Resumo

GUIMARAES, Rosane Cuber  e  LEAL, Alaide Aline Xavier. Analytical validation of LAL kinetic assay for detection and quantification of endotoxins in measles's vaccine diluents. Braz. arch. biol. technol. [online]. 2006, vol.49, n.spe, pp. 59-64. ISSN 1516-8913.  http://dx.doi.org/10.1590/S1516-89132006000200010.

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.

Palavras-chave : Bioanalytical method; endotoxin; validation.