RESUMO
Aim: This paper analyses the global and European responses to the break out of the H1N1 virus in 2009 and highlights the major deficiencies of the European authorization procedure of vaccines against H1N1 pandemic flu. Study Design: The study analyses the institutional reactions to the spread of the H1N1 pandemic flu (commonly called swine flu). The study reports the fundamental steps undertaken by global and European Institutions since 2009 to face the spreading of the H1N1 flu. Methodology: The study applies a legal methodology proceeding from formal rules towards the substantial effects taking place in the specific health protection field considered. Results: The analysis of the European authorization procedure of vaccines against H1N1 pandemic flu shows the lack of coordination between Member States and the European Union, as well as coordination between the European Medicines Agency (EMA) and the European Office of the World Health Organization (WHO); moreover, a fundamental violation of the precautionary principle emerged. In the European context, in fact, the principle does not coincide with the temporary nature of the measures, but reflects the fundamental distinction between assessment and risk management. Conclusions: The supranational mediation of the European Union has offered in many cases the guarantee of health protection within contexts in which the multiplicity of involved interests increases the level of conflict. That mediation has definitely failed in the case of swine flu because of the lack of supranational constituency representation within the European Medicines Agency that allows the intergovernmental component and the underlying unilateral protection of economic interests to resurface. In the case of swine flu, the trust relationships between global and European bodies have been affected by the lack of transparency of the responsible organizations (WHO and EMA) and the lack of pluralistic openness to different interests in the decision-making procedures.
RESUMO
La rapidez, eficacia y oportunidad del diagnóstico de influenza facilita el manejo de casos confirmados a nivel terapéutico más aun considerándose el estado actual del virus pandémico H1N1/2009. Objetivo: Analizar la concordancia de cuatro pruebas rápidas para la detección de Influenza A en Bogotá. Métodos: En este estudio descriptivo de corte transversal fueron comparadas cuatro pruebas rápidas para la detección de Influenza A (Quick Vue Influenza A+B; Directigen Ez Flu A+B®; SD Bioline Influenza Antigen® y Clearview Exact Influenza A and B®) en un grupo de 57 hisopados nasofaríngeos de pacientes sospechosos del virus pandémico H1N1/2009, los cuales fueron analizados previamente por PCR en tiempo real y clasificados como positivos o negativos para Influenza A. Resultados: El comportamiento de las pruebas rápidas valorado por su concordancia global con la prueba de referencia fluctuó entre 68,19% y 74,47%, sin evidencias de diferencias estadísticamente significativa entre ellas (c2=0,35; p=0,95). Tampoco se encontró un comportamiento diferencial estadísticamente significativo al valorar la proporción de concordancia entre los positivos de cada una de las pruebas rápidas con la prueba de referencia. Conclusión: Existen varios trabajos a favor y en contra de las pruebas rápidas para influenza, y algunos destacan su baja sensibilidad y especificidad comparadas con otras metodologías, como inmunofluorescencia directa, cultivo viral y RT-PCR. Sin embargo,ante la emergencia que actualmente se vive por la pandemia viral H1N1/2009, diferentes estrategias de vigilancia en salud pública, incluidas los estudios centinela y de conglomerados, pudieran ser implementados y las pruebas rápidas influenza (sin importar la casa comercial) serían útiles por sus características operativas, bajo costo y la posibilidad de lograr mayores coberturas de identificación de casos nuevos, descongestión de servicio y ajuste rápido de medidas en salud pública.
Rapidity, effectiveness and opportunity of influenza diagnosis make easy confirmed cases handling at therapeutic level most of all considering actual state of pandemic virus A H1N1/2009. Objective: To analyze agreement of four quick tests for Influenza A detection of in Bogotá. Methods: In a cross sectional fashion it was compared four quick tests designed for influenza detection (Quick Vue Influenza A + B; Directigen Ez Flu A + B®; SD Bioline Influenza Antigen® and Clearview Exact Influenza A and B®) in 57 nasopharynxeal hyssoped examples of suspicious patients of pandemic A H1N1/2009 virus, all of them were previously analyzed by real-time PCR and classified as positive for that virus. Results: Behavior of fast tests valued by its global agreement against test of reference fluctuated between 68.19% and 74,47%, without significant statistical differences among them (p=0,95). Neither significant statistical differences were found upon valuing proportion of agreement among positives each one of fast tests with reference test. Conclusions: There are some works on behalf or against of influenza rapid tests, and some of them emphasizes their low sensibility and specificity against other techniques, like direct inmunofluorescence inmunofluorescence, viral culture and RT-PCR. Nevertheless, in order to face the actual viral AH1N1/2009 pandemic, different strategies of public health surviellance, (including sentinel and conglomerate studies), could be implemented. Influenze Rapid tests (making exclusion of trade mark) would be serviceable by their operative characteristics, low cost and high possibility of identify new cases and by that way, it would possible emergence services decongestion and fast adjustment of measures in Public Health.