Comparação de manejo de hamster sírio em micro isolador e em gaiola aberta

Male and female Syrian hamsters were used to investigate the influence of two husbandry systems on their physiological aspects. The hypothesis is that there may be physiological, behavioral and final results differences in a litter that is managed in different housing systems (open cage or micro isolator). For the present study, 5 male and 5 female hamsters were kept separately in open cages and 5 male hamsters and 5 females separately in micro isolators from the age of 28 to reproductive age (60 days). Animal management was controlled by monitoring the supply and consumption of water, feed and environmental enrichment provided, with the micro isolator group receiving sterilized water and management carried out exclusively at a changing station. To evaluate metabolic changes caused by water supply, urine tests were carried out on dipstick in sample pools. After reaching reproductive age, ten couples were formed, 5 of them in micro isolators and the other 5 in open cages, uniting a male with a female from the same experimental group to evaluate reproductive data. The animals were weighed until the week of the females' birth, followed by counting and sexing the puppies for data analysis. The groups demonstrated through growth curves that the environment in which the animals are housed has an influence on the animal's physiology. The study showed differences in weight gain in addition to a lower rate of stress in the female, resulting in less aggression towards the male after mating. of couples when comparing the two experimental groups. It also showed a difference in the number of puppies per female between the groups. In addition to providing evidence that housing conditions can influence the hamster's physiology, there is evidence that it also influences the animals' aggressive behavior. This study aims to assist peers in breeding the species in breeding and experimental animal facilities, in addition to ensuring confidence in the reproducibility of future studies, since there is currently not enough information for the correct management of the biomodel.

Hamsters sírios machos e fêmeas foram utilizados para investigar a influência de dois sistemas de criação sob seus aspectos fisiológicos. A hipótese é que pode haver diferenças fisiológicas, comportamentais e no resultado final de uma ninhada a qual é manejada em sistemas diferentes de alojamento (gaiola aberta ou micro isolador). Para o presente estudo foram mantidos 5 hamsters machos e 5 fêmeas separadamente em gaiolas abertas e 5 exemplares machos e mais 5 fêmeas separadamente em micro isoladores na idade de 28 até a idade reprodutiva, (60 dias). O manejo dos animais foi controlado acompanhando a oferta e consumo de água, ração e enriquecimento ambiental fornecidos, sendo que o grupo de micro isolador recebeu água esterilizada e seu manejo feito exclusivamente em estação de troca. Para avaliação de alteração metabólica pelo fornecimento de água foram realizados testes de urina em fita reagente em pools de amostra. Após atingirem a idade reprodutiva foram formados dez casais, sendo 5 deles de micro isolador e os outros 5 de gaiolas abertas, unindo um macho com uma fêmea do mesmo grupo experimental para avaliação de dados reprodutivos. A pesagem dos animais foi feita até a semana de parto das fêmeas, seguindo com a contagem e sexagem dos filhotes para análise dos dados. Os grupos demonstraram por meio das curvas de crescimento que o meio em que os animais são alojados tem influência na fisiologia do animal, o estudo apontou diferenças no ganho de peso além de menor taxa de estresse da fêmea resultando em menor agressão ao macho após a união dos casais quando comparados os dois grupos experimentais. Apontou diferença também, no número de filhotes por fêmeas entre os grupos. Além de fornecer evidências de que as condições de alojamento podem influenciar na fisiologia do hamster há indícios de que também há influência no comportamento de agressividade dos animais. Este estudo visa auxiliar os pares na criação da espécie em biotérios de criação e experimentação, além de garantir confiança na reprodutibilidade de futuros estudos, uma vez que atualmente não existem informações o suficiente para o manejo correto do biomodelo.

Use of Schirmer strips and conjunctival swabs for virus detection on the ocular surface of adults: a scoping review / Fitas de Schirmer e swab conjunctival para detecção de vírus na superfície ocular de adultos: scoping review

ABSTRACT Schirmer strips and conjunctival swabs are used in ophthalmology for the collection of tears and fluids. One of the biggest challenges during the COVID-19 pandemic has been accurate diagnosis and, in some cases, ocular manifestations are among the first symptoms. In this context, this study aimed to collect evidence to support the use of Schirmer strips and conjunctival swabs as a method of sample collection for viral analysis. A literature search was conducted following the Scoping Review protocol defined by The Joanna Briggs Institute. Studies were analyzed regarding virus research, collection methods, and sample analysis. The findings support that viruses can be detected on the ocular surface through analysis of Schirmer strips and conjunctival swabs. However, additional studies with larger samples and time data are necessary to confirm these conclusions.

RESUMO A fita de Schirmer e o swab conjunctival são utilizados na oftalmologia como métodos de coleta para lágrimas e fluidos. Durante a pandemia da COVID-19, um dos desafios foi o diagnóstico correto e se sabe que, em alguns casos, as manifestações oculares podem ser um dos primeiros sintomas. Nesse contexto, este estudo tem como objetivo levantar evidência que destaque o uso de fitas de Schirmer e de swabs conjuntivais como método de coleta para análise viral. Conduziu-se uma revisão de literatura seguindo o protocolo para Scoping Review definido pelo Joanna Briggs Institute. Os pesquisadores analisaram os estudos em busca do vírus pesquisado, os métodos de coleta e os métodos de análise. Vírus podem ser detectados na superfície ocular através da análise de fitas de Schirmer e de swabs conjuntivais, entretanto novos estudos com populações maiores e com definições claras de tempo são necessários para conclusões mais assertivas no tema.

Patient and Healthcare Professional Insights of Home- and Remote-Based Clinical Assessment: A Qualitative Study from Spain and Brazil to Determine Implications for Clinical Trials and Current Practice.

INTRODUCTION: The SARS-CoV-2 virus pandemic has accelerated the growing trend towards using home- and remote-based medical testing (H/RMT). The aim of this study was to gather insights and explore the opinions of patients and healthcare professionals (HCPs) in Spain and Brazil regarding H/RMT and the impact of decentralised clinical trials. METHODS: This qualitative study consisted of in-depth open question interviews of HCPs and patients/caregivers followed by a workshop that aimed to determine the advantages and barriers to H/RMT in general, and in the context of clinical trials. RESULTS: There were 47 participants in the interviews (37 patients, 2 caregivers, 8 HCPs) and 32 in the validation workshops (13 patients, 7 caregivers, 12 HCPs). The main advantages for the use of H/RMT in current practice were the comfort and convenience, the ability to improve the relationship between HCPs and patients and personalise patient care, and the increased patient awareness towards their disease. Barriers to H/RMT included accessibility, digitalisation, and the training requirements for both HCPs and patients. Furthermore, according to the Brazilian participants, there is a general distrust in the logistical management of H/RMT. Patients indicated that the convenience of H/RMT did not influence their decision to participate in a clinical trial, with the main reason for participating in a clinical trial being to improve health; however, H/RMT in clinical research does aid adherence to the long-term follow-up associated with trials and provides access to patients living far from the clinical sites. CONCLUSION: Insights from patients and HCPs suggest that the advantages of H/RMT may outweigh the barriers, and that social, cultural and geographical factors and the HCP-patient relationship are critical aspects to be considered. Moreover, the convenience of H/RMT does not appear to be a driver for participating in a clinical trial but can facilitate patient diversity and study adherence.

Citopatológico do colo uterino e adequabilidade da amostra: ensaio clínico randomizado controlado / Cervical cytopathology and sample suitability: a randomized controlled clinical trial

Resumo Objetivo Avaliar duas técnicas de coleta cervicovaginal à adequabilidade da amostra e aos demais achados do laudo colpocitopatológico. Métodos O estudo foi realizado no período de setembro de 2018 a julho de 2019, em um centro de saúde-escola, localizado no município de Fortaleza - Ceará. A amostra foi composta por 365 mulheres divididas aleatoriamente, sendo 184 participantes no Grupo Controle (técnica na qual o esfregaço da ectocérvice foi disposto na lâmina antes da coleta do material da endocérvice) e 181 no Grupo Comparação (no qual o esfregaço da ectocérvice vaginal foi disposto na lâmina apenas após a coleta do material da endocérvice). Utilizou-se um instrumento contendo variáveis sociodemográficas, clínicas, sexuais, reprodutivas e referentes aos achados no laudo citopatológico. Incluíram-se mulheres na faixa etária de 18 a 64 anos, que já tinham iniciado vida sexual e que realizaram o exame de prevenção do câncer de colo uterino no período da coleta de dados. Os testes do qui-quadrado, Fisher e Kruskal-Wallis foram utilizados. Resultados Não houve associação estatística entre a adequabilidade da amostra citopatológica às duas técnicas de coleta cervicovaginal empregadas e às demais variáveis clínicas, sexuais, reprodutivas e referentes aos demais achados no laudo citopatológico, obtendo-se valor de p>5% em todas as associações realizadas. Conclusão As duas técnicas de coleta de células cervicais descritas em manuais oficiais não diferiram para a obtenção de uma amostra celular adequada, sendo igualmente eficazes e propiciando a garantia de um laudo colpocitopatológico preciso e oportuno. Registro Brasileiro de Ensaios Clínicos (ReBEC): RBR-2H4MPN.

Resumen Objetivo Evaluar dos técnicas de toma de muestra cervicovaginal con la adecuación de la muestra y con los demás resultados del informe colpocitológico. Métodos El estudio fue realizado durante el período de septiembre de 2018 a julio de 2019, en un centro de salud-escuela, ubicado en el municipio de Fortaleza, estado de Ceará. La muestra estaba compuesta por 365 mujeres divididas aleatoriamente, de las cuales 184 participantes estaban en el Grupo Control (técnica por la que el frotis del ectocérvix fue colocado en la lámina antes de la toma del material del endocérvix) y 181 en el Grupo Comparación (en el que el frotis del ectocérvix vaginal fue colocado sobre la lámina únicamente después de la toma del material del endocérvix). Se utilizó un instrumento con variables sociodemográficas, clínicas, sexuales, reproductivas y relativas a los resultados del informe citológico. Fueron incluidas mujeres del grupo de edad de 18 a 64 años, que ya habían empezado su vida sexual y que realizaron la prueba de prevención de cáncer de cuello uterino durante el período de la recopilación de datos. Se utilizaron las pruebas χ2 de Pearson, Fisher y Kruskal-Wallis. Resultados No hubo asociación estadística entre la adecuación de la muestra citológica con las dos técnicas de toma cervicovaginal utilizadas y con las demás variables clínicas, sexuales, reproductivas y referentes a los demás resultados del informe citológico, y se obtuvo un valor de p>5 % en todas las asociaciones realizadas. Conclusión Las dos técnicas de toma de células cervicales que se describen en manuales oficiales no difirieron en la obtención de una muestra celular adecuada y son igualmente eficaces y favorecen la garantía de un informe colpocitológico preciso y oportuno.

Abstract Objective To assess two cervicovaginal collection techniques to sample suitability and the other findings of Pap smear. Methods The study was conducted from September 2018 to July 2019, in a school health center located in the city of Fortaleza - Ceará. The sample consisted of 365 women randomly divided, with 184 participants in the Control Group (technique in which the ectocervix smear was placed on the slide before endocervical material was collected) and 181 in the Comparison Group (in which the vaginal ectocervix smear was placed on the slide only after collecting the material from the endocervix). An instrument containing sociodemographic, clinical, sexual, reproductive and findings in cytopathological report was used. Women aged between 18 and 64 years, who had already started their sexual life and who underwent the cervical cancer prevention test during the data collection period, were included. Chi-square, Fisher and Kruskal-Wallis tests were used. Results There was no statistical association between cytopathological sample suitability for the two cervicovaginal collection techniques used and for the other clinical, sexual, reproductive and other variables related to the other findings in cytopathological report, obtaining a value of p>5% in all associations performed. Conclusion The two techniques for collecting cervical cells described in official manuals did not differ for obtaining an adequate cell sample, being equally effective and providing the guarantee of an accurate and timely Pap smear. Brazilian Clinical Trial Registry (ReBEC): RBR-2H4MPN.

Preferências e expectativas de pacientes de ensaio clínico sobre exames em domicílio e testes remotos / Preferences and expectations of patients in clinical trial about laboratory exams at home and remote tests / Preferencias y expectativas de los pacientes en ensayo clínico sobre exámenes domiciliarios y pruebas remotas

Objetivo: Conhecer a aceitação de pacientes de ensaio clínico quanto a coleta de exames domiciliares, testes remotos e teleconsultas, compreendendo as suas preferências e expectativas. Método: Estudo qualitativo, exploratório, descritivo, com entrevistas em profundidade envolvendo profissionais de saúde (especialistas) e pacientes, com e sem experiência em ensaios clínicos, com posterior validação dos constructos por meio de workshop participativo. Resultados: Para os pacientes de ensaio clínico, a aceitação mostrou-se relativa. Diversos fatores influenciam suas preferências e expectativas, sendo as principais: a) O grau de confiabilidade nos processos e a acurácia dos resultados de exames domiciliares. b) Os testes remotos, apesar de bem aceitos, dependem da capacidade de entendimento no correto manuseio da tecnologia requerida. c) A teleconsulta, já bem utilizada e aceita, não substitui totalmente o encontro presencial com o médico em fases críticas. A preferência é pelo uso equilibrado do "presencial x remoto". Conclusão: A aceitação é influenciada por diversas variáveis. Devem ser definidas estratégias adequadas para cada caso, para garantir resultados seguros e confiáveis, com equilíbrio entre o presencial e remoto, através da participação ativa dos pacientes nas tomadas de decisão.

To understand the acceptance of clinical trial patients regarding in-house exams, remote tests and teleconsultations, revealing their preferences and expectations Method: Qualitative, exploratory-descriptive study, with in-depth interviews involving health professionals (specialists) and patients, with and without experience in clinical trials, with subsequent validation of the constructs through a participatory workshop. Results: For clinical trial patients, acceptance was relative. Several factors influence their preferences and expectations, the main ones being: a) The degree of reliability in the processes and the accuracy of the results of home exams. b) Remote tests, although well accepted, depend on the ability of the patient to understand the correct handling of the required technology. c) Teleconsultation, already well used and accepted, does not completely replace the face-to-face meeting with the doctor in critical phases. The preference is for the balanced use of "in person versus remote". Conclusion: Acceptance is influenced by several variables. Adequate strategies must be defined for each case, to ensure safe and reliable results, with a balance between face-to-face and remote, through the active participation of patients in decision-making

Objetivo: Conocer la aceptación de los pacientes de ensayos clínicos en cuanto a la recogida de exámenes domiciliarios, pruebas a distancia y teleconsultas, entendiendo sus preferencias y expectativas. Método: Estudio cualitativo, exploratorio-descriptivo, con entrevistas en profundidad involucrando a profesionales de la salud (especialistas) y pacientes, con y sin experiencia en ensayos clínicos, con posterior validación de los constructos a través de un taller participativo. Resultados: Para pacientes de ensayos clínicos, la aceptación fue relativa. Varios factores influyen en sus preferencias y expectativas, siendo los principales: a) El grado de confiabilidad en los procesos y la precisión de los resultados de los exámenes domiciliarios. b) Las pruebas a distancia, aunque bien aceptadas, dependen de la capacidad de comprender el manejo correcto de la tecnología requerida. c) La teleconsulta, ya muy utilizada y aceptada, no sustituye por completo al encuentro presencial con el médico en fases críticas. La preferencia es por el uso equilibrado de "en persona versus remoto". Conclusión: La aceptación está influenciada por varias variables. Se deben definir estrategias adecuadas para cada caso, para garantizar resultados seguros y confiables, con equilibrio entre presencial y remoto, a través de la participación activa de los pacientes en la toma de decisiones

Características microscópicas del cérvix uterino mediante citología líquida

Introducción: La citología líquida es un método que puede contribuir a identificar de manera precoz los cambios microscópicos del cérvix uterino que pudieran progresar a la malignidad, al disminuir el número de muestras insatisfactorias en relación a la citología convencional. Objetivo: Analizar las características microscópicas identificadas mediante la citología de base líquida del cérvix uterino en mujeres atendidas en la Unidad de Bienestar Estudiantil de la Universidad Técnica de Manabí, Ecuador. Métodos : Se realizó un estudio de serie de casos donde se analizaron las características sociodemográficas, microbiológicas e histológicas procedentes de las fichas médicas de 132 mujeres que participaron en la campaña de Papanicolaou realizado durante junio de 2019. Resultados: El rango de edad predominante fue el de 19 a 33 años, residían en área urbana, 64 % de las mujeres inició la vida sexual antes o durante sus 18 años. Los hallazgos microbiológicos mostraron presencia de flora cocoide en 50 % y 100 % de las muestras manifestaron la calidad adecuada. El estudio citológico presentó, según el sistema Bethesda, 75 % de muestras negativas, con 13 % de LIE de bajo grado y 11 % de ASCUS. El fondo del frotis inflamatorio leve se presentó en 52 %, mientras los antecedentes de más de tres citologías anteriores positivas resultaron en 34 % de las féminas. No se encontró relación entre la presencia de lesión intraepitelial y la edad de las pacientes (p=0,3076). Conclusiones: El total de las muestras fueron útiles lo cual puede indicar que la citología de base líquida ofrece una mayor calidad del diagnóstico histológico.

Introduction: Liquid-based cytology is a method that can contribute to the early identification of microscopic changes in the uterine cervix that can progress to malignancy, by reducing the number of unsatisfactory samples compared to conventional cytology. Objective: To analyze the microscopic characteristics identified by liquid-based cytology of the uterine cervix in women treated at the Student Welfare Unit of the Technical University of Manabí, Ecuador. Methods: A descriptive, cross-sectional, retrospective and quantitative study was carried out where the sociodemographic, microbiological and histological characteristics collected in the medical records of 132 women who participated in the Pap smear campaign carried out during June 2019 were analyzed. Results: The age range that prevailed was 19 to 33 years who lived in urban areas, 64% of women began their sexual life before or at 18 years of age. The microbiological findings showed the presence of coccoid flora in 50% and 100% of the samples showed adequate quality. The cytological study presented, according to the Bethesda system, 75% of negative samples, with 13% low-grade IEL and 11% ASCUS. The background of the mild inflammatory smears was present in 52%, the history of previous positive cytology in 34% was more than three. All of the samples were useful. No relationship was found between the presence of intraepithelial lesion and the age of the patients (p=0.3076). Conclusions: CBL can ensure a higher quality of histological diagnosis by guaranteeing a greater number of useful samples.

Optimizing pathological assessment of breast cancer in Brazil: recommendations from a multidisciplinary working group on the tumor-tissue journey

Timely and correct assessment of histopathological, immunohistochemical and molecular features of biopsy and surgical specimens is of paramount importance in the provision of care to patients with breast cancer, particularly in the current era of precision oncology. In order to ensure that tissue samples are obtained, processed, analyzed and reported in an optimal way, a concerted effort is required by institutions and individuals, taking into account state-of-the-art scientific and technical knowledge and circumventing logistic and operational constraints. This may be particularly challenging in some settings due to several sources of economic, structural, organizational and communication inefficiencies. In the current article, we present a brief review of breast cancer epidemiology and challenges in the disease diagnosis, especially in Brazil, and report the results of a multidisciplinary working group convened in May 2020 in an expert panel to identify and discuss the barriers and challenges related to the journey of breast cancer samples in Brazil. Following the identification of the issues, the working group also discussed and proposed recommendations for improving the journey and quality of breast cancer samples based on their professional experience and the current scientific literature, including guidelines of national and international health organizations (e.g. World Health Organization), consensus of medical societies and other published literature on the topic. We outline the most salient issues related to that journey in Brazilian public and private medical institutions, based on the experts' clinical experience, since all of them are actively working at both sectors, and discuss current recommendations to address these issues aiming at mitigating and preventing preanalytical and analytical issues affecting diagnostic and therapeutic decisions. Such issues are grouped under four headings pertaining to education, communication, procedures in the operating room and sample transportation, and procedures in the pathology laboratory. Selected recommendations based on the current literature and discussed by the group of Brazilian experts are reviewed, which may mitigate the issues identified and optimize diagnostic and therapeutic decisions for patients with breast cancer, currently the most frequent malignant tumor worldwide and in Brazil. This paper has been submitted and published jointly, upon invitation and consent, in both the Surgical and Experimental Pathology and the Mastology journals.

Recommendations for specimen collection for detection and diagnosis of COVID-19 / Recomendações para a realização de coleta de amostras para detecção e diagnóstico de COVID-19

INTRODUCTION: The spread of SARS-CoV-2 has caused a global public health crisis (pandemic). One of the most important measures to control the transmission chain of the new coronavirus is to identify those infected through laboratory testing. OBJECTIVE: Synthesize the recommendations for the specimen collection for detection and diagnosis of COVID-19. METHODS: This is an integrative review, considering the publications of the following databases: PubMed and Google Academic from January 2020. RESULTS: 468 publications were identified, 20 of which were considered eligible. The publications recommend that technical training for specimen collection and careful observation of infection prevention protocols are fundamental. This manuscript highlights the steps for specimen collection as materials for collection, storage, transportation, individual protection, and laboratory analysis of samples. Currently, the Reverse Transcription - Polymerase Chain Reaction test is the recommended and gold standard method of identifying COVID-19 cases. Serological tests play an important role in research and surveillance. CONCLUSION: In summary, the documents ensure that the RT-PCR is the gold standard for SARS-CoV-2 detection and recommend standardization of collection and conditioning methods to avoid errors related to the collection and false negative results.

INTRODUÇÃO: A disseminação do SARS-CoV-2 ocasionou uma crise na saúde pública mundial (pandemia). Uma das mais importantes medidas de controle da cadeia de transmissão do novo coronavírus consiste em identificar os infectados por meio de teste laboratorial. OBJETIVO: Sintetizar as recomendações para a coleta de amostras para detecção e diagnóstico da COVID-19. MÉTODO: Trata-se de uma revisão integrativa, considerando as publicações do Google Acadêmico e Pubmed a partir de janeiro de 2020. RESULTADOS: Foram identificadas 468 publicações, das quais 20 foram consideradas elegíveis. As publicações recomendam que a capacitação técnica para a coleta das amostras e a observação criteriosa de protocolos de prevenção de infecção são fundamentais. Destacam-se nesse artigo as etapas para a coleta de amostras como materiais para coleta, armazenamento, transporte, proteção individual e análise laboratorial das amostras. Atualmente, o teste de Reverse Transcription - Polymerase Chain Reaction é o método recomendado e padrão-ouro para a identificação dos casos de COVID-19. Os testes sorológicos desempenham um papel importante na pesquisa e vigilância. CONCLUSÃO: Em síntese, os documentos asseguram que o RT-PCR é o teste padrão-ouro para detecção do SARS-CoV-2 e recomenda a padronização dos métodos de coleta e acondicionamento, a fim de evitar erros relacionados com a coleta e resultados falso-negativos.

Concordancia entre autotoma y colección estándar de muestras endocervicales para identificar infecciones de trasmisión sexual en un área urbano-rural del Perú / Concordance between self-sampling and standar endocervical sample collection to identify sexual transmission infections in an urban-rural area of Peru

RESUMEN Con el objetivo de evaluar la concordancia entre la autotoma de muestras vaginales y la toma estándar de muestras endocervicales para la identificación de Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis y Candida spp. realizadas por el personal de salud en mujeres de un área urbano-rural del Perú, se realizó un estudio prospectivo y transversal en 206 mujeres en edad fértil, identificamos algunas infecciones de transmisión sexual como Chlamydia trachomatis o Trichomonas vaginalis en 9 mujeres (4,4%). Obtuvimos una concordancia casi perfecta en la identificación de Candida spp. (k=0,97), Chlamydia trachomatis (k=0,92) y Trichomonas vaginalis por microscopía (k=1,00), y considerable para la identificación de Trichomonas vaginalis por cultivo (k=0,66). La técnica de la autotoma de muestras vaginales podría ser usada para la identificación de algunas infecciones de transmisión sexual en población urbano-rural.

ABSTRACT With the objective of evaluating the concordance between the self-sampling of vaginal samples and the standard collection of endocervical samples for the identification of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Candida spp. carried out by health personnel in women from an urban-rural area of Peru, a prospective and cross-sectional study was carried out in 206 women of childbearing age, we identified some sexually transmitted infections such as Chlamydia trachomatis or Trichomonas vaginalis in 9/206 (4.4%). We obtained a high degree of agreement in the identification of Candida spp. (k = 0.97), Chlamydia trachomatis (k=0.92) and Trichomonas vaginalis by microscopy (k=1.00), and a considerable agreement for the identification of Trichomonas vaginalis by culture (k=0.66). The self-sampling technique can be used to identify some sexually transmitted infections in urban-rural populations.

Concordancia entre autotoma y colección estándar de muestras endocervicales para identificar infecciones de trasmisión sexual en un área urbano-rural del Perú / Concordance between self-sampling and standar endocervical sample collection to identify sexual transmission infections in an urban-rural area of Peru

RESUMEN Con el objetivo de evaluar la concordancia entre la autotoma de muestras vaginales y la toma estándar de muestras endocervicales para la identificación de Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis y Candida spp. realizadas por el personal de salud en mujeres de un área urbano-rural del Perú, se realizó un estudio prospectivo y transversal en 206 mujeres en edad fértil, identificamos algunas infecciones de transmisión sexual como Chlamydia trachomatis o Trichomonas vaginalis en 9 mujeres (4,4%). Obtuvimos una concordancia casi perfecta en la identificación de Candida spp. (k=0,97), Chlamydia trachomatis (k=0,92) y Trichomonas vaginalis por microscopía (k=1,00), y considerable para la identificación de Trichomonas vaginalis por cultivo (k=0,66). La técnica de la autotoma de muestras vaginales podría ser usada para la identificación de algunas infecciones de transmisión sexual en población urbano-rural.

ABSTRACT With the objective of evaluating the concordance between the self-sampling of vaginal samples and the standard collection of endocervical samples for the identification of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Candida spp. carried out by health personnel in women from an urban-rural area of Peru, a prospective and cross-sectional study was carried out in 206 women of childbearing age, we identified some sexually transmitted infections such as Chlamydia trachomatis or Trichomonas vaginalis in 9/206 (4.4%). We obtained a high degree of agreement in the identification of Candida spp. (k = 0.97), Chlamydia trachomatis (k=0.92) and Trichomonas vaginalis by microscopy (k=1.00), and a considerable agreement for the identification of Trichomonas vaginalis by culture (k=0.66). The self-sampling technique can be used to identify some sexually transmitted infections in urban-rural populations.

Garanticemos la calidad de las muestras respiratorias para diagnosticar COVID-19 / Let's guarantee the quality of respiratory samples to diagnose COVID-19

Resumen Este artículo y video disponibles en el OJS de la Revista describe los procedimientos para la recolección de hisopos respiratorios que garantizan la bioseguridad y el diagnóstico de COVID-19 en adultos y niños.

Abstract This article and video describes the procedures for the collection of respiratory swabs that guarantee biosecurity and the diagnosis of COVID-19 in adults and children.

Sample Management: Stability of Plasma and Serum on Different Storage Conditions.

BACKGROUND AND OBJECTIVE: The analytes stability on serum and plasma are critical for clinical laboratory, especially if there is a delay in their processing or if they need to be stored for future research. The objective of this research was to determine the stability of K3EDTA-plasma and serum on different storage conditions. MATERIALS AND METHODS: A total of thirty healthy adults were studied. The serum/plasma samples were centrifuged at 2000g for 10 minutes. Immediately after centrifugation, the serum/plasma analytes were assayed in primary tubes using a Cobas c501 analyzer (T0); the residual serum/plasma was stored at either 2-8°C or -20°C for 15 (T15) and 30 days (T30).Mean concentrations changes in respect of initial concentrations (T0) and the reference change values were calculated. For assessing statistical difference between samples, the Wilcoxon ranked-pairs test was applied. RESULTS: We evidenced instability for total bilirubin, uric acid, creatinine and glucose at T15 and T30 and stored at -20°C (p<0.05). However, potential clinical impact significance were observed only for total bilirrubin T30 at -20°C, and creatinine T30 at 2-8°C. CONCLUSIONS: Our results had shown that storage samples at -20°C is a better way to preserve glucose, creatinine, and uric acid. Therefore, laboratories should freeze their samples as soon as possible to guarantee proper stability when there is need to repeat analysis, verify a result, or add a laboratory testing.

Consideraciones éticas relacionadas al manejo de muestras de investigación en cáncer

El análisis molecular de material biológico humano permite la identificación de futuros biomarcadores para mejorar el manejo de pacientes con cáncer. Sin embargo, el manejo de estas muestras requiere consideraciones éticas particulares. Distintas organizaciones como el Consejo Europeo y agencias de gobierno de Estados Unidos han generado distintos documentos con definiciones, mecanismos y reglamentos para evitar poner en riesgo de daño o vulnerar los derechos de los donantes de muestras biológicas. Finalmente, todos estos documentos han evolucionado en el tiempo y han permitido que las instituciones de investigación cuenten con comités y regulaciones en ética estándares. Así, las instituciones legales puedan crear precedentes y generar sentencias coherentes.

Molecular analysis of human biological material allows the identification of future biomarkers to improve the management of patients with cancer. However, the handling of these samples requires particular ethical considerations. Different organizations such as the European Council and government agencies of the United States have generated different documents with definitions, mechanisms, and regulations to avoid putting at risk of harm or violating the rights of donors of biological samples. Finally, all these documents have evolved over time and have allowed research institutions to have standard committees and regulations in ethics. Thus, legal institutions can create precedents and generate coherent sentences.

Sample transport validation: experience of a medium-sized laboratory / Validação do transporte de amostras: experiência de um laboratório de médio porte

ABSTRACT INTRODUCTION: The adequacy of biological samples is a critical and important item in the clinical laboratory, so that reliable results can be obtained for patients. OBJECTIVE: To ensure integrity and stability of biological samples during the transport process. METHOD: Concurrent validation was carried out - in parallel with the production process and distribution of the product, from January to March 2017. The blood samples were packaged primarily in tube racks, and those of urine, feces and microbiological materials were packed in plastic bags. Materials were wrapped in a blanket of absorbent material to ensure temperature integrity and to avoid possible material losses. Thermal bags were the containers used to carry the samples. There were five transport routes, with two daily routes for each collection unit. A recommendation of the number of ice packs, predefined by the laboratory, was followed. RESULTS AND CONCLUSION: In the first month, the pre-established temperatures (blood: 10°C to 22°C/urine-feces: 2°C to 8°C) were not reached until arrival at the central laboratory, and the amount of ice in each bag was gradually increased, daily, until reaching the ideal temperature, in all collection units and the central. Transport routes were changed three times in the most distant units. Materials that arrived outside specifications were processed with restrictions, and results were evaluated by the professional responsible for the release. After these modifications, the temperature records of the biological materials were in accordance with the current legislation and the defined specifications, thus validating the process.

RESUMO INTRODUÇÃO: A adequação das amostras biológicas é um item crítico e importante no laboratório clínico, para que possamos oferecer resultados confiáveis aos pacientes. OBJETIVO: Garantir a integridade e a estabilidade das amostras biológicas durante o processo de transporte. MÉTODO: Foi realizada validação concorrente - concomitantemente ao processo produtivo e à distribuição do produto, no período de janeiro a março de 2017. As amostras de sangue foram acondicionadas primariamente em galerias; as de urina, fezes e materiais microbiológicos, em sacos plásticos. Os materiais foram envoltos por uma manta de material absorvente para garantir a integridade da temperatura e evitar possíveis perdas de material. Maletas térmicas foram os recipientes utilizados para transportar as amostras. Havia cinco rotas de transporte, com dois percursos diários para cada unidade de coleta. Foi seguida a recomendação da quantidade de barras de gelo predefinida pelo laboratório. RESULTADOS E CONCLUSÃO: No primeiro mês, as temperaturas preestabelecidas (sangue: 10°C a 22°C/urina e fezes: 2°C a 8°C) não foram atingidas até a chegada à matriz, e aumentou-se gradativamente a quantidade de gelo em cada maleta, com avaliações diárias, até se atingir a temperatura ideal, em todas as unidades de coleta e na matriz. Foi realizada mudança nas rotas de transporte com frequência de três vezes nas unidades mais distantes. Os materiais que chegaram fora das especificações foram processados com restrição; e os resultados, avaliados pelo profissional responsável pela liberação. Após essas modificações, os registros de temperatura dos materiais biológicos estavam de acordo com a legislação vigente e as especificações definidas, validando, portanto, o processo.

Evaluation of the usefulness of a device for Human Papilloma Virus DNA collection and reservation in self-collected cervicovaginal samples stored dry in women with cervical dysplasia, Bogotá, Colombia / Evaluación de la utilidad de un dispositivo para toma y preservación del ADN del virus del papiloma humano de muestras cérvico-vaginales autorrecolectadas y almacenadas en seco en mujeres con displasia cervical, Bogotá, Colombia

ABSTRACT Objective: To evaluate the usefulness of a device for collecting and preserving human papilloma virus (HPV) DNA in self-collected vaginal samples stored dry during 14 days. Materials and methods: Diagnostic concordance pilot study that included non-pregnant women over 25 years of age with a biopsy-confirmed result of cervical intraepithelial neoplasia (CIN) grade 1 or more, coming to two referral centres in Bogotá, Colombia. Women with a history of total hysterectomy were excluded. Convenience sampling was used. The device uses real-time PCR (polymerase chain reaction) for DNA detection. Sociodemographic and clinical variables were measured, as well as the results of the test when the sample was collected by the patient and when it was collected by the physician, and the amount of DNA in the samples taken and processed on day 1, and in those processed on day 14, using Ct thresholds. Descriptive statistics were applied. Overall concordance was estimated by means of the kappa coefficient and mean differences in DNA amount. Materials and methods: Diagnostic concordance pilot study that included non-pregnant women over 25 years of age with a biopsy-confirmed result of cervical intraepithelial neoplasia (CIN) grade 1 or more, coming to two referral centres in Bogotá, Colombia. Women with a history of total hysterectomy were excluded. Convenience sampling was used. The device uses real-time PCR (polymerase chain reaction) for DNA detection. Sociodemographic and clinical variables were measured, as well as the results of the test when the sample was collected by the patient and when it was collected by the physician, and the amount of DNA in the samples taken and processed on day 1, and in those processed on day 14, using Ct thresholds. Descriptive statistics were applied. Overall concordance was estimated by means of the kappa coefficient and mean differences in DNA amount. Results: A kappa coefficient of 0.84 (95% CI: 0.71-0.96) was found for concordance in high-risk HPV detection between the self-collected cervicovaginal sample and the sample taken by the clinician. There were no differences in terms of the amount of viral DNA between day 1 and day 14 (DM -0.34 cycles; 95% CI: - 2.29 to 1.61). Conclusion: Self-collected vaginal samples using the storage device are reliable for high-risk HPV detection in patients with cervical dysplasia, and preserve viral DNA for 14 days if stored dry at room temperature. Confirmation studies in the general population are required.

RESUMEN Objetivo: Evaluar la utilidad de un dispositivo para toma y preservación del DNA del virus del papiloma humano (VPH) de muestras vaginales recolectadas por autotoma y almacenadas en seco durante 14 días. Materiales y métodos: Estudio piloto de concordancia diagnóstica. Se incluyeron mujeres mayores de 24 años no gestantes con un resultado de neoplasia intraepitelial cervical (NIC) grado 1 o más, confirmado por biopsia en dos instituciones de referencia en Bogotá, Colombia. Se excluyeron mujeres con antecedente de histerectomía total. Se realizó un muestreo por conveniencia. El dispositivo utiliza PCR (reacción en cadena de la polimerasa) en tiempo real para detección del ADN. Se midieron variables sociodemográficas y clínicas, así como el resultado de la prueba por autotoma y tomada por el médico, y la cantidad de ADN de las muestras tomadas el día 1 procesadas ese día, y el día 14, por medio del Ct umbral. Se realizó estadística descriptiva. Se calculó la concordancia global por medio del índice de kappa ponderado y la diferencia de medias de la cantidad de ADN. Resultados: La concordancia en la detección de VPH de alto riesgo mostró un kappa = 0,84 (IC 95 %: 0,71-0,96) entre la muestra cervicovaginal recolectada por autotoma frente a la muestra cervical recolectada por el médico. No hubo diferencias en la cantidad de ADN viral entre el día 1 y el 14 (DM -0,34 ciclos; IC 95 %: -2,29 a 1,61). Conclusión: Las muestras vaginales recolectadas por autotoma usando el dispositivo de almacenamiento son confiables para la detección de VPH de alto riesgo en pacientes con displasia cervical, y preservan el ADN viral por 14 días si se almacenan en seco a temperatura ambiente. Se requieren estudios en población general para poder confirmar.

Caracterización de los procedimientos para la realización de hemocultivos en pacientes adultos, en instituciones hospitalarias del Área Metropolitana del Valle de Aburrá / Characterization of procedures for performing blood cultures in adult patients, in hospitals of the Metropolitan Area of Aburrá Valley

Objetivo: Caracterizar procedimientos para la toma, análisis, reporte y aseguramiento de la calidad en hemocultivos en pacientes adultos, en instituciones hospitalarias. Material Y método: Estudio descriptivo en 15 Hospitales de Medellín y alrededores. Se empleó un formulario semiestructurado para recolectarla información, se utilizó SPSS(r) para el análisis. Resultados: Todas las instituciones tienen protocolos basados en fuentes de autoridad reconocida; con diferencias importantes en procesos pre-analíticos y postanalíticos. Los Productos más empleados para la antisepsia fueron gluconato declorhexidina al 2-4%(66,7%) Y alcohol isopropílico o etílico al 70% (20,0%),Con discrepancias en los tiempos de acción. El 73,3% emplea guantes estériles y la misma proporción usa sistema abierto (jeringa) para la venopunción. En el 46,6% se toman dos botellas aerobias y una anaerobia por episodio y en 33,3% dos botellas aerobias. El 66,6% lleva un indicador de contaminación, 53,3% de positividad y 26,6% de volumen de sangre. La tasa promedio de hemocultivos contaminados durante el semestre de seguimiento fue 1,61%. Conclusión: Se observa heterogeneidad en los procedimientos, especialmente en fases pre-analítica y post-analítica. En La búsqueda de la excelencia y la seguridad del paciente son necesarios protocolos estandarizados e indicadores para medir y controlar el desempeño de los hemocultivos.

Objective: To characterize the procedures that are performed for the collection, analysis, reporting and quality assurance of blood cultures in adult patients in hospital institutions. Material and Methods: Descriptive study in 15 hospitals of Medellin and its surroundings. A semi-structured collection instrument was used to collect the information provided by each hospital; SPSS(r) was used for the analysis. Results: All Institutions have protocols based o nauthorized sources; there were important differences in the pre-analytic and post-analytic processes. The Products employed for skin antisepsis were2-4% Chlorhexidine gluconate (66.7%)And70% Isopropyl or ethyl alcohol(20.0%), with discrepancies in product action times. 73.3% use sterile gloves and an equal proportion uses an open system (syringe) for venipuncture. Two aerobic and one anaerobic bottles are taken per episode in adult patients in 46.6% of institutions and only two aerobic bottles in 33.3% of them. Indicators of contamination were used by 66.6 % of institutions, of positivity in 53.3% and of blood volume in 26.6%. The average rate of contaminated blood cultures during the follow-up period was 1.61%. Conclusion: Heterogeneity in the procedures was observed especially in the pre-analytic and post-analytical phases. In the pursuit of excellence and patient safety, standardized protocols and the use of indicators to measure and control the performance of blood cultures are needed.

Preanalytical Nonconformity Management Regarding Primary Tube Mixing in Brazil.

BACKGROUND: The multifaceted clinical laboratory process is divided in three essential phases: the preanalytical, analytical and postanalytical phase. Problems emerging from the preanalytical phase are responsible for more than 60% of laboratory errors. This report is aimed at highlighting and discussing nonconformity (e.g., nonstandardized procedures) in primary blood tube mixing immediately after blood collection by venipuncture with evacuated tube systems. METHODS: From January 2015 to December 2015, fifty different laboratory quality managers from Brazil were contacted to request their internal audit reports on nonconformity regarding primary blood tube mixing immediately after blood collection by venipuncture performed using evacuated tube systems. RESULTS AND CONCLUSIONS: A minority of internal audits (i.e., 4%) concluded that evacuated blood tubes were not accurately mixed after collection, whereas more than half of them reported that evacuated blood tubes were vigorously mixed immediately after collection, thus magnifying the risk of producing spurious hemolysis. Despite the vast ma jority of centers declaring that evacuated blood tubes were mixed gently and carefully, the overall number of inversions was found to be different from that recommended by the manufacturer. Since the turbulence generated by the standard vacuum pressure inside the primary evacuated tubes seems to be sufficient for providing solubilization, mixing and stabilization between additives and blood during venipuncture, avoidance of primary tube mixing probably does not introduce a major bias in tests results and may not be considered a nonconformity during audits for accreditation.

Educational intervention for collecting sputum for tuberculosis: a quasi-experimental study / Intervenção educativa para a coleta de escarro da tuberculose: um estudo quase experimental / Intervención educativa para recolección de esputo de la tuberculosis: un estudio casi experimental

Abstract Objective: to evaluate the quality of the sputum sample before and after the Nursing guidance to patients. Methods: this is a quasi-experimental research design, single group type, before and after, non-randomized study. The study enrolled patients with suspected pulmonary tuberculosis, respiratory symptomatic patients for over three weeks, aged over 18 years, of both genders and without tuberculosis history in the last two years. The educational intervention consisted of individualized guidance on the collection of sputum sample, which was based on the guidelines of the Ministry of Health of Brazil and on the explanatory folder delivery. Results: in this study participated 138 patients with suspected pulmonary tuberculosis. The results showed significant increase of the samples with purulent particles, volume greater than 5 mL and increased rate of patients diagnosed with tuberculosis, after the educational intervention. Conclusion: it was shown that after the educational intervention, it was observed sputum samples with better quality, with satisfactory aspect and volume for the effectiveness of the bacilloscopic examination.

Resumo Objetivo: avaliar a qualidade da amostra de escarro antes e após as orientações de Enfermagem ao paciente. Métodos: estudo com delineamento de pesquisa quase experimental, do tipo grupo único, antes e depois, não randomizado. Participaram do estudo pacientes com suspeita de tuberculose pulmonar, sintomáticos respiratórios por mais de três semanas, maiores de 18 anos, de ambos os sexos e sem antecedente de tuberculose nos últimos dois anos. A intervenção educativa consistiu em orientações individualizadas sobre a coleta da amostra de escarro, fundamentadas nas diretrizes do Ministério da Saúde do Brasil e na entrega de folder explicativo. Resultados: participaram 138 pacientes com suspeita de tuberculose pulmonar. Os resultados evidenciaram importante acréscimo das amostras com partículas purulentas, volume maior que 5mL e aumento na taxa de pacientes diagnosticados com tuberculose, após a intervenção educativa. Conclusão: comprovou-se que, após a intervenção educativa, obtiveram-se amostras de escarro com maior qualidade, com aspecto e volume satisfatórios para efetividade do exame baciloscópico.

Resumen Objetivo: evaluar la calidad de la muestra de esputo antes y después de las orientaciones de Enfermería al paciente. Métodos: de estudio con diseño de investigación casi experimental, del tipo grupo único, antes y después, no aleatorio. Participaron del estudio pacientes con sospecha de tuberculosis pulmonar, sintomáticos respiratorios por más de 3 semanas, mayores de 18 años, de los dos sexos y sin antecedente de tuberculosis en los últimos dos años. La intervención educativa consistió en orientaciones individualizadas sobre la recolección de la muestra de esputo, fundamentadas en las directrices del Ministerio de la Salud de Brasil y en la entrega de folder explicativo. Resultados: participaron 138 pacientes con sospecha de tuberculosis pulmonar. Los resultados evidenciaron un importante aumento de las muestras con partículas purulentas, volumen mayor que 5mL y aumento en la tasa de pacientes diagnosticados con tuberculosis, después de la intervención educativa. Conclusión: se comprobó que, después de la intervención educativa, se obtuvieron muestras de esputo con mejor calidad, con aspecto y volumen satisfactorios para efectividad del examen de baciloscopía.

[Impact of Lean methodology to improve care processes and levels of satisfaction in patient care in a clinical laboratory]. / Impacto de la metodología Lean en la mejora de procesos asistenciales y niveles de satisfacción en la atención de pacientes en un laboratorio clínico.

INTRODUCTION: The application of the Lean methodology in health institutions is an effective tool to improve the capacity and workflow, as well as to increase the level of satisfaction of patients and employees. OBJECTIVE: To optimise the time of outpatient care in a clinical laboratory, by implementing a methodology based on the organisation of operational procedures to improve user satisfaction and reduce the number of complaints for delays in care. MATERIAL AND METHODS: A quasi-experimental before and after study was conducted between October 2011 to September 2012. XBar and S charts were used to observe the mean service times and standard deviation. The user satisfaction was assessed using service questionnaires. RESULTS: A reduction of 17 minutes was observed in the time of patient care from arrival to leaving the laboratory, and a decrease of 60% in complaints of delay in care. Despite the high staff turnover and 38% increase in the number of patients seen, a culture of empowerment and continuous improvement was acquired, as well as greater efficiency and productivity in the care process, which was reflected by maintaining standards 12 months after implementation. CONCLUSION: Lean is a viable methodology for clinical laboratory procedures, improving their efficiency and effectiveness.

RePORT International: Advancing Tuberculosis Biomarker Research Through Global Collaboration.

Progress in tuberculosis clinical research is hampered by a lack of reliable biomarkers that predict progression from latent to active tuberculosis, and subsequent cure, relapse, or failure. Regional Prospective Observational Research in Tuberculosis (RePORT) International represents a consortium of regional cohorts (RePORT India, RePORT Brazil, and RePORT Indonesia) that are linked through the implementation of a Common Protocol for data and specimen collection, and are poised to address this critical research need. Each RePORT network is designed to support local, in-country tuberculosis-specific data and specimen biorepositories, and associated research. Taken together, the expected results include greater global clinical research capacity in high-burden settings, and increased local access to quality data and specimens for members of each network and their domestic and international collaborators. Additional networks are expected to be added, helping to spur tuberculosis treatment and prevention research around the world.