochromatographic assay for diagnosis of hepatitis C |
title |
Validação de kit imunocromatográfico rápido para diagnóstico da Hepatite C |
spellingShingle |
Validação de kit imunocromatográfico rápido para diagnóstico da Hepatite C Lima, Jéssica Caldeira de Hepatite C Diagnóstico Imunocromatografia Validação Point of care Hepatitis C Diagnosis Immunochromatography Validation CIENCIAS BIOLOGICAS::BIOQUIMICA::BIOLOGIA MOLECULAR CIENCIAS BIOLOGICAS::BIOQUIMICA CIENCIAS BIOLOGICAS::IMUNOLOGIA |
title_short |
Validação de kit imunocromatográfico rápido para diagnóstico da Hepatite C |
title_full |
Validação de kit imunocromatográfico rápido para diagnóstico da Hepatite C |
title_fullStr |
Validação de kit imunocromatográfico rápido para diagnóstico da Hepatite C |
title_full_unstemmed |
Validação de kit imunocromatográfico rápido para diagnóstico da Hepatite C |
title_sort |
Validação de kit imunocromatográfico rápido para diagnóstico da Hepatite C |
author |
Lima, Jéssica Caldeira de |
author_facet |
Lima, Jéssica Caldeira de |
author_role |
author |
dc.contributor.authorlattes.por.fl_str_mv |
http://lattes.cnpq.br/1179401876105619 |
dc.contributor.author.fl_str_mv |
Lima, Jéssica Caldeira de |
dc.contributor.advisor1.fl_str_mv |
Thiemann, Otávio Henrique |
dc.contributor.advisor1Lattes.fl_str_mv |
http://lattes.cnpq.br/4933022274560322 |
dc.contributor.authorID.fl_str_mv |
5f9cce49-f135-48b0-99c5-76639a1425e5 |
contributor_str_mv |
Thiemann, Otávio Henrique |
dc.subject.por.fl_str_mv |
Hepatite C Diagnóstico Imunocromatografia Validação |
topic |
Hepatite C Diagnóstico Imunocromatografia Validação Point of care Hepatitis C Diagnosis Immunochromatography Validation CIENCIAS BIOLOGICAS::BIOQUIMICA::BIOLOGIA MOLECULAR CIENCIAS BIOLOGICAS::BIOQUIMICA CIENCIAS BIOLOGICAS::IMUNOLOGIA |
dc.subject.eng.fl_str_mv |
Point of care Hepatitis C Diagnosis Immunochromatography Validation |
dc.subject.cnpq.fl_str_mv |
CIENCIAS BIOLOGICAS::BIOQUIMICA::BIOLOGIA MOLECULAR CIENCIAS BIOLOGICAS::BIOQUIMICA CIENCIAS BIOLOGICAS::IMUNOLOGIA |
description |
Hepatitis C is an infectious disease caused by the Hepatitis C Virus (HCV) and usually asymptomatic in the acute phase. Globally, an estimated 71 million people are infected with HCV and approximately 400,000 deaths happen annually due to complications from the disease, such as cirrhosis and liver cancer. This study aimed to develop and validate a rapid immunochromatographic test for the detection of anti-HCV antibodies, the Imuno-Rápido HCV, by comparing the performance of this product with a second commercially available test (Commercial A) with the same methodology and ELISA methodology (Murex anti-HCV 4.0, DiaSorin) considered gold standard. Tests for validation include repeatability and reproducibility analysis, real-time and accelerated stability analysis, clinical sensitivity and specificity measurements, and positive and negative predictive values. In this study, 383 samples characterized by ELISA methodology were included and, by comparing the results, the clinical sensitivity and specificity parameters, positive and negative predictive values for the immunochromatographic tests Imuno-Rápido HCV and Commercial A were measured. For both immunochromatographic tests, a value of 100% were found for clinical sensitivity and negative predictive value. Clinical specificity values were 99.7% for Imuno-Rápido HCV and 100% for Commercial A test and positive predictive values for these kits were 98.6% and 100%, respectively. Repeatability and reproducibility analyzes showed concordant results in 100% of the tests, and real-time and accelerated stability assessments demonstrated the ability of the kit to maintain its proper functioning over time even under temperature stress, suggesting its ability to maintain stable for at least 18 months. These results corroborate the hypothesis that the Imuno-Rápido HCV has performance similar to commercially available kits that use the same methodology and is able to assist in the diagnosis of HCV infection safely and quickly, combined with easy execution and low cost. |
publishDate |
2019 |
dc.date.accessioned.fl_str_mv |
2019-11-21T14:35:58Z |
dc.date.available.fl_str_mv |
2019-11-21T14:35:58Z |
dc.date.issued.fl_str_mv |
2019-09-17 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/masterThesis |
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masterThesis |
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publishedVersion |
dc.identifier.citation.fl_str_mv |
LIMA, Jéssica Caldeira de. Validação de kit imunocromatográfico rápido para diagnóstico da Hepatite C. 2019. Dissertação (Mestrado em Genética Evolutiva e Biologia Molecular) – Universidade Federal de São Carlos, São Carlos, 2019. Disponível em: https://repositorio.ufscar.br/handle/ufscar/12046. |
dc.identifier.uri.fl_str_mv |
https://repositorio.ufscar.br/handle/ufscar/12046 |
identifier_str_mv |
LIMA, Jéssica Caldeira de. Validação de kit imunocromatográfico rápido para diagnóstico da Hepatite C. 2019. Dissertação (Mestrado em Genética Evolutiva e Biologia Molecular) – Universidade Federal de São Carlos, São Carlos, 2019. Disponível em: https://repositorio.ufscar.br/handle/ufscar/12046. |
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https://repositorio.ufscar.br/handle/ufscar/12046 |
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Attribution-NonCommercial-NoDerivs 3.0 Brazil http://creativecommons.org/licenses/by-nc-nd/3.0/br/ |
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openAccess |
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Universidade Federal de São Carlos Câmpus São Carlos |
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UFSCar |
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Universidade Federal de São Carlos Câmpus São Carlos |
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