Evaluación del desempeño de un analizador POCT con relación a los resultados de los métodos convencionales rutinarios del laboratorio clínico en un hogar de ancianos. Cali. 2014 / Performance evaluation of a POCT analyzer in relation to the results of routine conventional clinical laboratory methods in a nursing home. Cali. 2014

RESUMEN Introducción: Los análisis en el sitio de atención (POCT, por sus siglas en ingles Point-of-care testing) son pruebas de diagnóstico clínico llevadas a cabo fuera de los espacios específicamente diseñados para los análisis clínicos, que proporcionan resultados rápidos que mejoran la oportunidad en la toma de decisiones médicas. En Colombia no hay información sobre su uso y desempeño en grupos etarios específicos como los de los hogares de ancianos en Colombia. Objetivo: Evaluar el desempeño de un analizador POCT para perfil lipídico (CT, LDL-c, HDL-c, TG) y glicemia con relación a los resultados de los métodos convencionales rutinarios del laboratorio clínico en un hogar de ancianos. Materiales y métodos: Estudio descriptivo de corte transversal. Se tomaron 52 residentes a quienes se les tomaron muestras pareadas (punción venosa y digital). Se usó un instrumento estandarizado para la descripción de las características deseadas del POCT. Se aplicó estadística univariada y bivariada. Resultados: La edad promedio de los participantes fue de 78, rango 64-91 años. El POCT mostró un desempeño aceptable frente a los métodos convencionales del laboratorio clínico, especialmente TG y HDL-c. Sin embargo, se observaron diferencias estadísticamente significativas en los resultados de glicemia, CT y LDL-c entregados por el POCT en comparación con los del laboratorio clínico. Conclusiones: La POCT puede ser una opción importante para tamizaje y control de enfermedades crónicas en hogares de ancianos. Sin embargo, es necesario una estructura organizacional que garantice la calidad de las mediciones del POCT. MÉD.UIS.2021;34(2): 9-18.

ABSTRACT Introduction: Point-of-care testing (POCT) are clinical diagnostic tests carried out than laboratory analysts, outside of spaces specifically designed for clinical analysis, and they provide quick results that improve the timeliness of medical decision making. In Colombia there is no information on its use and performance in specific age groups such as those in nursing homes. Objective: To evaluate the performance of a POCT analyzer for lipid profile (CT, LDL-c, HDL-c, TG) and glycemia in relation to the results of routine conventional methods of the clinical laboratory in a nursing home. Materials and methods: Descriptive cross-sectional. 52 residents were taken to whom paired samples were applied. Glucose and lipid levels were determined. Samples collected by fingerstick were analyzed by POCT and venipuncture by conventional methods certified by the CDC in the laboratory. A standardized instrument was used to describe the desired characteristics of the POCT. Univariate and bivariate statistics were applied. The results issued by the clinical reference laboratory were compared with those of the POCT through the ICC. Results: The average age of the participants was 78, range 64-91 years. The POCT showed an acceptable performance compared to conventional clinical laboratory methods, especially TG and HDL-c. However, statistically significant differences were observed in the results of glycemia, CT and LDL-c delivered by the POCT compared to those of the clinical laboratory. Conclusions: POCT can be an important option for chronic disease screening and management in nursing homes. However, an organizational structure is necessary to ensure the quality of the POCT measurements. MÉD.UIS.2021;34(2): 9-18.

The sensitivity, specificity, and agreement of a point of care method: an assessment of the diagnostic accuracy / Sensibilidade, especificidade e concordância do método point of care: um estudo de precisão diagnóstica

Abstract The use of new technologies can improve screening in communities with difficult access to health. This article aims to evaluate the sensitivity, specificity, and agreement of a point of care test in comparison to laboratory methods for the determination of glucose (GLI), triglyceride (TG), and total cholesterol (TC) concentrations. This prospective study used data from the remaining adult population of quilombolas in Brazil. Laboratory tests using conventional methods for the analysis of venipuncture samples were used as a standard method to measure the concentrations of GLI (mg/dL), TG (mg/dL), and TC (mg/dL) and compared to the metered dose from the collection of fingertip capillary blood (point of care). Contingency tables (2x2) were used to estimate the sensitivity and specificity of the methods. Lin and Bland & Altman coefficients were used to statistically assess agreement, the level of significance was 5%. There was substantial agreement between the methods for measuring TG and poor agreement for of TC and GLI. Analysis of the Bland & Altman coefficients revealed that the fingertip method did not produce good measures. The point of care method did not offer a good ability to measure compared to that of the reference laboratory method.

Resumo O uso de novas tecnologias pode melhorar o screening em comunidades de difícil acesso à saúde. O objetivo deste artigo é avaliar a sensibilidade, especificidade e concordância do teste de point of care em comparação com método laboratorial para dosagem de Glicose (GLI), Triglicerídeo (TG) e Colesterol total (CT). Estudo prospectivo com dados de população de adultos remanescentes de quilombolas no Brasil. Exames laboratoriais convencionais para análise foram obtidos por venopunção, utilizados como método padrão para mensuração das concentrações de GLI (mg/dL), TG (mg/dL) e CT (mg/dL) e comparados a mensuração por meio de técnica de ponta de dedo (point of care). Tabelas de contingência (2x2) foram utilizadas para estimar sensibilidade e especificidade dos métodos e o coeficiente de Lin e análises de Bland & Altman foram métodos de concordância com nível de significância de 5%. Houve concordância substancial entre os métodos para mensuração de TG e fraca concordância para mensuração de CT e GLI. Os coeficientes de Bland & Altman indicam que o método de ponta de dedo não apresentou boa mensuração. O método point of care não apresentou boa capacidade de mensuração de Glicose, Triglicerídeo e Colesterol total tendo como referência o método laboratorial.

Impact of an inpatient multidisciplinary glucose control management program

ABSTRACT Objective: Glycemic control has been increasingly recognized as a critical element in inpatient care, but optimal management of blood glucose in the hospital setting remains challenging. The aims of this study were to describe and evaluate the impact of the implementation of an inpatient multidisciplinary glucose control management program on glucose control in hospitalized patients. Materials and methods: Retrospective analysis of medical records and glucose monitoring data obtained by point- of-care testing (POCT) in hospitalized patients before (May 2014) and after (June 2015 and May 2017) the implementation of the program. Results: We analyzed 6888, 7290, and 7669 POCTs from 389, 545, and 475 patients in May 2014, June 2015, and May 2017, respectively. Hyperglycemia (≥ 180 mg/ dL) occurred in 23.5%, 19.6%, and 19.3% POCTs in May 2014, June 2015, and May/2017, respectively (p < 0.001), while severe hyperglycemia (≥ 300 mg/dL) was observed in 2.5%, 2.2%, and 1.8% of them, respectively (p = 0.003). Hyperglycemia (≥ 180 mg/dL) reduced significantly from May 2014 to June 2015 (16.3%, p < 0.001) and from May 2014 to May 2017 (178%, p < 0.001). No significant changes occurred in hypoglycemic parameters. Conclusions: The implementation of an inpatient multidisciplinary glucose control management program led to significant reductions in hyperglycemic events. The key elements for this achievement were the development of institutional inpatient glycemic control protocols, establishment of a multidisciplinary team, and continuing educational programs for hospital personnel. Altogether, these actions resulted in improvements in care processes, patient safety, and clinical outcomes of hospitalized patients.

Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy study / Avaliação de um aparelho de diagnóstico local para hemoglobina glicada (A1CNow+) comparado com um método imunoturbidimétrico: estudo de acurácia de teste diagnóstico

CONTEXT AND OBJECTIVE: To monitor glycemic control in diabetic patients, regular measurement of glycated hemoglobin (HbA1c) is recommended, but this can be difficult in remote places without access to laboratories. Portable point-of-care testing devices can prove a useful alternative. Our study aimed to assess the performance of one of them: A1CNow+, from Bayer. DESIGN AND SETTING: Cross-sectional accuracy study conducted at a university hospital in Brazil. METHODS: We made three successive measurements of capillary HbA1c using the A1CNow+ in 55 diabetic volunteers, while the same measurement was made on venous blood using the hospital reference method (Vitros 5,1 FS). We used the Bland-Altman graphical method to assess the A1CNow+ in relation to the Vitros 5,1 FS method. We also evaluated clinical usefulness by calculating the sensitivity and specificity of A1CNow+ for detecting patients with HbA1c lower than 7%, which is the usual limit for good glycemic control. RESULTS: The coefficient of variation between repeat testing for the A1CNow+ was 3.6%. The mean difference between A1CNow+ and Vitros 5,1 FS was +0.67% (95% confidence interval, CI: +0.52 to +0.81). The agreement limits of our Bland-Altman graph were -0.45 (95% CI: -0.71 to -0.19) and +1.82 (95% CI: +1.52 to +2.05). The sensitivity and specificity in relation to the 7% limit were respectively 100% and 67.7%. CONCLUSIONS: Although the A1CNow+ had good sensitivity, its accuracy was insufficient for use as a replacement for laboratory measurements of HbA1c, for glycemic control monitoring in diabetic patients.

CONTEXTO E OBJETIVO: Para monitorar o controle glicêmico dos diabéticos, é recomendado medir regularmente a hemoglobina glicada (HbA1c). Isso pode ser difícil em locais distantes sem acesso a laboratórios. Uma alternativa é usar aparelhos portáteis à beira do leito do paciente. Nosso estudo visou avaliar o desempenho de um deles: A1CNow+, da Bayer. TIPO DE ESTUDO E LOCAL: Estudo transversal de acurácia realizado em hospital universitário no Brasil. MÉTODOS: Medimos, com o A1CNow+, três vezes seguidas, a HbA1c capilar de 55 diabéticos voluntários, enquanto a mesma medida era feita em sangue venoso pelo método de referência do hospital (Vitros 5,1 FS). Usamos a análise gráfica de Bland-Altman para avaliar o A1CNow+ em relação ao Vitros 5,1 FS. Verificamos a utilidade clínica através do cálculo da sensibilidade e da especificidade do A1CNow+ para detectar pacientes com HbA1c abaixo de 7%, limite usual indicando glicemia controlada. RESULTADOS: O coeficiente de variação entre testes repetidos do A1CNow+ foi de 3,6%. A diferença média entre o A1CNow+ e o Vitros 5,1 FS foi de +0,67% (95% intervalo de confiança, IC: +0,52 para +0,81). Os limites de concordância do gráfico de Bland-Altman foram -0,45 (95% IC: -0,71 para -0,19) and +1,82 (95% IC: +1,52 para +2,05). A sensibilidade e a especificidade em relação ao limite de 7% foram 100% e 67,7%, respectivamente. CONCLUSÃO: Apesar da boa sensibilidade, o A1CNow+ não tem acurácia suficiente para ser utilizado no monitoramento do controle glicêmico de pacientes diabéticos em substituição das medidas da HbA1c em laboratório.