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1.
Washington; OPS; 23 mayo 2022. 12 p. ilus, tab.
Non-conventional in English, Spanish | LILACS | ID: biblio-1370042

ABSTRACT

Este documento está basado en la guía provisional de la Organización Mundial de la Salud sobre las pruebas de laboratorio para el virus de la viruela del mono, 23 de mayo de 2022, y tiene por objeto proporcionar orientación a los Laboratorios Nacionales de Referencia sobre la detección del virus de la viruela del mono


This document is based on World Health Organization interim guidance on Laboratory testing for monkeypox virus, 23 May 2022, and is intended to provide guidance to National Reference Laboratories on monkeypox virus laboratory detection


Subject(s)
Humans , Specimen Handling/standards , Monkeypox virus/isolation & purification , Containment of Biohazards/standards , Monkeypox/diagnosis , Laboratories/standards , Specimen Handling/methods , Monkeypox virus/genetics , Diagnosis, Differential
2.
Guatemala; MSPAS; 3 feb. 2021. 28 p. graf.
Non-conventional in Spanish | LILACS, LIGCSA | ID: biblio-1224546

ABSTRACT

En los antecedentes, brinda detalles técnicos de enfermedades previas al COVID-19 y sigue esta consigna internacional: "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." Aborda las tres mutaciones del virus conocidas hasta la fecha del documento y las tres variantes conocidas: Reino Unido e Irlanda del Norte, República de Sudáfrica y Brasil, siendo la de mayor transmisibilidad, según el documento, la del Reino Unido. El primero de los objetivos del documento es: "Brindar los lineamientos generales para la toma de muestra, conservación, transporte y diagnóstico del SARS-Cov-2 en los laboratorios descentralizados bajo la técnica de Reacción en Cadena de la Polimerasa (PCR) en tiempo Real, en atención a pacientes que cumplen con la definición de caso y se tipifica como "sospechoso inusitado"." Incluye como anexo 2 el documento: "Lineamientos para el abordaje de casos positivos para SARS-COV-2 de viajeros que ingresan al país por el aeropuerto internacional "La Aurora" (AILA)"


Subject(s)
Humans , Male , Female , Pneumonia, Viral/diagnosis , Specimen Handling/standards , Coronavirus Infections/diagnosis , Betacoronavirus , Containment of Biohazards/methods , Epidemiological Monitoring , Personal Protective Equipment/standards , Guatemala , Indicators and Reagents/administration & dosage , Laboratories/standards
3.
Guatemala; MSPAS; 29 ene. 2021. 6 p.
Non-conventional in Spanish | LILACS, LIGCSA | ID: biblio-1224473

ABSTRACT

En los antecedentes se presentan estadísticas del COVID-19 a la fecha en la que se elaboró el documento (enero 2021) y aborda las tres mutaciones del virus conocidas hasta la fecha del documento. "La caracterización genética de patógenos virales es la base para el desarrollo de protocolos de diagnóstico, vacunas y medicamentos antivirales. Esta estrategia también es una herramienta útil en salud pública para el seguimiento a brotes y control de enfermedades mediante estudios de epidemiología molecular." "…la secuenciación genómica del SARS-CoV-2 y la liberación oportuna de la información no solo permitió la caracterización del agente etiológico involucrado en el brote inicial, sino también el desarrollo oportuno de protocolos de diagnóstico y seguimiento a la evolución de la pandemia de COVID-19. Así, la secuenciación genómica se ha convertido en una herramienta esencial para generar datos virológicos de SARS-CoV-2, para impulsar la respuesta de laboratorio, y entender mejor los patrones de dispersión y evolución de SARS-CoV-2" De manera que el objetivo del documento es: "Generar información genética mediante la vigilancia genómica de casos confirmados de COVID-19 de pacientes que asisten a los servicios de salud públicos y privados del país, así como del Instituto Guatemalteco de Seguridad Social ­IGSS-."


Subject(s)
Humans , Male , Female , Coronavirus Infections/diagnosis , Coronavirus Infections/prevention & control , Betacoronavirus , Laboratories/standards , Infection Control/standards , Safety Management/statistics & numerical data , Genomics/trends , Pandemics/prevention & control , Public Health Surveillance/methods
4.
Rev. cuba. invest. bioméd ; 39(3): e611, jul.-set. 2020. tab
Article in Spanish | LILACS, CUMED | ID: biblio-1138933

ABSTRACT

Introducción: El organismo se adapta al lugar donde reside, pero este tema no ha sido estudiado en la población laboral peruana. Objetivo: Determinar las variaciones fisiológicas y antropométricas en trabajadores según su residencia en tres altitudes geográficas del Perú. Métodos: Se realizó una investigación transversal analítica, con los datos fisiológicos (6 parámetros de laboratorio) y antropométricos (peso y talla) de 7500 trabajadores en 3 altitudes diferentes: Lima (nivel del mar), Arequipa (2500 m sobre el nivel del mar) y Cerro de Pasco (4300 m sobre el nivel del mar). Estas mediciones fueron estándares, realizadas por clínicas ocupacionales con certificaciones de calidad. Se obtuvo los coeficientes y valores p para las diferencias según cada altitud y ajustados por el sexo y la edad de cada participante. Resultados: Todos los parámetros fisio-antropométricos variaron según la altitud de residencia (todos los valores p fueron menores a 0,005). Los que se incrementaron a mayor altitud fueron la hemoglobina, el colesterol total y el colesterol HDL; en cambio, disminuyeron a mayor altitud el peso y la glucosa en ayunas. En los hombres aumentaron todas las variables menos en el colesterol HDL (que disminuyó significativamente) y el colesterol LDL (que no tuvo variación estadística), en comparación con las mujeres. Conclusiones: Son evidentes las variaciones en las mediciones de los trabajadores según el lugar donde residían, lo que muestra que no se debe tomar parámetros fijos para su valoración laboral. Esto debe servir a los médicos del trabajo y las autoridades, para tener en cuenta al momento de la valoración de la aptitud médica y luego para la vigilancia ocupacional(AU)


Introduction: The human body adapts to its place of residence, but this topic has not been studied in the Peruvian working population. Objective: Determine physiological and anthropometric variations in workers due to their residence in three geographic altitudes in Peru. Methods: An analytical cross-sectional study was conducted of physiological data (6 laboratory parameters) and anthropometric data (weight and height) of 7 500 workers from three different altitudes: Lima (sea level), Arequipa (2 500 m above sea level) and Cerro de Pasco (4 300 m above sea level). The measures were standard and taken by occupational clinics with quality certifications. Coefficients and p values for differences between the altitudes were obtained and adjusted according to the sex and age of participants. Results: All the physio-anthropometric parameters varied with the altitude of the place of residence (all p values were under 0.005). The parameters which increased at a higher altitude were hemoglobin, total cholesterol and HDL cholesterol, whereas the ones which decreased at a higher altitude were weight and fasting glucose. Among men all variables increased except for HDL cholesterol (which decreased significantly) and LDL cholesterol (which did not show any statistical variation), in comparison with women. Conclusions: Variations in measurements taken from workers from different places of residence are obvious, which shows that fixed parameters should not be used for their labor assessment. This should be taken into account by occupational doctors and authorities for medical attitude assessment and occupational surveillance(AU)


Subject(s)
Humans , Male , Female , Body Weights and Measures/adverse effects , Altitude , Altitude Sickness/epidemiology , Laboratories/standards , Occupational Groups , Peru , Cross-Sectional Studies
6.
Florianópolis; s.n; 09 abr. 2020. 4 p.
Non-conventional in Portuguese | LILACS, ColecionaSUS, CONASS, SES-SC | ID: biblio-1119492

ABSTRACT

A presente portaria estabelece critérios para inclusão dos laboratórios interessados em integrarem a sub-rede de COVID-19, por meio da Coordenação da Rede de Referência Laboratorial do LACEN/SC, para realizar a metodologia RT PCR em tempo real para detecção do SARS CoV 2.


Subject(s)
Humans , Pneumonia, Viral/diagnosis , Coronavirus Infections/diagnosis , Laboratories/standards
7.
Acta bioquím. clín. latinoam ; 54(1): 45-54, mar. 2020. ilus, graf, tab
Article in Spanish | LILACS | ID: biblio-1130578

ABSTRACT

Los valores criticos (VC) son resultados de laboratorio que deben comunicarse inmediatamente al profesional responsable, representan una amenaza para la vida del paciente y requieren atencion clinica urgente. La deteccion y comunicacion efectiva de valores criticos (CEVC) impacta directamente en la seguridad del paciente y es responsabilidad del laboratorio. Entes acreditadores y la International Organization of Standardization (ISO- 15189:2012) incluyen los VC entre sus requisitos. En 2017 se desarrollo un proyecto para garantizar la CEVC en el Hospital Garrahan. Se reviso el proceso de CEVC documentado en 2015. Se realizaron encuestas y reuniones dentro del laboratorio que evidenciaron falta de adherencia al mismo. Los VC no se comunicaban de la forma estandarizada y frecuentemente no se registraban. Se evaluaron las causas utilizando el diagrama de Ishikawa, lo que reflejo ausencia de consenso para elaborar el documento inicial. Se realizaron encuestas y reuniones intralaboratorio y con los servicios medicos, para consensuar aspectos relacionados con la CEVC y umbrales para diferentes analitos. Se acordo un nuevo listado de VC y otro de valores de informe inmediato en los que era necesario garantizar la comunicacion efectiva, aunque no requirieran intervencion medica urgente. Se protocolizo la CEVC: informe telefonico al medico tratante registrado en un formulario estandar. Se redacto y difundio un nuevo procedimiento. Se desarrollo un sistema de monitoreo con indicadores de calidad. Promover la mejora continua y desarrollar proyectos interdisciplinarios favorece la atencion centrada en el paciente y su familia. El trabajo mancomunado de diferentes servicios permitio consensuar la lista de VC y un protocolo de comunicacion acorde a las necesidades de esta institucion pediatrica.


The critical values (CV) are laboratory results that should be reported immediately to the responsible professionals, representing a threat to the patient's life and being required for urgent clinical attention. Detection and effective communication of the critical values (ECCV) impacts directly on the patient's College of Americans Pathologists (CAP), Joint Commission on Accreditation of Health Care Organizations (JCAHO), Clinical Laboratory Improvements Amendments (CLIA) e safety and it is the laboratory's responsibility. Accrediting bodies and the International Organization of Standardization (ISO 15189:2012) include CV among their mandatory requisites. In 2017, a project was developed to guarantee the ECCV at the Hospital Garrahan. The ECCV process documented in 2015 was reviewed. Surveys and assemblies were carried out within the laboratory, finding evidence of the lack of compliance with standard procedures. The CV were neither reported according to the expected standardized rules nor registered regularly. The causes were evaluated using the Ishikawa diagram, which reflected the absence of consensus to elaborate the initial document. Surveys and intra-laboratory assemblies were performed alongside with medical Departments staff, in order to come to terms on aspects related to the ECCV as well as thresholds for different analytes. Agreement was reached on a new CV list and another list for immediate reporting, in which it is essential to guarantee effective communication, even though they do not require urgent medical intervention. The ECCV was standardized through a telephone report to the treating physician registered in standard forms. A new operation procedure was edited and shared. A monitoring system with quality indicators was developed. Promoting continuous improvements as well as developing interdisciplinary projects enhance patient and family-centred care. The joint work of different Service Departments made it possible to issue the CV list and a communication protocol according to the needs of this pediatric institution.


Os valores críticos (VC) são resultados laboratoriais que devem ser imediatamente comunicados ao profissional responsável, representam uma ameaça para a vida do paciente e requerem atenção clínica urgente. A detecção e comunicação efetiva de valores críticos (CEVC) é de responsabilidade do laboratório e impacta diretamente na segurança do paciente. Organismos de acreditação e a Organização Internacional de Padronização (ISO-15189: 2012) incluem os VC entre seus requisitos. Em 2017, um projeto foi desenvolvido para garantir a CEVC no Hospital Garrahan. O processo do CEVC documentado em 2015 foi revisado. Pesquisas e reuniões foram realizadas dentro do laboratório, evidenciando a falta de adesão a ele. VC não se comunicavam de maneira padronizada e frequentemente não se registravam. As causas foram avaliadas, usando o diagrama de Ishikawa, refletindo a ausência de consenso para preparar o documento inicial. Pesquisas e reuniões foram realizadas dentro do laboratório e com os serviços médicos, para acordar aspectos relacionados à CEVC e limiares para diferentes analitos. Uma nova listagem de VC foi acordada e outra de valores de relatório imediato nas quais era necessário garantir a comunicação efetiva, mesmo que não exijissem intervenção médica urgente. O CEVC foi registrado: relatório telefônico para o médico responsável pelo tratamento registrado em um formulário padrão. Um novo procedimento foi escrito e divulgado. Um sistema de monitoramento com indicadores de qualidade foi desenvolvido. Promover a melhoria contínua e desenvolver projetos interdisciplinares favorece o cuidado centrado no paciente e sua família. O trabalho conjunto de diferentes serviços permitiu chegar a um consenso sobre a lista de VC e um protocolo de comunicação de acordo com as necessidades dessa instituição pediátrica.


Subject(s)
Pediatrics , Patient-Centered Care , Patient Safety , Laboratories/standards , Reference Standards , Attention , Records , Causality , Compliance , Life , Total Quality Management , Guidelines as Topic , Notification , Patient Safety/standards , Laboratory Critical Values , Accreditation , Joints , Laboratories/ethics
8.
Gac. méd. Méx ; 155(1): 20-29, Jan.-Feb. 2019. tab
Article in English, Spanish | LILACS | ID: biblio-1286455

ABSTRACT

Resumen En 2005 se publicaron recomendaciones para la tipificación de hemopatías malignas en Latinoamérica. Se consideró necesario realizar una reunión nacional para actualizarlas. Se convocaron y reunieron 95 profesionales expertos en el tema para analizar y contrastar alternativas y llegar a un consenso. Se alcanzaron opiniones de consenso en lo relativo a indicaciones, tipos y manejo de muestras, anticuerpos, nomenclatura e informe de resultados para el diagnóstico y seguimiento de las leucemias agudas. Las recomendaciones se describen en este artículo y se hace hincapié en la necesidad de que los laboratorios nacionales se apeguen a ellas.


Abstract Recommendations for the typing of hematological malignancies in Latin America were published in 2005. Carrying out a national meeting to update them was deemed necessary. 95 professional experts on the subject were invited in order to analyze and contrast alternatives and reach a consensus. Consensus opinions were reached regarding indications, sample types and processing, antibodies, nomenclature and reporting of results for the diagnosis and monitoring of acute leukemias. This paper describes the recommendations and emphasizes on the need for national laboratories to adhere to them.


Subject(s)
Humans , Leukemia/diagnosis , Immunophenotyping/methods , Hematologic Neoplasms/diagnosis , Leukemia/immunology , Hematologic Neoplasms/immunology , Guideline Adherence , Laboratories/standards , Latin America
11.
Braz. j. med. biol. res ; 51(3): e6955, 2018. graf
Article in English | LILACS | ID: biblio-889047

ABSTRACT

The stability of samples is crucial for getting reliable concentrations of many analytes, including lipid profile. Thus, the goal of this study was to analyze lipid profile under different storage and temperature conditions. This was a prospective study with 809 patients of both genders. Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low density lipoprotein cholesterol and non-high-density lipoprotein were measured within 1 h from collection at room temperature, after 2-3 h of refrigeration (8°C) and after 4-5 h at room temperature. The processing time and storage conditions did not affect the analytes measured. These findings are important for multicenter studies, because of the difficulties related to centrifugation and freezing of samples immediately after collection.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Young Adult , Blood Specimen Collection/methods , Lipids/blood , Blood Chemical Analysis , Blood Preservation , Blood Specimen Collection/instrumentation , Blood Specimen Collection/standards , Cholesterol/blood , Laboratories/standards , Lipoproteins/blood , Prospective Studies , Temperature , Time Factors , Triglycerides/blood
12.
Acta bioquím. clín. latinoam ; 50(4): 643-648, dic. 2016. graf
Article in Spanish | LILACS | ID: biblio-837637

ABSTRACT

Uno de los desafíos más importantes del laboratorio de análisis clínicos es la obtención de muestras de calidad analítica, las cuales deben ser trazables al paciente. La mayor proporción de errores de laboratorio se produce en la etapa preanalítica y el estado de ayuno es una de las condiciones críticas de la misma. Los cambios metabólicos propios del estado posprandial pueden afectar la concentración de algunos analitos o interferir en los métodos de laboratorio y afectar los resultados de las pruebas, lo que puede dar por resultado informes espurios con impacto directo en la seguridad del paciente. Recientemente, el Working Group on Preanalytical Phase (WG-PA) de la European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) emitió recomendaciones respecto de los requisitos de ayuno para las pruebas de laboratorio. Este grupo de expertos sugiere obtener las muestras de sangre entre las 7 y 9 a.m., tras 12 horas de ayuno, con ingesta de agua permitida, no tomar alcohol 24 horas antes de la extracción y no fumar ni tomar bebidas que contengan cafeína durante la mañana en la que se realiza la extracción. Asimismo, proponen incorporar estas pautas en las sociedades profesionales locales con el fin de lograr la armonización global de esta variable preanalítica.


One of the most important challenges for clinical laboratory is obtaining a sample with the required analytical quality, which must be traceable to the patient. The largest proportion of laboratory errors occur in the preanalytical phase, where the fasting state is a critical condition. Metabolic changes due to postprandial state can affect some analyte concentrations or interfere in laboratory methods, which can produce spurious tests results with direct impact on patient safety. Recently, the Working Group on Preanalytical Phase (WG-PA) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) issued recommendations regarding fasting requirements for laboratory tests. The expert group suggests that blood samples should be obtained between 7 and 9 a.m., after 12 hours of fasting, water intake being allowed; no alcohol 24 hours before extraction and no smoking or drinking caffeinated beverages during the morning before the extraction is performed. The WG-PA-EFLM also proposes to incorporate these recommendations into local professional societies in order to achieve global harmonization of this preanalytical variable.


Um dos desafios mais importantes do laboratório clínico é a obtenção de amostras de qualidade analítica, que devem ser rastreáveis para o paciente. A maior parte dos erros de laboratório ocorre na fase pré-analítica e o estado de jejum é uma das condições críticas da mesma. As alterações metabólicas próprias do estado pós-prandial podem afetar a concentração de alguns analitos ou interferir nos métodos laboratoriais, afetando os resultados dos testes, o que pode resultar em relatórios falsos com impacto direto na segurança do paciente. Recentemente, o Working Group on Preanalytical Phase (WG-PA) da European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) emitiu recomendações a respeito dos requisitos de jejum para exames laboratoriais. Esse grupo de peritos sugere: obter as amostras de sangue entre 7 e 9 a.m., após 12 horas de jejum, sendo permitida a ingestão de água; não beber bebidas alcoólicas 24 horas antes da extração; não fumar ou beber bebidas com cafeína na manhã em que é realizada a extração. Do mesmo modo, propõem incorporar estas diretrizes nas sociedades profissionais locais, a fim de alcançar a harmonização global desta variável pré-analíticas.


Subject(s)
Fasting , Pre-Analytical Phase/standards , Laboratories/standards , Total Quality Management
13.
Braz. j. med. biol. res ; 49(9): e5381, 2016. tab, graf
Article in English | LILACS | ID: lil-788948

ABSTRACT

Multi-center epidemiological studies must ascertain that their measurements are accurate and reliable. For laboratory measurements, reliability can be assessed through investigation of reproducibility of measurements in the same individual. In this paper, we present results from the quality control analysis of the baseline laboratory measurements from the ELSA-Brasil study. The study enrolled 15,105 civil servants at 6 research centers in 3 regions of Brazil between 2008–2010, with multiple biochemical analytes being measured at a central laboratory. Quality control was ascertained through standard laboratory evaluation of intra- and inter-assay variability and test-retest analysis in a subset of randomly chosen participants. An additional sample of urine or blood was collected from these participants, and these samples were handled in the same manner as the original ones, locally and at the central laboratory. Reliability was assessed with the intraclass correlation coefficient (ICC), estimated through a random effects model. Coefficients of variation (CV) and Bland-Altman plots were additionally used to assess measurement variability. Laboratory intra and inter-assay CVs varied from 0.86% to 7.77%. From test-retest analyses, the ICCs were high for the majority of the analytes. Notably lower ICCs were observed for serum sodium (ICC=0.50; 95%CI=0.31–0.65) and serum potassium (ICC=0.73; 95%CI=0.60–0.83), due to the small biological range of these analytes. The CVs ranged from 1 to 14%. The Bland-Altman plots confirmed these results. The quality control analyses showed that the collection, processing and measurement protocols utilized in the ELSA-Brasil produced reliable biochemical measurements.


Subject(s)
Humans , Adult , Laboratories/standards , Quality Control , Brazil , Longitudinal Studies , Observer Variation , Reference Standards , Reproducibility of Results
14.
Braz. j. med. biol. res ; 49(12): e5646, 2016. tab, graf
Article in English | LILACS | ID: biblio-828175

ABSTRACT

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.


Subject(s)
Humans , Animals , Biomedical Research/standards , Drug Evaluation, Preclinical/standards , Laboratories/standards , Clinical Trials, Phase I as Topic , Drugs, Investigational/chemistry , Drugs, Investigational/pharmacokinetics , Mutagenicity Tests , Pharmacology, Clinical/standards
15.
Cad. Saúde Pública (Online) ; 32(supl.2): e00188814, 2016. tab
Article in English | LILACS | ID: lil-798194

ABSTRACT

Abstract: Technological innovations play a decisive role in societies' development by contributing to economic growth and the population's welfare. The state has a key role in this process by inducing innovative behavior, strategies, and decisions. This study addresses Brazil's current policy for development of the health industry and its effects on qualification of national public laboratories by contextualizing different cycles of interaction between health policy and the industrial base, discussing the government's development strategy and the transfer and absorption of health technology (through Industrial Development Partnerships), and presenting two current partnerships involving public laboratories in the production of medicines and vaccines.


Resumen: Las innovaciones tecnológicas juegan un papel decisivo en el proceso de desarrollo de las sociedades, pues contribuyen a generar crecimiento económico y bienestar de la población. El Estado tiene una gran importancia y centralidad en este proceso, pues puede inducir fuertemente el comportamiento, las estratégicas y las decisiones relativas a la innovación. El presente artículo tiene por objetivo investigar la actual política de desarrollo productivo en salud en Brasil y sus reflejos sobre la capacitación de los laboratorios públicos nacionales. Con este fin, contextualiza los diferentes ciclos de interacción entre la política de salud y su base productiva, discute la estrategia del gobierno brasileño para el desarrollo, la transferencia y absorción de tecnología en el área de salud (las colaboraciones para el desarrollo productivo) y presenta dos modelos de colaboración vigentes, involucrando laboratorios públicos para la producción de medicamentos y vacunas.


Resumo: As inovações tecnológicas jogam papel decisivo no processo de desenvolvimento das sociedades, visto que contribuem para gerar crescimento econômico e bem-estar da população. O Estado possui grande importância e centralidade nesse processo, pois pode induzir fortemente o comportamento, as estratégias e as decisões relativas à inovação. O presente artigo tem por objetivo investigar a atual política de desenvolvimento produtivo em saúde no Brasil e seus reflexos sobre a capacitação dos laboratórios públicos nacionais. Para essa finalidade, contextualiza os diferentes ciclos de interação entre a política de saúde e a sua base produtiva, discute a estratégia do governo brasileiro para o desenvolvimento, a transferência e a absorção de tecnologia na área da saúde (as parcerias para o desenvolvimento produtivo) e apresenta duas parcerias vigentes envolvendo laboratórios públicos para a produção de medicamentos e vacinas.


Subject(s)
Humans , Public Health , Occupational Health , Inventions , Health Policy , Laboratories/standards , Brazil
16.
Afr. j. lab. med. (Online) ; 5(1): 1-8, 2016. ilus
Article in English | AIM | ID: biblio-1257307

ABSTRACT

Background: The increase in disease burden has continued to weigh upon health systems in Africa. The role of the laboratory has become increasingly critical in the improvement of health for diagnosis; management and treatment of diseases. In response; the World Health Organization Regional Office for Africa (WHO AFRO) and its partners created the WHO AFRO Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program.SLIPTA implementation process: WHO AFRO defined a governance structure with roles and responsibilities for six main stakeholders. Laboratories were evaluated by auditors trained and certified by the African Society for Laboratory Medicine. Laboratory performance was measured using the WHO AFRO SLIPTA scoring checklist and recognition certificates rated with 1-5 stars were issued. Preliminary results: By March 2015; 27 of the 47 (57%) WHO AFRO member states had appointed a SLIPTA focal point and 14 Ministers of Health had endorsed SLIPTA as the desired programme for continuous quality improvement. Ninety-eight auditors from 17 African countries; competent in the Portuguese (3); French (12) and eng (83) languages; were trained and certified. The mean score for the 159 laboratories audited between May 2013 and March 2015 was 69% (median 70%; SD 11.5; interquartile range 62-77). Of these audited laboratories; 70% achieved 55% compliance or higher (2 or more stars) and 1% scored at least 95% (5 stars). The lowest scoring sections of the WHO AFRO SLIPTA checklist were sections 6 (Internal Audit) and 10 (Corrective Action); which both had mean scores below 50%.Conclusion: The WHO AFRO SLIPTA is a process that countries with limited resources can adopt for effective implementation of quality management systems. Political commitment; ownership and investment in continuous quality improvement are integral components of the process


Subject(s)
Accreditation , Laboratories/diagnosis , Laboratories/standards , Quality Improvement , World Health Organization
17.
Article in English | WPRIM | ID: wpr-56708

ABSTRACT

For two months between May and July 2015, a nationwide outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) occurred in Korea. On June 3, 2015, the Korean Society for Laboratory Medicine (KSLM) launched a MERS-CoV Laboratory Response Task Force (LR-TF) to facilitate clinical laboratories to set up the diagnosis of MERS-CoV infection. Based on the WHO interim recommendations, the Centers for Disease Control and Prevention of United States guidelines for MERS-CoV laboratory testing, and other available resources, the KSLM MERS-CoV LR-TF provided the first version of the laboratory practice guidelines for the molecular diagnosis of MERS-CoV to the clinical laboratories on June 12, 2015. The guidelines described here are an updated version that includes case definition, indications for testing, specimen type and protocols for specimen collection, specimen packing and transport, specimen handling and nucleic acid extraction, molecular detection of MERS-CoV, interpretation of results and reporting, and laboratory safety. The KSLM guidelines mainly focus on the molecular diagnosis of MERS-CoV, reflecting the unique situation in Korea and the state of knowledge at the time of publication.


Subject(s)
Coronavirus Infections/diagnosis , Disease Outbreaks , Humans , Laboratories/standards , Middle East Respiratory Syndrome Coronavirus/genetics , Product Packaging/standards , RNA, Viral/analysis , Real-Time Polymerase Chain Reaction , Republic of Korea/epidemiology , Societies, Scientific , Specimen Handling/standards
18.
Article in English | WPRIM | ID: wpr-59856

ABSTRACT

BACKGROUND: We aimed to compare the diagnostic accuracy of the Alere Triage Cardio3 Tropinin I (TnI) assay (Alere, Inc., USA) and the PathFast cTnI-II (Mitsubishi Chemical Medience Corporation, Japan) against the central laboratory assay Singulex Erenna TnI assay (Singulex, USA). METHODS: Using the Markers in the Diagnosis of Acute Coronary Syndromes (MIDAS) study population, we evaluated the ability of three different assays to identify patients with acute myocardial infarction (AMI). The MIDAS dataset, described elsewhere, is a prospective multicenter dataset of emergency department (ED) patients with suspected acute coronary syndrome (ACS) and a planned objective myocardial perfusion evaluation. Myocardial infarction (MI) was diagnosed by central adjudication. RESULTS: The C-statistic with 95% confidence intervals (CI) for diagnosing MI by using a common population (n=241) was 0.95 (0.91-0.99), 0.95 (0.91-0.99), and 0.93 (0.89-0.97) for the Triage, Singulex, and PathFast assays, respectively. Of samples with detectable troponin, the absolute values had high Pearson (R(P)) and Spearman (R(S)) correlations and were R(P)=0.94 and R(S)=0.94 for Triage vs Singulex, R(P)=0.93 and R(S)=0.85 for Triage vs PathFast, and R(P)=0.89 and R(S)=0.73 for PathFast vs Singulex. CONCLUSIONS: In a single comparative population of ED patients with suspected ACS, the Triage Cardio3 TnI, PathFast, and Singulex TnI assays provided similar diagnostic performance for MI.


Subject(s)
Acute Coronary Syndrome/diagnosis , Biomarkers/analysis , Emergency Service, Hospital , Humans , Laboratories/standards , Myocardial Infarction/diagnosis , Point-of-Care Systems , Prospective Studies , Reagent Kits, Diagnostic , Sensitivity and Specificity , Troponin I/analysis
19.
Guatemala; MSPAS; 2; 2015. 165 p. graf.
Non-conventional in Spanish | LILACS, LIGCSA | ID: biblio-1224472

ABSTRACT

"Este manual tiene el objetivo de dar a conocer el procedimiento para la toma, almacenamiento y transporte de muestras al LNS así como los conceptos básicos de Bioseguridad. Es de utilidad para personal de laboratorio, enfermería, epidemiología, clínicos y otros que intervienen en este proceso." Incluye un correo electrónico y número telefónico para cualquier consulta en relación al tema. Contiene además, las definiciones de los conceptos relacionados al tema principal, además de la infraestructura que deberá tener el transporte de muestras, incluidos el equipo y el manejo de las mismas. Especifica procedimiento para la toma de muestras de varias enfermedades, entre ellas: Rotavirus, Enfermedad diarreica aguda de etiología bacteriana, Cólera, Fiebre Tifoidea, Hepatitis A, B o C, Dengue, Chikungunya, entre muchas más. En los anexos, incluye los códigos geográficos departamentales y municipales (como herramienta para la identificación de personas con VHI) También contiene en la sección de anexos, una lista de "Laboratorios que realizan cultivos de microbacterias" en el país. Además incluye "Fichas epidemiológicas" de distintas enfermedades


Subject(s)
Humans , Male , Female , Specimen Handling/methods , Blood Specimen Collection/methods , Containment of Biohazards/methods , Containment of Biohazards/standards , Laboratories/standards , Food Samples , Water Samples , Preservation of Water Samples/methods , Urine Specimen Collection/methods , Epidemiological Monitoring , Guatemala
20.
Afr. j. lab. med. (Online) ; 3(2): 1-8, 2015. ilus
Article in English | AIM | ID: biblio-1257298

ABSTRACT

Background: Laboratory mentorship has proven to be an effective tool in building capacity and assisting laboratories in establishing quality management systems. The Zimbabwean Ministry of Health and Child Welfare implemented four mentorship models in 19 laboratories in conjunction with the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme.Objectives: This study outlines how the different models were implemented; cost involved per model and results achieved.Methods: Eleven of the laboratories had been trained previously in SLMTA (Cohort I). They were assigned to one of three mentorship models based on programmatic considerations: Laboratory Manager Mentorship (Model 1; four laboratories); One Week per Month Mentorship (Model 2; four laboratories); and Cyclical Embedded Mentorship (Model 3; three laboratories). The remaining eight laboratories (Cohort II) were enrolled in Cyclical Embedded Mentorship incorporated with SLMTA training (Model 4). Progress was evaluated using a standardised audit checklist.Results: At SLMTA baseline; Model 1-3 laboratories had a median score of 30%. After SLMTA; at mentorship baseline; they had a median score of 54%. At the post-mentorship audit they reached a median score of 75%. Each of the three mentorship models for Cohort I had similar median improvements from pre- to post-mentorship (17 percentage points for Model 1; 23 for Model 2 and 25 for Model 3; p 0.10 for each comparison). The eight Model 4 laboratories had a median baseline score of 24%; after mentorship; their median score increased to 63%. Median improvements from pre-SLMTA to post-mentorship were similar for all four models.Conclusion: Several mentorship models can be considered by countries depending on the available resources for their accreditation implementation plan


Subject(s)
Accreditation , Laboratories/standards , Mentors , Reference Standards , Zimbabwe
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