| Author | Silva, Cristiane Caldeira da | |
| Author | Presgrave, Octavio Augusto França | |
| Author | Hartung, Thomas | |
| Author | Moraes, Aurea Maria Lage de | |
| Author | Delgado, Isabella Fernandes | |
| Access date | 2016-06-02T12:43:56Z | pt_BR |
| Access date | 2016-06-03T12:34:12Z | |
| Available date | 2016-06-02T12:43:56Z | pt_BR |
| Available date | 2016-06-03T12:34:12Z | |
| Document date | 2016 | |
| Citation | SILVA, Cristiane Caldeira da; et al. Applicability of the Monocyte Activation Test (MAT) for hyperimmune sera in the routine of the quality control laboratory: Comparisonwith the Rabbit Pyrogen Test (RPT). Toxicology in Vitro, v.32, p.70-75, 2016. | pt_BR |
| ISSN | 0887-2333 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/14417 | |
| Language | eng | pt_BR |
| Publisher | Elsevier | pt_BR |
| Rights | restricted access | |
| Subject in Portuguese | Coelhos | pt_BR |
| Subject in Portuguese | Teste de pirogênios | pt_BR |
| Subject in Portuguese | Soros hiperimunes | pt_BR |
| Subject in Portuguese | Endotoxina | pt_BR |
| Subject in Portuguese | Teste de ativação de monócitos | pt_BR |
| Title | Applicability of the Monocyte Activation Test (MAT) for hyperimmune sera in the routine of the quality control laboratory: Comparisonwith the Rabbit Pyrogen Test (RPT) | pt_BR |
| Type | Article | |
| DOI | 10.1016/j.tiv.2015.12.004 | pt_BR |
| Abstract | Pyrogen tests are safety assays performed during the routine quality control of injectable products required by
regulatory agencies. Currently, there are three available testing possibilities: 1) the Rabbit Pyrogen Test (RPT);
2) the Bacterial Endotoxin Test (BET); and 3) test systems using human whole-blood or monocytes, termed
Monocyte Activation Test (MAT). Although BET is often considered as a replacement for the animal test, it is unable
to detect pyrogens other than endotoxin. MAT is based on the human fever reaction and thus, most closely
reflects the human response. The aim of this study was to conduct a parallel comparison of the RPT and MAT for
hyperimmune sera (HS) batches analyzed during the routine of a quality control laboratory.MATwas performed
in the same 43 batches of HS previously tested using RPT. The results showed thatMAT presented 100% sensitivity
and approximately 85% specificity as compared to RPT, i.e., no false-negative results were obtained. Few suspicious
samples,which were negative in the RPT after retesting, provided divergent positive results suggesting a
lower limit of detection of MAT. MAT is thus able to detect contaminants in biological products such as HS
batches. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde (INCQS). Departamento de Farmocologia e Toxicologia. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em saúde (INCQS). Centro de Validação de Métodos Alternativos (BraCVAM). Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde (INCQS). Departamento de Farmocologia e Toxicologia. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em saúde (INCQS). Centro de Validação de Métodos Alternativos (BraCVAM). Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Johns Hopkins University. Bloomberg School of Public Health. Center for Alternatives to Animal Testing (CAAT). Baltimore, USA / University of Konstanz. CAAT-Europe, Germany. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Taxonomia, Bioquímica e Bioprospecção de Fungos. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde (INCQS). Rio de Janeiro, RJ, Brasil. | pt_BR |
| Subject | Rabbit Pyrogen Test | pt_BR |
| Subject | Hyperimmune sera | pt_BR |
| Subject | Endotoxin | pt_BR |
| Subject | Monocyte Activation Test | pt_BR |
