The IFCC Reference Measurement System for HbA1c: A 6-Year Progress Report

Weykamp, Cas; John, W. Garry; Mosca, Andrea; Hoshino, Takao; Little, Randie R.; Jeppsson, Jan‐Olof; Goodall, Ian; Miedema, Kor; Myers, Gary L.; Reinauer, H.; Sacks, David B.; Slingerland, Robbert J.; Siebelder, Carla

doi:10.1373/clinchem.2007.097402

Cited by 174 publications

(109 citation statements)

References 11 publications

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“…This harmonization is accomplished using conversion formulas for A1C-NGSP and A1C-IFCC [9]. These conversion formulas are not necessarily applied in regular medical practice in each country or region where either A1C-NGSP or A1C-IFCC has been used to assess the degree of glycemic control [10].…”

Section: Subjectsmentioning

confidence: 99%

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The ratio of glycated albumin to hemoglobin A1c measured in IFCC units accurately represents the glycation gap

et al. 2015

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Section: Subjectsmentioning

confidence: 99%

“…The A1C-IFCC value was also obtained from the A1C-NGSP value using the conversion formula (A1C-IFCC value (mmol/mol) = 10.93 × A1C-NGSP value (%) − 23.52) [9].…”

Section: Statistical Analysesmentioning

confidence: 99%

The ratio of glycated albumin to hemoglobin A1c measured in IFCC units accurately represents the glycation gap

et al. 2015

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“…The IFCC primary reference method has been proven to be stable in many inter-comparison studies with designated comparison methods (DCMs), (the NGSP and the Japanese Diabetes Society (JDS)/Japanese Society of Clinical Chemistry (JSCC)), method and is recognized in a 2010 consensus statement as the only valid anchor for the standardization of HbA1c (1,2). The development of this reference method enabled the World Health Organization (WHO) and American Diabetes Association (ADA) to advocate the use of HbA1c for the diagnosis of type two diabetes (3).…”

Section: Global Standardization Of Hba1c Methods In Particular Throumentioning

confidence: 99%

Understanding the Use of Sigma Metrics in Hemoglobin A1c Analysis

Lenters-Westra

English

2017

Clinics in Laboratory Medicine

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The Authors have nothing to disclose KEY WORDS HbA1c, diabetes, sigma-metrics, analytical performance criteria 4-8 keywords to direct and optimize search results KEY POINTS 1) Performance of HbA1c analyzers is, on the whole, very good with many attaining the international guidance target of sigma >2 at a TAE of 10%, in addition many analysers perform well in excess of these targets, as individual analyzers or in networks of analysers across a wide geographical area 2) In strict evaluation conditions, point of care test devices can perform as well as routine laboratory analysers and may in future be considered suitable for use in the diagnosis of diabetes 3) Using direct calibration to the primary reference measurement procedure we have demonstrated that there is the capacity to improve performance of analysers in routine clinical practice 4) Whilst fewer analysers currently meet tighter targets of a TAE of 10% and four sigma and TAE of 6% at two sigma, the outcomes for pass or fail are comparable for the two criteria.5) Precision has a greater impact on the calculated sigma than bias does, in the current data set. There are many ways in which to calculate bias and imprecision and the method used to establish these values must be detailed in any evaluation or study. SYNOPSISProvide a brief summary of your article (100 to 150 words; no references or figures/tables). The synopsis appears only in the table of contents and is often used by indexing services such as PubMedThis study utilizes three unique data sets to demonstrate the state of the art of HbA1c analyzers in a range of settings and compares their performance against the international guidance set by the IFCC task force for HbA1c standardization. The data is used to demonstrate the effect of tightening of those criteria and the study serves as a guide to the practical implementation of the sigma metrics approach in a range of clinical settings.

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“…Dicho ensayo está validado por la NGSP (National Glycohemoglobin Standardization Program) con trazabilidad al método de referencia del DCCT (Diabetes Control and Complications Trial) [27][28][29] .…”

Section: Pacientes Y Métodounclassified

Control metabólico y rendimiento escolar en niños con diabetes tipo 1

Román

Garrido

Novoa

et al. 2017

Rev. chil. pediatr.

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ResumenEl impacto de la diabetes tipo 1 (DM1) en el rendimiento escolar es controversial. Objetivo: Evaluar la relación entre rendimiento escolar y control metabólico en niños con DM1 (N-DM1) y comparar sus resultados con niños de la población general (N-PG). Pacientes y Método: Se revisaron datos clínicos de 66 N-DM1. Se compararon las calificaciones de N-DM1 según Hemoglobina Glicosilada (HbA1c) < 7,5% y ≥ 7,5% con N-PG del mismo nivel, comuna, tipo de colegio (municipal, particular subvencionado y particular pagado) y localidad. Para la comparación de los grupos se utilizó la regresión lineal simple y el test de suma de los rangos de Wilcoxon (Mann y Whitney) previa comprobación de incumplimiento de normalidad con el test de Shapiro-Wilk según el caso. Se consideró un valor de p < 0,05 como estadísticamente significativo con una confiabilidad del 95%. Resultados: La edad fue 13,4 ± 2,9 años, tiempo de evolución DM1 5,3 ± 3,2 años, HbA1c 8,6 ± 1,9% y controles de glicemia capilar 3,2 ± 1,2 veces por día. Las calificaciones no mostraron correlación con HbA1c, duración de DM1, hipotiroidismo, problemas de salud mental, antecedentes de hipoglicemia ni de cetoacidosis. N-DM1 de educación básica mostraron calificaciones inferiores a N-PG del mismo nivel 5,6 ± 0,7 vs 6,0 ± 0,2 (p = 0,0002). Las calificaciones se correlacionaron con el número de controles diarios de glicemia capilar, coeficiente de correlación de Pearson (r) de 0,25, 0,41, 0,52 y 0,58 con el promedio general, matemática, lenguaje e historia respectivamente (p < 0,05). Un 6,1% de N-DM1 y 4,8% de N-PG no fue promovido de curso (p = 0,65). La deserción escolar fue 10,5% en N-DM1 y 7,7% en N-PG (p = 0,47). Conclusión: N-DM1que cursaban educación básica tuvieron calificaciones inferiores a N-PG y los pacientes que controlaban su glicemia capilar con mayor frecuencia mostraron mejores calificaciones. La DM1 puede tener un impacto deletéreo en el rendimiento escolar.

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The IFCC Reference Measurement System for HbA1c: A 6-Year Progress Report

Cited by 174 publications

References 11 publications

The ratio of glycated albumin to hemoglobin A1c measured in IFCC units accurately represents the glycation gap

The ratio of glycated albumin to hemoglobin A1c measured in IFCC units accurately represents the glycation gap

Understanding the Use of Sigma Metrics in Hemoglobin A1c Analysis

Control metabólico y rendimiento escolar en niños con diabetes tipo 1

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