Jury D R, Dunn P J
Clin Chem. 1987 Jan;33(1):158-61.
We have evaluated the laboratory performance and clinical usefulness of the Roche fructosamine kit. As used with an Abbott ABA 100 bichromatic analyzer, the kit response varied linearly with fructosamine concentration to 5.0 mmol/L (deoxymorpholinofructose equivalents). Interbatch precision was 4.1% and 3.6% for respective fructosamine concentrations of 3.2 and 5.0 mmol/L; intrabatch precision was 3.2% and 3.0% (fructosamine = 3.0 and 4.0 mmol/L). In 55 nondiabetic subjects all fructosamine values were less than 3.0 mmol/L, 95% were less than 2.7 mmol/L. For both fructosamine and glycated hemoglobin (Hb A1c) the 95th percentile of the reference range corresponded to approximately the 10th percentile of values observed in 108 diabetic subjects. In the latter subjects fructosamine concentrations correlated somewhat (r = 0.6504) with the Hb A1c value and for eight diabetic subjects indicated a similar degree of diabetic control over a 10-week period. From assessments of sensitivity and specificity for predicting abnormal glucose tolerance in 145 subjects, we conclude that this assay of serum fructosamine reflects diabetic control about as well as Hb A1c estimation, but neither can replace the glucose tolerance test for the diagnosis of diabetes.
我们评估了罗氏果糖胺检测试剂盒的实验室性能及临床实用性。该试剂盒与雅培ABA 100双波长分析仪配套使用时，其响应与果糖胺浓度在5.0 mmol/L（脱氧吗啉果糖当量）范围内呈线性变化。对于果糖胺浓度分别为3.2和5.0 mmol/L的样本，批间精密度分别为4.1%和3.6%；批内精密度分别为3.2%和3.0%（果糖胺浓度 = 3.0和4.0 mmol/L）。在55名非糖尿病受试者中，所有果糖胺值均低于3.0 mmol/L，95%低于2.7 mmol/L。对于果糖胺和糖化血红蛋白（Hb A1c），参考范围的第95百分位数大约对应于108名糖尿病受试者中观察值的第10百分位数。在这些糖尿病受试者中，果糖胺浓度与Hb A1c值有一定相关性（r = 0.6504），并且在8名糖尿病受试者中，显示了10周内相似程度的糖尿病控制情况。通过对145名受试者预测葡萄糖耐量异常的敏感性和特异性评估，我们得出结论，血清果糖胺检测反映糖尿病控制情况的程度与Hb A1c测定相近，但两者均不能替代葡萄糖耐量试验用于糖尿病的诊断。
