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- W4212844516 abstract "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. This study aimed to asses two HbA1c immunoassays, comparing them with high-performance liquid chromatography (HPLC) assay, three methods available in Ecuador. 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. Normal and pathological HbA1c ranges were included. Blood samples with variants of hemoglobin were excluded. HbA1c values were expressed in National Glycohemoglobin Standardization Program percentages and mmol/mol, as mean ± standard deviation. HbA1c results by HPLC and DCA-Vantage were similar: 6.3 ± 1.7% (45 ± 18.6 mmol/mol) vs. 6.3 ± 1.8% (45 ± 19.7 mmol/mol), respectively, P = 0.057; while HbA1c values by I-Chroma were lower than HPLC, 5.8 ± 1.9% (40 ± 20.8 mmol/mol), P < 0.001. The coefficient of variation was below 2% for high and low HbA1c levels, in all methods studied. HbA1c values by HPLC and DCA-Vantage were highly correlated (Spearman's Rank Correlation [SRC]: 0.916), while the correlation among HPLC and I-Chroma was weak (SRC: 0.368). 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 immunoassays DCA-Vantage was comparable to HPLC assay, showing good correlation, appropriate precision and low bias, whereas I-Chroma assay was precise but inaccurate. Therefore, DCA-Vantage has better performance than I-Chroma. These findings suggest that is convenient to assess the HbA1c immunoassays commercially available in our country, Ecuador. El nivel de hemoglobina glucosilada (HbA1c) refleja el estado glucémico crónico si se utilizan pruebas confiables. En algunas regiones del mundo los métodos de alto desempeño para medir la HbA1c no son fácilmente accesibles. 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 114 muestras de sangre entera medimos la HbA1c por DCA Vantage®, escáner fluorescente i-Chroma® y HPLC Bio-Rad Variant II® Turbo. Incluimos valores normales y patológicos de HbA1c. Excluimos muestras con variantes de la hemoglobina. La HbA1c fue expresada en porcentaje según el Programa Nacional de Estandarización de la Glicohemoglobina y en mmol/mol (media ± desviación estándar). La HbA1c medida por HPLC y DCA Vantage® fue semejante: 6,3 ± 1,7% (45 ± 18,6 mmol/mol) y 6,3 ± 1,8% (45 ± 19,7 mmol/mol), respectivamente, p = 0,057; pero la cuantificada por i-Chroma® fue menor a HPLC, 5,8 ± 1,9% (40 ± 20,8 mmol/mol), p < 0,001. El coeficiente de variación fue menor al 2% en los 3 ensayos estudiados. Los valores de HbA1c obtenidos por HPLC y DCA Vantage® estuvieron fuertemente correlacionados (correlación de Spearman [CS]: 0,916), mientras que la correlación entre HPLC y i-Chroma® fue débil (CS: 0,368). El sesgo medio entre DCA Vantage® y HPLC fue −0,02 ± 0,29% (−0,2 ± 3,2 mmol/mol), en cambio, entre i-Chroma® y HPLC fue −0,50 ± 1,62% (−5,5 ± 17,7 mmol/mol). El inmunoensayo DCA Vantage® fue comparable a HPLC, mostrando buena correlación, apropiada precisión y bajo sesgo, mientras que i-Chroma® fue preciso, pero inexacto. Por lo tanto, DCA Vantage® tiene mejor desempeño que i-Chroma®. Estos hallazgos sugieren que es conveniente evaluar los inmunoensayos comercialmente disponibles en nuestro país, Ecuador." @default.
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- W4212844516 date "2020-05-01" @default.
- W4212844516 modified "2023-10-18" @default.
- W4212844516 title "Assessment of two glycated hemoglobin immunoassays" @default.
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- W4212844516 doi "https://doi.org/10.1016/j.endien.2020.08.001" @default.
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