Analytical validation of LAL kinetic assay for detection and quantification of endotoxins in measles's vaccine diluents
Method validation is the process used to confirm that the analytical procedures employed for a specific test is able to produce reliable and replicable results. An analytical method should be conducted in order to demonstrate that it is suitable for its intended use [1]. The aim of this present work...
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Instituto de Tecnologia do Paraná (Tecpar)
2006-01-01
|
| Series: | Brazilian Archives of Biology and Technology |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-89132006000200010 |
| _version_ | 1818611937515143168 |
|---|---|
| author | Rosane Cuber Guimarães Alaide Aline Xavier Leal |
| author_facet | Rosane Cuber Guimarães Alaide Aline Xavier Leal |
| author_sort | Rosane Cuber Guimarães |
| collection | DOAJ |
| description | Method validation is the process used to confirm that the analytical procedures employed for a specific test is able to produce reliable and replicable results. An analytical method should be conducted in order to demonstrate that it is suitable for its intended use [1]. The aim of this present work is to demonstrate and evaluate the suitability of method validation. The analytical validation discussed herein was conducted by prescribed protocol, using 3 different batches of measles's vaccine diluents. All of the stipulated validation parameters: linearity, repeatability, reproducibility (intermediate precision) and accuracy were met. Additionally, this study demonstrated the method's capability for the determining endotoxin levels in measles's vaccine diluents and its further use in apirogenic water samples.<br>Validar um método é o processo de demonstrar que a seqüência analítica adotada é capaz de produzir resultados confiáveis e reprodutíveis. Dessa forma, um método analítico deve ser submetido a estudos laboratoriais que demonstrem que o mesmo atenda às exigências requeridas pelo tipo de determinação a que se destina [1]. Assim o objetivo do presente trabalho foi demonstrar a validação do método e a avaliação quanto a sua adequação. Esta validação analítica foi realizada conforme descrito em protocolo, utilizando 3 lotes de diluente para vacina contra sarampo. Todos os parâmetros de validação estipulados: linearidade, repetibilidade, reprodutibilidade intralaboratorial e exatidão foram atendidos. Este estudo também demonstrou a adequação ao método para a determinação de endotoxina para diluente de vacina contra sarampo e sua extensão para amostras de água apirogênica. |
| first_indexed | 2024-12-16T15:38:16Z |
| format | Article |
| id | doaj.art-d4573a5de8f44ab79802b4bae04c98e2 |
| institution | Directory Open Access Journal |
| issn | 1516-8913 1678-4324 |
| language | English |
| last_indexed | 2024-12-16T15:38:16Z |
| publishDate | 2006-01-01 |
| publisher | Instituto de Tecnologia do Paraná (Tecpar) |
| record_format | Article |
| series | Brazilian Archives of Biology and Technology |
| spelling | doaj.art-d4573a5de8f44ab79802b4bae04c98e22022-12-21T22:26:06ZengInstituto de Tecnologia do Paraná (Tecpar)Brazilian Archives of Biology and Technology1516-89131678-43242006-01-0149spe596410.1590/S1516-89132006000200010Analytical validation of LAL kinetic assay for detection and quantification of endotoxins in measles's vaccine diluentsRosane Cuber GuimarãesAlaide Aline Xavier LealMethod validation is the process used to confirm that the analytical procedures employed for a specific test is able to produce reliable and replicable results. An analytical method should be conducted in order to demonstrate that it is suitable for its intended use [1]. The aim of this present work is to demonstrate and evaluate the suitability of method validation. The analytical validation discussed herein was conducted by prescribed protocol, using 3 different batches of measles's vaccine diluents. All of the stipulated validation parameters: linearity, repeatability, reproducibility (intermediate precision) and accuracy were met. Additionally, this study demonstrated the method's capability for the determining endotoxin levels in measles's vaccine diluents and its further use in apirogenic water samples.<br>Validar um método é o processo de demonstrar que a seqüência analítica adotada é capaz de produzir resultados confiáveis e reprodutíveis. Dessa forma, um método analítico deve ser submetido a estudos laboratoriais que demonstrem que o mesmo atenda às exigências requeridas pelo tipo de determinação a que se destina [1]. Assim o objetivo do presente trabalho foi demonstrar a validação do método e a avaliação quanto a sua adequação. Esta validação analítica foi realizada conforme descrito em protocolo, utilizando 3 lotes de diluente para vacina contra sarampo. Todos os parâmetros de validação estipulados: linearidade, repetibilidade, reprodutibilidade intralaboratorial e exatidão foram atendidos. Este estudo também demonstrou a adequação ao método para a determinação de endotoxina para diluente de vacina contra sarampo e sua extensão para amostras de água apirogênica.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-89132006000200010Bioanalytical methodendotoxinvalidation |
| spellingShingle | Rosane Cuber Guimarães Alaide Aline Xavier Leal Analytical validation of LAL kinetic assay for detection and quantification of endotoxins in measles's vaccine diluents Brazilian Archives of Biology and Technology Bioanalytical method endotoxin validation |
| title | Analytical validation of LAL kinetic assay for detection and quantification of endotoxins in measles's vaccine diluents |
| title_full | Analytical validation of LAL kinetic assay for detection and quantification of endotoxins in measles's vaccine diluents |
| title_fullStr | Analytical validation of LAL kinetic assay for detection and quantification of endotoxins in measles's vaccine diluents |
| title_full_unstemmed | Analytical validation of LAL kinetic assay for detection and quantification of endotoxins in measles's vaccine diluents |
| title_short | Analytical validation of LAL kinetic assay for detection and quantification of endotoxins in measles's vaccine diluents |
| title_sort | analytical validation of lal kinetic assay for detection and quantification of endotoxins in measles s vaccine diluents |
| topic | Bioanalytical method endotoxin validation |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-89132006000200010 |
| work_keys_str_mv | AT rosanecuberguimaraes analyticalvalidationoflalkineticassayfordetectionandquantificationofendotoxinsinmeaslessvaccinediluents AT alaidealinexavierleal analyticalvalidationoflalkineticassayfordetectionandquantificationofendotoxinsinmeaslessvaccinediluents |