Concordancia diagnóstica entre dos métodos de detección de hemoglobina glucosilada A1c en Atención Primaria / Diagnostic agreement between two glycosylated a1b hemoglobin methods in Primary Care

Objetivo. Hay varios métodos para determinar hemoglobina glucosilada A1c (HbA1c), tanto rápidos para punto de uso en la consulta como de laboratorio. Nuestro objetivo ha sido comparar la concordancia diagnóstica entre 2 métodos de detección de HbA1c. Material y métodos. Se realizó un estudio descriptivo transversal de concordancia diagnóstica en el Centro de Salud Los Cármenes. Se incluyeron de forma consecutiva 2 grupos de pacientes con y sin diabetes mellitus tipo 2. Se compararon un método en punto de uso para consulta externa (DCATM Systems Siemens®) con otro de laboratorio (análisis cromatográfico). Se estudiaron la concentración de HbA1c y la concordancia entre los métodos con el coeficiente de correlación intraclase (CCI, A1) y con el método de Bland-Altman. Resultados. Se estudió a 102 pacientes, 62 diabéticos (60,8%) y 40 no diabéticos (39,2%). La media global ± desviación estándar de porcentaje de HbA1c fue de 6,46 ± 0,88 en el análisis con sangre capilar mediante sistema DCA(TM) y de 6,44 ± = 0,86 en el análisis del laboratorio (p > 0,05). El grado de acuerdo entre las 2 pruebas fue de 0,975 (intervalo de confianza del 95%, 0,963-0,983). La media de la diferencia entre las determinaciones de las 2 pruebas evaluadas fue de 0,024 ± 0,27. El porcentaje de puntos fuera de los límites de acuerdo óptimo definidos en el gráfico de Bland-Altman fue del 2,5%. Conclusiones. La concordancia diagnóstica entre un método para punto de uso en consulta y uno de laboratorio ha sido muy alta. La detección en punto de uso permite una rápida y sencilla valoración de la concentración de HbA1c (AU)

Objective. Several methods are available for measuring glycosylated A1c hemoglobin (HbA1c), all rapid methods for point of care use in a clinical or laboratory setting. This study attempts to compare the diagnostic agreement between two methods for detection of HbA1c. Material and methods. A descriptive cross-sectional study of diagnostic agreement was carried out in the Los Carmenes Health Centre. Two groups of patients -with and without type 2 diabetes- were consecutively included. A method for point-of-care use in a Primary Care Clinic setting (DCATM Systems Siemens®) was compared with a laboratory test (chromatographic analysis). An analysis was made of the mean concentration of HbA1c, the agreement between methods, using the intra-class correlation coefficient (CCLA1) and the Bland-Altman method. Results. A total of 102 patients were included, 62 diabetic (60.8%) and 40 non-diabetic (39.2%). The overall mean HbA1c was 6.46% (SD = 0.88) in the analysis using capillary blood in the clinic with the DCA(TM) system, and 6.44% (SD = 0.86) using the laboratory test (P>.05). The degree of agreement between the two tests was 0.975 (95% CI: 0.963-0.983). The mean of the differences between the results of the two assessed tests was 0.024 (SD = 0.27). The percentage of points outside the limits of optimal agreement, as defined in the Bland-Altman graph, was 2.5%. Conclusions. Diagnostic agreement between a method for point-of-care use in a Primary Health Care Clinic and a laboratory test was very high. Detection at the point-of-care allows a quick and simple assessment of HbA1c (AU)

[Diagnostic agreement between two glycosylated a1b hemoglobin methods in Primary Care]. / Concordancia diagnóstica entre dos métodos de detección de hemoglobina glucosilada A1c en Atención Primaria.

OBJECTIVE: Several methods are available for measuring glycosylated A1c hemoglobin (HbA1c), all rapid methods for point of care use in a clinical or laboratory setting. This study attempts to compare the diagnostic agreement between two methods for detection of HbA1c. MATERIAL AND METHODS: A descriptive cross-sectional study of diagnostic agreement was carried out in the Los Carmenes Health Centre. Two groups of patients -with and without type 2 diabetes- were consecutively included. A method for point-of-care use in a Primary Care Clinic setting (DCA(TM) Systems Siemens(®)) was compared with a laboratory test (chromatographic analysis). An analysis was made of the mean concentration of HbA1c, the agreement between methods, using the intra-class correlation coefficient (CCLA1) and the Bland-Altman method. RESULTS: A total of 102 patients were included, 62 diabetic (60.8%) and 40 non-diabetic (39.2%). The overall mean HbA1c was 6.46% (SD=0.88) in the analysis using capillary blood in the clinic with the DCA™ system, and 6.44% (SD=0.86) using the laboratory test (P>.05). The degree of agreement between the two tests was 0.975 (95% CI: 0.963-0.983). The mean of the differences between the results of the two assessed tests was 0.024 (SD=0.27). The percentage of points outside the limits of optimal agreement, as defined in the Bland-Altman graph, was 2.5%. CONCLUSIONS: Diagnostic agreement between a method for point-of-care use in a Primary Health Care Clinic and a laboratory test was very high. Detection at the point-of-care allows a quick and simple assessment of HbA1c.