Helander A, Fors M, Zakrisson B
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Alcohol Alcohol. 2001 Sep-Oct;36(5):406-12. doi: 10.1093/alcalc/36.5.406.
Carbohydrate-deficient transferrin (CDT) in serum has emerged as a useful biochemical marker for identifying current alcohol misuse and monitoring abstinence. This study evaluated the performance of Axis-Shield new %CDT turbidimetric immunoassay (TIA; microtitre and Cobas Mira applications). Comparison was made with the previous Axis %CDT-TIA immunoassay (reference value <5.5%) and %CDT with the high-performance liquid chromatography (HPLC) technique (reference value <1.2%). The new %CDT assay measures primarily the asialo, monosialo and disialo transferrin isoforms, and the result is expressed as the amount relative to total transferrin. The analytical precision (coefficient of variation: CV) of the %CDT assay ranged between 3.1 and 8.5% for kit controls and serum samples. The %CDT values in serum from healthy social drinkers [i.e. Alcohol Use Disorders Identification Test (AUDIT) score 1-7 for men, and 1-5 for women] were 2.07 +/- 0.37% (mean +/- SD, range 1.4-3.3%, n = 100) and this was not significantly different from healthy non-drinkers (1.88 +/- 0.43%, 1.3-2.9%, n = 14), whereas abstinent alcohol patients showed slightly higher values (2.26 +/- 0.41, 1.7-3.4, n = 25). In chronic heavy drinkers (mean daily intake 225 +/- 137 g ethanol according to self-report), the %CDT values were markedly increased (6.33 +/- 4.01%, 1.2-18.0%, n = 107). There was no significant difference in %CDT values between male and female social drinkers. The reference value of the new %CDT assay to be used in clinical practice was tentatively set at <3.0%, which is slightly higher than that obtained by receiver operating characteristics (ROC) curve analysis (<2.8%) and that proposed by the manufacturer in the Instruction Manual (<2.6%). The %CDT assay showed good overall correlation with %CDT-TIA (r = 0.986, P < 0.0001) and %CDT-HPLC (r = 0.978, P < 0.0001). The specificity of the %CDT assay in healthy social drinkers was 98% (%CDT-TIA 100%, %CDT-HPLC 99%) and the sensitivity for any drinking during last week in the alcohol patients was 75% (%CDT-TIA 71%, %CDT-HPLC 80%). The new Axis-Shield %CDT assay can be recommended for routine use. However, whenever a positive immunoassay test result could lead to serious consequences for the individual, it is recommended to confirm the CDT result by the HPLC technique.
血清中缺乏碳水化合物的转铁蛋白（CDT）已成为一种用于识别当前酒精滥用情况和监测戒酒情况的有用生化标志物。本研究评估了Axis-Shield新型%CDT比浊免疫分析法（TIA；微量滴定法和Cobas Mira应用）的性能。并与先前的Axis %CDT-TIA免疫分析法（参考值<5.5%）以及采用高效液相色谱（HPLC）技术的%CDT（参考值<1.2%）进行了比较。新型%CDT分析主要检测去唾液酸、单唾液酸和双唾液酸转铁蛋白异构体，结果以相对于总转铁蛋白的量表示。%CDT分析试剂盒对照品和血清样本的分析精密度（变异系数：CV）在3.1%至8.5%之间。健康社交饮酒者（即男性酒精使用障碍识别测试[AUDIT]评分为1 - 7分，女性为1 - 5分）血清中的%CDT值为2.07±0.37%（平均值±标准差，范围1.4 - 3.3%，n = 100），这与健康非饮酒者（1.88±0.43%，1.3 - 2.9%，n = 14）无显著差异，而戒酒的酒精患者的值略高（2.26±0.41，1.7 - 3.4，n = 25）。在慢性重度饮酒者（根据自我报告，平均每日乙醇摄入量为225±137 g）中，%CDT值显著升高（6.33±4.01%，1.2 - 18.0%，n = 107）。男性和女性社交饮酒者之间的%CDT值无显著差异。临床实践中使用的新型%CDT分析的参考值暂定为<3.0%，略高于通过受试者工作特征（ROC）曲线分析获得的值（<2.8%）以及制造商在说明书中建议的值（<2.6%）。%CDT分析与%CDT-TIA（r = 0.986，P < 0.0001）和%CDT-HPLC（r = 0.978，P < 0.0001）总体相关性良好。%CDT分析在健康社交饮酒者中的特异性为98%（%CDT-TIA为100%，%CDT-HPLC为99%），在酒精患者中对上周任何饮酒情况的敏感性为75%（%CDT-TIA为71%，%CDT-HPLC为80%）。新型Axis-Shield %CDT分析可推荐用于常规使用。然而，每当免疫分析测试结果呈阳性可能对个体产生严重后果时，建议通过HPLC技术确认CDT结果。
