ABSTRACT
To date, the potency of allergen products in Europe is expressed in manufacturer-specific units relative to a product-specific in-house reference. Consequently, cross-product comparability of allergen products from different manufacturers with respect to strength and efficacy is impossible. The Biological Standardisation Programme (BSP) project BSP090 addresses this issue via the establishment of reference standards in conjunction with ELISA methods for the quantification of major allergens in allergen products. Since the initiation of BSP090, the recombinant major allergen Bet v 1 has been adopted by the European Pharmacopoeia Commission as a Chemical Reference Substance (CRS). In parallel, two sandwich ELISA systems for quantification of Bet v 1 were found suitable in preliminary phases of BSP090 to be validated in a large collaborative study. In this study, the candidate ELISA systems were compared with respect to accuracy, precision and variability. Thirteen participating laboratories tested model samples containing the CRS as well as spiked and unspiked birch pollen extracts. Both in pre-testing and in the collaborative study, the 2 candidate ELISA systems confirmed their suitability to quantify recombinant and native Bet v 1. As no clear-cut decision for one of the ELISA systems could be made based on the results of the collaborative study, a post-study testing was performed. Bet v 1 content of 30 birch pollen allergen products was determined in parallel in both ELISA systems. Consequently, 1 candidate ELISA system was selected to be proposed as the future European Pharmacopoeia standard method for Bet v 1 quantification.
Subject(s)
Allergens/analysis , Antigens, Plant/analysis , Biological Products/analysis , Enzyme-Linked Immunosorbent Assay , Plant Proteins/analysis , Allergens/immunology , Antigens, Plant/immunology , Biological Products/immunology , Biological Products/standards , Enzyme-Linked Immunosorbent Assay/standards , Europe , Humans , Plant Proteins/immunology , Plant Proteins/standards , Quality Control , Reference Standards , Reproducibility of ResultsABSTRACT
La electromiografía (EMG) permite registrar datos de la actividad eléctrica de los músculos en forma certera, reproducible y objetiva. En la actualidad, la actividad muscular puede estudiarse asociada a la función mandibular y la oclusión dentaria La actividad muscular se estudia no sólo en función dela fuerza de contracción, sino también en función de la frecuencia de contracciones. Esta última es quizá lavaloración más importante ya que un músculo fatigado, con menor frecuencia de contracciones producto de una inadecuada irrigación, déficit de energía y acumulación de productos del catabolismo celular, disminuye su capacidad de rendimiento, predisponiendo al paciente al dolor y disfunción miofascial. Estos registros pueden efectuarse tanto con el músculoen reposo como en actividad. En la práctica profesional odontológica la rehabilitación oral es un desafío permanente, rehabilitar la oclusiónde un paciente con músculos en un estado de hipertonicidad o de fatiga, perpetúa la patología existente.La EMG añade una nueva dimensión al tratamiento, tanto de los pacientes odontológicos sintomáticos comoasintomáticos, facilitando al odontólogo la capacidad de garantizar resultados previsibles y fisiológicos.
