Recommendations for blood sampling in emergency departments from the European Society for Emergency Medicine (EUSEM), European Society for Emergency Nursing (EuSEN), and European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase. Executive summary.

AIM: Blood Sampling Guidelines have been developed to target European emergency medicine-related professionals involved in the blood sampling process (e.g. physicians, nurses, phlebotomists working in the ED), as well as laboratory physicians and other related professionals. The guidelines population focus on adult patients. The development of these blood sampling guidelines for the ED setting is based on the collaboration of three European scientific societies that have a role to play in the preanalytical phase process: EuSEN, EFLM, and EUSEM. The elaboration of the questions was done using the PICO procedure, literature search and appraisal was based on the GRADE methodology. The final recommendations were reviewed by an international multidisciplinary external review group. RESULTS: The document includes the elaborated recommendations for the selected sixteen questions. Three in pre-sampling, eight regarding sampling, three post-sampling, and two focus on quality assurance. In general, the quality of the evidence is very low, and the strength of the recommendation in all the questions has been rated as weak. The working group in four questions elaborate the recommendations, based mainly on group experience, rating as good practice. CONCLUSIONS: The multidisciplinary working group was considered one of the major contributors to this guideline. The lack of quality information highlights the need for research in this area of the patient care process. The peculiarities of the emergency medical areas need specific considerations to minimise the possibility of errors in the preanalytical phase.

Blood alcohol concentration in the clinical laboratory: a narrative review of the preanalytical phase in diagnostic and forensic testing.

The analysis of blood alcohol concentration (BAC), a pivotal toxicological test, concerns acute alcohol intoxication (AAI) and driving under the influence (DUI). As such, BAC presents an organizational challenge for clinical laboratories, with unique complexities due to the need for forensic defensibility as part of the diagnostic process. Unfortunately, a significant number of scientific investigations dealing with the subject present discrepancies that make it difficult to identify optimal practices in sample collection, transportation, handling, and preparation. This review provides a systematic analysis of the preanalytical phase of BAC that aims to identify and explain the chemical, physiological, and pharmacological mechanisms underlying controllable operational factors. Nevertheless, it seeks evidence for the necessity to separate preanalytical processes for diagnostic and forensic BAC testing. In this regard, the main finding of this review is that no literature evidence supports the necessity to differentiate preanalytical procedures for AAI and DUI, except for the traceability throughout the chain of custody. In fact, adhering to correct preanalytical procedures provided by official bodies such as European federation of clinical chemistry and laboratory medicine for routine phlebotomy ensures both diagnostic accuracy and forensic defensibility of BAC. This is shown to depend on the capability of modern pre-evacuated sterile collection tubes to control major factors influencing BAC, namely non-enzymatic oxidation and microbial contamination. While certain restrictions become obsolete with such devices, as the use of sodium fluoride (NaF) for specific preservation of forensic BAC, this review reinforces the recommendation to use non-alcoholic disinfectants as a means to achieve "error-proof" procedures in challenging operational environments like the emergency department.

Preanalytical, analytical and postanalytical considerations in circulating microRNAs measurement.

Microribonucleic acids (miRNAs) have emerged as a new category of biomarkers for many human diseases like cancer, cardiovascular and neurodegenerative disorders. MicroRNAs can be detected in various body fluids including blood, urine and cerebrospinal fluid. However, the literature contains conflicting results for circulating miRNAs, which is the main barrier to using miRNAs as non-invasive biomarkers. This variability in results is largely due to differences between studies in sample processing methodology, miRNA quantification and result normalization. The purpose of this review is to describe the various preanalytical, analytical and postanalytical factors that can impact miRNA detection accuracy and to propose recommendations for the standardization of circulating miRNAs measurement.

How pre-analytical conditions impact glucose measurement and (gestational) diabetes diagnosis: A real-world stability study and a call for harmonization.

BACKGROUND AND AIMS: Since 2023, guidelines of the AACC/ADA recommend the use of citrate buffer-containing tubes as a first option for glucose measurement. This study aims to assess the pre-analytical stability of glucose under various conditions (room temperature (RT) or at 4 °C) and the potential real-world impact of introducing these tubes on (gestational) diabetes and IFG prevalence. MATERIALS AND METHODS: 25 healthy volunteers were sampled to assess glucose stability across time, at 4 °C and at RT, before and following centrifugation. 701 patients undergoing fasting plasma glucose analysis and 109 women having OGTT were collected according to current procedures (NaFl K2C2O4 (NaFl) tubes) as well as with citrate-containing tubes (FC Mix). RESULTS: The mean glucose concentration bias between FC Mix and NaFl tubes when centrifugation occurred within 5 min was 0.53 % and this difference raised slowly to reach 2.3 %, six-hours post-centrifugation. When centrifugation was delayed, a rapid decrease in glucose concentrations was observed for NaFl tubes (4.9 % at 30 min) and this trend was only partially reduced by placing samples at 4 °C (3.1 %). The decrease reached 10.8 % (RT) and 7.8 % (4 °C) at 2 h, before reaching a plateau. Samples collected on citrate remained stable during 24 h. In real-life conditions, the mean bias between FC Mix and NaFl tubes increased progressively over time and reached 8.59 % for samples centrifuged between two- and four-hours following sampling. Compared to widespread practices, the use of citrate-containing tubes increased IFG, DM and GDM prevalences by 84.0 %, 36.7 % and 150 %, respectively. CONCLUSIONS: Glucose concentrations rapidly decrease in NaFl tubes following collection and placing samples at 4 °C reduces only marginally the decay. Citrate-containing tubes offer a valuable solution for direct and long-lasting glucose stabilization but, before wider adoption, large epidemiologic studies should confirm or redefine current diabetes diagnostic thresholds.

Performance evaluation and characterization of pre-analytical effects by sample types and storage conditions on tumor marker measurement by the point-of-care test platform IchromaTM II.

Tumor markers should be measured regularly and accurately to prevent, diagnose, and monitor cancers efficiently. We aimed to characterize the pre-analytical factors effecting on the analytical performance of point-of-care test (POCT) platform IchromaTM II (Boditech Med Inc., Gangwon-do, Korea) for alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), and prostate specific antigen (PSA) and evaluate their consequences in clinical practice. Based on comprehensive evaluation for the analytical performance of IchromaTM II including precision, linearity, and method comparison performed according to CLSI guidelines, pre-analytical factors of sample types and conditions were extensively analyzed. A total of five sample types [serum, plasma (PL) and whole blood (WB) from EDTA tube, PL and WB from sodium heparin tube] from 40 patients were used for comparing among specimen types. Additionally, stability was assessed up to 21 h at room temperature, refrigerated for 8 days, and frozen for 16 weeks by using 4 levels of pooled patient samples which were measured in triplicate. Precision, linearity and correlation with central laboratory analyzers observed in all three tumor markers were within acceptable criteria. However, variable degrees of percent deviations were observed according to sample type and storage conditions. Only EDTA PL samples presented clinically acceptable percentage biases for all three tumor markers when stored at room temperature or refrigerated condition. Positive bias of CEA and PSA in storage duration until 16 weeks were observed when stored in frozen condition. While IchromaTM II showed an adequate analytical performance as a POCT platform with simple operating procedures for the measurement of tumor markers, clinical laboratories should be aware of stability issues when different types of blood specimens are practically utilized.

Os principais erros da fase pré-analítica de exames laboratoriais / The main errors of the pre-analytical phase of laboratory exams

As análises clínicas laboratoriais possuem papel fundamental na saúde, pois é através de seus resultados que 70% dos diagnósticos são concluídos pelos médicos, e desta forma é necessário que se preze pela emissão de resultados confiáveis. Entretanto, uma das fases do processo de realização dos exames laboratoriais tem se destacado como a fase que concentra o maior percentual de erros no âmbito laboratorial até os dias atuais. Trata-se da fase pré-analítica, que se inicia com a solicitação do exame e finaliza quando se inicia a análise. Os erros pré-analíticos podem ser responsáveis por até 75% dos erros laboratoriais, o que mostra a vulnerabilidade desta fase. Portanto, este trabalho tem como objetivo identificar os principais erros que estão vinculados à fase pré-analítica, assim como os impactos que esses erros podem causar. Os tipos de erros pré-analíticos foram revisados na literatura entre os anos de 2011 a 2020. Os resultados apontaram que os principais erros pré-analíticos estão associados ao momento da coleta de amostras biológicas. Isto mostra a necessidade de gerar melhorias nos setores de coleta, através da realização de treinamentos voltados para as equipes de flebotomia, com o intuito de aperfeiçoar este processo e diminuir as taxas dos erros provocados nesta fase.

The clinical laboratory analyses have a fundamental role in health, because it is through their results that 70% of the diagnoses are concluded by the doctors, therefore, it is necessary to give priority to the issuance of reliable and safe results. However, one of the phases of the process of performing laboratory tests has been highlighted as the phase that concentrates the highest percentage of errors in the laboratory environment until the present day.It is the pre-analytical phase, which begins with the request of the exam and ends when the analysis begins.The pre-analytical errors can be responsible for up to 75% of laboratory errors, which shows the vulnerability of this phase. Therefore, this work aims to identify the main errors that are linked to the pre-analytical phase, as well as the impacts that these errors may cause. The types of pre-analytical errors were reviewed in the literature between 2011 and 2020. The results showed that the main pre-analytical errors are associated with the time of collection of biological samples. This shows the need to generate improvements in the collection sectors, through training for phlebotomy teams, in order to improve this process and decrease the rates of errors caused in this phase.

Stability of refrigerated whole blood samples for osmotic fragility test

ABSTRACT Background: The osmotic fragility test (OFT), conventionally used for assisting the diagnosis of many erythrocyte disorders, is a manual and time-consuming analysis not daily performed in many medical laboratories. This study was aimed at defining the stability of whole blood samples used for assessing erythrocyte osmotic resistance. Methods: Twenty-one consecutive routine whole blood samples collected into 5.4 mg K2EDTA were tested immediately after collection (day 0) and at different time intervals afterward (day 1, 2, 3, 4, 7, 10 and 14) after storage at 4 °C. The OFT was performed with the Osmored Monotest (1.3% glycerol; Eurospital, Trieste, Italy). Results at the different time points were compared with those obtained at day 0 and with the reference change value (i.e., 33%). Results: The median value of both hyperosmolar and hyposmolar resistance increased from baseline, reaching statistical significance at day 7 for hyperosmolar resistance and at day 1 for hyposmolar resistance, respectively. The median relative increase of hemolysis percentage values become greater than the reference change value at day 3 for hyposmolar resistance, while this limit was never overcome for hyperosmolar resistance. A significant inverse association was found between the mean increase in hyperosmolar resistance and the baseline value of hyperosmolar resistance (r = −0.92), mean corpuscular volume (MCV; r = −0.46) or mean corpuscular hemoglobin (MCH; r = −0.44), as well as between the mean increase in hyposmolar resistance and the baseline value of hyposmolar resistance (r = −0.86), or patient age (r = −0.56). Conclusions: The sample stability seems critical for the OFT. Whole blood specimens should not be stored refrigerated at 4 °C for >2 days before testing.

Mejora de la calidad en el preanálisis de la Unidad Técnica de Patología Clínica / Improvement of quality processes in the preanalysis of the Clinical Pathology Technical Unit

INTRODUCCIÓN. El preanálisis es un proceso en el que se presenta el 71,0% de errores en el laboratorio clínico, por la presencia de factores como: la falta de automatización y la intervención de personal propio y ajeno al servicio, que lo convierte en vulnerable. OBJETIVO. Identificar, definir y estandarizar sub procesos preanalíticos en base a la norma ISO 15189:2012, identificar y realizar pilotaje de la aplicación de indicadores armonizados como elementos de mejora continua de la calidad. MATERIALES Y MÉTODOS. Estudio de tipo observacional, descriptivo en el que se identificó el proceso preanalítico actual y sus sub procesos; se los estandarizó previo a un pilotaje, definiendo los indicadores para su aplicación en la Unidad Técnica de Patología Clínica del Hospital de Especialidades Carlos Andrade Marín de la ciudad de Quito, Ecuador en el periodo junio a diciembre de 2018. RESULTADOS. Los subprocesos preanalíticos estandarizados fueron: Atención al Usuario, Identificación y generación de códigos, Toma de muestras, Transporte, preservación interna, separación y distribución de muestras; y, Referencia y contra referencia con sus procedimientos correspondientes y el tablero de indicadores. CONCLUSIÓN. Utilizar la norma de acreditación ISO15189:2012 para identificar y estandarizar sub procesos del proceso preanalítico, permitirá la mejora continua de la gestión de la calidad del laboratorio hospitalario de alta complejidad en su nivel de productividad.

INTRODUCTION. Pre-analysis is a process where 71,0% of errors made in the clinical laboratory, due to the existence of factors such as: lack of automation and in tervention of own personnel and other personnel non-related to the service, which render the process vulnerable. OBJECTIVE: To identify, define and standardize preanalytic sub processes, based on ISO 15189:2012 standard, identify and pilot the application of harmonized indicators as elements of continuous quality improvement. MATERIALS AND METHODS. Observational-descriptive study where the current preanalytical process and its sub processes were identified; they were standardized prior to piloting, defining the indicators in the Clinical Pathology Technical Unit of the Hospital de Especialidades Carlos Andrade Marín of the city Quito, Ecuador in the period from June to December 2018. RESULTS. The standardized pre-analytic processes were: Customer service, Identification and generation of codes, Sampling, Transportation Internal preservation, separation and distribution of samples; and, Reference and counter reference with their corresponding procedures and the indicator board. CONCLUSION. To use the accreditation standard ISO15189:2012 to identify and standardize pre-analytic sub-processes, will allow the continuous improvement of the quality management of the hospital laboratory of high complexity in its level or productivity.

Tomar mate previo a la flebotomía no interfiere en las pruebas bioquímicas de rutina / Drinking mate prior to phlebotomy does not interfere with routine biochemical tests

En este estudio se evaluó el efecto de tomar mate en las pruebas bioquímicas de rutina. Se extrajo sangre a 32 mujeres voluntarias luego de 12 horas de ayuno y a la hora (T1), dos horas (T2) y tres horas (T3) posteriores a la toma de 5 mates. Se estudiaron parámetros hematológicos y analitos de química clínica. Los resultados se analizaron empleando pruebas estadísticas para muestras relacionadas. Se calculó la diferencia porcentual media (DM%) de cada analito en cada hora respecto del valor basal y se comparó con el valor de referencia del cambio (VRC). Una DM% mayor que el VRC se consideró clínicamente significativa. En T1, T2 y T3 los recuentos de neutrófilos, eosinófilos y linfocitos fueron más bajos que en T0, también los niveles de glucosa, urea, creatinina y cistatina C fueron más bajos que en T0, mientras que los valores de proteínas totales, colesterol transportado por lipoproteínas de baja densidad y la actividad enzimática de lactato deshidrogenasa fueron más altos que en T0. En todos los casos los cambios fueron estadísticamente significativos, aunque no lo fueron desde el punto de vista clínico. Tomar 5 mates antes de la flebotomía no interfiere en los resultados de las pruebas bioquímicas de rutina.

In the present study the effect of drinking mate in routine biochemical tests was evaluated. Blood was collected from 32 female volunteers after a 12 h fasting period. In addition, 1 hour (T1), 2 hours (T2), and 3 hours (T3) after drinking 5 mates, blood was collected again. Hematological parameters and clinical chemistry analytes were studied. The results were analyzed using statistical tests for related samples. Mean difference % (MD%) was calculated for each analyte and was further compared with reference change value (RCV). The MDs% higher than RCV were considered clinically significant. At T1, T2, and T3 the count neutrophils, eosinophils and lymphocytes were lower than at T0. Also glucose, urea, creatinine, and cystatin C values were lower than at T0 whereas total proteins, LDL-C, and LD enzymatic activity values were higher than at T0. In all cases, variability was statistically significant but not clinically significant. Drinking 5 mates prior to phlebotomy does not interfere with the results of routine biochemical tests.

Neste trabalho, o efeito de beber chimarrão foi avaliado em testes bioquímicos de rotina. O sangue foi extraído de 32 mulheres voluntárias após 12 horas de jejum, e uma hora (T1), duas horas (T2) e três horas (T3) após a tomada de 5 chimarrões. Parâmetros hematológicos e analitos de química clínica foram estudados. Os resultados foram analisados utilizando testes estatísticos para amostras relacionadas. A diferença percentual média% (DM%) de cada analito em cada hora foi calculada em relação ao valor basal e comparada com o valor de referência da modificação (VRM). Uma DM% maior que o VRM foi considerada clinicamente significativa. Em T1, T2 e T3 as contagens de neutrófilos, eosinófilos e linfócitos foram mais baixas que em T0, Também os níveis de glicose, ureia, creatinina e cistatina C foram mais baixos que em T0, ao passo que os valores de proteínas totais, colesterol transportado por lipoproteínas de baixa densidade e a atividade enzimática de lactato desidrogenase foram mais altos que em T0. Em todos os casos as alterações foram estatisticamente significativas, embora do ponto de vista clínico não o tenham sido. Tomar 5 chimarrões antes da flebotomia não interfere nos resultados dos testes bioquímicos de rotina.

Recomendaciones en el proceso preanalítico del análisis de semen II. Recomendación 2016 / Recommendations on the pre-analytical process of semen analysis II. Recommendation 2016

Las condiciones de obtención y transporte de las muestras tienen influencia en los resultados del análisis de semen en el laboratorio. El diseño y la implementación de un protocolo adecuado para la fase preanalítica es necesario para generar resultados fiables. Este documento trata de proporcionar una serie de recomendaciones en la información que debe ser incluida en las instrucciones a los pacientes. También caracteriza variables y factores de confusión, como el periodo de abstinencia, el lugar de obtención de la muestra, etc. en un listado de verificación

Collection and transport of semen samples can have an influence on the laboratory analysis results. The design and implementation of a protocol suitable for the pre-analytical phase is required in order to offer accurate results. This document is intended to provide a series of recommendations on the information that should be included in the instructions to the patients. Furthermore, it mentions pre-analytical confounders, such as the period of sexual abstinence, the location where the semen sample was obtain, as well as explanatory variables, included in a sample reception checklist

Recomendaciones preanalíticas para la obtención y análisis de ADN circulante a partir de sangre periférica. Recomendación (2018) / Preanalytical recomendations for circulating DNA extraction and analysis from peripheral blood. Recommendation (2018)

El análisis de ADN circulante a partir de sangre periférica ha demostrado ser de utilidad en campos clínicos tan diferentes como la oncología, los trasplantes y el cribado prenatal. Para su incorporación al laboratorio clínico es necesario asegurar protocolos preanalíticos adecuados, reproducibles y estandarizados. En este documento se pretenden dar unas recomendaciones preanalíticas para la obtención de ADN circulante a partir de sangre periférica. Incluyen el tipo de espécimen, el tipo de tubo de extracción, el modo de centrifugación de la muestra, la extracción del ADN circulante y cuantificación, así como su conservación

Cell-free DNA analysis in peripheral blood has been shown to be useful in oncology, organ transplantation, and prenatal screening. For its introduction into the clinical laboratory, it is necessary to ensure appropriate, reproducible and standardised pre-analytical protocols are in place. The aim of this document is to provide pre-analytical recommendations for obtaining of cell free DNA from peripheral blood. These recommendations include the type of sample and extraction tube, the method of centrifugation, the method for cell free DNA extraction, and measurement and storage conditions

Recomendaciones para el diseño e implementación de un programa de aseguramiento de la calidad de la fase preanalítica / Recommendations for the design and implementation of a Pre-analytical Phase Quality Assurance Program

El aseguramiento de la calidad de la fase preanalítica se orienta hacia 2 aspectos clave: la gestión de los errores preanalíticos desde la perspectiva de la seguridad del paciente, y la mejora y armonización de los procedimientos, basada en la aplicación de normativa además de recomendaciones profesionales. Al igual que el resto de las fases, debe incluir un programa interno de aseguramiento y la participación en programas de intercomparación entre laboratorios. El control de calidad interno debe basarse fundamentalmente en la identificación de riesgos, detección sistemática de errores y establecimiento de indicadores. La selección de los indicadores priorizando el impacto en el paciente, la forma de detectar y registrar los errores de forma sistemática y fácilmente explotable, así como las variables utilizadas en su cálculo, son aspectos importantes para medir la eficacia de las acciones de mejora y permitir la comparabilidad entre laboratorios. En este sentido, los programas externos de la calidad de la fase preanalítica basados en la comparación de indicadores, son una herramienta útil para el diseño e implantación de un programa de aseguramiento de la calidad. Este documento pretende servir de apoyo para que cada laboratorio seleccione, implante y evalúe sus propios indicadores, de acuerdo a las características individuales de sus procedimientos preanalíticos, pero sin perder de vista la armonización entre laboratorios

The quality assurance of the pre-analytical phase is oriented towards two key aspects; the management of pre-analytical errors from the perspective of patient safety, and the improvement and harmonisation of procedures, based on the application of regulations and professional recommendations. Like the rest of the phases, it should include an internal quality assurance program, as well as the participation in external quality assurance programs. The internal quality control should mainly be based on the identification of risks, systematic detection of errors, and establishment of indicators. The selection of indicators prioritising the impact on the patient, the way to detect and record errors in a systematic and easily exploitable manner, and also the variables used in the calculations, are important aspects to measure the effectiveness of improvement actions and to allow comparability between laboratories. In this sense, the external quality assurance programs of the pre-analytical phase based on the comparison of indicators are a useful tool for the design and implementation of a quality assurance program. This document is intended as a support for each laboratory to select, implement, and evaluate its own indicators, according to the individual characteristics of its pre-analytical procedures, but without losing sight of the harmonisation between laboratories

Recomendaciones preanalíticas para la medición del equilibrio ácido-base y los gases en sangre. Recomendación (2018) / Preanalytical recommendations in blood gas analysis

El análisis de gases en sangre es una prueba frecuentemente solicitada en diferentes ámbitos hospitalarios. La medida de los parámetros incluidos en este análisis puede verse afectada por un elevado número de condiciones preanalíticas y es responsabilidad del laboratorio garantizar que los resultados reflejan de forma segura el equilibrio ácido-base y el estado de oxigenación del paciente. Aunque muchas de estas condiciones son comunes al resto de las magnitudes del laboratorio, como la identificación correcta del espécimen, algunas son propias del análisis de gases debido a la estabilidad de las magnitudes incluidas en él. Este documento establece recomendaciones para el control de las condiciones preanalíticas y otras fuentes de error relacionadas con el análisis de gases en sangre, tales como las características de los materiales empleados para la toma de muestra (jeringas, agujas y anticoagulantes), tipo de muestra (sangre arterial, venosa y capilar «arterializada») y las condiciones para el manejo y transporte de la muestra, incluyendo la influencia del tiempo transcurrido entre la extracción y el análisis, la temperatura de la muestra durante el transporte y el transporte en sí

Blood gas analysis is a commonly ordered test in different hospital settings. The measurement of the parameters included in this analysis is vulnerable to a huge number of pre-analytical conditions. Laboratory staff are responsible for ensuring that these results accurately reflect the acid-base and oxygenation status of the patient. Despite many pre-analytical steps in blood gas testing being common to other laboratory tests, such as proper sample identification, others are particular for this determination, such as the stability of the analytes measured. The aim of this document is to provide recommendations for the control of the pre-analytical variables and other error sources related to blood gas analysis. These include the characteristics of the materials used to collect the blood samples (syringes, needles and anticoagulants), the sample types (arterial, venous and «arterialised» capillary blood), as well as the conditions for sample handling and transport, including the effect of the time between sampling and analysis, the temperature during transport, and the type of transport

¿Es necesario el ayuno para la determinación del perfil lipídico? / Is fasting necessary for the determination of the lipid profile?

El propósito de este estudio fue analizar los cambios post prandiales en el perfil lipídico en respuesta a una comida típica argentina. Se extrajo sangre a 33 mujeres voluntarias después de 12 h de ayuno (T0), 1 h después de un desayuno estandarizado (T1) y 1 h después de un almuerzo estandarizado (T2). Se midieron los niveles de: colesterol total, colesterol de lipoproteínas de alta densidad (C-HDL), colesterol de lipoproteínas de baja densidad (C-LDL) y triglicéridos. Los datos se analizaron utilizando la prueba t de Student pareada. Para cada analito se calculó la diferencia porcentual media (DM%) en T1 y T2 respecto de T0 y se comparó con el valor de referencia del cambio (VRC). Las DM% mayores al VRC se consideraron clínicamente significativas. En T1 y T2, los valores de C-HDL fueron más bajos que en T0, mientras que los valores de C-LDL en T1 fueron más bajos que en T0. Los niveles de triglicéridos fueron significativamente más altos en T1 que en T0. En todos los casos, la variabilidad fue estadísticamente significativa, aunque no clínicamente. En este estudio puede observarse que el perfil de lípidos en T1 y T2 no mostró diferencias clínicamente significativas con respecto a los valores basales.

The purpose of the present study was to analyze postprandial lipid profile changes in response to a typical Argentine meal. Blood was collected from 33 female volunteers after a 12 h fasting period (T0), 1 h after a standardized breakfast (T1) and 1 h after a standardized lunch (T2). The levels of total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides were measured. Data were analyzed using paired Student's t-test. Mean difference % (MD %) was calculated for each analyte at T1 and T2 and was further compared with reference change value (RCV). MDs % higher than RCV were considered clinically significant. At T1 and T2, HDL-C values were lower than at T0, whereas LDL-C values at T1 were lower than at T0. Triglycerides levels were significantly higher at T1 than baseline values. In all cases, variability was statistically, though not clinically, significant. This study demonstrates that at T1 and T2 lipid profile showed no clinically significant differences with respect to basal values.

O objetivo do presente estudo foi analisar as alterações do perfil lipídico pós-prandial em resposta a uma refeição típica argentina. O sangue foi coletado de 33 mulheres voluntárias após um período de jejum de 12 horas (T0),1 h após um café da manhã padronizado (T1) e 1 h após um almoço padronizado (T2). Foram medidos os níveis de: colesterol total (CT), colesterol HDL (C-HDL), colesterol LDL (C-LDL) e triglicérides. Os dados foram analisados utilizando o teste t de Student pareado. A diferença média% (DM%) foi calculada para cada analito em T1 e T2 e foi comparada com o valor de mudança de referência (VRC). Os MDs% maiores que o VRC foram considerados clinicamente significativos. Em T1 e T2, os valores de C-HDL foram menores que em T0, enquanto os valores de C-LDL em T1 foram menores que em T0. Os níveis de triglicérides foram significativamente maiores em T1 do que os valores basais. Em todos os casos, a variabilidade foi estatisticamente, embora não clinicamente, significativa. Este estudo demonstra que no perfil lipídico em T1 e T2 não houve diferenças clinicamente significativas em relação aos valores basais.

Influencia de los anticoagulantes EDTAK² y EDTAK³ en los resultados del hemograma / Influence of the EDTAK² and EDTAK³ anticoagulants on hematology testing results / Influência dos anticoagulantes EDTAK² e EDTAK³ nos resultados do hemograma

El International Council for Standardization in Haematology (ICSH) recomienda el uso de ácido etilendiaminotretaacético dipotásico (EDTAK2) como anticoagulante para el hemograma, mientras que el Clinical and Laboratory Standards Institute (CLSI) EDTAK2 o ácido etilendiaminotetraacético tripotásico (EDTAK3). El objetivo de este trabajo fue evaluar la influencia del tipo de sal de EDTA utilizado en la variación de los resultados de los parámetros hematológicos. Se recolectaron 24 muestras por venopunción, de cada una se cargó una alícuota en EDTAK3 y otra en EDTAK2. De los 23 parámetros evaluados en el autoanalizador Sysmex XN1000 (Roche Diagnostics), sólo los de la serie roja presentaron diferencias estadísticamente significativas en las muestras pareadas (p<0,05). El sesgo superó las especificaciones de calidad de Variabilidad Biológica Mínima para hematocrito (2,9%) y concentración de hemoglobina corpuscular media (1,7%), de Variabilidad Biológica Deseable para el volumen corpuscular medio (1,7%) y Variabilidad Biológica Óptima para hemoglobina (1,2%) y recuento de eritrocitos (1,2%). No se hallaron diferencias significativas en los parámetros de la serie blanca, ni en los plaquetarios y tampoco en los reticulocitarios. Para disminuir el error preanalítico, cada laboratorio debe estandarizar la extracción de los hemogramas empleando un único tipo de anticoagulante.

The International Council for Standardization in Haematology (ICSH) currently supports de use of ethylenediaminetetraacetic acid dipotassium (EDTAK2) anticoagulant for hematology testing, while the Clinical and Laboratory Standards Institute (CLSI) recommends EDTAK2 or ethylenediaminetetraacetic acid tripotassium (EDTAK3). The objective of this study was to evaluate the influence of the EDTA formulations in the results of hematologic parameters. A total of 24 samples were collected by venous puncture and two aliquots were loaded: one in EDTAK3 and another in EDTAK2. Of the 23 hematologic parameters tested with the use of Sysmex XN1000 (Roche diagnostics) hematologic analyser, only those in the red series showed statistically significant differences in the paired samples (p < 0.05). The bias exceeded the quality specifications of Minimum Biological Variability for hematocrit (2.9%) and mean corpuscular hemoglobin concentration (1.7%), Desirable Biological Variability for the mean corpuscular volume (1.7%) and Biological Variability Optimal for hemoglobin (1.2%) and erythrocyte count (1.2%). No significant differences were found in the parameters of white series, neither platelets, nor reticulocytes. To reduce the preanalytical error, each laboratory should standardize the extraction for complete blood cell count using a single type of anticoagulant.

A International Council for Standardization in Haematology (ICSH) recomenda a utilização do ácido etileno diamino treta-acético dipotássico (EDTAK2) como anticoagulante para hemograma, enquanto que a Clinical and Laboratory Standards Institute (CLSI) EDTAK2 ou ácido etileno diamino treta-acético tripotássico (EDTAK3). O objetivo deste trabalho foi avaliar a influência do tipo de sal de EDTA utilizado na variação dos resultados dos parâmetros hematológicos. Foram recolhidas 24 amostras por venopunção, de cada uma se carregou uma alíquota de EDTAK3 e outra de EDTAK2. Dos 23 parâmetros avaliados no autoanalisador Sysmex XN1000 (Roche Diagnostics), apenas aqueles da série vermelha apresentaram diferenças estatisticamente significativas nas amostras emparelhadas (p<0,05). O viés superou as especificações de qualidade da Variabilidade Biológica Mínima para o hematócrito (2,9%) e concentração de hemoglobina corpuscular média (1,7%), de Variabilidade Biológica Desejável para o volume corpuscular médio (1,7%) e Variabilidade Biológica Ótima para a hemoglobina (1,2%) e contagem de eritrócitos (1,2%). Não foram encontradas diferenças significativas nos parâmetros da série branca, nem nos plaquetários, nem nos reticulocitários. Para reduzir o erro pré-analítico, cada laboratório deve padronizar a extração dos hemogramas usando um único tipo de anticoagulante.

Necesidad de armonizar la etapa preanalítica de la orina de 24 horas: evidencias de una encuesta / Need to harmonize the pre-analytical phase of 24-hour urine: evidence from a survey / Necessidade de harmonizar a fase pré-analítica da urina de 24 horas: evidência de uma pesquisa

El objetivo del trabajo consistió en evaluar el estado de armonización de la etapa preanalítica de la orina de 24 horas (orina-24h). Se realizó una encuesta anónima sobre la etapa preanalítica de la orina-24h a bioquímicos de Argentina. Respondieron 92 profesionales. Del análisis de las respuestas surge que el 95% de los bioquímicos facilita a los pacientes instrucciones escritas para la recolección; 11% incluye instrucciones con información visual gráfica además de escrita; 37% registra hora de inicio y finalización de la recolección; 59% recomienda que durante la misma la muestra se mantenga refrigerada; 73% suministra al paciente el recipiente para la recolección; 47% proporciona el envase con conservante, si corresponde; 100% solicita al paciente llevar al laboratorio la totalidad de la orina juntada; 4% solicita al paciente medir y anotar la diuresis y entregar al laboratorio una alícuota de la orina-24h; 78% realiza una o más acciones para evaluar la correcta recolección. Los criterios de rechazo seleccionados en orden decreciente fueron: pérdida de micciones, incumplimiento del tiempo de recolección, según la diuresis, según la eliminación diaria de creatinina y recipiente no apto. Esta encuesta evidenció que existen aspectos de la etapa preanalítica de la orina- 24h que requieren de mejora y armonización entre los laboratorios.

The objective of the present work was to evaluate the harmonization state of the pre-analytical phase of 24-hour urine. To this aim, an anonymous survey on the pre-analytical phase of 24-hour urine (Moreno-Carbonell, et. al) was carried out by biochemists from Argentina. A total of 92 professionals responded to the the survey. As a result, 95% provide patients with written instructions for collection; 11% include visual graphic instructions; 37% record starting and finishing time of collection; 59% recommend sample refrigeration during collection time; 73% supply the container; 47% provide the container with a preservative, if necessary; 100% ask the patient to take the complete 24-hour volume to the laboratory; 4% indicate to measure and record sample volume and to take an aliquot of it; and 78% perform one or more actions to evaluate the proper collection procedure. The rejection criteria selected in decreasing order were: loss of micturition, non-compliance with collection time, according to the volume and daily creatinine excretion, and improper container. To conclude with, this survey showed that there are aspects of the pre-analytical phase of 24-h urine that need improvement and harmonization between laboratories.

O objetivo do trabalho foi avaliar o estado de harmonização da fase pré-analítica da urina de 24 horas (urina-24h). Foi realizado um levantamento anônimo sobre a fase pré-analítica da urina-24h a bioquímicos da Argentina. Responderam 92 profissionais. Da análise das respostas surge que 95% fornecem aos pacientes instruções escritas para a coleta; 11% inclui instruções com informação visual gráfica além de escrita; 37% registra hora de início e finalização da coleta; 59% recomenda que durante a coleta a urina seja mantida refrigerada; 73% fornece o recipiente para a coleta; 47% fornece o recipiente com um conservante, se necessário; 100% solicita ao paciente que leve o volume completo de 24 horas ao laboratório; 4% indica ao paciente medir e registrar a diurese e entregar ao laboratório uma alíquota da urina-24h; 78% realiza uma ou mais ações para avaliar o procedimento apropriado de coleta. Os critérios de rejeição selecionados em ordem decrescente foram: perda das micções, descumprimento do tempo de coleta, de acordo com a diurese, conforme a eliminação diária de creatinina, e recipiente inadequado. Esta pesquisa mostrou que há aspectos da fase pré-analítica da urina de 24h que precisam ser melhorados e harmonizados entre os laboratórios.

Calidad en la etapa preanalítica: importancia del ayuno / Quality in the preanalytical phase: the significance of fasting / Qualidade na fase pré-analítica: a importância do jejum

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

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

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

Evaluación de errores preanalíticos en el laboratorio de planta del HIGA O. Alende de Mar del Plata / Evaluation of preanalytical mistakes in the routine laboratory of HIGA O. Alende of Mar del Plata / Avaliação de erros pré-analíticos no laboratório de rotina do HIGA O. Alende de Mar del Plata

La etapa preanalítica corresponde a todos los pasos que deben seguirse en orden cronológico hasta iniciar el procedimiento analítico. Los objetivos de este trabajo fueron evaluar los errores preanalíticos de los ingresos diarios a la planta del laboratorio con al menos una solicitud que involucrara a las secciones de Química Clínica y/o Hematología-Hemostasia, en el HIGA O. Alende de Mar del Plata. Se definió como error preanalítico (EPA) a todo error cometido en la solicitud/ingreso o en la extracción/recogida de la muestra. Se calculó el porcentaje de ingresos con uno o más EPA, la frecuencia de cada tipo de error, y la distribución de errores por servicio y por día de la semana. Se analizaron, en total, 7850 ingresos, de los cuales el 82% presentó uno o más EPA. Se relevó un total de 9141 errores, siendo el 91% en la solicitud/ingreso de la muestra. Se concluye que existe un elevado número de errores preanalíticos, de los cuales el mayor porcentaje se encuentra en la solicitud/ingreso. Dado que en el origen de estos errores participa gran parte del personal hospitalario, es importante concientizarlo para lograr la mejora en la calidad de los resultados de laboratorio, fundamentales para la toma de decisiones médicas.

The preanalytical phase involves all steps to be followed in chronological order until the start of the analytical procedure. The objectives of this study were to evaluate pre-analytical mistakes of the daily routine proceeds to the laboratory with at least one application involving sections of Clinical Chemistry and/or Hematology Hemostasis in HIGA O. Alende of Mar del Plata. They were defined as pre-analytical errors (EPA) any error in the application/ admission or extraction/collection of the sample. Were calculated the percentage of applications with one or more EPA, the frequency of each type of error, and the error distribution per service and day of week. Seven thousand and eight hundred and fifty applications were analyzed, of which 82% had one or more EPA. A total of 9141 errors were surveyed, with 91% errors in the application / admission of the sample. It was concluded that there are a large number of pre-analytical errors, of which the highest percentage is in the application / admission. Much of the hospital staff participates in the origin of these mistake; therefore it is important to sensitize them to achieve improved quality of laboratory results, essential for making medical decisions.

A fase pré-analítica corresponde a todos os passos a serem seguidos em ordem cronológica até o início do procedimento analítico. O objetivo deste estudo foi avaliar os erros pré-analíticos das admissões diárias no laboratório com, no mínimo, uma solicitação que envolva as seções de Química Clínica e/ou Hematologia-Hemostasia no HIGA O. Alende de Mar del Plata. Foi definido como erro pré-analítico (EPA), qualquer erro na solicitação/ admissão ou na extração/coleta da amostra. Foi calculado o percentual de admissões com um ou mais EPA, a frequência de cada tipo de erro, e a distribuição de erros por serviço e por dia da semana. No total, 7850 admissões foram analisadas, das quais 82% apresentou um ou mais EPA. Levantaram-se em total 9.141 erros, sendo 91% erros na solicitação/admissão da amostra. Conclui-se que há um grande número de erros pré-analíticos, dos quais o maior percentual se encontra na solicitação/admissão. Visto que na origem desses erros participa grande parte de funcionários do hospital, é importante sensibilizá-los para alcançar a melhoria da qualidade dos resultados laboratoriais, fundamentais para a tomada de decisões médicas.