SciELO - Scientific Electronic Library Online

 
vol.18 número1Ensayo de inmunogenicidad y toxicidad local del cocleato de Neisseriameningitidis en ratas Sprague DawleyObtención y caracterización parcial de un extracto lipídico de la membrana externa de Mycobacterium smegmatis índice de autoresíndice de materiabúsqueda de artículos
Home Pagelista alfabética de revistas  

Servicios Personalizados

Revista

Articulo

Indicadores

  • No hay articulos citadosCitado por SciELO

Links relacionados

  • No hay articulos similaresSimilares en SciELO

Compartir


Vaccimonitor

versión impresa ISSN 1025-028Xversión On-line ISSN 1025-0298

Resumen

VALDERRAMA, Susset et al. Establishment and validation of an ELISA-type immunoenzymatic assay, used for quality control of human recombinant alpha-2b Interferon. Vaccimonitor [online]. 2009, vol.18, n.1, pp.8-14. ISSN 1025-028X.

An ELISA for quantification of human recombinant alpha-2b Interferon in the Active Pharmaceutical Ingredient (API) was established and validated, and the validity criteria for the assay were defined, based on Good Laboratory Practices compliance. The following parameters were evaluated: linearity, specificity, accuracy, range, precision and robustness. The assay was specific, with accuracy from 84.3 to 102.4%, a quadratic adjustment and a working range from 1 to 10 ng/mL, repetibility and intermediate precision with coefficients of variation lower than 10% and 20% respectively, and robustness confirmed in relation to the edge effect and the stability of solutions.

Palabras clave : ELISA; ELISA; human recombinant alpha-2b Interferon; validation.

        · resumen en Español     · texto en Español     · Español ( pdf )

 

Creative Commons License Todo el contenido de esta revista, excepto dónde está identificado, está bajo una Licencia Creative Commons