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.

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.

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

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.

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.

Rapid detection of tuberculosis and extrapulmonary rifampicin resistance by GeneXpert / 中国基层医药

Objective@#To investigate the clinical value of GeneXpert in the rapid diagnosis of rifampicin resistance in tuberculosis and extrapulmonary tuberculosis.@*Methods@#From June 2018 to March 2019, a total of 122 tuberculosis patients admitted to the People's Hospital of Yueqing were selected.Among them, 109 patients with pulmonary tuberculosis and 13 patients with extrapulmonary tuberculosis.GeneXpert MTB/RIF, smear, LJ solid medium, BACTEC MGIT 960 liquid medium four detection methods were used to detect tuberculosis secretion.GeneXpert MTB/RIF, LJ solid medium, BACTEC MGIT 960 liquid medium three detection methods were used to detect extrapulmonary tuberculosis secretion.The sensitivity and specificity of GeneXpert MTB/RIF, smear, LJ solid medium, BACTEC MGIT 960 liquid medium for tuberculosis specimens were detected and compared, and the monitoring results of rifampicin resistance in extracorporeal tuberculosis specimens in culture medium detected by GeneXpert MTB/RIF, LJ solid medium, BACTEC MGIT 960 liquid were observed.@*Results@#The GeneXpert MTB/RIF, smear, LJ solid medium, BACTEC MGIT 960 liquid medium were used to detect 109 cases of tuberculosis, and the detection rates were 94.50%(103/109), 55.04%(60/109), 57.79% (63/109), 61.47%(67/109), respectively.The detection rates of extrapulmonary tuberculosis were 7.69%(1/13), 0.00%(0/13) and 15.38%(2/13), respectively.The sensitivity and specificity of the four methods for the diagnosis of tuberculosis had statistically significant differences(χ2=121.540, 127.610, all P<0.05). The diagnostic efficiency of GeneXpert MTB/RIF was significantly better than smear, LJ solid medium, BACTEC MGIT 960 liquid medium.The results of stratification analysis of rifampicin resistance using GeneXpert MTB/RIF, LJ solid medium and BACTEC MGIT 960 liquid medium showed that there were no statistically significant differences among the three methods and gold standard(χ2=0.750, 0.942, 0.947, all P>0.05).@*Conclusion@#GeneXpert technology has the advantages of simple operation, rapid detection and high detection rate.It has high clinical value for the rapid diagnosis of tuberculosis and extrapulmonary specimens and the detection of rifampicin resistance.

Investigation on endometrium from menstrual blood as a source of non-invasive tissue / 中华妇产科杂志

Objective To investigate the feasibility of a non-invasive sampling method by collecting menstrual blood and obtaining endometrium for further research in menstruation-related diseases.Methods On the second day of menstruation,menstrual blood was collected with menstrual cups for 4 hours,and the menstrual endometrium was filtered through a metal screen for weighing,cryopreserved,immunohistochemical staining and cell culture.Results The collection process was painless and non-invasive.In the control group,the menstrual volume was (9.1±0.7) ml,and the endometrial tissue weight was (91.0+ 14.7) g.In the endometriosis group,the menstrual volume was (9.6± 1.9) ml (P=0.022),and the endometrial tissue weight was (134.7±43.9) g (P=0.057).Endometrial cell culture was successful in all patients and should not be contaminated.The growth curve was a finite cell line type.The expression of cytokeratin 19 and vimentin in menstrual endometrium and cells were positive.Conclusions By collecting menstrual blood and filtering endometrial tissue,it is an ideal non-invasive sampling method.In combination with advanced experimental technology,menstrual endometrium make further researches of endometriosis,endometrial lesions or other menstruation-related diseases possible.

Survey of the acceptance status of HPV self-sampling screening in female population for cervical cancer / 中华妇产科杂志

Objective To investigate the acceptance of HPV self-sampling mode in cervical cancer screening population and explore its feasibility. Methods From March 5 to 15, 2018, researchers investigated women who participated in cervical cancer screening organized by Beijing Shunyi Women＇s and Children＇s Hospital in the form of questionnaires. Questionnaires were conducted on their acceptance status and the factors that affect the self-sampling experience. The specific contents of the questionnaires were as follows: (1) the experience of using self-sampling included operability, comfortable, sample time-consuming, bleeding or not after sampling; (2) psychological changes after self-sampling, including the willingness to accept self-sampling again, the worrying problems during self-sampling process. According to whether or not have operating video guidance, the self-sampling experience and psychological changes after self-sampling were compared. Results (1) There were 1 375 women participated in the questionnaire survey, and 86.55% (1 190/1 375) of them thought the self-sampling was convenient, 78.40% (1 078/1 375) thought it was not uncomfortable, 88.58% (1 218/1 375) thought the sampling time was fast (less than 5 minutes), 94.04% (1 293/1 375) self-sampling without bleeding; and 83.27% (1 145/1 375) were willing to self-sampling for cervical cancer screening again, 85.82% (1 180/1 375) were afraid of inaccurate sampling. (2) Among the 1 375 women, 1 202 were in the video guidance group and 173 were in the non-guidance group. The self-sampling experience of women in video guidance group was better than those of non-guidance group in operability, comfortable, sampling time-consuming and bleeding after sampling. The proportion of women who willing to self-sampling again was higher than that of non-guidance group (86.69% vs 59.54%, respectively). The proportion of women who worried operating incorrectly was lower than that of non-guidance group (11.23% vs 32.37%, respectively). The differences were significant (all P<0.05). Conclusions Self-sampling for HPV testing in cervical cancer screening is easy to operate and has little discomfort complaint. It is feasible in cervical cancer screening. Operational video guidance during the screening process could effectively improve the women＇s experience and willingness to self-sampling again in the future.

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.

Comparison of epidermal growth factor receptor gene mutation in lung adenocarcinoma using biopsied tissue, pleural effusion and blood samples / 中华病理学杂志

Objective@#To compare different specimen types of lung adenocarcinoma in the detection of epidermal growth factor receptor (EGFR) gene and to correlate EGFR mutations with patient clinical features.@*Methods@#One hundred lung adenocarcinoma cases were collected from June to December in 2015, at the First Affiliated Hospital of Xinjiang Medical University.Of the 100 lung adenocarcinoma samples, 43 were male and 57 were female. The age was from 40 to 88 years old, and the average age was 66 years. One hundred lung adenocarcinoma cases were divided equally into two groups. Mutation analysis of EGFR gene by real-time PCR was performed using biopsied tissue and paired blood samples in one group (n=50) and using pleural effusion and paired blood samples in the other group (n=50).@*Results@#The mutation rate of EGFR gene in biopsy samples was 54% (27/50) , higher than that of blood samples (46%, 23/50), but without statistical differences (χ2=0.640, P=0.424). In contrast, mutation rate of EGFR gene in pleural effusion samples (42%, 21/50) was higher than that of blood samples (34%, 17/50), but without statistical differences(χ2=0.679, P=0.409). Two patients had EGFR mutation detected in paired blood samples but not in the corresponding biopsy samples, and four patients had EGFR mutation detected in pleural effusion samples but not in their paired blood samples. The mean progression-free survival of patients with detectable EGFR mutation were 9.5 months (tissue samples), 8.6 months (pleural effusion) and 8.5 months (blood). However, there was no statistical difference.@*Conclusions@#Blood samples may be used to assess EGFR mutations for patients with lung adenocarcinoma. However, further studies are needed to improve the sensitivity and accuracy in the detection of EGFR mutations using blood samples.

Feasibility of amplicon-based targeted next-generation sequencing of colorectal cancer in endoscopic biopsies / 中华病理学杂志

Objective@#To investigate whether small endoscopic biopsies of colorectal cancer were sufficient for quality and accurate mutational analysis by amplicon-based next-generation sequencing (NGS).@*Methods@#By using an amplicon-based targeted NGS panel for mutational detection on Illumina Miseq platform, a total of 109 formalin-fixed and paraffin-embedded (FFPE) endoscopic biopsies of colorectal cancer were retrospectively selected, based on specific histopathologic criteria, from January 2012 to June 2016 at West China Hospital of Sichuan University and Peking University Third Hospital. Twelve of these biopsies had corresponding FFPE surgical resection specimens. Quality control parameters of NGS testing were analyzed and NGS results were confirmed by other methods. Mutation calls of the 12 paired endoscopic biopsies and surgical resections were compared.@*Results@#Of the endoscopic biopsy specimens, 97.2% (106/109) had sufficient DNA and qualified sequencing library. NGS generated excellent sequencing data, with a median of 848× for median read depth and 95.7% for uniformity. The success rate of NGS was 95.4% (104/109). Conventional methods confirmed the results of NGS for KRAS and BRAF, and the concordance rate was 100.0%. The clinically actionable mutations detected in the 12 paired endoscopic biopsies and surgical resections were concordant.@*Conclusion@#FFPE endoscopic biopsies of colorectal cancer is suitable for targeted NGS, providing quality sequencing data and accurate mutational information to guide targeted therapy.

Improvement of the turnaround times of STAT biochemistry test in clinical laboratory / 中华检验医学杂志

Objective To shorten the stat test turnaround time (TAT) and improve the quality of service in clinical laboratory.Method Stat test TAT related data of clinical laboratory in Tongji hospital in Wuhan from August 1st to September 30th were collected by laboratory information system and hospital information system.EXCEL and SPSS were used for data analysis.Median and the 90th percentile were calculated for TATs from order to collection, collection to transfer, transfer to reception, reception to inspection and inspection to report.Outlier rates were calculated for TAT from collection to reception, reception to report, and collection to report using 2 h, 2 h, and 4h as target TAT value, respectively.Meanwhile descriptive statistics were calculated for TAT from order to collection in different clinical department, TAT from collection to reception during different collection time frames, and TAT from reception to report during different reception time frames.Results 32 235 stat biochemistry test data were included in this survey.Among three periods cut by collection and reception time, TAT from order to collection were the longest (P50: 681 min,P90:1261 min), followed by TAT from collection to reception(P50:94 min,P90:169 min) and TAT from reception to report(P50:68 min,P90:111 min).TATs from order to collection were longer in gynecological tumor department and organ transplantation department while shorter in infection department and cardiac vascular department.The TATs from collection to reception of specimen collected during 2:00 to 3:59 were longer than other collection time.While the TATs from reception to report of specimen received during 6:00 to 7:29 were longer than other reception time.There was no significant correlation between the amount of emergency specimens collected and TAT from collection to reception in different collection time period.However, the amount of emergency specimens collected was significantly correlated with the TAT from reception to report in different reception time period.Conclusions Analysis of TAT data can be used to identify existing problems and provide improved directions to shorten TAT in clinical laboratories.

The effect of hemolysis on 41 chemistry and immunology tests and determination of hemolysis alert index / 中华检验医学杂志

Objective To evaluate hemolyticinfluence on 41 chemistry and immunology tests and define the hemolysis alert index, which can be used as evidence for sample rejection and test report verification.Methods Method evaluation.As a pair, both hemolyzed and non-hemolyzed serum samples were collected from the same patient at the same time.Hemolysis index and 41 tests were analyzed.The effect of hemolysis in different hemolysis level was evaluated by comparing results of the paired samples.The alertindex were defined by senior laboratory techniciansand clinical professionals based on discussion of widely accepted quality requirements.Results The number of sample with hemolysis index of 1,2,3 and 4was 24, 17, 7 and 4 respectively.Of the 41 analytes, 6 analytes increased in hemolyzed samples comparing to non-hemolyzed samples, namelyaspartate aminotransferase(AST), creatine kinase(CK), potassium(K),lactate dehydrogenase(LD),inorganic phosphorus(iP)and total bilirubin(TBil).Another 9 analytesdecreased in hemolyzed samples comparing to non-hemolyzed samples.These analytes are alkaline phosphatase(ALP), chloride(Cl), creatinine(Cr), immunoglobin M(IgM), sodium(Na), prealbumin (PA),rheumatoid factor(RF),triglyceride(TG),uric acid(UA).Hemolysis alert index was defined as 1 for AST,K,Na and LD;2 for Cr;3 for CK,iP,PA and TBil; and 4 for the other 32 tests.Conclusions Hemolysisalertindex were defined based on the investigation of hemolyticinfluence on 41 chemistry and immunology tests in ourlaboratory.However, hemolytic influence on clinical laboratory tests are closely related to the assay systems.So clinical laboratory should evaluate the hemolytic influence on its own analysis system,and define assay specific hemolysis alert index.