2013, Number 2
VacciMonitor 2013; 22 (2)
Improvements in the potency assay of Bordetella pertussis
del Puerto CA, Mandiarote A, Valle O, Núñez JF, Izquierdo L, Baños N, Labrador I
Language: Spanish
References: 11
Page: 40-42
PDF size: 76.62 Kb.
ABSTRACT
Potency of pertussis component, present in DPT-vax, is evaluated by Kendrick assay. Strain Bordetella pertussis 18323 is recommended by WHO, which should be stored in a way that ensures its viability, purity and virulence. As part of the assay, the concentration of a strain suspension should be calculated, which opacity is compared at first sight with the Fifth Reference International Preparation of Opacity. This method is very inexact and frequently leads to errors. A seed lot from Bordetella pertussis 18323 was elaborated and characterized in this study and the concentration of the strain using a calibration curve was calculated. The lot was used in eight potency assays and they complied with established validity criterion.REFERENCES
World Health Organization. Manual of laboratory methods for testing of vaccines used in the WHO Expanded Programme on Inmunization. Global programme for vaccines and inmunization. Vaccine supply and quality. Assay for testing the potency of whole cell pertussis vaccines in monovalent or combined form. Geneva: WHO; 1997.