Evaluation of the Afinion AS100 Point-of-Care Analyzer for Hemoglobin A1c

Abstract

An evaluation of a new Afinion AS100 Analyzer was conducted to assess analytical performance. Precision was estimated by analyzing 2 control and 3 patient samples twice a day for 10 days. Accuracy was established by analysis of 6 samples from the National Glycated Hemoglobin Standardization Program for a 3-day period. Agreement was correlated to a laboratory method, the Variant II Turbo Hemoglobin Testing System, and a point-of-care method, the DCA2000+ Hemoglobin A 1c System, using leftover EDTA samples from laboratory analysis (n = 110, range of results = 4.6%Y13.7% HbA 1c ). The Afinion AS100 Analyzer (0.9%Y1.8% coefficient of variation [CV]) displayed laboratory comparable precision (Variant II Turbo = 1.1%Y1.9% CV) that was superior to the DCA2000+ (2.9%Y3.3% CV) with minimal bias to the National Glycated Hemoglobin Standardization Program target concentrations (G0.2% HbA 1c average unit bias or 3.1%). The Afinion AS100 Analyzer had good agreement with both the Variant II Turbo and DCA2000+ with r of greater than 0.9837 and Sy.x of T0.22% and T0.29% HbA 1c , respectively. Staff found the analyzer easy to train and use, providing faster results than the DCA2000+ (3 minutes vs 6 minutes). The Afinion AS100 Analyzer will be recommended over the DCA2000+ when requests for future point-of-care HbA 1c are made in our health system.

Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate ‘Lifestyle Africa’

“…Blood pressure is assessed by staff with calibrated portable automated instruments (Omrons HBP1300), averaging two or three independent measurements according to American Heart Association Council on High Blood Pressure Research Methods 48. Non-fasting HbA1C, triglycerides and low-density lipoprotein cholesterol are measured via automated assay from a capillary sample using an Afinion AS100 Analyzer 49. Medication use is assessed by asking participants to bring all their medications to the enrolment session.…”

Discrepancies in Assessing Symptoms of Depression in Adolescents With Diabetes Using the Patient Health Questionnaire and Semi-Structured Interviews

“…Items have four possible responses ("not at all," "various days," "more than half the days," and "almost every day"), with corresponding numeric scores of 0-3; total scores range from 0 to 27. Scores are classified into five categories: no/minimal depression (score 0-4), mild depression (score 5-9), moderate depression (score 10-14), moderately severe depression (score [15][16][17][18][19], and severe depression (score 20-27). The questionnaire is based on the criteria for diagnosing major depressive disorder in the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (15).…”

“…Patients' age at diagnosis and up to four clinic visits documented during the 1-year timeframe of the study were then determined. Attainment of glycemic targets was assessed by point-of-care A1C as part of routine clinical care using the Afinion AS100 Analyzer, which has exhibited comparable laboratory precision (0.9-1.8% coefficient of variation) (16). Patients' A1C results were retrieved from their electronic medical record (EMR).…”

Estudio de la determinación de la hemoglobina glucosilada en pacientes con diabetes mellitus 2 en sangre capilar en un centro de atención primaria

“…Sería útil realizar las determinaciones únicas de la HbA1c durante la visita para reducir el número de desplazamientos de los pacientes, consiguiendo rapidez en la toma de decisiones sobre el seguimiento, tratamiento y mejorando la productividad. Recientemente se han publicado varios estudios que evalúan diferentes analizadores POCT de HbA1c, tanto en comparación con el método tradicional [11][12][13][14][15][16][17] , como en distintos ámbitos de aplicación 18---22 . Para valorar esta opción en nuestro medio el Laboratorio Clínico Bon Pastor y el CAP Carmel se plantearon un estudio con el objetivo de determinar la fiabilidad analítica, la concordancia de los resultados con el laboratorio de referencia, y la idoneidad de implantar el analizador Afinion AS100 (AXIS-SHIELD) en los CAP para los controles intraanuales de los pacientes con DM2.…”