Circulating myeloid-derived suppressor cells may be a useful biomarker in the follow-up of unvaccinated COVID-19 patients after hospitalization.

SARS-CoV-2 infection is the cause of the disease named COVID-19, a major public health challenge worldwide. Differences in the severity, complications and outcomes of the COVID-19 are intriguing and, patients with similar baseline clinical conditions may have very different evolution. Myeloid-derived suppressor cells (MDSCs) have been previously found to be recruited by the SARS-CoV-2 infection and may be a marker of clinical evolution in these patients. We have studied 90 consecutive patients admitted in the hospital before the vaccination program started in the general population, to measure MDSCs and lymphocyte subpopulations at admission and one week after to assess the possible association with unfavorable outcomes (dead or Intensive Care Unit admission). We analyzed MDSCs and lymphocyte subpopulations by flow cytometry. In the 72 patients discharged from the hospital, there were significant decreases in the monocytic and total MDSC populations measured in peripheral blood after one week but, most importantly, the number of MDSCs (total and both monocytic and granulocytic subsets) were much higher in the 18 patients with unfavorable outcome. In conclusion, the number of circulating MDSCs may be a good marker of evolution in the follow-up of unvaccinated patients admitted in the hospital with the diagnosis of COVID-19.

Complete laboratory diagnosis of Insulin Autoimmune Syndrome.

The definition of Insulin autoimmune syndrome includes the presence of high levels of blood insulin and insulin autoantibodies. We encountered a 45-years-old white man with a high insulin serum value that do not fit with the C-peptide result. To discard or to confirm an analytical interference and diagnose a possible Insulin Autoimmune Syndrome we performed the following investigations: dilution linearity test, heterophilic antibody blocking, polyethylene glycol precipitation, measurements with alternative assays, and gel filtration chromatography by size exclusion. The latter technique confirmed that most of the insulin was complexed with a 150-kDa protein, corresponding to immunoglobulin G, identified as insulin autoantibodies. These antibodies were responsible for hypoglycemia attacks in the patient, who had a previous autoimmune disease. This case highlights the importance of carefully analyzing the results and ruling out possible interferences, as well as considering all kinds of pathologies, even if they are infrequent.

Evaluation of health outcomes after the implementation of rotational thromboelastometry in patients undergoing cardiac surgery.

BACKGROUND: Viscoelastic tests (rotational thromboelastometry, ROTEM®), together with the implementation of a specific algorithm for coagulation management in cardiac surgery, enable perioperative coagulopathy to be better controlled. METHODS: Retrospective cohort study including 675 patients who underwent cardiac surgery with cardiopulmonary bypass. The incidence of allogeneic blood transfusions and clinical postoperative complications were analyzed before and after ROTEM® implementation. RESULTS: Following viscoelastic testing and the implementation of a specific algorithm for coagulation management, the incidence of any allogeneic blood transfusion decreased (41.4% vs 31.9%, p = .026) during the perioperative period. In the group monitored with ROTEM®, decreased incidence of transfusion was observed for packed red blood cells (31.3% vs 19.8%, p = .002), fresh frozen plasma (9.8% vs 3.8%, p = .008), prothrombin complex concentrate administration (0.9% vs 0.3%, p = .599) and activated recombinant factor VII (0.3% vs 0.0%, p = .603). Increased incidence was observed for platelet transfusion (4.8% vs 6.8%, p = .530) and fibrinogen concentrate (0.9% vs 3.5%, p = .066), tranexamic acid (0.0% vs 0.6%, p = .370) and protamine administration (0.6% vs 0.9%, p = .908). Similar results were observed in the postoperative period, but with a decreased incidence of platelet transfusion (4.8% vs 3.8%, p = .813). In addition, statistically significant reductions were detected in the incidence of postoperative bleeding (9.5% vs 5.3%, p = .037), surgical reexploration (6.0% vs 2.9%, p = .035), and length of Intensive Care Unit (ICU) stay (6.0 days vs 5.3 days, p = .026). CONCLUSIONS: The monitoring of hemostasis by ROTEM® in cardiac surgery, was associated with decreased incidence of allogeneic blood transfusion, clinical hematologic postoperative complications and lengths of ICU stay.

Emergency severity level-3 patient flow based on point-of-care testing improves patient outcomes.

BACKGROUND: Overcrowding of the Emergency Department is rapidly becoming a global challenge and a major source of concern for emergency physicians. The desire to improve Emergency Department throughput requires novel approaches to patient flow. MATERIALS AND METHODS: We conducted a prospective and cluster-randomized study, to evaluate the impact in patient outcomes of a new patient flow based on Point-of-Care Testing (POCT). A total of 380 Emergency Severity Level-3 patients were enrolled and studied in two different groups, interventional arm (laboratory analyses performed on POCT analyzers implemented in the Emergency Department) or control arm (central laboratory). The primary outcome was the Emergency Department length of stay. Secondary outcome included the time to first medical intervention, the laboratory turnaround time and the time to disposition decision. Readmission within the 7 days after discharge was also calculated. RESULTS: Length of stay significantly decreased by 88.50 min (from 247.00 to 158.50), time to disposition decision by 89.00 min (from 192.00 to 103.00) and laboratory turnaround time by 67.11 min (from 89.84 to 22.73) in the POCT group. No increase in readmission was found. CONCLUSION: Our strategy based on POCT represents a good approach to optimize patient flow in the Emergency Department and it should be seen as a starting point for further studies focusing on improving throughput.

Midregional proadrenomedullin safely reduces hospitalization in a low severity cohort with infections in the ED: a randomized controlled multi-centre interventional pilot study.

INTRODUCTION: The midregional fragment of proadrenomedullin (MR-proADM) is known to provide accurate short-, mid- and long term prognostic information in the triage and multi-dimensional risk assessment of patients in the emergency department (ED). In two independent observational cohorts MR-proADM values identified low disease severity patients without risk of disease progression in the ED with no 28 days mortality that wouldn´t require hospitalization. In this interventional study we want to show that the combination of an MR-proADM algorithm with clinical assessment is able to identify low risk patients not requiring hospitalization to safely reduce the number of hospital admissions. METHODS: A randomized-controlled interventional multicenter study in 4 EDs in Spain. The study protocol was approved by Ethics Committees. Control arm patients received Standard Care. MR-proADM guided arm patients with low MR-proADM value (≤0.87 nmol/L) were treated as out-patients, with high MR-proADM value (>0.87 nmol/L) were hospitalized. The hospitalization rate was compared between the study arms. RESULTS: Two hundred patients with suspicion of infection were enrolled. In the MR-proADM guided arm the hospital admission rate in the intention-to-treat (ITT) population was 17% lower than in the control arm (40.6% vs. 57.6%, p=0.024) and 20% lower in the per protocol (PP) population (37.2% vs. 57.6%, p=0.009). No deaths of out-patients and no significant difference for the safety endpoints readmission and representation rates were observed. The readmission rate was only slightly higher in the MR-proADM guided arm compared to the control arm (PP population: at 14 days 9.3% vs. 7.1%, difference 2.1% (95% CI: -11.0% to 15.2%); and at 28 days 11.1% vs. 9.5%, difference 1.6% (95% CI: -12.2% to 15.4%)). The rate of 28 days representation was slightly lower in the MR-proADM guided arm compared to the control arm (20.4% vs. 26.2%, difference -5.8% (95% CI: -25.0% to 13.4%); PP population). CONCLUSIONS: Implementing a MR-proADM algorithm optimizes ED workflows efficiently and sustainably. Hospitals can highly benefit from a reduced rate of hospitalizations by 20% using MR-proADM. The safety in the MR-proADM guided study arm was similar to the Standard Care arm. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03770533.

Recomendaciones para la elaboración de un cuadro de mando integral para la gestión de pruebas en el lugar de asistencia del paciente (POCT). Recomendación (2017) / Recommendations for constructing a balanced scorecard for point-of-care testing (POCT) management. Recommendation (2017)

El avance tecnológico en el campo del diagnóstico clínico ha generado una diversidad de pruebas de laboratorio aplicables en el lugar de asistencia al paciente (POCT), y ha permitido contar con una mayor calidad analítica de los procedimientos implementados. La elaboración de un cuadro de mando integral es una herramienta útil para el éxito en la gestión de un proceso trasversal, complejo e interdisciplinario, como es el de obtener resultados analíticos fiables, transferibles de forma inmediata mediante sistemas POCT. Para la elaboración de un cuadro de mando integral se deben considerar cuatro perspectivas: la de los clientes (pacientes, médicos, grupos de interés), la financiera (inversores privados o públicos), la de los procesos operativos internos (sistemas, procesos) y la de los profesionales (cultura organizativa). El objeto de este documento es establecer recomendaciones para la elaboración de un cuadro de mando integral para gestionar los sistemas POCT disponibles en una institución

Technological development of in vitro diagnostics has led to a diversity of new tests for point-of-care testing (POCT) and at the same time provides quality in the process. Construction of a balanced scorecard is a useful tool for the success in the management of a cross-sectional, complex and interdisciplinary process, as well as to obtain reliable analytical results for immediately use with POCT systems. In constructing a balanced scorecard, four perspectives should be considered: Customer (patients, doctors), Financial (private or public investors), Operating procedures (systems, processes), and Professionals (organisational culture). The aim of this document is to establish the recommendations for the development of an adequate balanced scorecard to manage a point-of-care network in a healthcare system

Comparison of automated devices UX-2000 and SediMAX/AutionMax for urine samples screening: A multicenter Spanish study.

OBJECTIVES: In this study we aim to compare UX2000 (Sysmex Corp, Japan) and SediMAX/AutionMax (Arkray Factory Inc., Japan), totally automatized analyzers, against Fuchs-Rosenthal counting chamber, the gold standard technique for sediment analysis. DESIGN AND METHODS: Urine samples of 1454 patients from three Spanish hospitals were assessed for red and white blood cells (RBC; WBC) using three different techniques: flow cytometry, image-based method and Fuchs-Rosenthal counting chamber. Test strip results were subjected to concordance evaluation. Agreement was assessed by Cohen's weighted kappa for multinomial results. Sensitivity (SE) and specificity (SP) were calculated. RESULTS: The categorization of the results showed that UX-2000 had higher concordance over SediMAX for WBC (0.819 vs. 0.546) and similar for RBC (0.573 vs. 0.630). For RBC, UX-2000 had higher SE (92.7% vs. 80.3%) but lower SP (77.1% vs. 87.4%), and showed higher both SE (94.3% vs. 76.7%) and SP (94.7% vs. 88.2%) for WBC. Inter-devices test strip agreement was substantial (kappa>0.600) for all variables except for bilirubin (kappa: 0.598). Intra-device test strip agreement was similar for UX2000 and SediMAX with regard to RBC (kappa: 0.553 vs. 0.482) but better for UX2000 with regard to WBC (0.688 vs. 0.465). CONCLUSIONS: Both analyzers studied are acceptable for daily routine lab work, even though SediMAX is easier to use in laboratories thanks to its lower maintenance procedure. UX-2000 has shown to have better concordance with the gold standard method. However, it needs some improvements such as an image module in order to decrease manual microscopy review for urine samples.

Guía sobre las pruebas de laboratorio en el lugar de asistencia al paciente (POCT) / Point-of-care testing guidance (POCT)

No disponible

Evaluation of a HbA1c point-of-care analyzer.

OBJECTIVES: A better glycemic monitoring of diabetic patients and avoiding complications of poorly controlled diabetes could be possible with point-of-care testing technology (POCT) for HbA1c determination. B-Analyst® was studied to check whether it complied with the quality requirements for this purpose. DESIGN AND METHODS: We evaluated the B-Analyst® (Menarini Diagnostics), which is based in the principle of latex agglutination immunoturbidimetry, to assess the validity of the technique of HbA1c. We carried out the method comparison with the HA-8180® (Menarini Diagnostics) as a reference method [High Performance Liquid Chromatography (HPLC)]. We assessed the analytical quality of the B-Analyst® studying the accuracy: inter-assay variability and intra-assay study. Furthermore, possible interferences by hemoglobinopathies were studied. RESULTS: Regression analysis of the data for the method comparison between HA-8180® and B-Analyst® showed a slope of 1.0085 and an intercept of 0.1208. The Pearson's correlation coefficient was 0.9958 (p<0.0001). Bias study showed a mean difference from B-Analyst® with respect to HA-8180® of 0.1872 with a 95% confidence interval. The standard error of the estimate (Syx) was 0.2091. The concordance correlation coefficient to assess accuracy was 0.9922 (0.9891-0.9945). The CV for the inter-assay study was 1.4%. For the intra-assay study we analyzed 3 samples with different HbA1c % whose CV were 1.03% [4.7% HbA1c (28 mmol/mol)], 0.46% [6.4% HbA1c (46 mmol/mol)] and 0.78% [8.1% HbA1c (65 mmol/mol)]. CONCLUSION: The B-Analyst® evaluated not only showed good correlation with HA-8180®, but also it presented a great accuracy both in the inter-assay and in the intra-assay studies. The B-Analyst® complies with quality specifications required for monitoring of diabetic patients.

Evaluation of two HbA1c point-of-care analyzers.

BACKGROUND: Measurement of HbA1c is the most important parameter to assess glycemic control in diabetic patients. Different point-of-care devices for HbA1c are available. The aim of this study was to evaluate two point-of-care testing (POCT) analyzers (DCA Vantage from Siemens and Afinion from Axis-Shield). We studied the bias and precision as well as interference from carbamylated hemoglobin. METHODS: Bias of the POCT analyzers was obtained by measuring 53 blood samples from diabetic patients with a wide range of HbA1c, 4%-14% (20-130 mmol/mol), and comparing the results with those obtained by the laboratory method: HPLC HA 8160 Menarini. Precision was performed by 20 successive determinations of two samples with low 4.2% (22 mmol/mol) and high 9.5% (80 mmol/mol) HbA1c values. The possible interference from carbamylated hemoglobin was studied using 25 samples from patients with chronic renal failure. RESULTS: The means of the differences between measurements performed by each POCT analyzer and the laboratory method (95% confidence interval) were: 0.28% (p<0.005) (0.10-0.44) for DCA and 0.27% (p<0.001) (0.19-0.35) for Afinion. Correlation coefficients were: r=0.973 for DCA, and r=0.991 for Afinion. The mean bias observed by using samples from chronic renal failure patients were 0.2 (range -0.4, 0.4) for DCA and 0.2 (-0.2, 0.5) for Afinion. Imprecision results were: CV=3.1% (high HbA1c) and 2.97% (low HbA1c) for DCA, CV=1.95% (high HbA1c) and 2.66% (low HbA1c) for Afinion. CONCLUSIONS: Both POCT analyzers for HbA1c show good correlation with the laboratory method and acceptable precision.

Resultados de la implantación de un sistema de control de calidad para los glucómetros del Área Hospitalaria Virgen Macarena, con conexión on-line al Laboratorio de Bioquímica Clínica, durante el período 2003-2007 / Implementation of an on-line quality control system for glucose meters in the Virgen Macarena University Hospital Health Area

Objetivo: Implantar un sistema de control de calidad on-line en todos los glucómetros del Área Hospitalaria Virgen Macarena (2 hospitales, 3 centros de especialidades, 1 centro de diálisis y 2 centros de salud), para conseguir los objetivos analíticos recomendados por la ADA/AACC/NACB y mantenerlos por medio del seguimiento y control de todos los datos de pacientes y controles desde el Laboratorio de Bioquímica Clínica. Material y métodos: Noventa equipos de determinación de glucemia portátiles (glucómetros de uso profesional PCx de Abbott©) conectados on-line a la red informática del hospital. Los glucómetros envían todos los datos a la estación central de datos, donde quedan registrados todos los resultados de pacientes y controles de calidad, centralizado en el Departamento de Bioquímica Clínica. Previa a la implantación de los sistemas se llevó a cabo un programa de formación para el personal con responsabilidad en la monitorización de la glucemia de los pacientes del área (más de 900 profesionales de enfermería). Se emiten informes de forma periódica a los responsables de las diferentes unidades asistenciales, donde se les facilita el consumo de tiras y los resultados de los controles. Resultados: Durante 5 años (2003-2007) se han realizado más de 1.500.000 determinaciones de glucemia a pacientes y más de 140.000 determinaciones de controles de calidad, con un error medio del 6,37% (2,18-7,52) en los valores bajos de glucemia y de 5,39% (1,53-7,52) en los valores altos. Conclusiones: La responsabilidad de los resultados analíticos de la monitorización de la glucemia en los pacientes del área ha sido asumida por parte de nuestro Laboratorio de Bioquímica Clínica, y se ha basado en un control de calidad con seguimiento on-line, asý como en el esfuerzo de formación del personal. El nuevo sistema ha demostrado que los glucómetros utilizados en un área hospitalaria de 1.200 camas, que atiende a una población de 550.000 habitantes y con más de 350.000 determinaciones/año de glucosas POCT, se pueden controlar en tiempo real, consiguiendo los objetivos analíticos de la ADA/AACC/NACB, para ello ha sido fundamental la implicación del personal de enfermería, garantizando la calidad analítica de los resultados, siempre que este dirigido desde el laboratorio (Unidad POCT). © 2008 AEBM, AEFA y SEQC. Todos los derechos reservados(AU)

Objectives: To implement an on-line quality control system in the Virgen Macarena Hospital Health Area (2 hospitals, 3 specialised care centres, 1 dialisis centre and 2 primary care centres), in order to achieve the ADA/AACC/NACB recommended analytical goals, and maintain them by on-line control from the Clinical Biochemistry Laboratory. Materials and methods: 90 glucose meters (PCx from Abbott) connected on-line to the central information network of the hospital. Meters send the patient and control measurements to the Central Data Station, where they are registered. Then data are analysed in the Clinical Biochemistry laboratory. Before implementing the system, we carried out training program for personnel with responsibilities for glucose monitoring (more than 900 nurses). Periodical reports are sent to the different health care units. The report includes quality control data and the consumables used. Results: During the last 5 years more than 1,500,000 blood glucos determinations and more than 140,000 controls were measured. Mean total error of control measurements was 6.37% (2.18¿7.52) at a low glucose level and 5.39% (1.53¿7.52) at high glucose levels. Conclusions: Glucose monitoring of the patients from the Virgen Macarena University Hospital Health Area is now under the responsibility of the Clinical Biochemistry Labratory. The new system has demonstrated that the glucose meters from Specialised Care in a whole Health Area can be controled on-line, and achieving the analyical goals recommended by ADA/AACC/NACB. The success has been based on the educational program together wit the motivation of nurses(AU)