Teresa Arrobas Velilla, Carlos Guijarro, Raquel Campuzano Ruiz, Manuel Rodríguez Piñero, José Francisco Valderrama Marcos, Antonio Pérez Pérez, Antonio M. Botana López, Ana Morais López, José Antonio García Donaire, Juan Carlos Obaya, Luis Castilla Guerra, Vicente Pallares Carratalá, Isabel Egocheaga Cabello, Mercedes Salgueira Lazo, María Mar Castellanos Rodrigo, José María Mostaza Prieto, Juan José Gómez Doblas, Antonio Buño Soto
{"title":"Consensus document for lipid profile testing and reporting in Spanish clinical laboratories: what parameters should a basic lipid profile include?","authors":"Teresa Arrobas Velilla, Carlos Guijarro, Raquel Campuzano Ruiz, Manuel Rodríguez Piñero, José Francisco Valderrama Marcos, Antonio Pérez Pérez, Antonio M. Botana López, Ana Morais López, José Antonio García Donaire, Juan Carlos Obaya, Luis Castilla Guerra, Vicente Pallares Carratalá, Isabel Egocheaga Cabello, Mercedes Salgueira Lazo, María Mar Castellanos Rodrigo, José María Mostaza Prieto, Juan José Gómez Doblas, Antonio Buño Soto","doi":"10.1515/almed-2023-0047","DOIUrl":"https://doi.org/10.1515/almed-2023-0047","url":null,"abstract":"Abstract Cardiovascular diseases (CVD) continue to be the main cause of death in our country. Adequate control of lipid metabolism disorders is a key challenge in cardiovascular prevention that is far from being achieved in real clinical practice. There is a great heterogeneity in the reports of lipid metabolism from Spanish clinical laboratories, which may contribute to its poor control. For this reason, a working group of the main scientific societies involved in the care of patients at vascular risk, has prepared this document with a consensus proposal on the determination of the basic lipid profile in cardiovascular prevention, recommendations for its realization and unification of criteria to incorporate the lipid control goals appropriate to the vascular risk of the patients in the laboratory reports.","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136371018","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Quo vadis, colesterol de las LDL?","authors":"Andrés Cobos, P. Valdivielso","doi":"10.1515/almed-2023-0049","DOIUrl":"https://doi.org/10.1515/almed-2023-0049","url":null,"abstract":"","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"4 1","pages":"135 - 137"},"PeriodicalIF":0.0,"publicationDate":"2023-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43017927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Teresa Arrobas Velilla, Carlos Guijarro, Raquel Campuzano Ruiz, Manuel Rodríguez Piñero, José Francisco Valderrama Marcos, Manuel Antonio Botana López, Ana Morais López, José Antonio García Donaire, Juan Carlos Obaya, Luis Castilla Guerra, Vicente Pallares Carratalá, Isabel Egocheaga Cabello, Mercedes Salgueira Lazo, María Mar Castellanos Rodrigo, José María Mostaza Prieto, Juan José Gómez Doblas, Antonio Buño Soto, Antonio Pérez Pérez
{"title":"Documento de consenso para la determinación e informe del perfil lipídico en laboratorios clínicos españoles: ¿Qué parámetros debe incluir un perfil lipídico básico?","authors":"Teresa Arrobas Velilla, Carlos Guijarro, Raquel Campuzano Ruiz, Manuel Rodríguez Piñero, José Francisco Valderrama Marcos, Manuel Antonio Botana López, Ana Morais López, José Antonio García Donaire, Juan Carlos Obaya, Luis Castilla Guerra, Vicente Pallares Carratalá, Isabel Egocheaga Cabello, Mercedes Salgueira Lazo, María Mar Castellanos Rodrigo, José María Mostaza Prieto, Juan José Gómez Doblas, Antonio Buño Soto, Antonio Pérez Pérez","doi":"10.1515/almed-2023-0010","DOIUrl":"https://doi.org/10.1515/almed-2023-0010","url":null,"abstract":"Resumen Las enfermedades cardiovasculares (ECV) siguen siendo la principal causa de muerte en nuestro país. El control adecuado de las alteraciones del metabolismo lipídico es un reto clave en prevención cardiovascular que está lejos de alcanzarse en la práctica clínica real. Existe una gran heterogeneidad en los informes del metabolismo lipídico de los laboratorios clínicos españoles, lo que puede contribuir al mal control del mismo. Por ello, un grupo de trabajo de las principales sociedades científicas implicadas en la atención de los pacientes de riesgo vascular hemos elaborado este documento con una propuesta básica de consenso sobre la determinación del perfil lipídico básico en prevención cardiovascular, recomendaciones para su realización y unificación de criterios para incorporar los objetivos de control lipídico adecuados al riesgo vascular de los pacientes en los informes de laboratorio.","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"13 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135767505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
G. Lippi, B. M. Henry, Laura Pighi, Simone De Nitto, Gian Luca Salvagno
{"title":"¿Son los anticuerpos IgG e IgM contra los antígenos S y N del SARS-CoV-2 siempre predictores de infección previa por SARS-CoV-2?","authors":"G. Lippi, B. M. Henry, Laura Pighi, Simone De Nitto, Gian Luca Salvagno","doi":"10.1515/almed-2023-0036","DOIUrl":"https://doi.org/10.1515/almed-2023-0036","url":null,"abstract":"Resumen Objetivos Evaluamos si los inmunoensayos con anticuerpos IgG e IgM contra las proteínas spike (S) y nucleocápside (N) del SARS-CoV-2 detectan infecciones previas por SARS-CoV-2. Métodos Analizamos una cohorte de profesionales sanitarios que había completado el ciclo de vacunación. Desde 2020, y cada 2–4 semanas, se les realizaron revisiones médicas y pruebas moleculares para diagnosticar una posible infección por SARS-CoV-2. Se extrajeron muestras de sangre venosa para medir los niveles de anticuerpos contra el SARS-CoV-2 con los ensayos MAGLUMI® 2019-nCoV lgG y 2019-nCoV lgM CLIA dirigidos a las proteínas S y N del SARS-CoV-2. Resultados En total, la prueba RT-PCR fue positiva para SARS-CoV-2 en 31 (58,5 %) sujetos (el resultado fue positivo una vez en 24 sujetos y dos veces en 7). No se observó una relación directa entre los niveles de anticuerpos IgM contra S y N del SARS-CoV-2 y la positividad de la prueba molecular. El análisis de regresión univariante reveló una relación estadísticamente significativa entre los anticuerpos IgG contra S y N del SARS-CoV-2 y una prueba molecular positiva (r=0,33; p=0,015) y el número de pruebas moleculares positivas (r=0,43; p=0,001). Sin embargo, no se observó correlación con el número de dosis de la vacuna (r=−0,12; p=0,392). La significación se mantuvo en el análisis de regresión lineal (p=0,029 y p<0,001, respectivamente) tras controlar el efecto del sexo, edad, índice de masa corporal y dosis de la vacuna. En el análisis de la curva ROC, los IgG contra S y N del SARS-CoV-2 predijeron significativamente la positividad de la prueba molecular (AUC, 0,69; IC95 %; 0,55–0,84). El mejor valor umbral fue 0,05 AU/mL, con una precisión del 67,9 %, una sensibilidad del 0,97, y una especifidad de 0,27. Conclusiones Aunque los anticuerpos IgG contra S y N del SARS-CoV-2 proporcionan información útil para identificar infecciones previas por SARS-CoV-2, se debería emplear un valor umbral inferior al de la reactividad de la muestra. Los anticuerpos IgM contra S y N del SARS-CoV-2 no son válidos para tal fin.","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"4 1","pages":"180 - 184"},"PeriodicalIF":0.0,"publicationDate":"2023-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42965753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Patricia Rayo Hidalga, Carlos Domingo Bautista, Rosa Fernandez Bonifacio, Jose L Bedini Chesa, Naira Rico Santana
{"title":"Testing the stability of internal quality controls stored in the automated Atellica Solution refrigerated storage module.","authors":"Patricia Rayo Hidalga, Carlos Domingo Bautista, Rosa Fernandez Bonifacio, Jose L Bedini Chesa, Naira Rico Santana","doi":"10.1515/almed-2023-0015","DOIUrl":"10.1515/almed-2023-0015","url":null,"abstract":"<p><strong>Objectives: </strong>Atellica Solution (AS) is a platform that incorporates immunoassay and chemistry modules. AS is fitted with a refrigerated storage module (RSM) for internal quality controls (QC). The objective of this study was to assess the maximum permissible storage time in AS for QCs.</p><p><strong>Methods: </strong>A total of 48 analytes were tested using QC materials: Liquid Assayed Multiqual (MQ), Liquichek Immunology (LI), Liquichek Lipids (LL), and Liquichek Urine Chemistry (UC). The percentage of variation between results (Xt%) was calculated as the difference between the mean value of the triplicate performed at every time point of the study (Xt) and the average of the triplicate performed in the baseline time (Xo). Stability was assessed based on the total change limit (TCL), which combines analytical and biological variation: TCL=±√((1.65 * CVa)<sup>2</sup> + (0.5 * CVb)<sup>2</sup>).</p><p><strong>Results: </strong>A total of 40 of the 48 analytes tested remained stable at the end of the study. In relation to MQ and UC QCs, 32 of the 39 analytes remained stable for the whole study period (15 days) except for alkaline phosphatase, aspartate aminotransferase, calcium, lactate dehydrogenase, and total bilirubin in MQ, and chlorine and glucose in UC. In LI and LL QCs, eight of the nine analytes were stable throughout the 20 days of the study, except transferrin in LI.</p><p><strong>Conclusions: </strong>The Atellica Solution refrigerated storage module is a reliable system for the storage of quality control materials.</p>","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"4 1","pages":"157-174"},"PeriodicalIF":0.0,"publicationDate":"2023-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10701482/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45726108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Paloma Oliver, Marina Pellicer, Daniel Prieto, Jorge Diaz-Garzon, Roberto Mora, Ileana Tomoiu, Noemi Gonzalez, Atilano Carcavilla, Isabel Gonzalez-Casado, Itsaso Losantos, Antonio Buño, Pilar Fernandez-Calle
{"title":"Impact of COVID-19 pandemic on HbA<sub>1c</sub> management and results in pediatric and adult outpatients with diabetes.","authors":"Paloma Oliver, Marina Pellicer, Daniel Prieto, Jorge Diaz-Garzon, Roberto Mora, Ileana Tomoiu, Noemi Gonzalez, Atilano Carcavilla, Isabel Gonzalez-Casado, Itsaso Losantos, Antonio Buño, Pilar Fernandez-Calle","doi":"10.1515/almed-2022-0098","DOIUrl":"https://doi.org/10.1515/almed-2022-0098","url":null,"abstract":"<p><strong>Objectives: </strong>Diabetes mellitus intensify the risks and complications related to COVID-19 infection. A major effect of the pandemic has been a drastic reduction of in-person visits. The aim of this study was to evaluate the impact of the COVID-19 pandemic on HbA<sub>1c</sub> management and results among pediatric and adult outpatients with diabetes, considering the laboratory and point-of-care testing (POCT) HbA<sub>1c</sub> measurements.</p><p><strong>Methods: </strong>Observational retrospective study including patients from pediatric and adult diabetes units was conducted. HbA<sub>1c</sub> results obtained in the laboratory and POCT over 3 years (2019-2021) were collected from the laboratory information system.</p><p><strong>Results: </strong>After the lockdown, the number of HbA<sub>1c</sub> plummeted. Children returned soon to routine clinical practice. The number of HbA<sub>1c</sub> increased gradually in adults, especially in POCT. Globally, HbA<sub>1c</sub> results were lower in children compared with adults (p<0.001). HbA<sub>1c</sub> values in children (p<0.001) and adults (p=0.002) decreased between pre-pandemic and post-pandemic periods, though lower than the HbA<sub>1c</sub> reference change value. The percentage of HbA<sub>1c</sub> results above 8% remained stable during the study period.</p><p><strong>Conclusions: </strong>Continuous glucose monitoring and a telemedicine have been crucial, even allowing for improvements in HbA<sub>1c</sub> results. During the lockdown, patients with better metabolic control were managed in the laboratory whereas patients with poorer control or a severe clinical situation were attended in diabetes units by POCT. Adults returned to pre-pandemic management slowly because they were more susceptible to morbidity and mortality due to COVID-19. Coordination among all health professionals has been essential to offering the best management, especially in difficult scenarios such as the COVID-19 pandemic.</p>","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"4 1","pages":"105-119"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10197181/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10091846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Imma Caballé, Antonio Buño, Francisco A Bernabeu, Francesca Canalias, Antonio Moreno, Mercè Ibarz, José Puzo, Concepción González, Álvaro González
{"title":"State of affairs and future challenges in laboratory medicine in Spain: an analysis of the Spanish Society of Laboratory Medicine (SEQC<sup>ML</sup>).","authors":"Imma Caballé, Antonio Buño, Francisco A Bernabeu, Francesca Canalias, Antonio Moreno, Mercè Ibarz, José Puzo, Concepción González, Álvaro González","doi":"10.1515/almed-2023-0013","DOIUrl":"https://doi.org/10.1515/almed-2023-0013","url":null,"abstract":"<p><strong>Objectives: </strong>Laboratory Medicine is a crucial discipline that contributes to the diagnosis, management and monitoring of patients. This branch of medicine faces two major challenges: New technologies and increased demand. There is limited information available of the state of affairs in Laboratory Medicine in Spain. This study provides a picture of clinical laboratories and clinical laboratory professionals.</p><p><strong>Methods: </strong>The Spanish Society of Laboratory Medicine distributed a questionnaire among the 250 most representative centers (the ones with the largest volume of determinations and training programs), of which 174 (69.6%) returned the questionnaire providing data for 2019.</p><p><strong>Results: </strong>Laboratories were classified according to the number of determinations. In total, 37% identified themselves as small (<1 million determinations per year); 40% considered themselves medium-sized (1-5 million determinations per year) and 23% considered they were large laboratories (>5 million determinations). The level of specialization of laboratory physicians and laboratory performance were higher in large laboratories. Most requests (87%) and determinations (93%) corresponded to biochemistry and hematology. As many as 63% of physicians had an indefinite contract, and 23% were older than 60 years.</p><p><strong>Conclusions: </strong>Laboratory medicine is a consolidated discipline that is gaining relevance in Spain. It adds value to the diagnosis, prognosis and follow-up of diseases, and to treatment response monitoring. The results of this study will help us address challenges such as the need for specialized training for laboratory professionals; the emergence of technological innovations; exploitation of Big Data; optimization of quality management systems and patient safety.</p>","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"4 1","pages":"70-91"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10197191/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10073187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Recommendations for the measurement of sexual steroids in clinical practice. A position statement of SEQC<sup>ML</sup>/SEEN/SEEP.","authors":"Gregori Casals, Roser Ferrer Costa, Eulàlia Urgell Rull, Héctor F Escobar-Morreale, Jesús Argente, Gemma Sesmilo, Betina Biagetti","doi":"10.1515/almed-2023-0020","DOIUrl":"https://doi.org/10.1515/almed-2023-0020","url":null,"abstract":"<p><p>The proper clinical approach to a wide range of disorders relies on the availability of accurate, reproducible laboratory results for sexual steroids measured using methods with a high specificity and sensitivity. The chemiluminescent immunoassays currently available have analytical limitations with significant clinical implications. This position statement reviews the current limitations of laboratory techniques for the measurement of estradiol and testosterone and their impact on diverse clinical scenarios. A set of recommendations are provided to incorporate steroid hormone analysis by mass spectrometry in national health systems. International societies have recommended this methodology for a decade.</p>","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"4 1","pages":"52-69"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10197192/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9768886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}