Confirmation of radiant catalytic ionization efficacy for airborne SARS-CoV-2 elimination indoors using "COVID19 traps".

Radiant catalytic ionization (RCI) is a novel technology that uses the appropriate wavelength (240-260 nm) and the phenomenon of photo-oxidation leading to permanent removal of viruses, bacteria, and fungi. Here, two analyses were performed. The first of them was a complete analysis of environmental biosecurity in a hospital environment. The second one was a longitudinal study with 40 patients with confirmed COVID19 and high viral load to assess the efficacy of RCI technology eliminating airborne SARS-CoV-2 indoors. A significant decrease in the number of bacteria and fungi colony-forming units (CFUs) was found in rooms with RCI when compared with rooms without it (p=0.03 for both of them). In the second part of the study, 16 samples out of 40 (40%) were positives when RCI technology was absent; whereas, these samples were negative when the equipment was on. Incidence rates (IR) with their Poisson 95% Confidence Intervals (CI) were calculated as the number of positive tests with the purifier or without it, showing an IR difference of 48.5% [CI(15.9-81), p=0.004]. Furthermore, the IR ratio was calculated obtaining a value of 3.3, confirming that RCI diminished more than 3-fold the presence of the SARS-CoV-2 in the air of the patients' rooms, thus laying the first stone in the fight for prevention of SARS-CoV-2 dissemination indoors.

Validación de la técnica de determinación de proteínas totales por el método microcoomassie a doble longitud de onda para la muestra de producto terminado del antígeno de la nucleocápsida del virus de la hepatitis C / Validation of the technique of determination of total proteins by microcoomassie method to double wave longitude for the sample of Finished Product of hepatitis C core antigen

En el Centro de Ingeniería Genética y Biotecnología se obtuvo una formulación para un candidato vacunal del virus de la hepatitis C (VHC). Es un plásmido para la inmunización con ADN que contiene los genes de los tres antígenos estructurales del virus, mezclado con una variante truncada recombinante de la nucleocápsida del VHC como adyuvante molecular. Ambos compuestos se formularon en bulbos separados y se mezclaron en el momento de la inmunización. En el laboratorio de Desarrollo Analítica se validó la técnica de determinación de proteínas totales por el método de microcoomassie para la muestra de producto terminado (PT) del antígeno de la nucleocápsida del virus de la hepatitis C (HCcAg). Los parámetros validados fueron: especificidad, linealidad, rango, exactitud, precisión y estabilidad de la muestra de PT, bajo dos condiciones diferentes de almacenamiento. El método resultó ser específico para la cuantificación del HCcAg, sin interferencias del placebo de la muestra, a diluciones superiores a 1:8. La curva del microcoomasie fue lineal en el rango de trabajo de 5-40 µg/mL. Se demostró la exactitud del método (recuperación 100 ± 10por ciento). En la evaluación del sistema se cumplieron los criterios de aceptación establecidos para la precisión: repetibilidad (CV £ 5 por ciento) y precisión intermedia (CV £ 10 por ciento). El PT es estable a (4 ºC y 22-25 ºC) durante los tiempos estudiados sin alteración en la concentración del HCcAg. La validación fue satisfactoria y el método fue adecuado para cuantificar proteínas en la muestra de PT. Este resultado permite dar cumplimiento a las especificaciones establecidas para este producto(AU)

A formulation was obtained for a vaccinal candidate of hepatitis C virus (VHC) in the CIGB. It is a plasmid for the immunization with DNA contianing the genes of the three structural antigens of the virus, blended with a recombinant truncated variant of the protein of the core of the VHC, as molecular adjuvant. Both compounds were formulated in separate vials and were mixed at the moment of the immunization. In the laboratory of Development-analytic the technique of determination of total proteins was validated by the microcoomassie method for the sample of Finished Product (FP) of Hepatitis C core antigen (HCVcoreAg). The validated parameters were: Specificity, Linearity and Range, Accuracy, Precision, Stability of the FP sample under two different conditions of storage. The method was specific for the quantification of the HCcAg without interferences of sample placebo of FP to superior dilutions at 1:8. The curve of the microcoomassie for the FP was lineal in the range of work of 5-40 µg/mL. It demonstrated the accuracy of the method (100±10percent recovery). In the evaluation of the system, the established acceptance criteria were completed for Precision: Repeatability (CV £ 5percent) and Intermediate Precision (CV £ 10 percent). Temperatures studied in stability did not cause alteration in HCcAg concentration, and the FP can be stored for 15 days. Validation was satisfactory. The method is adequate to quantify the sample of the FP. This result allows us to comply with the specifications established for this product(AU)

Perfil de seguridad de las terapias biológicas intravenosas en una cohorte de pacientes con artritis reumatoide. Monitorización clínica por enfermería (estudio Sebiol) / Safety profile of biological intravenous therapy in a rheumatoid arthritis patients cohort. Clinical nursing monitoring (Sebiol study)

Introducción. El uso de biológicos ha permitido conocer de manera exhaustiva su seguridad gracias a registros como BIOBADASER. El presente trabajo permite, con un estudio observacional de cohortes, describir el perfil de seguridad perinfusional de dichos tratamientos por vía intravenosa. Objetivos. Conocer el perfil de seguridad en la práctica clínica, tras la administración de biológicos por vía intravenosa y durante las 24 h posteriores. Material y métodos. Cohorte transversal de 114 pacientes con AR tratados con agentes biológicos (criterios ACR) durante un mes de 2009 por enfermería de hospital de día de 12 centros hospitalarios catalanes. Se analizaron la edad, el sexo, los tratamientos actuales y previos, los datos de vacunación previa y la premedicación. Se registró también cualquier acontecimiento adverso (AA) durante la administración o en las 24 h posteriores. Se clasificó según el diccionario internacional MedDRAv11.0 y se describieron la intensidad (leve, moderada, severa), la relación con la administración del fármaco según el algoritmo de Karch y Lasagna (no relacionada, improbable, posible, probable, definitiva) y las medidas emprendidas. El análisis estadístico se realizó mediante SPSS 18.0. Resultados. Ciento once con criterios de inclusión (edad media ± desviación estándar 56,06 ± 12,12 años), 90 mujeres (81,1%) y evolución de 11,97 ± 7,95 años; 24 pacientes (21,6%) con antecedentes de alergia. Se observaron 12 AA en 7 pacientes, 9 de ellos durante la administración y 3 en las 24 h posteriores. No hubo ningún acontecimiento adverso grave y uno de los AA se calificó de intensidad moderada (urticaria). El resto de los AA fueron de intensidad leve (AU)

Introduction: The Biologics used in the management of rheumatoid arthritis (RA) in recent years, have comprehensively permitted to understand its security, as shown in registries such as BIOBADASER. The present manuscript represents an observational cohort study to describe the safety perinfusional profile of those intravenous treatments. Objectives: To confirm the safety profile of biological therapies in routine clinical practice, after the administration of intravenous drugs and 24 hours post-administration. Material and methods: We evaluated a cross-sectional cohort of 114 patients with RA (according to the American College of Rheumatology ACR criteria), attending within one month in 2009 the nursing clinics of day care hospital of 12 Catalonian hospitals. All patients were treated with intravenous biological agents. We recorded the age, sex, current and previous drug treatments, we also collected data about previous vaccination and premedication received and any adverse event occurring at the time of drug administration or within 24 hours. If an adverse event occurred, was categorized by MedDRAv11.0 International Dictionary, and categorized in terms of intensity (mild, moderate, severe), relationship to drug administration according to Karch and Lasagna algorithm (unrelated, unlikely, possible, probable, definite) and the further measures taken. Results: 111 patients met the inclusion criteria, with a mean age of 56.06 years (SD: 12.12), 90 of them women (81.1%) and mean time since diagnosis of the disease of 11.97 years (SD: 7.95). 24 patients (21.6%) had a history of allergy. 12 adverse events were observed in 7 patients, 9 of which at the time of administration and 3 in 24 hours after. There were no serious adverse events and only one of the adverse events (AEs) was rated as moderate (urticaria). The remaining AA were mild (AU)

Safety profile of biological intravenous therapy in a rheumatoid arthritis patients cohort. Clinical nursing monitoring (Sebiol study).

INTRODUCTION: The Biologics used in the management of rheumatoid arthritis (RA) in recent years, have comprehensively permitted to understand its security, as shown in registries such as BIOBADASER. The present manuscript represents an observational cohort study to describe the safety perinfusional profile of those intravenous treatments. OBJECTIVES: To confirm the safety profile of biological therapies in routine clinical practice, after the administration of intravenous drugs and 24 hours post-administration. MATERIAL AND METHODS: We evaluated a cross-sectional cohort of 114 patients with RA (according to the American College of Rheumatology ACR criteria), attending within one month in 2009 the nursing clinics of day care hospital of 12 Catalonian hospitals. All patients were treated with intravenous biological agents. We recorded the age, sex, current and previous drug treatments, we also collected data about previous vaccination and premedication received and any adverse event occurring at the time of drug administration or within 24 hours. If an adverse event occurred, was categorized by MedDRAv11.0 International Dictionary, and categorized in terms of intensity (mild, moderate, severe), relationship to drug administration according to Karch and Lasagna algorithm (unrelated, unlikely, possible, probable, definite) and the further measures taken. RESULTS: 111 patients met the inclusion criteria, with a mean age of 56.06 years (SD: 12.12), 90 of them women (81.1%) and mean time since diagnosis of the disease of 11.97 years (SD: 7.95). 24 patients (21.6%) had a history of allergy. 12 adverse events were observed in 7 patients, 9 of which at the time of administration and 3 in 24 hours after. There were no serious adverse events and only one of the adverse events (AEs) was rated as moderate (urticaria). The remaining AA were mild.

Results of the application of the American Diabetes Association guidelines regarding tobacco dependency in subjects with diabetes mellitus.

The objective of the study was to evaluate the stages of change for cessation in smoking after the application of American Diabetes Association recommendations in diabetic patients who smoke. This longitudinal descriptive study involved smokers with diabetes mellitus (DM) who were attended for their DM between September 2003 and December 2006. Intervention used was dependent on the stage of change for cessation (according to Prochaska and Di Clemente). For precontemplation subjects, a brief session was carried out where information regarding the risks of smoking in conjunction with DM was given. Patients at the contemplation stage of smoking cessation were offered the chance to participate in a cessation program. Later evaluation was carried out after a follow-up of more than 6 months. Seven hundred thirty-three subjects with DM were evaluated, including 156 smokers (21.28%): 103 (66.02%) in the precontemplation stage, 25 (16.02%) in the contemplation stage, 12 (7.69%) in the preparation stage, 12 (7.69%) in the action stage, and 4 (2.56%) in the maintenance stage. By the last follow-up, 65 (41.6%) subjects had quit smoking (36 ex-smokers), of whom 20 (30.77%) had subsequently relapsed. The use of the American Diabetes Association recommendations for the treatment of tobacco dependence in diabetes treatment results in an increased change of smoking cessation stages in subjects with DM as well as a higher overall percentage in abstinence.