Panorama do controle de qualidade em laboratórios clínicos e a experiência do Instituto Adolfo Lutz / Overview of quality control in clinical laboratories and the Adolfo Lutz Institute experience

No cenário dos laboratórios clínicos é de suma importância controlar e melhorar continuamente a qualidade dos serviços para obtenção de resultados confiáveis. Para alcançar essa condição, é imprescindível acompanhar os avanços tecnológicos. Uma das causas fundamentais tem sido a introdução e o monitoramento de indicadores de qualidade, tais como as especificações de desempenho analítico, principalmente a precisão e a exatidão. São componentes-chave desse processo a utilização do controle de qualidade interno (CQI) e a participação em programas de avaliação externa da qualidade (AEQ). Este relato de experiência se propõe a apresentar algumas tendências passadas e presentes da utilização do controle de qualidade nos processos de monitoramento da fase analítica em laboratórios clínicos. Destina-se também a compartilhar a experiência do Instituto Adolfo Lutz (IAL) no desenvolvimento e na implementação de programas de controle de qualidade em ensaios sorológicos, contextualizando seu propósito e benefício dos resultados. A qualidade em laboratórios clínicos torna-se cada vez mais relevante à medida que as evidências científicas destacam o seu papel importante no processo de tomada de decisão clínica e no monitoramento de pacientes. No desempenho de suas atividades, o Centro de Imunologia do IAL tem contribuído para a melhoria da qualidade dos resultados oferecidos à população pelos laboratórios da sub-rede do estado de São Paulo.

In the clinical laboratories setting, it is extremely important to continuously control and improve the quality of services to obtain reliable results. To achieve this condition, it is essential to keep up with technological advances. One of the fundamental causes has been the introduction and monitoring of quality indicators such as the analytical performance specifications in particular accuracy and precision. The key components of this process are the use of internal quality control (IQC) and participation in external quality assessment programs (EQA). This experience report intends to present some past and present trends in the use of quality control for monitoring analytical phase in clinical laboratories. It is also intended to share the experience of the Adolfo Lutz Institute (IAL) in the development and implementation of quality control programs in serological assays, which contextualizes their purpose and benefit of the results. The quality in clinical laboratories has become increasingly relevant as scientific evidence highlights the important role it plays in the clinical decision-making and patient monitoring process. In carrying out its activities, the Center of Immunology at IAL has contributed for improving the quality of results offered to the population by laboratories of the sub-network of São Paulo State.

Development and application of proficiency testing (PT) to evaluate the diagnostic capacity of SARS-CoV-2 by RT-qPCR - A practical and metrological approach.

It is necessary to use quality tools to evaluate the diagnostic capacity of laboratories, such as implementing a proficiency testing (PT) program. The goal of this work is to develop and apply a PT protocol to assess the diagnostic capacity of SARS-CoV-2 through the RT-PCR method, based on appropriate metrological tools. A 5-item test panel containing items with different dilutions of SARS-CoV-2, including negative controls, was developed to perform this PT with the application of different performance assessment tools to score and differentiate performance between laboratories, according to Table 2. Based on the participants' total qualitative result, 95% of the negative samples and 73% of the positive samples were correctly identified by the laboratories. The results obtained were compared e validate the systematics of the PT developed, so that it can be implemented and used to monitor and improve the diagnostic capacity of SARS-CoV-2, also helping to improve the quality of these results.

Resultados del ejercicio de calidad de la Sociedad Latinoamericana de Genética Forense, 2023 / Results of the quality exercise of the Latin American Society of Forensic Genetics, 2023

Introducción: La Sociedad Latinoamericana de Genética Forense, desde el año 2003 organiza ejercicios colaborativos de comparación interlaboratorios a fin de apoyar el fortalecimiento de los laboratorios de Genética Forense de Latinoamérica, siendo el ejercicio de calidad de SLAGF el único que incluye muestras óseas. Objetivo: Presentar los resultados del análisis del ejercicio de calidad de SLAGF correspondientes al año 2023. Metodología: Se diseñó un ejercicio práctico con cinco muestras: dos hisopados bucales (M1 y M2), una muestra de sangre en FTA (M3), una muestra mezcla 1:1 de sangre- sangre en FTA (M4) y un resto óseo (M5), Se envió a los laboratorios un ejercicio teórico con cinco casos; dos de los cuales eran opcionales. Al igual que cinco ejercicios teóricos para los peritos independientes participantes. Por primera vez se incluyó un ejercicio de IVD opcional, los ejercicios están disponibles en: http://slagf.org/resultados-control- slagf-2023/x Resultados: Participaron 30 laboratorios y 12 peritos independientes. En el ejercicio práctico, la muestra cadavérica de restos óseos presentó los mayores desafíos, en la parte teórica fue el ejercicio de IVD. Conclusión: Los desafíos que enfrentan los laboratorios de Genética Forense Latinoamericanos, reflejados en el ejercicio de calidad de SLAGF 2023, son similares a los encontrados por otros grupos que realizan ejercicios de control de calidad en Genética Forense...(AU)

Development of Avocado Reference Material for Pesticide Residue Analysis.

BACKGROUND: Pesticide quantitation in foods relies on the availability of matrix reference materials, which, however, are scarce because of the general instability of pesticides. In particular, no avocado reference material has been developed. OBJECTIVE: This research aimed to develop a reference material to support the determination of pesticide residues in avocado. METHOD: Avocado was spiked with 11 selected pesticides at levels of 0.01-0.35 mg/kg. The production process included the assessment of between-unit heterogeneity, stability during dispatch, and best storage conditions according to ISO 17034. Reference values were estimated through an interlaboratory comparison study involving laboratories of demonstrated competence and adhering to ISO/IEC 17025. The corresponding expanded uncertainties were calculated as 4-19% in compliance with the Guide to the Expression of Uncertainty in Measurement. RESULTS: The reference material was sufficiently homogeneous and stable at 4°C during the entire study period (365 days) for most of the pesticides, and at 40°C during 10 days, but it was unstable at 50 and 60°C during 10 days. Four pesticides showed downward trends; however, this behavior was considered in the uncertainty budget. As this material complied with all requirements of proficiency testing, it was used in an interlaboratory proficiency test designed to investigate analytical performance and assist laboratories in improving the quality of measurement results. CONCLUSIONS: The presented material can be used for the development of novel analytical methods or in-house reference materials and adds to the scarce supply of reference materials for the determination of pesticides in vegetable matrixes with high oil contents and intermediate water contents. HIGHLIGHTS: A novel reference material has been developed for the reliable and accurate quantitation of multiple pesticides in avocado, allowing researchers to avoid the preparation of in-house reference materials for this purpose.

Avaliação de desempenho dos laboratórios de sorologia para HIV pelo Instituto Adolfo Lutz / Performance avaliation of HIV serology laboratories by the Adolfo Lutz Instituto

A participação de laboratórios em programas de avaliação externa da qualidade (AEQ), também conhecidos como testes de proficiência, é essencial para todos os laboratórios clínicos. O objetivo deste estudo foi descrever o desempenho dos laboratórios participantes do Programa AEQ em ensaios sorológicos para o diagnóstico da infecção pelo vírus da imunodeficiência humana (HIV). No período de março de 2020 a junho de 2021, 26 laboratórios participaram do Programa AEQ ­ HIV no Instituto Adolfo Lutz. Dentre os participantes, sete laboratórios (26,9%) aderiram ao ensaio de triagem sorológica, dez (38,5%) ao confirmatório, e nove (34,6%) em ambos os ensaios. Em 2020, o desempenho satisfatório alcançado pelos laboratórios participantes em ensaios de triagem e confirmatório, foi de 93,8% (15/16) e 84,2% (16/19), respectivamente. No entanto, em 2021, a porcentagem de participantes com avaliação adequada foi inferior a 2020, 86,7% (13/15) em triagem e 78,9% (15/19) em ensaio confirmatório. Os resultados apresentados reforçaram a necessidade do monitoramento contínuo dos laboratórios, por meio de ensaios de proficiência, visando oferecer melhor qualidade aos serviços prestados à população. (AU)

The participation of laboratories in external quality assessment programs (EQA), also known as proficiency testing, is essential for all clinical laboratories. The aim of this study was to describe the performance of laboratories participating in the EQA Program in serological assays for the diagnosis of human immunodeficiency virus (HIV) infection. From March 2020 to June 2021, 26 laboratories participated in the EQA - HIV Program promoted by Instituto Adolfo Lutz. Seven of them (26.9%) participated in the serological screening, ten (38.5%) had participation in the confirmatory assay and nine (34.6%) in both assays. In 2020, the satisfactory performance achieved by laboratories participating in screening and confirmatory assays was 93.8% (15/16) and 84.2% (16/19), respectively. However, in 2021, the percentage of participants with adequate assessment was lower than 2020, 86.7% (13/15) in screening and 78.9% (15/19) in confirmatory assays. The results presented reinforce the need for continuous monitoring of laboratories through proficiency tests for providing the high-quality services which are offered to the population. (AU)

Elaboration of reference material for cadmium and arsenic in hydrobiological products, for the purpose of being used in a laboratory intercomparation program / Elaboración de un material de referencia para cadmio y arsénico en productos hidrobiológicos, para propósito de ser utilizado en un programa de intercomparación de laboratorios

Reference materials (RM) are tools used in the comparability and traceability of measurements. They are widely used by laboratories for method validation and quality control of assay. Chile must evaluate theperformance of laboratories that analyzing metals in fishery products, despite RM have high prices and are scarce. For that reason, a RM in a hydrobiological product was developed. Reference values for arsenic and cadmium elements for a fishmeal were assigned. The measurement methods for characterization of the material were Inductively Coupled Plasma Mass Spectrometry, Atomic Absorption Spectrometry and Neutron Activation Analysis. Reference values with their expanded uncertainty (U) were established for arsenic 2.64 ± 0.42 mg/kg (U; k = 2) and for cadmium 0.86 ± 0.16 mg/kg (U; k = 2). Homogeneity and stability of the RM allowed its use in a proficiency test for eleven food control laboratories. Results for median were 2.114 mg/kg for arsenic, and 0.863 mg/kg for cadmium. The performance values of the participants were evaluated with a z score obtaining 60% satisfaction for arsenic and 73% for cadmium.The material demonstrated to be suitable for use in interlaboratory proficiency assay. (AU)

Materiales de referencia (MR) son herramientas utilizadas en la comparabilidad y trazabilidad entre mediciones. Laboratorios los utilizan ampliamente en validación de métodos y control de calidad. Chile debe evaluar el desempeño de los laboratorios que analizan metales en productos pesqueros, a pesar de los altos precios y escasez del MR. Por esa razón, se desarrolló un MR en producto hidrobiológico. Se asignaron valores de referencia para arsénico y cadmio en harina de pescado. Los métodos de medición para la caracterización del material fueron Espectrometría de Masas de Plasma Acoplado Inductivamente, Espectrometría de Absorción Atómica y Análisis de Activación de Neutrones. Se establecieron valores de referencia con su incertidumbre (U) para arsénico 2.64 ± 0.42 mg/kg (U; k = 2) y para cadmio 0.86 ± 0.16 mg/kg (U; k = 2). La homogeneidad y estabilidad del MR permitieron su uso en una prueba de aptitud para once laboratorios de control de alimentos. Las medianas fueron 2,114 mg/kg para arsénico y 0,863 mg/kg para cadmio. Se evaluaron los rendimientos de los participantes con un estadístico de puntaje z satisfactorio del 60% para el arsénico y 73% para el cadmio. El material demostró ser adecuado para uso en ensayo de aptitud de intercomparación. (AU)

Automated Measurement of Plasma Cell-Free Hemoglobin Using the Hemolysis Index Check Function.

BACKGROUND: The Roche Cobas chemistry analyzer's hemolysis index (HI) check function can directly report hemoglobin (Hb) concentrations. We aimed to validate the HI check function for the measurement of plasma cell-free Hb. METHODS: Plasma samples (6 µl) were taken by the analyzer and diluted in normal saline to measure the absorbance for Hb at 570 and 600 nm. Hb concentrations were calculated based on the molar extinction coefficient. Imprecision, lower limit of quantification (LLOQ), and analytical measurement range (AMR) of the assay were evaluated. The accuracy was determined by comparing the results between the new method and an existing spectrophotometric method. We further studied interference of icterus and lipemia and carryover. The performance of the assay in proficiency testing was also evaluated. The reference range was transferred from the existing method. RESULTS: Within-run and total CVs were 1.7%-4.2% and 2.1%-7.0%, respectively (n = 20). The LLOQ was 11 mg/dL (CV = 8.1%) with the upper limit of AMR of 506 mg/dL. The results of the new method correlated well with the existing reference assay: Y (new method) = 0.974 x (reference method) + 4.9, r = 0.9990, n = 52. Bilirubin with a concentration up to 60 mg/dL and lipemic index up to 389 did not show significant interference. No significant carryover was detected. The average standard deviation index in proficiency testing was 0.03 ± 0.29. The reference range was <22 mg/dL. CONCLUSIONS: Plasma cell-free Hb measurement using the HI check function meets the analytical requirements of the plasma cell-free Hb assays. It is simple and cost-effective.

Development and Validation of Real-Time RT-LAMP Assays for the Specific Detection of Zika Virus.

Two one-step real-time reverse transcription loop-mediated isothermal amplification (RT-LAMP) assays for the detection of Zika virus (ZIKV) were developed, based on two different primer design approaches: (1) open source, based on a combination of sequence diversity clustering (phylogeny and principal component analysis) and LAVA algorithm, using 45 whole genome ZIKV sequences retrieved from the National Center for Biotechnology Information (NCBI) database; (2) standard software for LAMP primer design (Primer Explorer V4), using 59 sequences of the ZIKV 3' UTR. The assays were firstly evaluated with External Quality Assessment panels from INSTAND e.V. (Germany) and EVD-LabNet (The Netherlands) including 4 and 12 unknown samples, respectively, and secondly, with 9 human, mosquito, and monkey ZIKV isolates from Africa (Senegal, Ivory Coast, and Uganda) and America (Brazil). The limit of detection as determined by probit analysis was 181 molecules for both RT-LAMP assays, and 100% reproducibility in the assays was obtained for 103 molecules (4/8 repetitions were positive for 102 molecules). Both assays were specific, amplifying only ZIKV RNA and not cross-detecting other arboviruses included in this study.

First inter-laboratory comparison of Echinococcus granulosus sensu lato diagnosis in Latin America

[ABSTRACT]. Objective. To compare the performance of polymerase chain reaction (PCR) and enzyme-linked immunosorbent assay (ELISA) tests for diagnosing Echinococcus granulosus in dog feces among national reference laboratories in Argentina, Chile, Peru, and Uruguay. Methods. National laboratories affiliated with the Ministry of Health/Agriculture of each country exchanged panels of 10 positive/negative samples obtained from their regular national surveillance programs in November 2015 – November 2016. All laboratories applied PCR; two also applied ELISA techniques. Sensitivity and specificity were determined for each laboratory and concordance of results among the laboratories was evaluated by Cohen Kappa coefficient. Results. Poor concordance (3 of 10 paired comparisons had values of Kappa > 0.4), low sensitivity and specificity across all laboratories, and poor performance of both techniques in detecting E. granulosus in canine feces was demonstrated in this study. An ex-post comparison of the laboratories’ test protocols showed substantial heterogeneity that could partially explain poor concordance of results. Conclusion. The results underscore the heterogeneity of canine echinococcosis diagnosis across the region and indicate possible sources of variability. Efforts to standardize canine echinococcosis testing must be included in the plan of action for the Regional Initiative for the Control of Cystic Echinococcosis. Future comparisons with fecal samples of known parasite load are needed.

[RESUMEN]. Objetivo. Comparar el rendimiento de los ensayos de la reacción en cadena de la polimerasa y el enzimoinmunoanálisis de adsorción en fase sólida (o ELISA, por su sigla en inglés) para diagnosticar Echinococcus granulosus en heces caninas en los laboratorios de referencia nacionales de Argentina, Chile, Perú y Uruguay. Métodos. Los laboratorios nacionales, afiliados a los ministerios de salud y agricultura y ganadería de cada país, intercambiaron paneles de diez muestras positivas y negativas obtenidas de sus respectivos programas nacionales de vigilancia desde el mes de noviembre del año 2015 hasta el mismo mes del año siguiente. Todos los laboratorios emplearon la reacción en cadena de la polimerasa y dos emplearon también técnicas de ensayo inmunoenzimático (ELISA). Se determinó la sensibilidad y la especificidad de cada laboratorio y se evaluó la concordancia entre los resultados de los laboratorios mediante el coeficiente kappa de Cohen. Resultados. Este estudio descubrió una escasa concordancia (3 de 10 comparaciones de pares obtuvieron valores de kappa > 0,4), una sensibilidad y especificidad bajas en todos los laboratorios y un rendimiento deficiente de ambas técnicas de diagnóstico de Echinococcus granulosus en heces caninas. La comparación ex post de los protocolos de ensayo de los laboratorios mostró una heterogeneidad sustancial que podría explicar parcialmente la escasa concordancia de los resultados. Conclusiones. Los resultados subrayan la heterogeneidad del diagnóstico de equinococosis canina en toda la región e indican posibles fuentes de esta variabilidad. Deben incluirse medidas para estandarizar la prueba de equinococosis canina en el plan de acción de la Iniciativa Sudamericana para el Control de la Equinococosis Quística. En el futuro serán necesarias comparaciones adicionales con muestras fecales con una carga de parásitos conocida.

[RESUMO]. Objetivo. Comparar o desempenho dos métodos de reação em cadeia da polimerase (PCR) e ensaio imunoenzimático (ELISA) no diagnóstico de infecção pelo Echinococcus granulosus em fezes de cães entre laboratórios de referência nacional na Argentina, Chile, Peru e Uruguai. Métodos. Laboratórios nacionais conveniados ao Ministério da Saúde/Agricultura de cada país participante intercambiaram grupos de 10 amostras positivas/negativas coletadas rotineiramente pelos programas nacionais de vigilância no período de novembro de 2015 a novembro de 2016. Todos os laboratórios empregaram o método de PCR e dois empregaram também o método de ELISA. A sensibilidade e a especificidade dos métodos foram determinadas em cada laboratório, e a concordância dos resultados entre os laboratórios participantes foi avaliada com o coeficiente kappa de Cohen. Resultados. Observou-se fraca concordância (3 de 10 comparações pareadas com kappa >0,4), baixa sensibilidade e especificidade e fraco desempenho de ambos os métodos na identificação do E. granulosus em amostras fecais de cães nos laboratórios participantes do estudo. Uma comparação retroativa revelou considerável heterogeneidade dos protocolos de análise laboratorial, o que poderia em parte explicar a fraca concordância entre os resultados. Conclusões. Os resultados deste estudo apontam para a falta de uniformidade no diagnóstico de equinococose canina em toda a Região e indicam possíveis causas para variabilidade. A padronização da análise laboratorial da equinococose canina deve constar do plano de ação para a Iniciativa Regional para Controle da Hidatidose. Outras comparações de amostras fecais de parasitas conhecidos devem ser realizadas.

Programa de Evaluación Externa de la Calidad "Prof. Dr. Daniel Mazziotta": una nueva etapa asegurando la mejora continua de la calidad / External Quality Assessment Program "Prof. Dr. Daniel Mazziotta ": a new stage ensuring continuous quality improvement

Las determinaciones de los laboratorios clínicos tienen un papel muy importante en la evaluación, diagnóstico, tratamiento y evolución del estado de salud de las personas. La confiabilidad de sus resultados se logra a través del aseguramiento de la calidad y mejora continua. El Programa de Evaluación Externa de la Calidad "Prof. Dr. Daniel Mazziotta" acompaña a los laboratorios de análisis clínicos desde hace 31 años brindando distintas herramientas para garantizar la calidad analítica. Ofrece los servicios de evaluación externa de la calidad, suministro de material para control de calidad interno para determinaciones en Química Clínica y soluciones para control de instrumental y pruebas de suficiencia. Desde la creación del programa se establecieron objetivos estratégicos a desarrollarse en tres etapas: establecimiento, consolidación y apoyo a la gestión de la calidad. Se genera ahora una nueva etapa, cuyo objetivo final es la acreditación. Como primer paso de este ciclo, se implementó un sistema de gestión de la calidad (SGC) de acuerdo a los requisitos establecidos en la norma argentina IRAM-ISO 9001:2015. En agosto de 2019, el Instituto Argentino de Normalización y Certificación (IRAM), representante en Argentina de la International Organization for Standarization (ISO), certificó que el SGC del programa cumple lo establecido en dicha norma. Su aplicación tiene como objetivo asegurar que los servicios ofrecidos satisfagan las necesidades de los laboratorios clínicos cumpliendo los requisitos legales requeridos y asegurando la mejora continua. El objetivo de este trabajo fue describir las acciones realizadas en la implementación del SGC y la posterior certificación de IRAM-ISO 9001:2015, por el IRAM.

Clinical laboratory determinations have a very important role in the evaluation, diagnosis, treatment and evolution of the health status of people. The reliability of their results is achieved through quality assurance and continuous improvement. The External Quality Assessment Programme Prof. Dr. Daniel Mazziotta has been accompanying clinical analysis laboratories for 31 years offering different tools to ensure analytical quality. It provides the services of external quality assessment, supply of material for internal quality control for determinations in Clinical Chemistry and solutions for instrumental control and sufficiency tests. Since the creation of the program, strategic objectives have been established to be developed in three stages: establishment, consolidation and support for quality management. A new stage is now being generated, whose final objective is accreditation. As a first step of this cycle, a quality management system (QMS) was implemented according to the requirements established in the IRAM Argentina standard-ISO 9001:2015. In August 2019, the Argentine Institute for Standardization and Certification (IRAM), representative in Argentina of the International Organization for Standardization (ISO), certified that the Programme's QMS complies with the provisions of said standard. Its application aims to ensure that the services offered meet the needs of clinical laboratories by fulfilling the legal requirements and ensuring continuous improvement. The objective of this work is to describe the actions carried out in the implementation of the QMS and the subsequent IRAM-ISO 9001: 2015 certification by the IRAM.

As determinações laboratoriais clínicas têm um papel muito importante na avaliação, diagnóstico, tratamento e evolução do estado de saúde das pessoas. A confiabilidade de seus resultados é alcançada através da garantia de qualidade e melhoria contínua. O Programa de Avaliação da Qualidade Externa "Prof. Dr. Daniel Mazziotta" apoia os laboratórios de análises clínicas há 31 anos, oferecendo diferentes ferramentas para garantir a qualidade analítica. Oferece os serviços de: avaliação externa de qualidade, fornecimento de material de controle interno de qualidade para determinações em Química Clínica e soluções para controle instrumental e testes de suficiência. Desde a criação do programa, os objetivos estratégicos foram estabelecidos para serem desenvolvidos em três etapas: estabelecimento, consolidação e suporte para a gestão da qualidade. Uma nova etapa é agora gerada, cujo objetivo final é a Acreditação. Como primeira etapa desse ciclo, um sistema de gestão da qualidade (SGQ) foi implementado de acordo com os requisitos estabelecidos na norma IRAM Argentina - ISO 9001:2015. Em agosto de 2019, o Instituto Argentino de Normalização e Certificação (IRAM), representante na Argentina da Organização Internacional de Normalização (ISO), certificou que o SGC do programa está em conformidade com as disposições da referida norma. Sua aplicação visa garantir que os serviços oferecidos satisfaçam as necessidades dos laboratórios clínicos, atendendo aos requisitos legais exigidos e garantindo a melhoria contínua. O objetivo deste trabalho é descrever as ações realizadas na implementação do SGQ e a subsequente certificação da IRAM-ISO 9001:2015, pela IRAM.

Controle externo da qualidade em espermograma: avaliação do desempenho de laboratórios clínicos participantes de dois provedores de ensaio de proficiência / External quality control in spermogram: performance evaluation of participating clinical laboratories of two proficiency testing providers

Objetivo: Identificar os parâmetros com maior incidência de erros no programa de controle de qualidade externo em espermograma e descrever o panorama da participação dos laboratórios brasileiros em ensaios de proficiência para espermograma. Métodos: Trata-se de um estudo descritivo, retrospectivo de análise de dados com abordagem quantitativa que descreve e avalia o desempenho de laboratórios de análises clínicas participantes do Programa Nacional de Controle de Qualidade (PNCQ) e Controllab entre os anos de 2010 ­ 2017. Resultados: Os resultados obtidos revelaram que até o momento existe um total de 273 participantes de controle externo da qualidade na especialidade de espermograma e, quando comparado com o total de laboratórios de análises clínicas no Brasil (20.800), esse percentual é de 1,3%. Em ambos os programas, o maior percentual de erros foi na análise da concentração espermática com 12,6% (PNCQ) e 20,7% Controllab) e esses dados podem inferir as deficiências de padronização na contagem espermática. Conclusão: Esses resultados apontam para um déficit de participação, que, apesar de não poder ser estatisticamente comprovado, alerta para a nula participação de alguns estados. Os ensaios de proficiência associados ao treinamento constante do pessoal do laboratório são importantes medidas em atenção à qualidade da análise seminal.

Objective: To identify the parameters with higher incidence of errors in the program of external quality control in spermogram and to describe the panorama of the participation of the Brazilian laboratories in tests of proficiency for spermogram. Methods: This is a descriptive, retrospective study of data analysis with a quantitative approach that describes and evaluates the performance of clinical analysis laboratories participating in the National Quality Control Program (PNCQ) and Controllab between the years 2010 - 2017. Results: The results show that up to now there are 273 participants of external quality control in the specialty of sperm

Quality evaluation of malaria diagnosis in the local laboratories network and in intermediate laboratories in a setting towards the disease elimination in Ecuador / Evaluación de la calidad del diagnóstico de malaria en la red local de laboratorios y en los laboratorios intermedios en el contexto de la eliminación de la enfermedad en Ecuador

Introduction: To reach the goal of malaria elimination in Ecuador for the year 2020, it is necessary to have a laboratory network with the capacity to perform microscopic diagnosis according to the WHO/PAHO quality standards and to provide the adequate treatment of cases. Objective: To determine the level of competence for parasitological diagnosis of the microscopists from the local public network and the performance of intermediate reference laboratories. Materials and methods: We conducted a cross-sectional study based on the information collected in workshops carried out to appraise the competence for microscopic diagnosis of the local laboratory network (zonal health coordinating offices 1 to 8) using a slide panel to evaluate diagnosis agreement, as well as the diagnostic performance of the intermediate laboratories using an external quality assessment program. The results were compared against the reference standards of the supranational laboratory in Perú. Results: We evaluated the competencies of 191 microscopists in 11 workshops and 153 (80.1%) of them were approved. The medians of the indicators were the following: concordance for parasite detection, 100% (Q1- Q3: 96-100), concordance for species identification, 100% (Q1- Q3: 93-100), and concordances for stage identification, 93.0% (Q1- Q3: 86-95) and parasite counting, 77.0% (Q1- Q3: 71-82). In the external quality assessment, the three intermediate laboratories obtained 100% in parasite detection concordance and 96% for species detection concordance. Conclusions: The results for the primary network and the performance indicators for the intermediate laboratories showed the high-quality standards of the training program implemented in the country.

Introducción. El cumplimiento de la meta de eliminación de la malaria en Ecuador en el 2020 exige contar con la capacidad requerida para el diagnóstico microscópico ajustado a los estándares de calidad de la Organización Mundial de la Salud (OMS) y de la Organización Panamericana de la Salud (OPS) y proveer el tratamiento adecuado a los pacientes. Objetivo. Conocer la idoneidad o competencia de los microscopistas de la red pública local para el diagnóstico parasitológico de la malaria y el desempeño de los laboratorios intermedios de referencia. Materiales y métodos. Se hizo un estudio descriptivo de corte transversal a partir de la información obtenida en los talleres de evaluación de idoneidad en el diagnóstico microscópico de la red de laboratorios en las coordinaciones zonales de salud utilizando un panel de láminas para evaluar la concordancia del diagnóstico. Además, se calificó el desempeño de los laboratorios intermedios en el diagnóstico en el marco del programa de evaluación externa del desempeño. Los resultados se compararon con los obtenidos por el laboratorio supranacional de Perú. Resultados. En los 11 talleres realizados, se evaluó la idoneidad de 191 microscopistas, de los cuales 153 (80,1 %) aprobaron las pruebas. Las medianas de los indicadores fueron las siguientes: concordancia entre la detección y el resultado, 100 % (Q1- Q3: 96-100); concordancia en la especie, 100 % (Q1- Q3: 93-100); concordancia en el estadio, 93,0 % (Q1- Q3: 86-95) y concordancia en el recuento, 77 % (Q1- Q3: 71-82). En el programa de evaluación externa de desempeño, los tres laboratorios intermedios obtuvieron una concordancia del 100 % en el resultado y una del 96 % en la especie. Conclusiones. Los indicadores de competencia de la red local y de desempeño de los laboratorios intermedios alcanzaron altos estándares de calidad acordes con el proceso de entrenamiento implementado en el país.

Evaluación de la calidad del diagnóstico de malaria en la red local de laboratorios y en los laboratorios intermedios en el contexto de la eliminación de la enfermedad en Ecuador / Quality evaluation of malaria diagnosis in the local laboratories network and in intermediate laboratories in a setting towards the disease elimination in Ecuador

Resumen Introducción. El cumplimiento de la meta de eliminación de la malaria en Ecuador en el 2020 exige contar con la capacidad requerida para el diagnóstico microscópico ajustado a los estándares de calidad de la Organización Mundial de la Salud (OMS) y de la Organización Panamericana de la Salud (OPS) y proveer el tratamiento adecuado a los pacientes. Objetivo. Conocer la idoneidad o competencia de los microscopistas de la red pública local para el diagnóstico parasitológico de la malaria y el desempeño de los laboratorios intermedios de referencia. Materiales y métodos. Se hizo un estudio descriptivo de corte transversal a partir de la información obtenida en los talleres de evaluación de idoneidad en el diagnóstico microscópico de la red de laboratorios en las coordinaciones zonales de salud utilizando un panel de láminas para evaluar la concordancia del diagnóstico. Además, se calificó el desempeño de los laboratorios intermedios en el diagnóstico en el marco del programa de evaluación externa del desempeño. Los resultados se compararon con los obtenidos por el laboratorio supranacional de Perú. Resultados. En los 11 talleres realizados, se evaluó la idoneidad de 191 microscopistas, de los cuales 153 (80,1 %) aprobaron las pruebas. Las medianas de los indicadores fueron las siguientes: concordancia entre la detección y el resultado, 100 % (Q1- Q3: 96-100); concordancia en la especie, 100 % (Q1- Q3: 93-100); concordancia en el estadio, 93,0 % (Q1- Q3: 86-95) y concordancia en el recuento, 77 % (Q1- Q3: 71-82). En el programa de evaluación externa de desempeño, los tres laboratorios intermedios obtuvieron una concordancia del 100 % en el resultado y una del 96 % en la especie. Conclusiones. Los indicadores de competencia de la red local y de desempeño de los laboratorios intermedios alcanzaron altos estándares de calidad acordes con el proceso de entrenamiento implementado en el país.

Abstract Introduction: To reach the goal of malaria elimination in Ecuador for the year 2020, it is necessary to have a laboratory network with the capacity to perform microscopic diagnosis according to the WHO/PAHO quality standards and to provide the adequate treatment of cases. Objective: To determine the level of competence for parasitological diagnosis of the microscopists from the local public network and the performance of intermediate reference laboratories. Materials and methods: We conducted a cross-sectional study based on the information collected in workshops carried out to appraise the competence for microscopic diagnosis of the local laboratory network (zonal health coordinating offices 1 to 8) using a slide panel to evaluate diagnosis agreement, as well as the diagnostic performance of the intermediate laboratories using an external quality assessment program. The results were compared against the reference standards of the supranational laboratory in Perú. Results: We evaluated the competencies of 191 microscopists in 11 workshops and 153 (80.1%) of them were approved. The medians of the indicators were the following: concordance for parasite detection, 100% (Q1- Q3: 96-100), concordance for species identification, 100% (Q1- Q3: 93-100), and concordances for stage identification, 93.0% (Q1- Q3: 86-95) and parasite counting, 77.0% (Q1- Q3: 71-82). In the external quality assessment, the three intermediate laboratories obtained 100% in parasite detection concordance and 96% for species detection concordance. Conclusions: The results for the primary network and the performance indicators for the intermediate laboratories showed the high-quality standards of the training program implemented in the country.

An inter- laboratory proficiency testing exercise for rabies diagnosis in Latin America and the Caribbean.

The direct fluorescent antibody test (DFA), is performed in all rabies reference laboratories across Latin America and the Caribbean (LAC). Despite DFA being a critical capacity in the control of rabies, there is not a standardized protocol in the region. We describe the results of the first inter-laboratory proficiency exercise of national rabies laboratories in LAC countries as part of the regional efforts towards dog-maintained rabies elimination in the American region. Twenty three laboratories affiliated to the Ministries of Health and Ministries of Agriculture participated in this exercise. In addition, the laboratories completed an online questionnaire to assess laboratory practices. Answers to the online questionnaire indicated large variability in the laboratories throughput, equipment used, protocols availability, quality control standards and biosafety requirements. Our results will inform actions to improve and harmonize laboratory rabies capacities across LAC in support for the regional efforts towards elimination of dog-maintained rabies.

Cádmio, Cromo e Chumbo Exames de Proficiência do Setor de Metais no Laboratório de Pediatria do HCFMRP-USP / Cadmium, Chromium and Lead Testing of Metal Sector Proficiency at the Laboratory of Pediatrics of the HCFMRP - USP

O laboratório clínico deve assegurar que os resultados produzidos reflitam, de forma fidedigna e consistente, a situação clínica apresentada pelos pacientes, de modo que não representem o resultado de alguma interferência no processo de aná-lise. A melhoria contínua dos processos envolvidos deve representar o foco principal de qualquer laboratório, tendo-se total e absoluto controle sobre todas as etapas do processo de realização dos exames, que compreende as fases pré-analítica, analítica e pós-analítica. Para isso, o controle de qualidade tem o objetivo de assegurar aos laboratórios um funcionamento confiável e eficiente, a fim de fornecer resultados válidos, em tempo útil e auxiliar os médicos nas decisões diagnósticas...

HLA-B*15:04:04, a novel HLA allele identified during proficiency testing in Brazil.

HLA-B*15:04:04 differs from HLA-B*15:04:01 by one nucleotide at codon 238 (gat > gac).