Manual de procesos y procedimientos para análisis clínicos de muestras biológicas / Manual of processes and procedures for clinical analysis of biological simples

El presente manual de procesos y procedimientos documenta las principales actividades de atención integral que se ofrecen al usuario interno y externo para el análisis clínico de muestras biológicas, como parte del proceso de atención en salud integral e integrada a la persona en el curso de vida, describe el sistema de operación de los servicios ofrecidos para el análisis clínico de estas muestras en los establecimientos de salud, mediante el enfoque por procesos, fomentando el desarrollo organizacional y el mejoramiento continuo para el cumplimiento de la misión institucional

This manual of processes and procedures documents the main comprehensive care activities offered to the internal and external user for the clinical analysis of biological samples, as part of the process of comprehensive and integrated health care for the person in the course of life, describes the system of operation of the services offered for the clinical analysis of these samples in health establishments, through the process approach, fostering organizational development and continuous improvement for the fulfilment of the institutional misión

Minimal improvement in coronary artery disease risk prediction in Chinese population using polygenic risk scores: evidence from the China Kadoorie Biobank / 中华医学杂志(英文版)

BACKGROUND@#Several studies have reported that polygenic risk scores (PRSs) can enhance risk prediction of coronary artery disease (CAD) in European populations. However, research on this topic is far from sufficient in non-European countries, including China. We aimed to evaluate the potential of PRS for predicting CAD for primary prevention in the Chinese population.@*METHODS@#Participants with genome-wide genotypic data from the China Kadoorie Biobank were divided into training ( n = 28,490) and testing sets ( n = 72,150). Ten previously developed PRSs were evaluated, and new ones were developed using clumping and thresholding or LDpred method. The PRS showing the strongest association with CAD in the training set was selected to further evaluate its effects on improving the traditional CAD risk-prediction model in the testing set. Genetic risk was computed by summing the product of the weights and allele dosages across genome-wide single-nucleotide polymorphisms. Prediction of the 10-year first CAD events was assessed using hazard ratios (HRs) and measures of model discrimination, calibration, and net reclassification improvement (NRI). Hard CAD (nonfatal I21-I23 and fatal I20-I25) and soft CAD (all fatal or nonfatal I20-I25) were analyzed separately.@*RESULTS@#In the testing set, 1214 hard and 7201 soft CAD cases were documented during a mean follow-up of 11.2 years. The HR per standard deviation of the optimal PRS was 1.26 (95% CI:1.19-1.33) for hard CAD. Based on a traditional CAD risk prediction model containing only non-laboratory-based information, the addition of PRS for hard CAD increased Harrell's C index by 0.001 (-0.001 to 0.003) in women and 0.003 (0.001 to 0.005) in men. Among the different high-risk thresholds ranging from 1% to 10%, the highest categorical NRI was 3.2% (95% CI: 0.4-6.0%) at a high-risk threshold of 10.0% in women. The association of the PRS with soft CAD was much weaker than with hard CAD, leading to minimal or no improvement in the soft CAD model.@*CONCLUSIONS@#In this Chinese population sample, the current PRSs minimally changed risk discrimination and offered little improvement in risk stratification for soft CAD. Therefore, this may not be suitable for promoting genetic screening in the general Chinese population to improve CAD risk prediction.

Biobancos en otorrinolaringología / Biobanks in otolaryngology

Resumen Los biobancos son una innovadora herramienta biotecnológica y un recurso fundamental para el continuo avance en la investigación científica biomédica, y para el advenimiento de la medicina de precisión. Se han desarrollado de forma exponencial durante los últimos 20 años en el mundo, como también a nivel de nuestro país, con la creación de 10 biobancos desde el año 2004. En ellos se almacenan y organizan distintos tipos de muestras biológicas, asociadas a datos epidemiológicos y genéticos de donantes voluntarios. Todos los especímenes almacenados deben ser preservados con estándares de calidad garantizados, a modo de asegurar trazabilidad, integridad y calidad de las muestras. A pesar de que la mantención de un biobanco puede significar altos costos, a fin de cuentas, abaratan costos de los estudios clínicos, dado que es precisamente el biobanco quien se encarga de la obtención de datos y muestras clínicas confiables, permitiendo realizar múltiples estudios a partir de las mismas muestras. A través de este proceso, los biobancos permiten mantener una fuente confiable de recur-sos para la investigación en diversas áreas de la medicina, dentro de ellas la otorrinolaringología. En otorrinolaringología, los biobancos han significado un gran avance, facilitando la investigación en relación con hipoacusia, presbiacusia y tinnitus, así como en el área oncológica. En un futuro, se espera que la comunidad científica haga uso de este recurso, pudiendo expandir su utilidad no solo en el área médica, sino también en otras profesiones de la salud, maximizando así su gigantesco potencial.

Abstract Biobanks are novel biotechnological tools and a fundamental resource for the constant development of biomedical research, as much as for the growing practice of precision medicine. They have proliferated worldwide over the past 20 years and Chile has not been left behind with the creation of 10 bio-banks since 2004. Biobanks store and organize different types of biological samples associated with epidemiological and genetic data from volunteer donors. These samples are stored and preserved under guaranteed quality standards to ensure their traceability, integrity, and quality. Even though the price of maintaining a biobank may seem high, after all, they reduce the costs of research, since biobanks are responsible of the acquisition and storage of data and samples, allowing the performance of multiple studies from the same collection of specimens. In this direction, biobanks grant a constant source of well-founded scientific material for investigation in a wide range of medical fields, such as otolaryngology among them. In otolaryngology, the biobanks have meant a great improvement, facilitating investigations related to deafness, presbycusis, tinnitus and oncology. In the future we hope the scientific community will expand the use this innovative tool over a broader medical field and towards other health-related professions, making the most of its enormous potential.

Abordaje multidisciplinar del concepto Biobanco: revisión integrativa / A multidisciplinary approach to the Biobank concept: integrative review

Resumen Los biobancos son infraestructuras multidisciplinares y esta investigación integradora pretende exponer su concepto a las diferentes ciencias que lo construyen e interpretan, para entender sus elementos esenciales de forma holística. La revisión integradora se realizó siguiendo la guía PRISMA y la evaluación de la calidad según CASPe dando como resultado un total de 30 trabajos. El análisis de los datos se realizó a través de las categorías aristotélicas y los resultados se interpretaron según el paradigma de la complejidad de Edgar Morin. El concepto de Biobanco fue aclarado al considerarlo como la representación de un fenómeno bio-socio-cultural en el que los campos científicos desarrollan relaciones de tipo: complementarias, antagónicas y ambiguas de conocimientos y prácticas. Esta red de significación, desde la filosofía, impacta en la construcción de la subjetividad y en las formas de socialización.

Abstract Biobanks are multidisciplinary infrastructures and, accordingly, this integrative research seeks to bring out the concept of biobank in the various sciences that construct and interpret it, so as to arrive at a holistic understanding of its essential components. This integrative review - guided by PRISMA and with quality assessment following CASPe - resulted in a selection of 30 articles. Data were analysed by Aristotelian categories and the results were interpreted on the complexity paradigm of Edgar Morin. The biobank concept was clarified by considering it to be the representation of a biological, social and cultural phenomenon in which knowledge and practices from diverse scientific fields enter into complementary, antagonistic and ambiguous types of relationship. This network of signification, analysed here using categories from Aristotelian philosophy, has impacts on the construction of subjectivity and forms of socialisation.

Creación de la colección COVID-19 del Biobanco de Enfermedades Infecciosas en Argentina / Establishment of a COVID-19 collection within the Biobank of Infectious Diseases in ArgentinaEsta obra está bajo una licencia de CreativeCommons Reconocimiento-NoComercial 4.0Internacionalhttps://creativecommons.org/licenses/by-nc/4.0/i

La pandemia de COVID-19 ha puesto en jaque a los sistemas de salud en el mundo; la vinculación entre la investigación biomédica y la práctica asistencial ha probado ser un requisito fundamental para dar respuesta a la misma de manera eficiente y rápida. En este sentido, los biobancos se constituyen como un componente clave ya que favorecen el almacenamiento de grandes volúmenes de muestras biológicas gestionadas en base a criterios que garanticen su óptima calidad, armonización y seguridad, respetando requisitos éticos y legales que aseguran los derechos de los ciudadanos. La cesión de estas muestras a distintos grupos de investigación promueve el desarrollo de nuevas herramientas diagnósticas y terapéuticas y vacunas. Frente a la llegada del SARS-CoV-2 a la Argentina, el Biobanco de Enfermedades Infecciosas estableció rápidamente la colección COVID-19 constituida por muestras de plasma, suero y células mononucleares de sangre periférica de personas cursando la enfermedad o recuperadas. En solo seis meses se enrolaron 825 donantes, lo que significa alrededor de 14.000 viales de material biológico almacenados y a disposición de los investigadores que lo soliciten. A tal efecto, se realizaron seis actos de cesión a diversos grupos pertenecientes a instituciones de investigación, mientras que tres se encuentran en evaluación. Las muestras cedidas han permitido, por ejemplo, el desarrollo de kits serológicos de producción nacional; lo que pone de manifiesto que el rápido establecimiento de esta colección, bajo un sistema de gestión eficiente, constituye una herramienta muy valiosa en la respuesta a esta nueva enfermedad

The COVID-19 pandemic has driven an unprecedented health crisis. Cooperation between biomedical research and healthcare practice has been shown to be a fundamental requirement to provide an efficient and timely response. In this regard, biobanks are key components since they allow the storage of large volumes of biological samples with guaranteed optimum quality, harmonization and safety, ensuring ethical and legal requirements which protect citizen rights. The transfer of these samples to different research groups fosters the development of new diagnostic and therapeutic tools as well as vaccines. Upon SARS-CoV-2 arrival to Argentina, the Biobank of Infectious Diseases rapidly established the COVID-19 collection comprised by plasma, serum and peripheral blood mononuclear cells samples obtained from people within the acute phase of the infection or who have already recovered. In only 6 months, 825 donors were enrolled, representing around 14,000 vials of biological material stored and available to researchers who might require it. In this line, 6 transfer agreements have been already performed to different groups belonging to national research institutions, while 3 are under evaluation. The transferred samples have allowed, for instance, the development of nationally produced serologic kits, which shows that the rapid establishment of this collection, under an efficient management system, represents a highly valuable tool in the response to this new disease.

A review on the application of UK Biobank in neuroimaging / 生物医学工程学杂志

UK Biobank (UKB) is a forward-looking epidemiological project with over 500, 000 people aged 40 to 69, whose image extension project plans to re-invite 100, 000 participants from UKB to perform multimodal brain magnetic resonance imaging. Large-scale multimodal neuroimaging combined with large amounts of phenotypic and genetic data provides great resources to conduct brain health-related research. This article provides an in-depth overview of UKB in the field of neuroimaging. Firstly, neuroimage collection and imaging-derived phenotypes are summarized. Secondly, typical studies of UKB in neuroimaging areas are introduced, which include cardiovascular risk factors, regulatory factors, brain age prediction, normality, successful and morbid brain aging, environmental and genetic factors, cognitive ability and gender. Lastly, the open challenges and future directions of UKB are discussed. This article has the potential to open up a new research field for the prevention and treatment of neurological diseases.

A retrospective safety study on screening of the samples in the clinical biobank of Beijing Hospital / 中华预防医学杂志

To investigate whether the laboratory specimens preserved in Beijing Hospital Biobank during a specific period had been contaminated by SARS-Cov-2 through a cross-sectional study, and to establish a retrospective biobank safety screening system. Laboratory specimens were collected from the Department of Respiratory and Critical Care Medicine and the Fever Clinic of Beijing Hospital from November 1, 2019 to January 22, 2020, nucleic acid and serological antibody testing were performed for SARS-CoV-2 in these specimens (including 79 serum, 20 urine, 42 feces and 21 bronchoalveolar lavage fluid specimens). The safety of the stored samples during this period was defined by negative and positive results. Both the nucleic acid test and serological antibody test showed negative for SARS-CoV-2, indicating that these specimens were safely stored in the biobank. High-risk specimens collected in our hospital during the early stage of the COVID-19 outbreak are free of SARS-CoV-2, and a safety screening strategy for the clinical biobank is established to ensure the biosafety of these samples.

Plano municipal de contingenciamento para o enfrentamento da crise do Coronavirus (covid-19) 2020 [Aliança do Tocantins] / Municipal contingency plan to face the Coronavirus crisis (covid-19) 2020 [Aliança do Tocantins]

Descreve ações de Vigilância e Atenção em Saúde do Município de Aliança do Tocantins, a serem executadas na rotina das Unidades de Saúde e fluxograma de atendimento frente a casos suspeitos de Infecção Humana pelo Novo CoronaVírus (COVID-2019). Busca minimizar riscos à população frente a casos suspeitos de COVID-2019. Divulga informações em Saúde e estabelece estratégia de Comunicação de Risco além de orientar a adoção de medidas preventivas e indicação de uso de Equipamento de proteção individual ­ EPI.

Describes Health Surveillance and Attention actions in the municipality of Aliança do Tocantins, to be carried out in the routine of the Health Units and flowchart of care in the face of suspected cases of Human Infection by the New CoronaVirus (COVID-2019). It seeks to minimize risks to the population in the face of suspected cases of COVID-2019. Discloses information on Health and establishes a Risk Communication strategy in addition to guiding the adoption of preventive measures and the indication of the use of Personal Protective Equipment - PPE.

Describe las acciones de Vigilancia y Atención en Salud en el municipio de Aliança do Tocantins, a realizarse en la rutina de las Unidades de Salud y diagrama de flujo de atención ante casos sospechosos de Infección Humana por el Nuevo CoronaVirus (COVID-2019). Busca minimizar riesgos a la población ante casos sospechosos de COVID-2019. Divulga información sobre Salud y establece una estrategia de Comunicación de Riesgos además de orientar la adopción de medidas preventivas y la indicación del uso de Equipos de Protección Individual - EPI.

Il décrit les actions de surveillance et de soins de santé dans la municipalité d'Aliança do Tocantins, à réaliser dans la routine des unités de santé et le diagramme de flux de soins pour les cas suspects d'infection humaine par le nouveau coronavirus (COVID-2019). Il cherche à minimiser les risques pour la population face aux cas suspects de COVID-2019. Diffuse des informations sur la santé et établit une stratégie de communication des risques en plus de guider l'adoption de mesures préventives et l'indication de l'utilisation des équipements de protection individuelle - EPI.

Directrices provisionales de bioseguridad de laboratorio para el manejo y transporte de muestras asociadas al nuevo coronavirus 2019 (2019-nCoV) / Interim laboratory biosecurity guidelines for handling and transporting samples associated with the new coronavirus 2019 (2019-nCoV)

En enero de 2020, el agente etiológico responsable de un grupo de casos de neumonía grave en Wuhan, China, fue identificado como un nuevo betacoronavirus (2019-nCoV), distinto del SARS-CoV y MERS-CoV (1) (2) (3). La secuencia genómica completa de este nuevo agente está disponible y se han desarrollado diferentes protocolos de detección, aunque aún no se han validado por completo. Sin embargo, a la luz de la posible introducción de un caso sospechoso relacionado con el 2019-nCoV en la Región de las Américas, la Organización Panamericana de la Salud / Organización Mundial de la Salud (OPS / OMS) recomienda a los Estados Miembros garantizar su identificación oportuna, el envío de las muestras a laboratorios Nacionales o de referencia y la implementación del protocolo de detección molecular para 2019-nCoV, según la capacidad del laboratorio.

El desarrollo de pautas éticas y legales para biobancos con fines de investigación en Argentina / The development of ethical and legal guidance for biobanking in Argentina

Los biobancos que almacenan muestras biológicas humanas y datos asociados de los donantes se han constituido en una herramienta esencial para la investigación biomédica. Su valor radica en el intercambio de las grandes cantidades de muestras y datos que almacenan para la realización de múltiples investigaciones futuras. Este nuevo escenario presenta desafíos éticos, legales y sociales relacionados con la protección de los derechos e intereses de los donantes y de la comunidad a la que pertenecen. En respuesta a estos desafíos y con el fin de promover en Argentina la existencia de biobancos con muestras de alta calidad para la realización de investigaciones con valor científico y social, que respeten en todo momento los derechos e intereses de los donantes y de la comunidad, la Secretaría de Gobierno de Salud ha elaborado una Guía de pautas éticas y legales para los biobancos con fines de investigación. Este artículo describe y analiza los puntos clave de la Guía

National production of certified reference fungal cultures / Producción nacional de cultivos fúngicos de referencia certificados

Reference fungal cultures (RFCs) are essential for the internal quality control of laboratories. The production of these cultures requires standardized procedures (IRAM 14950:2016 and ISO 17034:2016 standards) carried out by a recognized and accredited laboratory. The aim of this work was to produce RFC in paper disks of autochthonous strains, characterized by two, homogeneous and stable reference methods traceable at species level. RFC were produced using 14 regional species (7 yeasts and 7 filamentous fungi) from the fungal culture collection (DMic). Paper disks were impregnated with a culture suspension, dried and packed. Homogeneity, viability, identity and purity were verified. Short-and long-term stability at different temperatures and storage times were studied. Characterization of each strain allowed to confirm its identity and to ensure its traceability at international level. Produced batches were homogeneous and stable at -20 ±5 °C for 30 months. This method of production was adequate to produce homogeneous and stable RFC with phenotypic and genotypic characteristics correctly defined and internationally traceable. Standardized procedures were developed for the production of certified RFC that could be transferred to other microorganisms. Providing RFC that represent regional strains allows laboratories to produce more reliable results with a favorable impact on medical diagnosis, the environment or the food industry.

Los cultivos microbianos de referencia (CR) son imprescindibles para el control de calidad interno de los laboratorios. Asegurar su producción requiere de procedimientos estandarizados (IRAM 14950:2016 e ISO 17034:2016) realizados en un laboratorio reconocido y acreditado. El objetivo de este estudio fue producir cultivos fúngicos de referencia en discos de papel, a partir de un panel de cultivos autóctonos caracterizados por dos métodos de referencia, trazables a nivel taxonómico de especie, homogéneos y estables. Se produjeron CR de 14 especies circulantes en Argentina (7 de levaduras y 7 de hongos miceliales), depositadas en la colección de hongos de interés médico (DMic). Los discos de papel fueron embebidos con una suspensión del cultivo por producir, secados y envasados. Se verificó la homogeneidad, viabilidad, identidad y pureza de cada lote. Se evaluó la estabilidad a corto y largo plazo a distintas temperaturas y tiempos de almacenamiento. La caracterización de cada CR nos permitió confirmar su identidad y asegurar su trazabilidad a nivel internacional. Los lotes producidos fueron homogéneos y estables durante 30 meses conservados a -20 ±5 °C. Este método resultó adecuado para producir CR homogéneos y estables, con características fenotípicas y genotípicas correctamente definidas y trazables a nivel internacional. Los procedimientos estandarizados desarrollados en este trabajo pueden ser transferidos para producir CR certificados de otros microorganismos. La provisión de CR que represente cepas regionales permite a los laboratorios producir resultados más confiables con un impacto favorable en el diagnóstico médico, los estudios ambientales y la industria alimenticia.

Identification of Brucella abortus biovar 4 of bovine origin in Colombia / Identificación de Brucella abortus biovar 4 de origen bovino en Colombia

The objective of this study was to identify twelve Brucella abortus isolates of bovine origin from the department of Nariño in Colombia up to the biovar level. These isolates are included in the collection of the Germplasm Bank of Microorganisms of Animal Health Interest -Bacteria and Virus (BGSA-BV). The identification was carried out through conventional methods such as macro and microscopic morphological descriptions, enzymatic activity, biochemical profile, substrate use and sensitivity to dyes. Complementary genotypic characterization was carried out using multiplex PCR for B. abortus, Brucella melitensis, Brucella ovis, and Brucella suis-Erytritol (AMOS-ERY-PCR), RFLP-IS711, by southern blot hybridization, as well as by the multiple locus variable number of tandem repeat analysis (MLVA) using the ery gene and the insertion sequence IS711 and variable number of tandem repeats (VNTR) as molecular markers. The results of the phenotypic and molecular characterization allowed to identify twelve isolates as B. abortus biovar 4 as well as to differentiate field from vaccine strains. This is the first study on the phenotypic and molecular identification of B. abortus isolates in Colombia. It was concluded that the phenotypic and molecular identification of twelve isolates as B. abortus biovar 4 could be achieved using conventional and molecular techniques with enough resolution power. The identification of these isolates to the biovar level in taxonomic and epidemiological terms will allow the use of this genetic resource as reference strains in future research. This finding constitutes the basis for identifying biotypes not previously reported in the country that might be useful to support brucellosis survey programs in Colombia.

El objetivo de este estudio fue identificar 12 aislamientos de Brucella abortus de origen bovino procedentes del departamento de Narino, Colombia, hasta la descripción de biovar. Estos aislamientos conforman la colección del Banco de Germoplasma de Microorganismos de Interés en Salud Animal, Bacterias y Virus. La identificación se hizo mediante métodos convencionales, como la descripción morfológica macro y microscópica de actividad enzimática, de perfiles bioquímicos, de utilización de sustratos y de sensibilidad a colorantes. Se hizo una caracterización genotipica complementaria mediante PCR múltiple para Brucella abortus, Brucella melitensis, Brucella ovisy Brucella suis-eritritol (AMOS-ERY-PCR); RFLP-/S7II; hibridación Southern blot y análisis multi-locus de repeticiones en tándem de número variable (MLVA), empleando como marcadores moleculares el gen ery, la secuencia de inserción /S711 y el número variable de repeticiones en tándem (VNTR). Los resultados de la caracterización fenotípica y molecular permitieron identificar 12 aislamientos de campo como B. abortus biovar 4 y diferenciar cepas de campo de cepas vacunales. Este es el primer estudio de identificación fenotípica y molecular de aislamientos de B. abortus en Colombia. Por su importancia taxonómica y epidemiológica, la identificación de estos aislamientos hasta el nivel de biovar permitirá disponer de recursos genéticos que se pueden emplear como cepas de referencia en futuras investigaciones. Estos resultados pueden considerarse como una base para la identificación de biotipos no reportados en el país y podrán ser utilizados en programas de monitoreo y vigilancia de la brucelosis bovina en Colombia.

Una red de biobancos para Chile: investigar hoy, para curar mañana / The implementation of a Biobank network for Chile

The concept "Biobank" is relatively new in the scientific literature, and is not yet consensually defined, even for the World Health Organization (WHO). However, the use of human samples in biomedical research is a very old activity. The organized development of Biobanks in different places has grown in the last decade. The experience in different countries and continents has been diverse. In this special article we intend to summarize, organize and communicate to the national medical and scientific community, (i) the concept of Biobank, (ii) the international experience and a map of the Research Biobanks working in Chile, (iii) the basic biomedical and essential operational aspects to manage a Biobank for Research and (iv) the impact of a National Network of Biobanks implementation in the Chilean Health System. Ethical and regulatory aspects will not be included, given their intrinsic complexity, which should be discussed elsewhere.

Detection and clearance of a mosquito densovirus contaminant from laboratory stocks of Zika virus

BACKGROUND The Zika virus (ZIKV) epidemics that affected South America in 2016 raised several research questions and prompted an increase in studies in the field. The transient and low viraemia observed in the course of ZIKV infection is a challenge for viral isolation from patient serum, which leads to many laboratories around the world sharing viral strains for their studies. C6/36 cells derived from Aedes albopictus larvae are commonly used for arbovirus isolation from clinical samples and for the preparation of viral stocks. OBJECTIVES Here, we report the contamination of two widely used ZIKV strains by Brevidensovirus, here designated as mosquito densovirus (MDV). METHODS Molecular and immunological techniques were used to analyse the MDV contamination of ZIKV stocks. Also, virus passages in mammalian cell line and infecting susceptible mice were used to MDV clearance from ZIKV stocks. FINDINGS MDV contamination was confirmed by molecular and immunological techniques and likely originated from C6/36 cultures commonly used to grow viral stocks. We applied two protocols that successfully eliminated MDV contamination from ZIKV stocks, and these protocols can be widely applied in the field. As MDV does not infect vertebrate cells, we performed serial passages of contaminated stocks using a mammalian cell line and infecting susceptible mice prior to re-isolating ZIKV from the animals' blood serum. MDV elimination was confirmed with immunostaining, polymerase chain reaction (PCR), and analysis of the mosquitoes that were allowed to feed on the infected mice. MAIN CONCLUSIONS Since the putative impact of viral contaminants in ZIKV strains generally used for research purposes is unknown, researchers working in the field must be aware of potential contaminants and test viral stocks to certify sample purity.