Reference Intervals for Thyrotropin Hormone in the General Andean Population of Quito-Ecuador Using Electrochemiluminescence Assay.

BACKGROUND: Thyroid function is one of the most current procedures in the evaluation of endocrine function performed in daily practice; the reference intervals for thyrotropin (TSH) depend on the assay technology and the instruments in each laboratory. The main objective of this study is to determine the thyrotropin reference values in patients considered as euthyroid, living in the Andean region, at 2850 meters above sea level (Quito, Ecuador). METHODS: A cross-sectional, analytical, epidemiological study was conducted using a sample of 595 healthy adult volunteer donors from the Military Hospital Blood Bank in Quito-Ecuador. Serum samples were analyzed for thyrotropin levels using electrochemiluminescence. The reference values were calculated using recommendations from the CLSI C28A3 guide. RESULTS: The mean age of the overall sample was 35.7 (7.2) years, 50.9% (n = 303) were women. TSH recovered in the total sample showed a median of 2.64 mIU/L (2.5th-97.5th percentiles: 0.91-8.35 mIU/L); after removing outliers the reference values for the studied population were 0.87 to 5.21 mIU/L, without differences by sex. CONCLUSIONS: General laboratory practice should improve harmonization of TSH assays. This is a must in daily clinical practice, since it would allow us to share real reference intervals in an established population and may be related to the presence or absence of thyroid pathology.

A simplified alternative diagnostic algorithm for SARS-CoV-2 suspected symptomatic patients and confirmed close contacts (asymptomatic): A consensus of Latin American experts.

INTRODUCTION: Latin America accounts for one-quarter of global COVID-19 cases and one-third of deaths. Inequalities in the region lead to barriers to the best use of diagnostic tests during the pandemic. There is a need for simplified guidelines that consider the region's limited health resources, international guidelines, medical literature, and local expertise. METHODS: Using a modified Delphi method, 9 experts from Latin American countries developed a simplified algorithm for COVID-19 diagnosis on the basis of their answers to 24 questions related to diagnostic settings, and discussion of the literature and their experiences. RESULTS: The algorithm considers 3 timeframes (≤7 days, 8-13 days, and ≥14 days) and presents diagnostic options for each. SARS-CoV-2 real- time reverse transcription-polymerase chain reaction is the test of choice from day 1 to 14 after symptom onset or close contact, although antigen testing may be used in specific circumstances, from day 5 to 7. Antibody assays may be used for confirmation, usually after day 14; however, if clinical suspicion is very high, but other tests are negative, these assays may be used as an adjunct to decision-making from day 8 to 13. CONCLUSION: The proposed algorithm aims to support COVID-19 diagnosis decision-making in Latin America.

Sigma and Risk in the Quality Control Routine: Analysis in Chilean Clinical Laboratories.

BACKGROUND: The Six Sigma methodology is focused toward improvement, based on the Total Quality Management. It has been implemented in analytical procedures for clinical laboratories in the form of Sigma Metrics. This method is used in the evaluation of analytical procedures, providing evidence for risk-based management. METHODS: A descriptive study was carried using data from 18 Chilean clinical laboratories. The information of their performance and quality specifications used in their routine work was obtained from UNITY, an internal quality comparison program. RESULTS: A total of 3461 sigma evaluations was gathered, mostly from biyearly controls. The general distribution shows a median of 5.5 with positive asymmetry similar to other publications. The reported quality specifications are based in CLIA for 51.2% of the cases, 30.2% from biological variation, and 10.7% from other programs for the external quality evaluation. Significant differences (P < 0.05) were found between medians against their specification source. CONCLUSIONS: In the studied series, it would be feasible to implement a risk-based quality control system with simple rules and minimal control materials for 55.5% of the evaluated sigmas. 19.6% of the sigmas require improvement mainly in precision. The variety in specifications reveals a lack of harmonization in the specification's selections.

Algorithms for testing COVID-19 focused on use of RT-PCR and high-affinity serological testing: A consensus statement from a panel of Latin American experts.

The COVID-19 pandemic has caused an unprecedented public health, social, and economic crisis. Improving understanding on available tests for detecting COVID-19 is critical for effective management of the pandemic. We proposed that a multidisciplinary expert panel can establish recommendations on ideal use of diagnostic tools, with a focus on RT-PCR and serological high-affinity antibodies (both IgM and IgG) tests for the Latin America region. STUDY DESIGN: A collaborative multidisciplinary panel of 5 recognized experts in Latin America (an infectious disease specialist, three pathologists, and an immunologist) was convened and supported by Roche Diagnostics to develop standard guidelines and an evidence-based document of best practices on the use of diagnostic tools for COVID-19. RESULTS: The authors reached consensus on the applicability of diagnostic tools to provide testing algorithms for the use of RT-PCR and serological high-affinity antibodies (both IgM and IgG) tests in three settings: 1) For asymptomatic subjects exposed to a SARS-CoV-2 infected person; 2) For epidemiological purposes and; 3) For symptomatic subjects. CONCLUSION: The serological high-affinity SARS-CoV-2 antibodies (both IgM and IgG) tests play a key role in COVID-19 diagnosis. These tests can be applied for suspected false-negative RT-PCR results and for individual determination of response. The use of these tests can also contribute greatly to public health strategies, such as population screening and supporting vaccination planning. Serological status for high-affinity antibodies (both IgM and IgG) should be performed ideally 21 days after potential infectious contact, given that the majority of exposed individuals will have seroconverted.

Sample Management: Stability of Plasma and Serum on Different Storage Conditions.

BACKGROUND AND OBJECTIVE: The analytes stability on serum and plasma are critical for clinical laboratory, especially if there is a delay in their processing or if they need to be stored for future research. The objective of this research was to determine the stability of K3EDTA-plasma and serum on different storage conditions. MATERIALS AND METHODS: A total of thirty healthy adults were studied. The serum/plasma samples were centrifuged at 2000g for 10 minutes. Immediately after centrifugation, the serum/plasma analytes were assayed in primary tubes using a Cobas c501 analyzer (T0); the residual serum/plasma was stored at either 2-8°C or -20°C for 15 (T15) and 30 days (T30).Mean concentrations changes in respect of initial concentrations (T0) and the reference change values were calculated. For assessing statistical difference between samples, the Wilcoxon ranked-pairs test was applied. RESULTS: We evidenced instability for total bilirubin, uric acid, creatinine and glucose at T15 and T30 and stored at -20°C (p<0.05). However, potential clinical impact significance were observed only for total bilirrubin T30 at -20°C, and creatinine T30 at 2-8°C. CONCLUSIONS: Our results had shown that storage samples at -20°C is a better way to preserve glucose, creatinine, and uric acid. Therefore, laboratories should freeze their samples as soon as possible to guarantee proper stability when there is need to repeat analysis, verify a result, or add a laboratory testing.

Adherencia a las buenas prácticas de transfusión, observada en el personal de enfermería del Hospital Pediátrico Baca Ortiz / Adherence to good transfusion practices, observed in the nursing staff of the Baca Ortiz Pediatric Hospital

Contexto: el personal de enfermería cumple un rol fundamental en el proceso transfusional; el nivel de conocimientos debe ser periódicamente evaluado a fin de garantizar una buena práctica transfusional. Objetivo: evaluar el nivel de conocimientos que posee el personal de enfermería del Hospital Pediátrico Baca Ortiz (HPBO) previo y posterior a la intervención, frente a los procedimientos para solicitud, administración y monitoreo de los componentes sanguíneos. Sujetos y métodos: estudio no-experimental pre y post-evaluatorio en el personal de enfermería del Hospital Pediátrico Baca Ortiz de la ciudad de Quito. Se diseñó y aplicó una encuesta estructurada a los profesionales de enfermería del Hospital Pediátrico Baca Ortiz a través de la cual se evaluaron aspectos técnicos relativos a la práctica transfusional en lo relativo a solicitud, administración y monitoreo de los componentes sanguíneos. Resultados: la intervención se realizó en 176 profesionales, distribuidos en tres grupos de capacitación; se observó un incremento global del 14,27% en el puntaje post-intervención sobre 20 puntos, con una p<0,002, estadísticamente significativa. La pre-intervención demostró un menor porcentaje de respuestas correctas en lo referente a la toma y envío de muestras (45,2%). Al evaluar el impacto de la intervención se observó que en la etapa relativa a "recepción de hemocomponentes en el servicio hospitalario, verificación, condiciones de envío, validación del paciente y administración de la transfusión" paso del 67,7% al 79,06% de respuestas válidas con una diferencia porcentual de 11,3%. El área hospitalaria que mayor impacto tuvo fue consulta externa, desde un 22,2% de respuestas correctas en la etapa de pre-intervención y la de menor impacto fue el área quirúrgica con 14,15%. Conclusión: la pre-intervención evidenció debilidades y puntos de mejora en los conocimientos del personal de enfermería que fueron fortalecidos significativamente por la intervención realizada. La educación continua reviste utilidad y relevancia para mejorar percepciones y prácticas en medicina transfusional (AU)

Context: nurses play a fundamental role in the transfusion process; The level of knowledge should be periodically evaluated in order to guarantee good transfusion practice. Objective: to evaluate the level of knowledge held by the nursing staff of the Baca Ortiz Pediatric Hospital (HPBO) before and after the intervention, as opposed to the procedures for requesting, administering and monitoring the blood components. Subjects and methods: pre and post-evaluation non-experimental study in the nursing staff of the Baca Ortiz Pediatric Hospital in the city of Quito. A structured survey was designed and applied to the nursing professionals of the Baca Ortiz Pediatric Hospital through which technical aspects related to the transfusion practice regarding the application, administration and monitoring of the blood components were evaluated. Results: the intervention was carried out in 176 professionals, divided into three training groups; an overall increase of 14.27% was observed in the post-intervention score over 20 points, with p <0.002, statistically significant. The pre-intervention showed a lower percentage of correct answers regarding the taking and sending of samples (45.2%). When evaluating the impact of the intervention it was observed that in the stage relative to "reception of blood components in the hospital service, verification, delivery conditions, patient validation and administration of the transfusion" step from 67.7% to 79.06% of valid answers with a percentage difference of 11.3%. The hospital area that had the greatest impact was external consultation, from 22.2% of correct responses in the pre-intervention stage and the one with the least impact was the surgical area with 14.15%. Conclusion: the pre-intervention showed weaknesses and points of improvement in the knowledge of the nursing staff that were significantly strengthened by the intervention performed. Continuing education has utility and relevance to improve perceptions and practices in transfusion medicine. (AU)

Valores de referencia hematológicos en población altoandina ecuatoriana, empleando analizador SYSMEX XE-2100®* / Hematological reference values in Ecuador's Andean population, using analyzer Sysmex XE-2100 ®*

Contexto: La biometría hemática, es el análisis más solicitado para la evaluación del estado de salud de unsujeto. Sus valores de referencia son importantes en poblaciones de altura, dada la disminución de la presiónparcial de oxígeno que afecta la concentración de hemoglobina, hematocrito e indicadores hematimétricos.En la ciudad de Quito, el último estudio de estimación de valores de referencia, se lo hizo en 1985,empleando métodos manualesMaterial y Métodos: Se realizó un estudio epidemiológico descriptivo de conjunto. Se seleccionó unamuestra de 2613 biometría hematícas de sujetos de ambos sexos con edades entre 18 y 45 años, remitidasa Net-L@b S.A. (Quito), todas realizadas en estudios de salud preventiva en contador Sysmex XE-2100®.Resultados: La edad promedio de los sujetos estudiados fue de 28.76 ± 7.6 años, siendo el 53.6 por ciento de sexomasculino. Se encontraron diferencias significativas entre los valores de referencia calculados y losreportados por otras publicaciones en poblaciones a diferentes altitudes, en todos los parámetros evaluados,persistiendo incluso al compararlos con poblaciones de altitud similar a la de Quito.Conclusiones: Se evidencia la necesidad que los laboratorios calculen los valores de referencia de supoblación atendida o que sustente el uso de valores de referencia calculados en otras poblaciones.