Evaluation of five immunoassays and one lateral flow immunochromatography for anti-SARS-CoV-2 antibodies detection.

INTRODUCTION: In order to deal with the current pandemic caused by the novel SARS-CoV-2 coronavirus several serological immunoassays have been recently developed with the objective of being used as a complementary diagnostic tool and to support the RT-PCR technique currently considered the "gold-standard" method. However, these new assays need to be evaluated and validated. The purpose of this study was to assess the performance of five immunoassays (two ELISA and three CLIA assays) and one rapid immunochromatographic test for the detection of anti-SARS-CoV-2 antibodies. METHODS: Five semiquantitative immunoassays (MENARINI®, PALEX®, VIRCLIA®, ROCHE® and SIEMENS®) and one lateral flow rapid test (WONDFO®) were performed. A total of 124 samples were studied. Case serum samples (n=78) were obtained from COVID-19 patients confirmed by real-time RT-PCR/epidemiological-clinical-radiological criteria, and control non-SARS-CoV-2 samples (n=46) belonged to healthy healthcare workers involved in a seroprevalence study. RESULTS: Overall, the tests showed sensitivities around 70-90% and specificities greater than 95%, including the immunochromatographic test. In addition, we observed very good agreements among them, being better for the detection of IgG than for IgM antibodies (Cohen's kappa index of 0.95 for VIRCLIA® IgG with ROCHE®), as well as good diagnostic power of the tests as determined by the ROC curves. CONCLUSIONS: This study demonstrates the proper performance of the different immunoassays in order to be applied in the clinical practice as support in the diagnostic approach and in the development of vaccines and seroepidemiological studies of COVID-19.

Evaluation of five immunoassays and one lateral flow immunochromatography for anti-SARS-CoV-2 antibodies detection / Evaluación de cinco inmunoensayos y una inmunocromatografía de flujo lateral para la detección de anticuerpos anti-SARS-CoV-2

Introduction: In order to deal with the current pandemic caused by the novel SARS-CoV-2 coronavirus several serological immunoassays have been recently developed with the objective of being used as a complementary diagnostic tool and to support the RT-PCR technique currently considered the “gold-standard” method. However, these new assays need to be evaluated and validated. The purpose of this study was to assess the performance of five immunoassays (two ELISA and three CLIA assays) and one rapid immunochromatographic test for the detection of anti-SARS-CoV-2 antibodies. Methods: Five semiquantitative immunoassays (MENARINI®, PALEX®, VIRCLIA®, ROCHE® and SIEMENS®) and one lateral flow rapid test (WONDFO®) were performed. A total of 124 samples were studied. Case serum samples (n=78) were obtained from COVID-19 patients confirmed by real-time RT-PCR/epidemiological-clinical-radiological criteria, and control non-SARS-CoV-2 samples (n=46) belonged to healthy healthcare workers involved in a seroprevalence study. Results: Overall, the tests showed sensitivities around 70–90% and specificities greater than 95%, including the immunochromatographic test. In addition, we observed very good agreements among them, being better for the detection of IgG than for IgM antibodies (Cohen's kappa index of 0.95 for VIRCLIA® IgG with ROCHE®), as well as good diagnostic power of the tests as determined by the ROC curves. Conclusions: This study demonstrates the proper performance of the different immunoassays in order to be applied in the clinical practice as support in the diagnostic approach and in the development of vaccines and seroepidemiological studies of COVID-19.(AU)

Introducción: Para hacer frente a la pandemia actual causada por el nuevo coronavirus SARS-CoV-2 se han desarrollado recientemente varios inmunoensayos serológicos con el objetivo de ser utilizados como herramienta diagnóstica complementaria y apoyar la técnica de RT-PCR actualmente considerada como el “estándar de oro”. Sin embargo, estos nuevos ensayos deben evaluarse y validarse. El objetivo de este estudio fue evaluar cinco inmunoensayos (dos ELISA y tres ensayos CLIA) y una prueba inmunocromatográfica rápida para la detección de anticuerpos anti-SARS-CoV-2. Métodos: Se utilizaron cinco inmunoensayos semicuantitativos (MENARINI®, PALEX®, VIRCLIA®, ROCHE® y SIEMENS®) y un test de inmunocromatografía rápida (WONDFO®). Se estudiaron un total de 124 muestras. Las muestras de suero (n=78) se obtuvieron de pacientes COVID-19 confirmados por RT-PCR en tiempo real/criterios epidemiológicos-clínico-radiológicos. Las muestras control negativas (n=46) pertenecieron a personal sanitario involucrado en un estudio de seroprevalencia. Resultados: En general, las pruebas mostraron sensibilidades en torno al 70-90% y especificidades superiores al 95%, incluso la prueba inmunocromatográfica. Además, observamos muy buenas concordancias entre ellas, presentando mayores sensibilidades para la detección de anticuerpos IgG que para IgM (índice kappa de Cohen de 0,95 para VIRCLIA® IgG con ROCHE®), así como un buen poder diagnóstico de las técnicas determinado por las curvas ROC. Conclusiones: Este estudio demuestra el buen rendimiento de los diferentes inmunoensayos para ser empleados en la práctica clínica como apoyo en el proceso de diagnóstico, en el desarrollo de vacunas y estudios seroepidemiológicos de COVID-19.(AU)

Trimester-Specific Reference Ranges for Saturated, Monounsaturated and Polyunsaturated Fatty Acids in Serum of Pregnant Women: A Cohort Study from the ECLIPSES Group.

In the course of pregnancy, increasing importance is being placed on maintaining optimal fatty acid (FA) levels and particularly n-3 PUFAs to ensure correct fetal development. However, reference ranges for FA have been reported in only a few studies. Our objective is to provide quantitative reference intervals for SFAs, MUFAs, and PUFAs (n-6 and n-3) in a large population of healthy pregnant women from a developed country. A prospective study of pregnant women (n = 479) was conducted from the first trimester (T1) to the third trimester (T3). A total of 11 fatty acids were analyzed in serum by gas chromatography mass spectrometry and were expressed as absolute (µmol/L) and relative (percentage of total FA) concentration units. Serum concentrations of SFAs, MUFAs, n-6 PUFAs, n-3 PUFAs, various FA ratios, and the EFA index were determined. The reference intervals (2.5/97.5 percentiles) in absolute values from T1 ranged from 1884.32 to 8802.81 µmol/L for SFAs, from 959.91 to 2979.46 µmol/L for MUFAs, from 2325.77 to 7735.74 µmol/L for n-6 PUFAs, and from 129.01 to 495.58 µmol/L for n-3 PUFAs. These intervals mainly include the values of other studies from European populations. However, reference ranges vary according to some maternal factors. The FA levels proposed, obtained from a large sample of pregnant women, will be a useful tool for assessing the degree of adequacy of FAs in pregnant women and will help to carry out dietary interventions based on certain maternal factors.

Evaluation of five immunoassays and one lateral flow immunochromatography for anti-SARS-CoV-2 antibodies detection.

INTRODUCTION: In order to deal with the current pandemic caused by the novel SARS-CoV-2 coronavirus several serological immunoassays have been recently developed with the objective of being used as a complementary diagnostic tool and to support the RT-PCR technique currently considered the "gold-standard" method. However, these new assays need to be evaluated and validated. The purpose of this study was to assess the performance of five immunoassays (two ELISA and three CLIA assays) and one rapid immunochromatographic test for the detection of anti-SARS-CoV-2 antibodies. METHODS: Five semiquantitative immunoassays (MENARINI®, PALEX®, VIRCLIA®, ROCHE® and SIEMENS®) and one lateral flow rapid test (WONDFO®) were performed. A total of 124 samples were studied. Case serum samples (n=78) were obtained from COVID-19 patients confirmed by real-time RT-PCR/epidemiological-clinical-radiological criteria, and control non-SARS-CoV-2 samples (n=46) belonged to healthy healthcare workers involved in a seroprevalence study. RESULTS: Overall, the tests showed sensitivities around 70-90% and specificities greater than 95%, including the immunochromatographic test. In addition, we observed very good agreements among them, being better for the detection of IgG than for IgM antibodies (Cohen's kappa index of 0.95 for VIRCLIA® IgG with ROCHE®), as well as good diagnostic power of the tests as determined by the ROC curves. CONCLUSIONS: This study demonstrates the proper performance of the different immunoassays in order to be applied in the clinical practice as support in the diagnostic approach and in the development of vaccines and seroepidemiological studies of COVID-19.

Maternal Factors Associated with Levels of Fatty Acids, Specifically n-3 PUFA during Pregnancy: ECLIPSES Study.

An optimal fatty acid (FA) profile during pregnancy, especially docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), is essential for the health of the mother and child. Our aim was to identify the socioeconomic and maternal lifestyle factors associated with serum FA concentration in pregnant women. A longitudinal study was conducted on 479 pregnant women, who were assessed during the first (T1) and third (T3) trimesters of pregnancy. Data on maternal characteristics, food consumption, and lifestyle were collected. Serum FA concentrations were analysed by a gas chromatography-mass spectrometry combination. The multiple linear regression showed that high educational level and older age were significantly associated with higher EPA and DHA concentrations and lower values of n-6/n-3 and arachidonic acid (AA)/EPA in T1 and/or T3. Regarding diet-fish and seafood consumption increased EPA concentration and reduced n-6/n-3 and AA/EPA values in both trimesters, whereas its consumption increased DHA concentration only in T1. Smoking was associated with lower DHA concentration in T1 and higher values of n-6/n-3 ratio in both trimester. Overweight and obesity were associated with higher values of n-6/n-3 ratio and AA/EPA ratio in T1. A statistically non-significant association was observed with saturated fatty acids (SFA) and monounsaturated fatty acids (MUFA). In conclusion, high educational levels, older age, fish, seafood consumption, and/or non-smoking, are factors that influence better omega-3 polyunsaturated fatty acid (n-3 PUFA) profile in both trimesters of pregnancy. Further research is needed to go in-depth into these findings and their health consequences.

Procedimiento para la transferencia y revisión de intervalos de referencia biológicos / Procedure for transference and review of biological reference intervals

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Quality indicators for extra-analytical processes in clinical laboratory: ten years’ experience / Indicadores de calidad para los procesos extra-analíticos en el laboratorio clínico: 10 años de experiencia

Introduction. The selection and definition of quality indicators is essential for proper control of processes. This is not always easy, particularly with extra-analytical indicators, due to the complexity and degree of comparison of processes between laboratories, and the fact that data collection is not always automated. For this reason, the indicators and specifications need to be dynamic and re-designed in accordance with changes in the system. The aim of this paper is to describe the methodology used in the selection and definition of quality indicators, and their specifications for extra-analytical processes in public laboratories in Catalonia. Material and methods. During the study period (2004-2013), the members of the working group reported the mean annual value for each indicator, and the overall yearly mean of all participants was calculated. These results were compared and analyzed during periodic meetings, with regards to the pre-established specifications of the different laboratories. Results. Quality indicators and their specifications are presented. The evaluation of the validity of each quality indicator was made taking into account aspects including usefulness of the indicator in process monitoring, a clear definition, and a precise and reliable quantification. This methodology has made it possible to contrast the validity of the indicators or to reconsider the specification. Conclusions. The last 10 years’ experience of the Catalonian Health Institute Working Group on Quality Indicators in designing indicators and establishing quality specifications has proved very useful for improving the monitoring of processes in clinical laboratories included in the group (AU)

Introducción. La selección y definición de los indicadores de la calidad es imprescindible para controlar adecuadamente un proceso. Ello no siempre es fácil, sobre todo en el caso de los indicadores extraanalíticos, dada la complejidad y grado de comparabilidad de los procesos entre laboratorios y la necesaria recogida de datos que en muchas ocasiones no está automatizada. Asimismo, los indicadores y especificaciones deben ser dinámicos y rediseñarse en función de los cambios del sistema. El objetivo de este trabajo es describir la metodología utilizada en la selección y definición de indicadores de calidad y especificaciones para los procesos extraanalíticos en los laboratorios públicos de Cataluña. Material y métodos. Durante el período de estudio (2004-2013), los miembros del grupo han informado del valor medio anual para cada indicador, y se ha calculado la media anual de todos los participantes para cada uno de ellos. Estos resultados se han comparado y analizado a través de reuniones periódicas, con respecto a las especificaciones preestablecidas de los diferentes laboratorios. Resultados. Se presentan los indicadores de calidad y sus especificaciones. La evaluación de la validez de cada indicador de calidad se llevó a cabo teniendo en cuenta los aspectos incluyendo la utilidad del indicador en la supervisión de procesos, una definición clara y una cuantificación precisa y fiable. Esta metodología ha permitido contrastar la validez de los indicadores o reconsiderar la especificación. Conclusiones. Los últimos 10 años de experiencia del Grupo de Trabajo del Instituto Catalán de la Salud de Indicadores de Calidad en el diseño de indicadores y en establecer especificaciones de calidad ha demostrado ser muy útil para mejorar el seguimiento de los procesos en los laboratorios clínicos integrados en el grupo (AU)

Estado periconcepcional de ácido fólico: revisión sobre su relevancia para la salud de la madre y de la descendencia. Relevancia del estado periconcepcional de ácido fólico sobre el neurodesarrollo / Perioconceptional folic acid status: review about his relevance on the health of the mother and the offspring. Relevance of perioconceptional folic acid status on neurodevelopment

Fundamento: El déficit de ácido fólico durante el embarazo puede derivar en defectos del tubo neural en el feto, bajo peso al nacer y desórdenes del neurodesarrollo como trastornos de la conducta y de la cognición en el niño pero también puede conllevar anemia megaloblástica en la madre así como desprendimiento de la placenta, abortos, partos prematuros, preeclampsia e incluso eclampsia en algunas ocasiones. Objetivo: El objetivo de este trabajo es revisar los principales hallazgos científicos con relación a la importancia fisiológica del ácido fólico durante el embarazo así como los efectos negativos resultantes de un inadecuado nivel de folato periconcepcional, tanto por déficit como por exceso, y la evidencia existente sobre la relación entre suplementación con folato y los diferentes parámetros de salud, tanto de la madre como del recién nacido. Métodos: Se ha realizado una búsqueda amplia en la que se incluyen artículos originales, revisiones y guías de recomendaciones. Resultados/Conclusión: Tanto el déficit como el exceso de ácido fólico durante el embarazo pueden desencadenar efectos adversos para la madre y para el hijo. Por ello, la suplementación de ácido fólico debería ser individualizada para cada mujer teniendo en cuenta sus características fenotípicas, genotípicas y metabólicas (AU)

Background: The folic acid deficit during pregnancy may lead to a neural tube defects in the fetus, low birth weight and neurodevelopmental disorders as behavior disturbance or cognitive disabilities. Also may carry to the megaloblastic anemia in the mother as well as placental abruption, abortion, premature labor, pre-eclampsia and sometimes eclampsia. Objective: The objective of this work is to review the main scientific finds in relation with the physiological importance of folic acid during pregnancy and negative effects resulting of the inadequate level of folate periconceptional, both deficit and excess. Also review the evidence about the relationship between the folate supplementation and the different health parameters in the mother and the newborn. Methods: The search has been wide and this review includes original articles, review articles and recommendation guides. Results/Conclusion: Both deficit and excess folic acid during pregnancy can trigger adverse effects to the mother and the child. Therefore, supplementation with folic acid should be individualized for each woman considering its phenotypic, genotypic and metabolic characteristics (AU)