RESUMO
Any modification to a validated assay must be evaluated in terms of the impact on the assay's performance characteristics and whether the assay remains fit for the intended purpose. The comparison is referred to as a 'method comparison', 'method comparability', 'method change', or 'comparative validation'. This review presents recommendations and examples of studies found in the current literature as a means of assessing minor modifications. In addition, the authors discuss common statistical approaches used for these comparisons.
Toute modification apportée à un essai validé doit être évaluée afin de mesurer l'impact de cette modification sur les paramètres de performances de l'essai et déterminer si l'aptitude à l'emploi qui lui a été assigné demeure valable suite à la modification en question. Cette comparaison est désignée sous les termes de « comparaison de méthodes d'essai ¼, « comparabilité de méthodes ¼, « changement de méthode d'essai ¼ ou « validation comparative ¼. Les auteurs font part de leurs recommandations et donnent des exemples d'études émanant de la littérature récente concernant l'évaluation de modifications mineures. En outre, ils examinent les approches statistiques couramment utilisées pour ces comparaisons.
Toda modificación que se introduzca en un ensayo validado debe ser objeto de evaluación para determinar la influencia del cambio en las características de funcionamiento del ensayo y saber si este sigue estando adaptado a su función. Para referirse a la comparación, los autores emplean expresiones como 'comparación de métodos', 'comparabilidad de métodos', 'cambio de método' o 'validación comparativa'. Los autores presentan aquí recomendaciones y ejemplos de estudios extraídos de la bibliografía actual como medio de evaluar modificaciones de importancia menor. Además, los autores examinan las lógicas estadísticas comunes utilizadas para estas comparaciones.
Assuntos
BioensaioRESUMO
Recently, confirmed occurrences of persistent bovine viral diarrhea virus (BVDV) infection in North American alpacas have raised concerns about the role of persistently infected (PI) alpacas in transmission of virus among herds, yet only limited pathological descriptions of persistent infections in alpacas have been reported. The objective of this study was to characterize BVDV antigen distribution in 10 PI alpacas of varying age and to compare viral antigen distribution and localization in tissues of PI alpacas with 5 PI calves of varying age. Ocular dysplasia was evident in 1 PI alpaca, constituting the first reported congenital ocular lesion in PI alpacas. Viral antigen was widely distributed in alpaca tissues and was prominent in neurons, endothelial cells, and vascular tunica media myocytes but had limited distribution in lymphoid tissues and moderate distribution in epithelium of several organ systems of alpacas. Macrophages in the alpaca gastrointestinal system submucosa and lymph node medullary sinuses often had prominent labeling. In addition, only 1 alpaca had antigen labeling in the bone marrow in contrast to PI cattle. Labeled cells in calf tissues were more widely distributed, occurring prominently in lymphoid and epithelial tissues. Common features of the 2 host species were widespread antigen labeling and absence of lymphoid depletion.
