Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays. Final order.

The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

Microbiología. bacteriología, características y clasificación bacteriana. virología, características y técnicas bioquímicas

Obra profusamente ilustrada que por su estructura didáctica facilita notablemente el aprendizaje de esta materia. Recomendada para estudiantes de Formación Profesional y Técnicos Especialistas de Laboratorio. Incorpora ejercicios prácticos de autoevaluación para determinar el nivel de conocimientos adquiridos por el alumno.

Uma nova estratégia para PDT antimicrobiana em Endodontia / A new approach for antimicrobial Endodontic PDT

O presente estudo avaliou diferentes parâmetros como concentração do fotossensibilizador,tempo/energia de irradiação e uso de fibras ópticas, na a PDT para redução bacteriana intracanal.Avaliou-se, in vitro, em cubetas de quartzo contendo concentrações de 50, 100, 150 e 300μM de solução aquosa de Azul de Metileno (AM) a produção de espécies reativas de oxigênio (EROs) em irradiações adicionais de 30s com um laser de diodo emitindo em 660nm. Utilizando-se a mesma metodologia, foi avaliado os efeitos na produção de EROs com e sem o uso de fibra óptica. Concentrações de 50, 150 e 300μM de AM e análise por imagens, avaliaram a formação do fenômeno escudo óptico. Dez incisivos contaminados com P. Aeruginosas bioluminescentes, foram utilizados para analisar as energias/tempo para redução bacteriana intracanal. Imagens obtidas nos dentes avaliaram a contaminação inicial. Os canais foram preenchidos com o fotossensibilizador (PS) eirradiações de 2,4J foram realizadas. A cada irradiação, imagens foram obtidas e a redução bacteriana avaliada. A formação de EROs é maior em concentrações menores do PS, assim como a formação de escudo óptico. O uso de fibra aumenta a formação de ERO quando comparado a irradiação sem fibra. Irradiação com 7J impossibilitou a detecção de biofilme intracanal. A concentração do PS em que há maior eficiência na formação de EROs e menor formação de escudo óptico se encontra entre 50 a 100μM. O uso de fibras ópticas contribui para maior formação de EROs. Energia de irradiação mínima de 7J promove significativa redução bacteriana intracanal.

This study evaluates different approach such as photos sensitizer (PS) concentration, irradiation time/energy, and the use of optical fiber for intracanal microbial reduction. In a quartzcurvet, aqueous solution of Methylene blue at 50, 100, 150 and 300μM was tested for reactive oxygen species production (ROS) after successive irradiations of 30s with a diode laser (660nm,100mW). Using the same methodology, the ROS production was tested using an optical fiber. Image analyses evaluated the presence of optical shield in 3 different concentration of PS. Tencentral incisors were contaminated with bioluminescent P. aeruginosas to test the ideal energy/time for endodontic microbial reduction. Initial contamination was recorded by image after biofilm grown. The root canals were ful filled with Ps and irradiated with successive energiesof 2.4J. After every irradiation new images were recorded to compare the microbial reduction. ROS formation was improved using low concentration of PS, such as optical shield formation. The use of optical fiber did enhance the ROS formation when compared to irradiation with thelaser tip. Energy of 7J was the minimal energy to achieve lost of bioluminescent signal. For more efficient ROS production and minor optical shield presence, a concentration between 50 and 100μM seams to be ideal. The use of an optical fiber improves ROS production. Energy of 7J promotes significative intracanal de contamination.

Divorcing Strain Classification from Species Names.

Confusion about strain classification and nomenclature permeates modern microbiology. Although taxonomists have traditionally acted as gatekeepers of order, the numbers of, and speed at which, new strains are identified has outpaced the opportunity for professional classification for many lineages. Furthermore, the growth of bioinformatics and database-fueled investigations have placed metadata curation in the hands of researchers with little taxonomic experience. Here I describe practical challenges facing modern microbial taxonomy, provide an overview of complexities of classification for environmentally ubiquitous taxa like Pseudomonas syringae, and emphasize that classification can be independent of nomenclature. A move toward implementation of relational classification schemes based on inherent properties of whole genomes could provide sorely needed continuity in how strains are referenced across manuscripts and data sets.

Primer caso de bacteriemia por Sphingomonas anadarae en un paciente con cáncer / First case of bacteremia by Sphingomonas anadarae in an patient with cancer

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Medical devices; immunology and microbiology devices; classification of nucleic acid-based devices for the detection of Mycobacterium tuberculosis complex and the genetic mutations associated with antibiotic resistance. Final order.

The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.

Habilidades lingüísticas sobre nomenclatura microbiana en profesionales de la salud / Linguistic skills of health professionals regarding the microbial nomenclature

En los programas de estudios donde se aplican la Microbiología o Parasitología Médica aparece en todos los casos como objetivo nombrar a los microorganismos. Objetivo: analizar el estado de las habilidades lingüísticas sobre taxonomía microbiana en profesionales de la salud. Métodos: se realizó un estudio descriptivo donde fueron revisados 270 trabajos científicos escritos, relacionados con estas dos especialidades médicas y se efectuaron 250 entrevistas a profesionales de las distintas especialidades médicas, se respetó el anonimato en todos los casos. Resultados: se observaron problemas en la gramática en el 73 por ciento de los artículos, 22 por ciento de las tesis de maestría y 14 por ciento de las tesis de doctorado, mientras que en la nomenclatura estos se reportaron en 29 %, 13 por ciento y 5 por ciento, respectivamente. En el 91 por ciento de las entrevistas se detectaron problemas de dicción. Conclusiones: existen problemas de dicción, gramaticales y escritura sobre los nombres de los microorganismos entre los profesionales de la salud...

The curricula in which microbiology and medical parasitology are involved have as an objective in all the cases to name the various microorganisms. Objective: to analyze the linguistic skills of health professionals in terms of microbial taxonomy. Methods: a descriptive study was carried out to review 270 scientific papers related to these specialties and 250 interviews were made to professionals from different medical specialties. They were all anonymous. Results: grammatical mistakes were observed in 73 per cent of the papers, in 22 per cent of master's theses and in 14 per cent of Ph D's theses, whereas nomenclature errors were found in 29 per cent, 13 per cent and 5 per cent respectively. Pronunciation problems were noticed in 91 per cent of interviews. Conclusions: pronunciation, grammatical and writing problems related to the names of microorganisms were detected in the health professionals participating in this research...

Chemical and microbiological comparison of biodeterioration inColombian heritage constructions / Comparación química y microbiológica del biodeterioro en construcciones patrimoniales en Colombia

Se compararon química y microbiológicamente morterosde Bogotá, Villa de Leyva y Barichara. Las muestras seanalizaron por espectrometría de absorción y emisión atómica,espectroscopia infrarroja con transformada de Fourier,difracción de Rayos X, microscopía electrónica de barrido yespectroscopia por dispersión de energía. Se encontraron óxidosde silicio, aluminio, calcio, hierro, magnesio, yeso, weddellita,despuljosita, cuarzo, berlinita, carbonatos, mica, feldespatos,silicatos, sales de nitratos, sulfitos y compuestos orgánicos.A su vez, se hallaron partículas irregulares entre 10, 50 y 100µm y fibras de tipo orgánico de 20 µm. Se realizó el conteo deunidades formadoras de colonias por el método de dilucionespara identificar microorganismos fúngicos. Se identificaron lossiguientes géneros Aspergillus, Penicillium, Alternaria, Fusarium,Mucor y Syncephalastrum. La muestra de Bogotá presentó el mayornúmero de UFC/mL y el mayor porcentaje de humedad relativa.La concentración de hongos en esta muestra, a diferencia delas de Villa de Leyva y de Barichara, causó la degradación de lamayoría de los metales identificados. Esta comparación químicay microbiológica propone un plan eficaz de intervención paraeliminar y prevenir el biodeterioro en apoyo a la conservación deobras patrimoniales...

Mortars from Bogotá, Villa de Leyvaand Barichara were compared chemically andmicrobiologically. We analyzed the samples using atomicabsorption and emission spectrometry, Fourier-transforminfrared spectroscopy, X-ray diffraction, scanningelectron microscopy and energy dispersive spectroscopy.Oxides of silicon, aluminum, calcium, iron, magnesium,gypsum, weddellite, despujolsite, quartz, berlinite,carbonate, mica, feldspars, silicates, nitrate salts, sulfites,and organic compounds were identified. In addition,irregular particles between 10, 50 an 100 µm werefound, as well organic fibers of 20 µm. Was performeda CFU count using a dilution method to identify fungalmicroorganisms and found following genera Aspergillus,Penicillium, Alternaria, Fusarium, Mucor and Syncephalastrum.The mortar sample taken in Bogotá presented thehighest number of CFU/mL and the highest percentageof relative humidity. The concentration of fungi in thissample, unlike those from Villa de Leyva and Barichara,caused degradation in most of the metals identified.This chemical and microbiological comparison proposesan effective plan of action to eliminate and preventbiodeterioration in support of the conservation ofheritage constructions...

As amostras foram analisadas por espectrometria deemissão e espectroscopia de absorção atômica, infravermelhocom transformada de Fourier, difração de raios X, microscopiaeletrônica de varredura e espectroscopia de energia dispersiva.Foram identificados óxidos de silício, alumínio, cálcio, ferro,magnésio, gesso, weddellita, despuljosita, quartzo, berlinita,carbonato, mica, feldspato, silicatos, sais de nitratos, sulfitos, ecompostos orgânicos. Partículas irregulares entre os 10, 50 e 100µm foram encontradas bem como fibras de tipo orgânico de20 µm. Realizou-se uma contagem CFU usando um método dediluição para identificar microorganismos fúngicos e encontrousefungos dos gêneros Aspergillus, Penicillium, Alternaria, Fusarium,Mucor e Syncephalastrum. A amostra de Bogotá apresentou o maiornúmero de UFC/mL e umidade relativa do ar. A maior presençade fungos desta amostra, ao contrário das amostras da Villa deLeyva e Barichara, causou degradação na maioria dos metaisidentificados. Esta comparação química e microbiológica podesugerir um plano de ação eficaz para a eliminação e prevenção dabiodegradação e assim preservar obras patrimoniais.Departamento de Química, Facultad de Ciencias. PontificiaUniversidad Javeriana. Bogotá, D.C., Colombia.Departamento de Microbiología, Facultad de Ciencias. PontificiaUniversidad Javeriana. Bogotá, D.C., Colombia.Departamento de Biología, Facultad de Ciencias. PontificiaUniversidad Javeriana. Bogotá, D.C., Colombia.Departamento de Arquitectura, Facultad de Arquitectura y Diseño.Pontificia Javeriana. Bogotá, D.C., Colombia.Received: 15-12-2012 Accepted: 02-02-2013 Published on line: 28-02-2013 Edited by Alberto Acosta mUniversitas Scientiarum, Journal of the Faculty of Sciences, Pontificia Universidad Javeriana, is licensed under the Creative Commons 2.5 of Colombia: Attribution - Noncommercial - No Derivative...

Microbial systematics and taxonomy: relevance for a microbial commons.

The issues of microbial taxonomy and potential interactions with a microbial commons are discussed, with emphasis on three components: characterization; classification; and nomenclature. The current state of technology and the spectrum of methods that are used for phenotypic and genotypic characterization of prokaryotes, classification at different taxonomic levels and points of prokaryote nomenclature are reviewed. While all taxonomic ranks comprise a cohesive systematic framework for microorganisms, the prokaryotic genus and species provide the "working unit" of taxonomy. Since 2004, the number of validly published genera and species has increased by approximately 50%. Extensive development of technology will continue to enable ever higher resolution characterization and more refined classification of microorganisms. Characterization and classification at the species level may be most relevant for bacterial taxonomy, although reproducible differentiation at the strain level will probably prove to be more relevant for a microbial commons. A dynamic microbial taxonomy, albeit with well-founded and stable guidelines for defining microorganisms, provides an efficient organizational system for dealing with the enormous spectrum of microbial diversity.

Microbiology devices; reclassification of Herpes simplex virus types 1 and 2 serological assays. Direct final rule.

The Food and Drug Administration (FDA) is implementing a direct final rule correcting the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than type 1 and type 2. When reclassifying this device, FDA mistakenly distinguished between HSV serological assays type 1 and type 2 and all other HSV serological assays. At that time, and today, the only preamendments HSV serological assays which FDA was aware of were type 1 and type 2 and, therefore, the classification of HSV assays other than type 1 and type 2 was incorrect. FDA is correcting the classification of this device to eliminate possible confusion resulting from this error. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.

Practical issues in using SNOMED CT as a reference terminology.

SNOMED CT was created by the merger of SNOMED RT (Reference Terminology) and Read Codes Version 3 (also known as Clinical Terms Version 3). SNOMED CT is considered to be among the most extensive and comprehensive biomedical vocabularies available today. It is considered for use as the Reference Terminology of various institutions. We review the adequacy of SNOMED CT as a Reference Terminology and discuss the issues in its use as such. We discuss issues with content coverage of various clinical domains, data integrity and validity, and the update frequency of SNOMED CT, and why SNOMED CT alone is not adequate to serve as the Reference Terminology of a healthcare organization.

[Overview and analysis of general projects in microbiology funded by NSFC during 2000 - 2006].

The general projects on subdisciplines of Microbiology which were funded by the National Natural Science Foundation of China (NSFC) during the financial years of 2000 to 2006 are reviewed in this article. The number of general projects and funds involved are analyzed to give an overview of fundamental research in microbiology in China. Some important research fields in microbiology that the NSFC should support in the future are also recommended.