Clinica chimica acta; international journal of clinical chemistry · 2015
Evaluation of hemoglobin A1c measurement by Capillarys 2 electrophoresis for detection of abnormal glucose tolerance in African immigrants to the United States.
СтатьяResearch Support, N.I.H., IntramuralНазвание и аннотация: Перевод пока не подготовлен
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Zhao Zhen, Basilio Jeffrey, Hanson Steven, Little Randie R, Sumner Anne E, Sacks David B
Аннотация
BACKGROUND: Hemoglobin A1c (HbA1c) is used to monitor long-term glycemic control in individuals with diabetes, guide therapy, predict the risk of microvascular complications, and more recently to diagnose diabetes. An automated liquid-flow capillary electrophoresis method was recently developed to measure HbA1c using the Capillarys 2 Flex Piercing instrument.
METHODS: Analytical evaluation was performed at 2 clinical centers. A clinical analysis was conducted in 109 African-born individuals, 24% of whom have variant hemoglobin (HbAS or HbAC). Abnormal glucose tolerance (which includes both diabetes and prediabetes) was defined as 2h glucose of ≥ 140 mg/dl (7.8 mmol/l) during an oral glucose tolerance test.
RESULTS: Interlaboratory CVs were ≤ 2.1%. The method showed satisfactory correlation with 2 other analyzers that measure HbA1c by high-performance liquid chromatography. Neither labile HbA1c, carbamylated hemoglobin, uremia, bilirubin nor common hemoglobin variants (HbC/HbS/HbE) interfered. Forty-five individuals (41%) had abnormal glucose tolerance. The sensitivity of HbA1c for diagnosing abnormal glucose tolerance was 38%, 36% and 42% for total, normal and variant hemoglobin groups, respectively.
CONCLUSIONS: The analytical performance of HbA1c on the Capillarys 2 is suitable for clinical application. Variant hemoglobin in Africans did not interfere with the detection of abnormal glucose tolerance by HbA1c measured on the Capillarys 2.
METHODS: Analytical evaluation was performed at 2 clinical centers. A clinical analysis was conducted in 109 African-born individuals, 24% of whom have variant hemoglobin (HbAS or HbAC). Abnormal glucose tolerance (which includes both diabetes and prediabetes) was defined as 2h glucose of ≥ 140 mg/dl (7.8 mmol/l) during an oral glucose tolerance test.
RESULTS: Interlaboratory CVs were ≤ 2.1%. The method showed satisfactory correlation with 2 other analyzers that measure HbA1c by high-performance liquid chromatography. Neither labile HbA1c, carbamylated hemoglobin, uremia, bilirubin nor common hemoglobin variants (HbC/HbS/HbE) interfered. Forty-five individuals (41%) had abnormal glucose tolerance. The sensitivity of HbA1c for diagnosing abnormal glucose tolerance was 38%, 36% and 42% for total, normal and variant hemoglobin groups, respectively.
CONCLUSIONS: The analytical performance of HbA1c on the Capillarys 2 is suitable for clinical application. Variant hemoglobin in Africans did not interfere with the detection of abnormal glucose tolerance by HbA1c measured on the Capillarys 2.