Evaluation of a new immunoassay for urinary ethyl glucuronide testing
Evaluation of a new immunoassay for urinary ethyl glucuronide testing
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DOI：
10.1093/alcalc/agm153
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发表时间：
2008-01-01
影响因子：
2.8
通讯作者：
Helander, Anders
中科院分区：
文献类型：
--
作者：
Boettcher, Michael;Beck, Olof;Helander, Anders
目的：次要乙醇代谢产物乙基葡萄糖醛酸苷（EtG）被用作近期饮酒的敏感和特异性检测，具有临床和法医应用。本研究评价了一种新的酶免疫测定法（DRI-EtG EIA，Microgenics Corp.）用于测定尿样中的EtG浓度。研究方法：使用试剂盒校准品（范围0-5.0 mg/L）和质控品、外部质控样本和常规样本池中的400份连续尿液进行评价。通过用盐水稀释尿样，扩大了测量范围。与已建立的液相色谱-质谱（LC-MS）方法进行比较。结果如下：在0.4-2.5 mg/L范围内，DRI-EtG EIA的批内和批间不精密度< 2.2%（变异系数，CV），定量限< 0.1 mg/L。对于400份尿样，使用DRI-EtG EIA（平均值24.2 mg/L，范围0-830）和LC-MS方法（平均值22.4 mg/L，范围0-959）获得的EtG浓度显示总体良好且具有统计学显著性的一致性（r（2）= 0.931，P < 0.0001）。结论：这些结果表明，高水平的准确性和选择性的DRI-EtG EIA定量尿EtG。在缺乏普遍接受的尿EtG临界限的情况下，建议阈值为0.5 mg/L（2.2 μ mol/L），以获得高灵敏度，但避免由于意外乙醇暴露而导致的阳性结果。
Aims: The minor ethanol metabolite ethyl glucuronide (EtG) is used as a sensitive and specific test for recent alcohol consumption with clinical and forensic applications. This study evaluated a new enzyme immunoassay (DRI-EtG EIA, Microgenics Corp.) for determination of the EtG concentration in urine samples. Methods: Evaluation was done using the kit calibrators (range 0-5.0 mg/L) and controls, an external quality control sample, and 400 consecutive urines from the routine samples pool. The measuring range was extended by dilution of urine samples with saline. Comparison was made with an established liquid chromatographic-mass spectrometric (LC-MS) method. Results: The intra-and inter-assay imprecision of the DRI-EtG EIA in the range 0.4-2.5 mg/L was < 2.2% (coefficient of variation, CV), and the limit of quantification was < 0.1 mg/L. For the 400 urine samples, the EtG concentrations obtained using the DRI-EtG EIA (mean 24.2 mg/L, range 0-830) and LC-MS method (mean 22.4 mg/L, range 0-959) showed an overall good and statistically significant agreement (r(2) = 0.931, P < 0.0001). Conclusions: These results indicated a high level of accuracy and selectivity of the DRI-EtG EIA for quantification of urinary EtG. In the absence of a commonly accepted cut-off limit for urinary EtG, a threshold of 0.5 mg/L (2.2 mu mol/L) is proposed, to obtain a high sensitivity but avoid positive results due to unintentional ethanol exposure.