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El coeficiente de variación fue menor al 2% en los 3 ensayos estudiados. La HbA 1c fue expresada en porcentaje según el Programa Nacional de Estandarización de la Glicohemoglobina y en mmol/mol (media ± desviación estándar). Excluimos muestras con variantes de la hemoglobina. Incluimos valores normales y patológicos de HbA1c. Materiales y métodosĮn 114 muestras de sangre entera medimos la HbA 1c por DCA Vantage®, escáner fluorescente i-Chroma® y HPLC Bio-Rad Variant II® Turbo. Nuestros objetivos fueron evaluar 2 inmunoensayos, comparándolos con la cromatografía líquida de alta resolución (HPLC, por sus siglas en inglés), 3 ensayos disponibles en Ecuador.

En algunas regiones del mundo los métodos de alto desempeño para medir la HbA 1c no son fácilmente accesibles. These findings suggest that is convenient to assess the HbA1c immunoassays commercially available in our country, Ecuador.Įl nivel de hemoglobina glucosilada (HbA 1c) refleja el estado glucémico crónico si se utilizan pruebas confiables. Therefore, DCA-Vantage has better performance than I-Chroma. HbA1c immunoassays DCA-Vantage was comparable to HPLC assay, showing good correlation, appropriate precision and low bias, whereas I-Chroma assay was precise but inaccurate. The mean bias between DCA-Vantage and HPLC was −0.02 ± 0.29% (−0.2 ± 3.2 mmol/mol), while for I-Chroma and HPLC mean bias was −0.50 ± 1.62% (−5.5 ± 17.7 mmol/mol). HbA1c values by HPLC and DCA-Vantage were highly correlated (Spearman's Rank Correlation : 0.916), while the correlation among HPLC and I-Chroma was weak (SRC: 0.368). The coefficient of variation was below 2% for high and low HbA1c levels, in all methods studied. HbA1c results by HPLC and DCA-Vantage were similar: 6.3 ± 1.7% (45 ± 18.6 mmol/mol) vs. HbA1c values were expressed in National Glycohemoglobin Standardization Program percentages and mmol/mol, as mean ± standard deviation. Blood samples with variants of hemoglobin were excluded.

Normal and pathological HbA1c ranges were included. HbA1c were measured in 114 fresh whole blood-samples by DCA-Vantage point-of-care analyzer, I-Chroma portable fluorescent scanner immunoassay and BioRad Variant II Turbo HPLC. This study aimed to asses two HbA1c immunoassays, comparing them with high-performance liquid chromatography (HPLC) assay, three methods available in Ecuador.

Glycated hemoglobin (HbA1c) level reflects chronic glycemic status if reliable tests are used, however, in some regions worldwide high performing assays might not be readily available.

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